"REMSID","REMS_Name","VersionID","Version_Date","Released_Flag","Moved_to_Shared_System_Flag","Medication_Guide_Flag","Communication_Plan_Flag","Elements_to_Assure_Safe_Use_Flag","Implementation_System_Flag","Prescriber_Certification_Flag","Dispenser_Certification_Flag","Patient_Enrollment_Flag","Prescriber_Training_Flag","Revision_Flag","Current_Approved_Flag","REMS_Goals"
"1","Actemra","17","01/08/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"1","Actemra","18","04/15/2011","0","0","0","1","0","0","0","0","0","0","0","0",""
"1","Actemra","19","06/20/2012","0","0","0","1","0","0","0","0","0","0","0","0",""
"1","Actemra","20","10/11/2012","0","0","0","1","0","0","0","0","0","0","0","0",""
"2","Adasuve","21","12/21/2012","0","0","0","1","1","1","0","1","0","0","0","0",""
"3","Ampyra","22","01/22/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"3","Ampyra","25","06/18/2013","1","0","0","0","0","0","0","0","0","0","0","0",""
"4","Androgel 1%","26","09/18/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"4","Androgel 1%","27","03/10/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"4","Androgel 1%","28","11/30/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"5","Androgel 1.62%","29","04/29/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"5","Androgel 1.62%","30","09/07/2012","0","0","1","0","0","0","0","0","0","0","0","0",""
"6","Aranesp","31","02/16/2010","0","0","1","1","1","1","1","1","0","1","0","0",""
"6","Aranesp","32","06/24/2011","0","0","1","1","1","1","1","1","0","1","0","0",""
"6","Aranesp","33","05/31/2012","0","0","1","1","1","1","1","1","0","1","0","0",""
"6","Aranesp","34","03/27/2013","0","0","1","1","1","1","1","1","0","1","0","0",""
"7","Axiron","35","11/23/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"7","Axiron","36","03/31/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"8","Brilinta","37","07/20/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"8","Brilinta","38","01/24/2013","0","0","1","1","0","0","0","0","0","0","0","0",""
"10","Bydureon","39","01/27/2012","0","0","0","1","0","0","0","0","0","0","0","0",""
"11","Caprelsa","40","04/06/2011","0","0","1","1","1","1","1","1","0","1","0","0",""
"11","Caprelsa","41","06/22/2011","0","0","1","1","1","1","1","1","0","1","0","0",""
"12","Chantix","42","10/19/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"12","Chantix","43","04/22/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"12","Chantix","44","07/22/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"13","Darvon","45","09/25/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"14","Eliquis","46","12/28/2012","0","0","0","1","0","0","0","0","0","0","0","0",""
"15","Entereg","47","05/20/2008","0","0","0","1","1","1","0","1","0","0","0","0",""
"15","Entereg","48","02/05/2009","0","0","0","1","1","1","0","1","0","0","0","0",""
"15","Entereg","49","09/25/2012","0","0","0","1","1","1","0","1","0","0","0","0",""
"16","Epogen / Procrit","50","02/16/2010","0","0","1","1","1","1","1","1","0","1","0","0",""
"16","Epogen / Procrit","51","06/24/2011","0","0","1","1","1","1","1","1","0","1","0","0",""
"16","Epogen / Procrit","52","05/31/2012","0","0","1","1","1","1","1","1","0","1","0","0",""
"16","Epogen / Procrit","53","03/27/2013","0","0","1","1","1","1","1","1","0","1","0","0",""
"18","Extraneal","54","03/09/2011","0","0","1","0","1","1","0","0","0","0","0","0",""
"19","Forteo","55","07/22/2009","0","0","1","1","0","0","0","0","0","0","0","0",""
"19","Forteo","56","03/13/2012","0","0","1","1","0","0","0","0","0","0","0","0",""
"20","Fortesta","57","12/29/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"21","Gattex","58","12/21/2012","0","0","0","1","1","0","0","0","0","1","0","0",""
"22","Gilenya","59","09/21/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"22","Gilenya","61","03/01/2012","0","0","0","1","0","0","0","0","0","0","0","0",""
"25","Juxtapid","62","12/21/2012","0","0","0","0","1","1","1","0","0","1","0","0",""
"26","Krystexxa","63","09/14/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"26","Krystexxa","64","10/19/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"26","Krystexxa","65","04/16/2012","0","0","0","1","0","0","0","0","0","0","0","0",""
"27","Kynamro","66","01/29/2013","0","0","0","0","1","1","1","0","0","1","0","0",""
"28","Letairis","67","05/29/2009","0","0","1","0","1","1","1","0","1","1","0","0",""
"28","Letairis","68","07/01/2009","0","0","1","0","1","1","1","0","1","1","0","0",""
"28","Letairis","69","08/05/2009","0","0","1","0","1","1","1","0","1","1","0","0",""
"28","Letairis","70","08/24/2010","0","0","1","0","1","1","1","0","1","1","0","0",""
"28","Letairis","71","10/13/2010","0","0","1","0","1","1","1","0","1","1","0","0",""
"28","Letairis","72","03/03/2011","0","0","1","0","1","1","1","0","1","1","0","0",""
"28","Letairis","73","02/15/2012","0","0","1","0","1","1","1","0","1","1","0","0",""
"28","Letairis","74","10/19/2012","0","0","1","0","1","1","1","0","1","1","0","0",""
"29","Lotronex","75","09/02/2010","0","0","1","0","1","1","1","0","0","1","0","0",""
"30","Lumizyme","76","05/24/2010","0","0","0","1","1","1","1","1","1","1","0","0",""
"30","Lumizyme","77","09/12/2011","0","0","0","1","1","1","1","1","1","1","0","0",""
"30","Lumizyme","78","07/16/2012","0","0","0","1","1","1","1","1","1","1","0","0",""
"31","Meridia","79","08/04/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"32","Metoclopramide (ANDA 71402)","82","09/16/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"35","Mifeprex","83","06/08/2011","0","0","1","0","1","1","1","0","0","0","0","0","
To provide information to patients about the benefits and risks of MIFEPREX before they make a decision whether to take the drug.
To minimize the risk of serious complications by requiring prescribers to certify that they are qualified to prescribe MIFEPREX and are able to assure patient access to appropriate medical facilities to manage any complications.
"
"36","Multaq","84","07/01/2009","0","0","1","1","0","0","0","0","0","0","0","0",""
"36","Multaq","85","02/11/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"36","Multaq","86","08/05/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"36","Multaq","87","06/13/2012","0","0","1","1","0","0","0","0","0","0","0","0",""
"36","Multaq","88","09/07/2012","0","0","1","1","0","0","0","0","0","0","0","0",""
"38","Nplate","89","08/22/2008","0","0","1","1","1","1","1","1","1","1","0","0",""
"38","Nplate","90","08/14/2009","0","0","1","1","1","1","1","1","1","1","0","0",""
"38","Nplate","91","03/23/2010","0","0","1","1","1","1","1","1","1","1","0","0",""
"38","Nplate","92","07/21/2011","0","0","1","1","1","1","1","1","1","1","0","0",""
"38","Nplate","93","12/06/2011","0","0","0","1","0","0","0","0","0","0","0","0","
To inform healthcare providers about the risks of progression of myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML), thrombotic/thromboembolic complications, bone marrow reticulin formation, bone marrow fibrosis, worsened thrombocytopenia after cessation of Nplate, and Nplate medication errors associated with serious outcomes.
"
"39","Nulojix","94","06/15/2011","0","0","1","1","0","0","0","0","0","0","0","0","The goals of the NULOJIX REMS are:
To inform healthcare providers of the increased risk of post-transplant lymphoproliferative disorder (PTLD), predominantly in the central nervous system (CNS), associated with NULOJIX.
To inform healthcare providers of the increased risk of progressive multifocal leukoencephalopathy (PML), a CNS infection, associated with NULOJIX.
To inform patients of the serious risks associated with NULOJIX."
"40","Omontys","95","03/27/2012","0","0","0","1","0","0","0","0","0","0","0","0","
To inform healthcare professionals that OMONTYS Injection is indicated only for use in the treatment of patients with anemia due to chronic kidney disease on dialysis.
To inform healthcare professionals of the serious risks associated with the use of OMONTYS Injection including potentially fatal cardiovascular and/or thromboembolic adverse events, and the increased risk of these events in nondialysis patients.
"
"41","Pomalyst","96","02/08/2013","0","0","0","0","1","1","1","0","1","0","0","0",""
"42","Potiga","97","06/10/2011","0","0","0","1","0","0","0","0","0","0","0","0",""
"42","Potiga","98","03/19/2012","0","0","0","1","0","0","0","0","0","0","0","0",""
"43","Prolia","99","06/01/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"43","Prolia","100","09/16/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"43","Prolia","101","05/10/2012","0","0","1","1","0","0","0","0","0","0","0","0",""
"44","Promacta","102","11/20/2008","0","0","1","0","1","1","1","1","1","1","0","0",""
"44","Promacta","103","03/05/2010","0","0","1","0","1","1","1","1","1","1","0","0",""
"44","Promacta","104","02/25/2011","0","0","1","0","1","1","1","1","1","1","0","0",""
"44","Promacta","105","12/06/2011","0","0","0","1","0","0","0","0","0","0","0","0",""
"45","Qsymia","106","07/17/2012","0","0","1","0","1","1","0","1","0","1","0","0",""
"45","Qsymia","107","11/01/2012","0","0","1","0","1","1","0","1","0","1","0","0",""
"45","Qsymia","108","04/16/2013","0","0","1","0","1","1","0","1","0","1","0","0",""
"46","Revlimid","109","08/03/2010","0","0","1","0","1","1","1","0","1","0","0","0",""
"46","Revlimid","110","05/09/2012","0","0","1","0","1","1","1","0","1","0","0","0",""
"46","Revlimid","111","02/08/2013","0","0","0","0","1","1","1","0","1","0","0","0",""
"46","Revlimid","112","06/05/2013","0","0","0","0","1","1","1","0","1","0","0","0",""
"48","Sabril","113","08/21/2009","0","0","1","1","1","1","1","0","1","1","0","0",""
"48","Sabril","114","01/18/2011","0","0","1","1","1","1","1","0","1","1","0","0",""
"48","Sabril","115","12/11/2012","0","0","1","1","1","1","1","0","1","1","0","0",""
"49","Soliris","116","06/04/2010","0","0","1","0","1","0","1","0","0","1","0","0",""
"49","Soliris","117","09/23/2011","0","0","1","0","1","0","1","0","0","1","0","0",""
"50","Stelara","118","09/25/2009","0","0","1","1","0","0","0","0","0","0","0","0",""
"50","Stelara","119","12/30/2009","0","0","1","1","0","0","0","0","0","0","0","0",""
"50","Stelara","120","10/20/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"50","Stelara","121","05/02/2012","0","0","0","1","0","0","0","0","0","0","0","0",""
"52","Suboxone sublingual film","123","08/30/2010","0","0","1","0","1","1","0","0","0","0","0","0",""
"53","Subutex","124","12/22/2011","0","0","1","0","1","1","0","0","0","0","0","0",""
"54","Nucynta IR","125","11/20/2008","0","0","1","0","0","0","0","0","0","0","0","0",""
"55","Tasigna","126","03/15/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"55","Tasigna","127","06/17/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"55","Tasigna","128","01/14/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"55","Tasigna","130","11/18/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"56","Testim","131","09/18/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"56","Testim","132","11/22/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"57","testosterone (NDA 202763)","133","02/14/2012","0","0","1","0","0","0","0","0","0","0","0","0",""
"58","Thalomid","134","08/03/2010","0","0","1","0","1","1","1","1","1","0","0","0",""
"58","Thalomid","135","02/08/2013","0","0","0","0","1","1","1","1","1","0","0","0",""
"59","Tikosyn","136","07/11/2011","0","0","1","0","1","1","1","1","0","0","0","0",""
"61","Tracleer","137","08/07/2009","0","0","1","0","1","1","1","1","1","1","0","0",""
"61","Tracleer","138","02/19/2010","0","0","1","0","1","1","1","1","1","1","0","0",""
"61","Tracleer","139","10/02/2012","0","0","1","0","1","1","1","1","1","1","0","0",""
"62","Truvada","140","07/16/2012","0","0","1","0","1","0","0","0","0","1","0","0",""
"62","Truvada","141","06/17/2013","0","0","1","0","1","0","0","0","0","1","0","0",""
"63","Tysabri","142","10/07/2011","0","0","1","0","1","1","1","1","1","1","0","0",""
"63","Tysabri","143","01/20/2012","0","0","1","0","1","1","1","1","1","1","0","0",""
"64","Versacloz","144","02/06/2013","0","0","0","0","1","1","1","1","1","1","0","0",""
"65","Vibativ","145","09/11/2009","0","0","1","1","0","0","0","0","0","0","0","0",""
"65","Vibativ","146","07/27/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"65","Vibativ","147","06/21/2013","0","0","1","1","0","0","0","0","0","0","0","0",""
"66","Victoza","148","01/25/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"66","Victoza","149","05/18/2011","0","0","0","1","0","0","0","0","0","0","0","0",""
"67","Vivitrol","150","03/22/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"67","Vivitrol","151","10/12/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"68","Xarelto","152","11/04/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"68","Xarelto","153","07/12/2012","0","0","1","1","0","0","0","0","0","0","0","0",""
"69","Xeljanz","154","11/06/2012","0","0","1","1","0","0","0","0","0","0","0","0",""
"70","Xenazine","155","08/15/2008","0","0","1","1","0","0","0","0","0","0","0","0",""
"70","Xenazine","156","12/01/2009","0","0","1","1","0","0","0","0","0","0","0","0",""
"70","Xenazine","157","05/04/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"70","Xenazine","158","08/17/2012","0","0","0","1","0","0","0","0","0","0","0","0",""
"71","Xiaflex","159","02/02/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"71","Xiaflex","160","02/24/2012","0","0","0","1","0","0","0","0","0","0","0","0",""
"72","Yervoy","161","03/25/2011","0","0","0","1","0","0","0","0","0","0","0","0",""
"72","Yervoy","162","02/16/2012","0","0","0","1","0","0","0","0","0","0","0","0",""
"73","Zyban","163","02/26/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"74","Zyprexa Relprevv","164","12/11/2009","0","0","1","1","1","1","1","1","1","1","0","0",""
"74","Zyprexa Relprevv","165","07/08/2010","0","0","1","1","1","1","1","1","1","1","0","0",""
"74","Zyprexa Relprevv","166","08/03/2012","0","0","1","1","1","1","1","1","1","1","0","0",""
"74","Zyprexa Relprevv","167","03/27/2013","0","0","1","1","1","1","1","1","1","1","0","0",""
"9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","168","02/22/2013","0","0","1","0","1","1","0","0","0","0","0","0",""
"17","Opioid Analgesic REMS","169","07/09/2012","0","0","1","0","1","0","0","0","0","1","0","0",""
"17","Opioid Analgesic REMS","170","08/28/2012","0","0","1","0","1","0","0","0","0","1","0","0",""
"17","Opioid Analgesic REMS","171","04/15/2013","0","0","1","0","1","0","0","0","0","1","0","0",""
"24","Isotretinoin iPLEDGE","172","10/22/2010","0","0","1","0","1","1","1","1","1","0","0","0",""
"37","Mycophenolate","173","09/25/2012","0","0","1","0","1","0","0","0","0","1","0","0",""
"47","Rosiglitazone","174","01/25/2013","0","0","1","0","1","1","0","0","0","1","0","0",""
"60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","175","12/28/2011","0","0","1","0","1","1","1","1","1","1","0","0",""
"60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","176","06/05/2012","0","0","1","0","1","1","1","1","1","1","0","0",""
"1","Actemra","177","04/29/2013","0","0","0","1","0","0","0","0","0","0","0","0",""
"1","Actemra","178","07/02/2013","0","0","0","1","0","0","0","0","0","0","0","0",""
"1","Actemra","179","10/21/2013","0","0","0","1","0","0","0","0","0","0","0","0",""
"149","Adempas","180","10/08/2013","0","0","1","0","1","1","1","1","1","1","0","0",""
"5","Androgel 1.62%","181","05/20/2013","0","0","1","0","0","0","0","0","0","0","0","0",""
"4","Androgel 1%","182","05/20/2013","0","0","1","0","0","0","0","0","0","0","0","0",""
"11","Caprelsa","183","11/27/2013","0","0","1","1","1","1","1","1","0","1","0","0","
The goals of the CAPRELSA REMS are:
- To educate prescribers about the risk, appropriate monitoring, and management of QT prolongation to help minimize the occurrence of Torsades de pointes and sudden death associated with CAPRELSA.
- To inform patients about the serious risks associated with CAPRELSA.
"
"15","Entereg","184","10/18/2013","0","0","0","0","1","1","0","1","0","0","0","0","The goal of the E.A.S.E. ENTEREG REMS Program is to mitigate the potential risk of myocardial infarction by:
- Ensuring that ENTEREG (alvimopan) is used only for short-term use (no more than 15 doses) in a hospital inpatient setting.
- Informing healthcare providers about the potential risk of myocardial infarction observed with long-term use of ENTEREG.
"
"20","Fortesta","185","09/11/2013","0","0","1","0","0","0","0","0","0","0","0","0",""
"22","Gilenya","186","05/28/2013","0","0","0","1","0","0","0","0","0","0","0","0",""
"25","Juxtapid","187","08/13/2013","0","0","0","0","1","1","1","0","0","1","0","0","The goals of the JUXTAPID REMS Program are:
- To educate prescribers about:
- The risk of hepatotoxicity associated with the use of JUXTAPID; and
- the need to monitor patients during treatment with JUXTAPID as per product labeling.
- To restrict access to therapy with JUXTAPID to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
"
"26","Krystexxa","188","10/10/2013","0","0","0","1","0","0","0","0","0","0","0","0",""
"28","Letairis","189","08/17/2013","0","0","1","0","1","1","1","0","1","1","0","0",""
"76","Opsumit","191","10/18/2013","0","0","1","0","1","1","1","1","1","1","0","0",""
"41","Pomalyst","192","11/15/2013","0","0","0","0","1","1","1","0","1","0","0","0",""
"43","Prolia","193","07/03/2013","0","0","1","1","0","0","0","0","0","0","0","0",""
"46","Revlimid","194","11/15/2013","0","0","0","0","1","1","1","0","1","0","0","0",""
"48","Sabril","195","10/26/2013","0","0","1","1","1","1","1","0","1","1","0","0",""
"50","Stelara","196","09/20/2013","0","0","0","1","0","0","0","0","0","0","0","0","To evaluate and mitigate the potential risks of serious infections and malignancy, and reversible posterior leukoencephalopathy syndrome (RPLS) associated with STELARA by:
- alerting and warning healthcare providers about the risks.
"
"58","Thalomid","197","11/15/2013","0","0","0","0","1","1","1","0","1","0","0","0",""
"59","Tikosyn","198","12/06/2013","0","0","1","0","1","1","1","1","0","0","0","0",""
"61","Tracleer","199","07/01/2013","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the Tracleer risk evaluation and mitigation strategy are as follows:
- To enable informed risk-benefit decisions for treating patients with Tracleer.
- To minimize the risk of hepatotoxicity in patients who are exposed to Tracleer.
- To minimize the risk of fetal exposures in female patients who are exposed to Tracleer.
- To educate prescribers, patients, hospitals, and pharmacies on the safe-use conditions for Tracleer.
"
"63","Tysabri","200","05/24/2013","0","0","1","0","1","1","1","1","1","1","0","0",""
"64","Versacloz","201","12/05/2013","0","0","0","0","1","1","1","1","1","1","0","0",""
"67","Vivitrol","202","07/29/2013","0","0","1","1","0","0","0","0","0","0","0","0",""
"68","Xarelto","203","08/07/2013","0","0","0","1","0","0","0","0","0","0","0","0",""
"69","Xeljanz","204","11/08/2013","0","0","1","1","0","0","0","0","0","0","0","0",""
"70","Xenazine","205","08/02/2013","0","0","0","1","0","0","0","0","0","0","0","0",""
"71","Xiaflex","206","12/06/2013","0","0","0","1","1","1","1","1","0","1","0","0",""
"9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","207","09/04/2013","0","0","1","0","1","1","0","0","0","0","0","0",""
"24","Isotretinoin iPLEDGE","208","04/12/2012","0","0","1","0","1","1","1","1","1","0","0","0",""
"37","Mycophenolate","209","09/27/2013","0","0","1","0","1","0","0","0","0","1","0","0",""
"60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","210","11/07/2013","0","0","1","0","1","1","1","1","1","1","0","0",""
"151","Actonel","215","08/22/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"152","Actonel with calcium","216","08/22/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"155","Actoplus Met XR","218","05/17/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"157","Advair Diskus","220","08/09/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"158","Advair HFA","221","08/09/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"159","Aplenzin","222","04/29/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"160","Arcapta Neohaler","223","12/18/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"161","Atelvia","224","08/22/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"163","Banzel","226","06/10/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"165","Boniva","228","07/01/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"8","Brilinta","230","10/30/2013","1","0","0","0","0","0","0","0","0","0","0","0",""
"167","Brovana","231","08/09/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"168","Byetta","232","08/05/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"169","Cambia","233","07/20/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"170","Carbatrol","234","08/22/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"171","Celontin","235","06/15/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"172","Cimzia","236","07/29/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"173","Colcrys (NDA 022351)","237","07/20/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"174","Copegus","238","05/09/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"175","Creon","239","05/09/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"176","Dilantin oral suspension","240","05/27/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"176","Dilantin oral suspension","241","01/17/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"177","Duetact","242","05/17/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"177","Duetact","243","09/09/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"178","Dulera","245","06/22/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"178","Dulera","247","11/27/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"179","Dysport","248","04/29/2009","0","0","1","1","0","0","0","0","0","0","0","0",""
"179","Dysport","249","05/22/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"151","Actonel","250","01/25/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"152","Actonel with calcium","251","01/25/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"156","Actos","252","09/09/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"153","Actoplus Met","254","09/14/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"153","Actoplus Met","255","08/04/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"155","Actoplus Met XR","256","05/12/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"155","Actoplus Met XR","257","08/04/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"157","Advair Diskus","258","04/30/2008","0","0","1","0","0","0","0","0","0","0","0","0",""
"158","Advair HFA","260","07/31/2008","0","0","1","0","0","0","0","0","0","0","0","0",""
"158","Advair HFA","261","06/27/2011","0","0","0","1","0","0","0","0","0","0","0","0",""
"180","Serevent Diskus","262","11/18/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"180","Serevent Diskus","263","06/27/2011","0","0","0","1","0","0","0","0","0","0","0","0",""
"180","Serevent Diskus","264","08/09/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"160","Arcapta Neohaler","266","07/01/2011","0","0","0","1","0","0","0","0","0","0","0","0",""
"162","Avelox","268","04/27/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"162","Avelox","269","08/03/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"165","Boniva","273","01/25/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"166","Botox/Botox Cosmetic","274","07/31/2009","0","0","1","1","0","0","0","0","0","0","0","0",""
"167","Brovana","276","02/01/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"167","Brovana","277","02/16/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"168","Byetta","278","10/30/2009","0","0","1","1","0","0","0","0","0","0","0","0",""
"169","Cambia","279","06/17/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"170","Carbatrol","280","01/26/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"171","Celontin","281","10/11/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"172","Cimzia","282","04/22/2008","0","0","1","0","0","0","0","0","0","0","0","0",""
"181","Cipro","285","08/03/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"181","Cipro","286","04/27/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"173","Colcrys (NDA 022351)","288","07/30/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"182","Colcrys (NDA 022352)","289","07/20/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"183","Colcrys (NDA 022353)","292","10/16/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"183","Colcrys (NDA 022353)","293","07/20/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"174","Copegus","294","06/09/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"175","Creon","296","04/30/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"153","Actoplus Met","298","10/21/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"2","Adasuve","324","12/09/2013","0","0","0","1","1","1","0","1","0","0","0","0","The goal of the ADASUVE REMS is to mitigate the negative outcomes associated with ADASUVE induced bronchospasm by:
- Ensuring that ADASUVE is dispensed only in certified healthcare settings that have immediate access on-site to equipment and personnel trained to provide advanced airway management, including intubation and mechanical ventilation.
- Informing healthcare professionals in these settings that ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest.
- Informing healthcare professionals in these settings about the safe use of ADASUVE, including appropriate patient selection, monitoring, and management.
"
"6","Aranesp","325","12/31/2013","0","0","0","0","1","1","1","1","0","1","0","0","To support informed discussions between patients with cancer and their healthcare providers by:
- Educating healthcare providers about the risks and safe use conditions of Aranesp for patients with cancer.
- Informing patients about the risk of shortened overall survival and/or increased risk of tumor progression or recurrence when Aranesp is used to treat anemia due to concomitant myelosuppressive chemotherapy.
"
"16","Epogen / Procrit","326","12/31/2013","0","0","0","0","1","1","1","1","0","1","0","0","To support informed discussions between patients with cancer and their healthcare providers by:
- educating healthcare providers about the risks and safe use conditions of Epogen/Procrit for patients with cancer.
- informing patients about the risk of shortened overall survival and/or increased risk of tumor progression or recurrence when Epogen/Procrit is used to treat anemia due to concomitant myelosuppressive chemotherapy.
"
"186","Iclusig","327","12/20/2013","0","0","0","1","0","0","0","0","0","0","0","0","The goals of the Iclusig REMS are to:
- Inform prescribers of the indications for Iclusig which are limited to:
- Treatment of adult patients with T315I-positive chronic myeloid leukemia (CML) (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
- Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
- Inform prescribers of the serious risk of vascular occlusion and thromboembolism associated with Iclusig treatment.
"
"33","Metoclopramide (ANDA 074703)","328","09/15/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"34","Metoclopramide (ANDA 072744)","329","09/15/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"63","Tysabri","330","12/15/2013","0","0","1","0","1","1","1","1","1","1","0","0",""
"153","Actoplus Met","331","05/17/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"155","Actoplus Met XR","335","12/22/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"156","Actos","336","05/17/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"156","Actos","337","08/04/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"156","Actos","338","02/03/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"158","Advair HFA","339","05/10/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"158","Advair HFA","340","01/04/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"158","Advair HFA","341","06/25/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"158","Advair HFA","342","09/15/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"157","Advair Diskus","343","06/25/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"157","Advair Diskus","344","01/04/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"157","Advair Diskus","345","05/10/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"157","Advair Diskus","346","06/27/2011","0","0","0","1","0","0","0","0","0","0","0","0",""
"3","Ampyra","347","11/17/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"3","Ampyra","348","07/20/2012","0","0","0","1","0","0","0","0","0","0","0","0",""
"159","Aplenzin","349","04/23/2008","0","0","1","0","0","0","0","0","0","0","0","0",""
"161","Atelvia","350","01/25/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"163","Banzel","351","11/14/2008","0","0","1","0","0","0","0","0","0","0","0","0",""
"163","Banzel","352","11/08/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"163","Banzel","353","03/03/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"166","Botox/Botox Cosmetic","354","07/16/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"166","Botox/Botox Cosmetic","356","03/09/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"166","Botox/Botox Cosmetic","359","10/15/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"166","Botox/Botox Cosmetic","361","08/24/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"172","Cimzia","362","12/31/2008","0","0","1","1","0","0","0","0","0","0","0","0",""
"172","Cimzia","363","05/13/2009","0","0","1","1","0","0","0","0","0","0","0","0",""
"172","Cimzia","364","11/18/2009","0","0","1","1","0","0","0","0","0","0","0","0",""
"182","Colcrys (NDA 022352)","366","07/29/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"182","Colcrys (NDA 022352)","367","04/29/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"174","Copegus","368","10/08/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"175","Creon","370","08/12/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"177","Duetact","371","08/04/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"178","Dulera","372","08/18/2011","0","0","0","1","0","0","0","0","0","0","0","0",""
"187","Edluar","373","08/10/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"187","Edluar","374","03/13/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"187","Edluar","375","12/17/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"188","Effient","376","03/23/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"188","Effient","377","07/10/2009","0","0","1","1","0","0","0","0","0","0","0","0",""
"188","Effient","378","04/16/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"188","Effient","379","12/06/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"188","Effient","380","09/26/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"189","Enbrel","381","08/10/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"189","Enbrel","382","06/23/2008","0","0","1","0","0","0","0","0","0","0","0","0",""
"189","Enbrel","383","11/18/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"189","Enbrel","384","06/03/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"189","Enbrel","385","10/13/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"190","Epzicom","386","05/13/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"190","Epzicom","387","03/09/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"190","Epzicom","388","08/04/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"190","Epzicom","389","02/02/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"191","Equetro","390","01/27/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"191","Equetro","391","10/24/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"192","Extavia","392","06/22/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"192","Extavia","393","08/14/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"4","Androgel 1%","394","09/20/2012","0","0","1","0","0","0","0","0","0","0","0","0",""
"43","Prolia","395","06/07/2012","0","0","1","1","0","0","0","0","0","0","0","0",""
"43","Prolia","396","09/20/2012","0","0","1","1","0","0","0","0","0","0","0","0",""
"193","Factive","397","08/04/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"193","Factive","398","04/27/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"194","Foradil","399","03/29/2013","1","0","0","0","0","0","0","0","0","0","0","0",""
"194","Foradil","400","05/18/2011","0","0","0","1","0","0","0","0","0","0","0","0",""
"195","Fosamax","401","01/25/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"196","Fosamax Plus D","402","07/01/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"196","Fosamax Plus D","403","01/25/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"195","Fosamax","404","07/01/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"197","Gabitril","405","01/25/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"197","Gabitril","406","10/11/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"198","Gralise","407","04/28/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"198","Gralise","408","01/28/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"199","HalfLytely Bisacodyl Bowel Prep Kit","409","07/06/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"199","HalfLytely Bisacodyl Bowel Prep Kit","410","07/16/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"54","Nucynta IR","411","07/11/2013","1","0","0","0","0","0","0","0","0","0","0","0",""
"56","Testim","412","08/30/2013","0","0","1","0","0","0","0","0","0","0","0","0",""
"23","H.P. Acthar Gel","413","07/05/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"23","H.P. Acthar Gel","414","10/15/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"200","Humira","415","04/08/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"200","Humira","416","07/13/2011","0","0","0","1","0","0","0","0","0","0","0","0",""
"200","Humira","417","12/13/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"200","Humira","418","03/14/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"201","Infergen","419","06/01/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"201","Infergen","420","08/07/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"202","Intron A","421","05/02/2008","0","0","1","0","0","0","0","0","0","0","0","0",""
"202","Intron A","422","08/07/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"202","Intron A","423","02/01/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"202","Intron A","424","05/13/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"203","Zubsolv","425","07/03/2013","0","0","1","0","1","1","0","0","0","1","0","0",""
"203","Zubsolv","426","09/04/2013","0","1","0","0","0","0","0","0","0","0","0","0",""
"204","Invirase","427","05/26/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"204","Invirase","428","10/06/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"205","Janumet","429","04/14/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"205","Janumet","430","02/26/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"206","Januvia","431","04/14/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"206","Januvia","432","02/26/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
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"286","Trizivir","637","03/09/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"286","Trizivir","638","03/31/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"286","Trizivir","640","08/04/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"287","Ziagen","641","07/18/2008","0","0","1","0","0","0","0","0","0","0","0","0",""
"287","Ziagen","642","05/13/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"287","Ziagen","643","08/04/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"288","Tyzeka","644","05/05/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"288","Tyzeka","645","01/23/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"288","Tyzeka","646","04/28/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"288","Tyzeka","647","09/10/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"289","Venlafaxine ER","648","07/31/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"289","Venlafaxine ER","649","05/20/2008","0","0","1","0","0","0","0","0","0","0","0","0",""
"290","Videx","650","05/10/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"290","Videx","651","01/25/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"291","Viibryd","652","06/29/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"291","Viibryd","653","01/21/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"292","Vimpat","654","08/10/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"292","Vimpat","655","10/28/2008","0","0","1","0","0","0","0","0","0","0","0","0",""
"292","Vimpat","656","04/20/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"293","Viramune","658","05/06/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"293","Viramune","659","06/24/2008","0","0","1","0","0","0","0","0","0","0","0","0",""
"293","Viramune","660","03/25/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"293","Viramune","661","01/07/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"293","Viramune","662","07/20/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"293","Viramune","663","01/13/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"294","Votrient","664","04/21/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"294","Votrient","665","04/27/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"294","Votrient","666","10/19/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"295","Wellbutrin","667","08/02/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"295","Wellbutrin","668","02/26/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"297","Xeomin","671","07/16/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"297","Xeomin","672","07/20/2011","0","0","1","1","0","0","0","0","0","0","0","0",""
"297","Xeomin","673","07/30/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"298","Xolair","674","12/22/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"298","Xolair","675","07/24/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"298","Xolair","676","12/21/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"299","Zarontin","677","06/15/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"299","Zarontin","678","09/14/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"300","Zenpep","679","06/10/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"300","Zenpep","680","08/27/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"301","Zerit","681","05/11/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"301","Zerit","682","12/10/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"302","Zipsor","683","05/04/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"302","Zipsor","684","06/16/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"303","Zolpimist","685","09/28/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"303","Zolpimist","686","12/19/2008","0","0","1","0","0","0","0","0","0","0","0","0",""
"303","Zolpimist","687","10/11/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"304","Zonegran","688","05/27/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"304","Zonegran","689","04/23/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"304","Zonegran","690","04/19/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"305","Zortress","691","05/02/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"305","Zortress","692","04/20/2010","0","0","1","1","0","0","0","0","0","0","0","0",""
"305","Zortress","693","11/21/2011","0","0","0","1","0","0","0","0","0","0","0","0",""
"306","Zyprexa","694","06/21/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"306","Zyprexa","695","03/19/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"306","Zyprexa","696","12/04/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"28","Letairis","700","01/31/2014","0","0","1","0","1","1","1","0","1","1","0","0",""
"201","Infergen","703","07/02/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"309","Metoclopramide (ANDA 073680)","706","03/14/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"309","Metoclopramide (ANDA 073680)","707","09/11/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"250","Proquin XR","708","04/27/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"250","Proquin XR","709","02/25/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"18","Extraneal","710","02/25/2014","0","0","1","0","1","1","0","0","0","0","0","0",""
"19","Forteo","711","08/30/2013","0","0","1","1","0","0","0","0","0","0","0","0","To mitigate the potential risk of osteosarcoma associated with FORTEO by:
- Alerting and warning healthcare providers and patients about the potential risk.
- Informing healthcare providers of the 2-year maximum lifetime duration of treatment with FORTEO and proper patient selection.
- Informing and educating healthcare providers and patients about the voluntary FORTEO Patient Registry.
"
"68","Xarelto","713","02/12/2014","1","0","0","0","0","0","0","0","0","0","0","0",""
"310","Darvocet","714","09/25/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"310","Darvocet","715","03/10/2014","1","0","0","0","0","0","0","0","0","0","0","0",""
"13","Darvon","716","03/10/2014","1","0","0","0","0","0","0","0","0","0","0","0",""
"17","Opioid Analgesic REMS","717","10/25/2013","0","0","1","0","1","0","0","0","0","1","0","0",""
"31","Meridia","718","12/21/2010","1","0","0","0","0","0","0","0","0","0","0","0",""
"312","Wellbutrin XL","719","02/26/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"312","Wellbutrin XL","720","08/02/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"34","Metoclopramide (ANDA 072744)","721","09/10/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"32","Metoclopramide (ANDA 71402)","722","07/31/2012","1","0","0","0","0","0","0","0","0","0","0","0",""
"313","Aveed","723","03/05/2014","0","0","0","0","1","1","1","1","0","1","0","0","The goals and the objectives of the AVEED REMS are to mitigate the negative outcomes associated with AVEED-induced pulmonary oil microembolism (POME) and anaphylaxis by:
- Ensuring that AVEED is dispensed only in certified healthcare settings that have immediate access on-site to equipment and personnel trained to manage POME and anaphylaxis;
- Informing healthcare providers that AVEED can cause POME and anaphylaxis, which have the potential to lead to serious medical consequences (e.g., respiratory distress and syncope);
- Informing healthcare providers about the safe use of AVEED, including proper administration technique and patient observation; and
- Informing patients about the risks of POME and anaphylaxis associated with AVEED and the importance of remaining at the healthcare setting for 30 minutes after each injection.
"
"20","Fortesta","724","03/24/2014","0","0","1","0","0","0","0","0","0","0","0","0",""
"36","Multaq","725","03/19/2014","0","0","0","1","0","0","0","0","0","0","0","0",""
"314","Myalept","726","02/24/2014","0","0","0","0","1","1","1","0","0","1","0","0",""
"69","Xeljanz","727","03/26/2014","0","0","1","1","0","0","0","0","0","0","0","0",""
"73","Zyban","729","03/27/2014","0","0","1","0","0","0","0","0","0","0","0","0","The goal of this REMS is to inform patients about the potential serious risk of neuropsychiatric adverse events associated with the use of ZYBAN.
"
"33","Metoclopramide (ANDA 074703)","730","04/08/2014","1","0","0","0","0","0","0","0","0","0","0","0",""
"52","Suboxone sublingual film","731","04/28/2014","0","0","1","0","1","1","0","0","0","0","0","0",""
"52","Suboxone sublingual film","732","08/10/2012","0","0","1","0","1","1","0","0","0","0","0","0",""
"315","Suboxone sublingual tablets","733","12/22/2011","0","0","1","0","1","1","0","0","0","1","0","0",""
"316","Tanzeum","734","04/15/2014","0","0","0","1","0","0","0","0","0","0","0","0",""
"49","Soliris","735","04/30/2014","0","0","1","0","1","0","1","0","0","1","0","0",""
"56","Testim","736","05/01/2014","0","0","1","0","0","0","0","0","0","0","0","0",""
"27","Kynamro","737","05/07/2014","0","0","0","0","1","1","1","0","0","1","0","0",""
"29","Lotronex","738","05/08/2014","0","0","1","0","1","1","1","0","0","1","0","0",""
"47","Rosiglitazone","739","05/07/2014","0","0","0","0","1","1","0","0","0","1","0","0",""
"149","Adempas","740","06/11/2014","0","0","1","0","1","1","1","1","1","1","0","0",""
"4","Androgel 1%","741","06/19/2014","0","0","1","0","0","0","0","0","0","0","0","0",""
"5","Androgel 1.62%","742","06/19/2014","0","0","1","0","0","0","0","0","0","0","0","0",""
"7","Axiron","743","06/19/2014","0","0","1","0","0","0","0","0","0","0","0","0",""
"20","Fortesta","744","06/19/2014","0","0","1","0","0","0","0","0","0","0","0","0",""
"43","Prolia","745","06/16/2014","0","0","1","1","0","0","0","0","0","0","0","0",""
"56","Testim","746","06/19/2014","0","0","1","0","0","0","0","0","0","0","0","0",""
"62","Truvada","748","06/18/2014","0","0","1","0","1","0","0","0","0","1","0","0",""
"317","testosterone (NDA 203098)","749","01/31/2013","0","0","1","0","0","0","0","0","0","0","0","0",""
"317","testosterone (NDA 203098)","750","06/19/2014","0","0","1","0","0","0","0","0","0","0","0","0",""
"318","Vogelxo","751","06/04/2014","0","0","1","0","0","0","0","0","0","0","0","0","The goal of this REMS is to inform patients about the serious risks associated with the use of testosterone gel."
"319","Afrezza","752","06/27/2014","0","0","0","1","0","0","0","0","0","0","0","0",""
"320","Symlin","753","06/27/2014","0","0","0","1","0","0","0","0","0","0","0","0",""
"21","Gattex","754","06/26/2014","0","0","0","1","1","0","0","0","0","1","0","0","
To inform prescribers and patients about the risks of possible acceleration of neoplastic growth and enhancement of colon polyp growth, gastrointestinal obstruction, and biliary and pancreatic disorders associated with GATTEX.
"
"314","Myalept","755","06/30/2014","0","0","0","0","1","1","1","0","0","1","0","0",""
"17","Opioid Analgesic REMS","756","06/30/2014","0","0","1","0","1","0","0","0","0","1","0","0",""
"44","Promacta","757","07/16/2014","1","0","0","0","0","0","0","0","0","0","0","0",""
"321","Zydelig","758","07/23/2014","0","0","0","1","0","0","0","0","0","0","0","0","
The goal of the Zydelig REMS is to mitigate the risks of fatal and /or serious hepatotoxicity, fatal/or serious and severe diarrhea or colitis, fatal and serious pneumonitis, and fatal and serious intestinal perforation associated with Zydelig treatment by informing prescribers of the risks of
- fatal and/or serious hepatotoxicity
- fatal and/or serious and severe diarrhea or colitis
- fatal and serious pneumonitis
- fatal and serious intestinal perforation
"
"30","Lumizyme","759","08/01/2014","1","0","0","0","0","0","0","0","0","0","0","0",""
"66","Victoza","760","07/31/2014","0","0","0","1","0","0","0","0","0","0","0","0",""
"20","Fortesta","761","07/31/2014","0","0","1","0","0","0","0","0","0","0","0","0",""
"57","testosterone (NDA 202763)","762","06/19/2014","0","0","1","0","0","0","0","0","0","0","0","0",""
"17","Opioid Analgesic REMS","763","07/23/2014","0","0","1","0","1","0","0","0","0","1","0","0",""
"14","Eliquis","764","08/12/2014","0","0","0","1","0","0","0","0","0","0","0","0","The goal of the ELIQUIS REMS is to inform healthcare providers (HCPs) about:
- The increased risk of thrombotic events in patients with nonvalvular atrial fibrillation when discontinuing ELIQUIS without introducing an adequate alternative anticoagulant.
- The importance of following the recommendations in the US Prescribing Information (USPI) on how to convert patients with nonvalvular atrial fibrillation from ELIQUIS to warfarin or other anticoagulants.
"
"17","Opioid Analgesic REMS","765","08/19/2014","0","0","1","0","1","0","0","0","0","1","0","0",""
"12","Chantix","766","09/19/2014","0","0","1","0","0","0","0","0","0","0","0","0",""
"41","Pomalyst","767","09/12/2014","0","0","0","0","1","1","1","0","1","0","0","0",""
"45","Qsymia","768","09/26/2014","0","0","1","0","1","1","0","1","0","1","0","0","To inform prescribers and females of reproductive potential about:
- the increased risk of congenital malformations, specifically orofacial clefts, in infants exposed to Qsymia during the first trimester of pregnancy
- the importance of pregnancy prevention for females of reproductive potential receiving Qsymia
- the need to discontinue Qsymia immediately if pregnancy occurs.
"
"46","Revlimid","769","09/12/2014","0","0","0","0","1","1","1","0","1","0","0","0",""
"58","Thalomid","770","09/12/2014","0","0","0","0","1","1","1","0","1","0","0","0",""
"322","Trulicity","771","09/18/2014","0","0","0","1","0","0","0","0","0","0","0","0",""
"49","Soliris","772","10/10/2014","0","0","1","0","1","0","1","0","0","1","0","0",""
"12","Chantix","773","10/15/2014","0","0","1","0","0","0","0","0","0","0","0","0","The goal of this REMS is to inform patients about the potential serious risk of neuropsychiatric adverse events associated with the use of CHANTIX.
"
"28","Letairis","774","10/29/2014","0","0","1","0","1","1","1","0","1","1","0","0",""
"4","Androgel 1%","779","11/12/2014","0","0","1","0","0","0","0","0","0","0","0","0",""
"5","Androgel 1.62%","780","11/14/2014","0","0","1","0","0","0","0","0","0","0","0","0",""
"65","Vibativ","781","11/12/2014","0","0","1","1","0","0","0","0","0","0","0","0",""
"340","Lemtrada","782","11/14/2014","0","0","0","1","1","1","1","1","1","1","0","0",""
"341","Blincyto","783","12/03/2014","0","0","0","1","0","0","0","0","0","0","0","0","
The goal of the BLINCYTO REMS is to mitigate the risk of cytokine release syndrome which may be life-threatening or fatal; the risk of neurological toxicities which may be severe, life-threatening, or fatal; and the risk of preparation and administration errors associated with use of BLINCYTO by:
- Informing healthcare providers about the risk of cytokine release syndrome which may be life-threatening or fatal.
- Informing healthcare providers about the risk of neurological toxicities which may be severe, life-threatening, or fatal.
- Informing pharmacists, who will prepare and dispense BLINCYTO, and nurses, who will administer BLINCYTO, about the risk of preparation and administration errors associated with use of BLINCYTO.
"
"17","Opioid Analgesic REMS","784","11/20/2014","0","0","1","0","1","0","0","0","0","1","0","0",""
"74","Zyprexa Relprevv","785","10/30/2014","0","0","1","1","1","1","1","1","1","1","0","0","The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS) by:
- ensuring Zyprexa Relprevv is prescribed only by certified prescribers, dispensed only by certified dispensers, and dispensed for use only in certified healthcare facilities with ready access to emergency response services, and dispensed for use only with documentation of safe use conditions;
- informing healthcare providers and patients about the risks and the need for continuous observation of patients for at least 3 hours in certified health care facilities; and
- establishing long-term safety and safe use of Zyprexa Relprevv through periodic monitoring for the risk of PDSS events and by enrolling all patients who receive Zyprexa Relprevv in the Zyprexa Relprevv Patient Care Program Registry.
"
"60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","786","11/04/2014","0","0","1","0","1","1","1","1","1","1","0","0",""
"60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","787","12/24/2014","0","0","1","0","1","1","1","1","1","1","0","0",""
"9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","788","06/06/2014","0","0","1","0","1","1","0","0","0","0","0","0",""
"342","Saxenda","789","12/23/2014","0","0","0","1","0","0","0","0","0","0","0","0",""
"17","Opioid Analgesic REMS","790","12/29/2014","0","0","1","0","1","0","0","0","0","1","0","0",""
"343","Natpara","791","01/23/2015","0","0","0","0","1","1","1","1","1","1","0","0",""
"69","Xeljanz","792","02/11/2015","0","0","0","1","0","0","0","0","0","0","0","0",""
"46","Revlimid","793","02/17/2015","0","0","0","0","1","1","1","0","1","0","0","0",""
"9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","794","02/12/2015","0","0","1","0","1","1","0","0","0","0","0","0",""
"344","Farydak","795","02/23/2015","0","0","0","1","0","0","0","0","0","0","0","0","The goal of the FARYDAK REMS is to mitigate the risks of severe diarrhea and cardiac toxicities (severe and fatal cardiac ischemic events, severe arrhythmias, and ECG changes) associated with FARYDAK treatment
- by informing healthcare providers about the risks of severe diarrhea and cardiac toxicities associated with FARYDAK.
"
"345","Xywav and Xyrem","796","02/27/2015","0","0","1","0","1","1","1","0","1","1","0","0",""
"43","Prolia","797","02/26/2015","0","0","1","1","0","0","0","0","0","0","0","0",""
"319","Afrezza","798","04/20/2015","0","0","0","1","0","0","0","0","0","0","0","0","The goal of the Afrezza REMS is to mitigate the risk of acute bronchospasm associated with Afrezza by:
- Informing healthcare providers that there is risk of acute bronchospasm associated with AFREZZA in patients with chronic lung disease.
- Informing healthcare providers that acute bronchospasm has been observed with AFREZZA in patients with asthma and COPD.
- Informing healthcare providers that AFREZZA is contraindicated in patients with chronic lung disease.
- Informing healthcare providers of the need to evaluate patients for lung disease before starting on AFREZZA.
"
"10","Bydureon","800","04/29/2015","1","0","0","0","0","0","0","0","0","0","0","0",""
"41","Pomalyst","801","04/23/2015","0","0","0","0","1","1","1","0","1","0","0","0",""
"346","Ionsys","802","04/30/2015","0","0","0","0","1","1","0","1","0","0","0","0",""
"347","Alosetron (moved to shared system, do not use)","803","05/04/2015","0","0","1","0","1","1","1","0","0","1","0","0",""
"4","Androgel 1%","804","05/11/2015","0","0","1","0","0","0","0","0","0","0","0","0","To inform patients about the serious risks associated with the use of AndroGel (testosterone gel) 1%.
"
"56","Testim","805","05/11/2015","0","0","1","0","0","0","0","0","0","0","0","0","
The goal of this REMS is to inform patients about the serious risks associated with the use of testosterone gel.
"
"20","Fortesta","806","05/11/2015","0","0","1","0","0","0","0","0","0","0","0","0","
The goal of this REMS is to inform patients about the serious risks associated with the use of testosterone gel.
"
"5","Androgel 1.62%","807","05/11/2015","0","0","1","0","0","0","0","0","0","0","0","0","
To inform patients about the serious risks associated with the use of AndroGel (testosterone gel) 1.62%.
"
"7","Axiron","808","05/11/2015","0","0","1","0","0","0","0","0","0","0","0","0","
To inform patients about the serious risks associated with the use of AXIRON® (testosterone) topical solution.
"
"57","testosterone (NDA 202763)","809","05/11/2015","0","0","1","0","0","0","0","0","0","0","0","0",""
"317","testosterone (NDA 203098)","810","05/11/2015","0","0","1","0","0","0","0","0","0","0","0","0","
To inform patients about the serious risks associated with the use of testosterone gel.
"
"318","Vogelxo","811","05/11/2015","0","0","1","0","0","0","0","0","0","0","0","0","The goal of this REMS is to inform patients about the serious risks associated with the use of testosterone gel."
"63","Tysabri","812","05/12/2015","0","0","1","0","1","1","1","1","1","1","0","0","
The goals of the Tysabri REMS are:
- To inform prescribers, infusion center healthcare providers, and patients about the risk of progressive multifocal leukoencephalopathy (PML) associated with TYSABRI including the increased risk of PML with longer treatment duration, prior immunosuppressant use and the presence of anti-JCV antibodies.
- To warn against concurrent use with antineoplastic, immunosuppressant, or immunomodulating agents, and in patients who are immunocompromised.
- To promote early diagnosis of PML and timely discontinuation of TYSABRI in the event of suspected PML.
"
"22","Gilenya","813","05/14/2015","0","0","0","1","0","0","0","0","0","0","0","0","The goal of the GILENYA (fingolimod) REMS is:
- To inform healthcare professionals (HCPs) about the serious risks of GILENYA (fingolimod) including bradyarrhythmia and atrioventricular (AV) block at treatment initiation, infections, macular edema, posterior reversible encephalopathy syndrome (PRES), respiratory effects, liver injury, and fetal risk.
"
"43","Prolia","814","05/21/2015","0","0","1","1","0","0","0","0","0","0","0","0","The goal of the PROLIA REMS is to mitigate the risks of hypocalcemia, osteonecrosis of the jaw, atypical femoral fractures, serious infections, and dermatologic reactions by:
- informing healthcare providers and patients about the risks of (1) hypocalcemia, (2) osteonecrosis of the jaw, (3) atypical femoral fractures, (4) serious infections, and (5) dermatologic reactions associated with PROLIA
- informing healthcare providers they should counsel patients about the risks associated with PROLIA.
"
"9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","815","06/04/2015","0","0","1","0","1","1","0","0","0","0","0","0",""
"71","Xiaflex","816","10/20/2014","0","0","0","1","1","1","1","1","0","1","0","0","The goals of the XIAFLEX REMS for the treatment of Dupuytren’s contracture are:
- To mitigate the risks of tendon rupture and serious adverse reactions affecting the injected extremity associated with the use of XIAFLEX by informing healthcare providers about how to properly inject XIAFLEX and perform finger extension procedures.
- To inform healthcare providers about the potential risk of serious hypersensitivity reactions (including the potential for anaphylaxis) associated with XIAFLEX treatment.
The goals of the XIAFLEX REMS for Peyronie’s disease are:
- To mitigate the risks of corporal rupture (penile fracture) and other serious penile injuries associated with the use of XIAFLEX by:
- Training healthcare providers in how to properly administer XIAFLEX.
- Informing healthcare providers about the risks of corporal rupture (penile fracture) and other serious injuries to the penis.
- Informing healthcare providers about the need to counsel patients to communicate that risks of corporal rupture and other serious penile injuries are associated with the use of XIAFLEX in treating Peyronie’s disease and that patient adherence to post-injection instructions is important for the drug’s safety and effectiveness.
- Ensuring that XIAFLEX is dispensed only in certified pharmacies or healthcare settings.
- Informing patients about the risks of corporal rupture and other serious penile injuries associated with the use of XIAFLEX in treating Peyronie’s disease and that adherence to post-injection instructions is important for the drug’s safety and effectiveness.
"
"69","Xeljanz","817","06/19/2015","0","0","0","1","0","0","0","0","0","0","0","0",""
"17","Opioid Analgesic REMS","818","06/26/2015","0","0","1","0","1","0","0","0","0","1","0","0",""
"57","testosterone (NDA 202763)","819","07/01/2015","0","0","1","0","0","0","0","0","0","0","1","0","The goal of this REMS is to inform patients about the serious risks associated with the use of testosterone gel 1%.
"
"66","Victoza","820","07/01/2015","0","0","0","1","0","0","0","0","0","0","0","0","
The goal of the VICTOZA REMS is to mitigate the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis (including necrotizing pancreatitis) associated with VICTOZA by:
- Informing healthcare providers about the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis (including necrotizing pancreatitis) associated with VICTOZA.
"
"59","Tikosyn","822","07/08/2015","0","0","1","0","1","1","1","1","0","0","0","0",""
"345","Xywav and Xyrem","823","07/15/2015","0","0","1","0","1","1","1","0","1","1","0","0","The goal of the XYREM REMS is to mitigate the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion of XYREM by:
- Informing prescribers, pharmacists, and patients of:
- The risk of significant CNS and respiratory depression associated with XYREM.
- The contraindication of use of XYREM with sedative hypnotics and alcohol.
- The potential for abuse, misuse, and overdose associated with XYREM.
- The safe use, handling, and storage of XYREM.
- Ensuring that pharmacy controls exist prior to filling prescriptions for XYREM that:
- Screen for concomitant use of sedative hypnotics and other potentially interacting agents.
- Monitor for inappropriate prescribing, misuse, abuse, and diversion of XYREM.
- Notify prescribers when patients are receiving concomitant contraindicated medications or there are signs of potential abuse, misuse, or diversion.
"
"29","Lotronex","824","07/24/2015","0","0","1","0","1","1","1","0","0","1","0","0",""
"316","Tanzeum","825","07/27/2015","0","0","0","1","0","0","0","0","0","0","0","0","The goal of the TANZEUM REMS is to mitigate the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis associated with TANZEUM by:
- Informing healthcare providers (HCPs) about the potential risk of medullary thyroid carcinoma associated with TANZEUM.
- Informing HCPs about the risk of acute pancreatitis associated with TANZEUM.
"
"322","Trulicity","826","07/27/2015","0","0","0","1","0","0","0","0","0","0","0","0","The goal of the TRULICITY REMS is to mitigate the potential risk of medullary thyroid carcinoma and the risk of pancreatitis associated with the use of TRULICITY by:
- Informing healthcare providers (HCPs) about the potential risk of medullary thyroid carcinoma associated with TRULICITY.
- Informing HCPs about the risk of pancreatitis associated with TRULICITY.
"
"27","Kynamro","827","07/28/2015","0","0","0","0","1","1","1","0","0","1","0","0","The goals of the KYNAMRO REMS Program are:
- To educate prescribers about:
- the risk of hepatotoxicity associated with the use of KYNAMRO; and
- the need to monitor patients during treatment with KYNAMRO as per product labeling.
- To restrict access to therapy with KYNAMRO to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
"
"26","Krystexxa","828","07/30/2015","0","0","0","1","0","0","0","0","0","0","0","0","The goal of the KRYSTEXXA Risk Evaluation and Mitigation Strategy (REMS) is:
- To inform healthcare providers about anaphylaxis, infusion reactions, and contraindication of use of KRYSTEXXA in patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency.
"
"348","testosterone 1.62% (ANDA 204268)","829","08/04/2015","0","0","1","0","0","0","0","0","0","0","0","0","To inform patients about the serious risks associated with the use of testosterone gel.
"
"349","testosterone (ANDA 204571)","830","08/05/2015","0","0","1","0","0","0","0","0","0","0","0","0","
The goal of this REMS is to inform patients about the serious risks associated with the use of Testosterone Topical Gel.
"
"320","Symlin","831","08/07/2015","0","0","0","1","0","0","0","0","0","0","0","0",""
"9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","832","08/10/2015","0","0","1","0","1","1","0","0","0","0","0","0","
The goals of the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS are to:
- Mitigate the risks of accidental overdose, misuse, and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with buprenorphine-containing products.
"
"17","Opioid Analgesic REMS","833","08/13/2015","0","0","1","0","1","0","0","0","0","1","0","0",""
"350","Addyi","834","08/18/2015","0","0","0","0","1","1","1","1","0","1","0","0","The goal of the Addyi REMS is to mitigate the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol by:
- Ensuring prescribers and pharmacists are educated about the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol and the need to counsel patients about this risk.
- Informing patients of the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol.
"
"314","Myalept","836","08/27/2015","0","0","0","0","1","1","1","0","0","1","0","0","The goal of the MYALEPT REMS is to mitigate:
- the risks of serious adverse sequelae (such as severe infections, excessive weight gain, glucose intolerance, diabetes mellitus) due to the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or MYALEPT, and
- the risk of lymphoma by:
- Educating prescribers about the development of neutralizing anti-metreleptin antibodies, the serious adverse sequelae that may result from these antibodies, and the risk for lymphoma associated with MYALEPT.
- Limiting the population exposed to MYALEPT by requiring prescriber certification, pharmacy certification, and prescriber attestation that each patient has a diagnosis consistent with the approved indication.
"
"24","Isotretinoin iPLEDGE","837","09/03/2015","0","0","1","0","1","1","1","1","1","0","0","0",""
"58","Thalomid","838","09/13/2015","0","0","0","0","1","1","1","0","1","0","0","0",""
"351","Clozapine","840","09/15/2015","0","0","0","0","1","1","1","1","0","1","0","0","The goal of the Clozapine REMS Program is to mitigate the risk of severe neutropenia associated with the use of clozapine by:
- Educating prescribers and pharmacists about the risk of severe neutropenia and appropriate monitoring requirements.
- Informing patients about the risk of severe neutropenia and appropriate monitoring requirements.
- Ensuring compliance with the monitoring schedule for absolute neutrophil count (ANC) prior to dispensing clozapine.
- Ensuring the prescriber documents a risk-benefit assessment when ANC falls below the acceptable range as described in the Prescribing Information.
- Establishing long-term safety and safe use of clozapine by enrolling all patients who receive clozapine in the registry.
"
"64","Versacloz","841","09/14/2015","0","1","0","0","0","0","0","0","0","0","0","0",""
"46","Revlimid","842","09/13/2015","0","0","0","0","1","1","1","0","1","0","0","0",""
"41","Pomalyst","843","09/14/2015","0","0","0","0","1","1","1","0","1","0","0","0",""
"320","Symlin","844","09/18/2015","0","0","0","1","0","0","0","0","0","0","1","0","The goal of the SYMLIN REMS is to mitigate the risk of severe hypoglycemia associated with SYMLIN by:
- informing health care providers about the risk of severe hypoglycemia as SYMLIN is used with insulin and the importance of insulin dose reduction
- informing health care providers of the importance of proper patient selection for treatment with SYMLIN.
"
"72","Yervoy","845","03/16/2015","1","0","0","0","0","0","0","0","0","0","0","0",""
"340","Lemtrada","846","09/18/2015","0","0","0","1","1","1","0","1","1","1","0","0","The goal of the LEMTRADA REMS is to mitigate the risks of autoimmune conditions, infusion reactions, and malignancies associated with LEMTRADA by:
- Helping to ensure informed decisions about the safe use of LEMTRADA by:
- Informing patients about the serious risks of autoimmune conditions, infusion reactions, and malignancies with LEMTRADA and the need for baseline and periodic monitoring; and
- Informing healthcare providers about the serious risks of autoimmune conditions, infusion reactions, and malignancies with LEMTRADA, the need to counsel patients, and the need for baseline and periodic monitoring.
- Helping to ensure the safe use of LEMTRADA by:
- Ensuring that only certified prescribers prescribe LEMTRADA;
- Ensuring that LEMTRADA is dispensed only in certain healthcare settings, by certified pharmacies, and certified infusion sites, which have on-site access to equipment and personnel trained to manage infusion reactions; and
- Ensuring that only enrolled and authorized patients receive LEMTRADA;
- Ensuring that certified prescribers submit documentation of periodic monitoring of patients who receive LEMTRADA to identify autoimmune conditions and malignancies.
"
"52","Suboxone sublingual film","847","09/22/2015","0","1","0","0","0","0","0","0","0","0","0","0",""
"315","Suboxone sublingual tablets","848","09/22/2015","0","1","0","0","0","0","0","0","0","0","0","0",""
"53","Subutex","849","09/22/2015","0","1","0","0","0","0","0","0","0","0","0","0",""
"352","Suboxone/Subutex","850","09/22/2015","0","0","1","0","1","1","0","0","0","0","0","0","The goals of the REMS for SUBOXONE sublingual film, SUBOXONE sublingual tablets and SUBUTEX sublingual tablets are to:
- Mitigate the risks of accidental overdose, misuse and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with SUBOXONE sublingual film, SUBOXONE sublingual tablets and SUBUTEX sublingual tablets.
"
"353","testosterone (ANDA 076744)","851","09/25/2015","0","0","1","0","0","0","0","0","0","0","0","0","The goal of this REMS is to inform patients about the serious risks associated with the use of testosterone gel 1%.
"
"28","Letairis","852","10/02/2015","0","0","1","0","1","1","1","0","1","1","0","0","
The goals of the Letairis Risk Evaluation and Mitigation Strategy (REMS) Program are:
- To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Letairis.
- To minimize the risk of fetal exposure and adverse fetal outcomes in Females of Reproductive Potential (FRP) prescribed Letairis
- Females who are pregnant must not be prescribed Letairis.
- Females taking Letairis must not become pregnant.
"
"17","Opioid Analgesic REMS","853","10/02/2015","0","0","1","0","1","0","0","0","0","1","0","0",""
"70","Xenazine","854","08/25/2015","1","0","0","0","0","0","0","0","0","0","0","0",""
"18","Extraneal","855","10/16/2015","0","0","1","0","1","1","0","0","0","0","0","0","To mitigate the risk of morbidity and mortality associated with the use of non-specific glucose monitors and test strips in patients using EXTRANEAL by:
- Informing the dialysis clinic staff managing the patient’s treatment (such as peritoneal dialysis nurses) about the drug-device interaction and the potential for falsely elevated blood glucose readings in patients using EXTRANEAL.
- Informing patients of the drug-device interaction and the need to alert health care providers of this interaction whenever they receive treatment outside of a dialysis clinic.
"
"17","Opioid Analgesic REMS","856","10/23/2015","0","0","1","0","1","0","0","0","0","1","0","0","The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extended-release or long-acting (ER/LA) opioid analgesics while maintaining patient access to pain medications. Adverse outcomes of concern include addiction, unintentional overdose, and death.
"
"48","Sabril","857","10/22/2015","0","0","1","1","1","1","1","0","1","0","1","0","
The goals of the REMS are:
- To reduce the risk of a Sabril-induced vision loss while delivering benefit to the appropriate patient populations;
- To ensure that all patients receive a baseline ophthalmologic evaluation unless a patient is formally exempted from vision testing; 50% of patients will receive the evaluation within 2 weeks of starting Sabril and 100% within 4 weeks;
- To discontinue Sabril therapy in patients who experience an inadequate clinical response;
- To detect Sabril-induced vision loss as early as possible;
- To ensure regular vision monitoring to facilitate ongoing benefit-risk assessments;and
- To inform patients/parent or legal guardian of the serious risks associated with Sabril, including vision loss and increased risk of suicidal thoughts and behavior.
"
"58","Thalomid","858","10/27/2015","0","0","0","0","1","1","1","0","1","0","0","0",""
"41","Pomalyst","859","10/27/2015","0","0","0","0","1","1","1","0","1","0","0","0",""
"46","Revlimid","860","10/27/2015","0","0","0","0","1","1","1","0","1","0","0","0",""
"355","testosterone 1% (ANDA 076737)","861","11/05/2015","0","0","1","0","0","0","0","0","0","0","0","0","The goal of this REMS is to inform patients about the serious risks associated with the use of Testosterone Gel 1%.
"
"346","Ionsys","862","11/12/2015","0","0","0","0","1","1","0","1","0","0","0","0","
The goal of the IONSYS REMS is to mitigate the risk of respiratory depression resulting from accidental exposure to persons for whom it is not prescribed by:
- Ensuring dispensing to patients in certified hospitals only; and
- Informing healthcare providers of the serious risk of respiratory depression resulting from accidental exposure.
"
"37","Mycophenolate","863","11/13/2015","0","0","0","0","1","0","0","0","0","1","0","0","The goal of the Mycophenolate REMS is to mitigate the risk of embryofetal toxicity associated with use of mycophenolate during pregnancy by:
- Educating healthcare providers on the following:
- The increased risks of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy.
- The need to counsel females of reproductive potential on the importance of pregnancy prevention and planning when taking mycophenolate.
- The need to report pregnancies to the Mycophenolate Pregnancy Registry.
- Informing females of reproductive potential who are prescribed mycophenolate about:
- The increased risks of first trimester pregnancy loss and congenital malformations when taking mycophenolate during pregnancy.
- The importance of pregnancy prevention and planning when taking mycophenolate.
"
"76","Opsumit","864","11/17/2015","0","0","1","0","1","1","1","1","1","1","0","0",""
"1","Actemra","865","08/18/2015","1","0","0","0","0","0","0","0","0","0","0","0",""
"59","Tikosyn","866","11/25/2015","0","0","1","0","1","1","1","1","0","0","0","0",""
"41","Pomalyst","867","12/01/2015","0","0","0","0","1","1","1","0","1","0","0","0","The goals of the POMALYST risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to POMALYST.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for POMALYST.
"
"46","Revlimid","868","12/01/2015","0","0","0","0","1","1","1","0","1","0","0","0","The goals of the REVLIMID risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to REVLIMID.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for REVLIMID.
"
"58","Thalomid","869","12/01/2015","0","0","0","0","1","1","1","0","1","0","0","0","The goals of the THALOMID risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to THALOMID.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for THALOMID.
"
"49","Soliris","870","12/03/2015","0","0","1","0","1","0","1","0","0","1","0","0","The goals of the REMS are:
- To mitigate the occurrence and morbidity associated with meningococcal infections.
- To educate Healthcare Professionals (HCPs) and Patients (or Caregivers, or Legal Guardians) regarding:
- the increased risk of meningococcal infections with Soliris
- the early signs of invasive meningococcal infections, and
- the need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections.
"
"149","Adempas","871","12/04/2015","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the Adempas Risk Evaluation and Mitigation Strategy (REMS) are:
- To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Adempas.
- To minimize the risk of fetal exposure and adverse fetal outcomes in Females of Reproductive Potential (FRP) prescribed Adempas.
- Females who are pregnant must not be prescribed Adempas.
- Females taking Adempas must not become pregnant.
"
"61","Tracleer","872","12/04/2015","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the Tracleer REMS are:
- To inform prescribers, patients, and pharmacists about the risks of Tracleer
- To minimize the risk of hepatotoxicity in patients who are exposed to Tracleer
- To minimize the risk of fetal exposures in female patients who are exposed to Tracleer
- To educate prescribers, patients, and pharmacies on the safe-use conditions for Tracleer
"
"47","Rosiglitazone","873","12/16/2015","1","0","0","0","0","0","0","0","0","0","0","0",""
"60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","874","12/21/2015","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the TIRF REMS Access program are to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors by:
- Prescribing and dispensing TIRF medicines only to appropriate patients, which includes use only in opioid-tolerant patients.
- Preventing inappropriate conversion between TIRF medicines.
- Preventing accidental exposure to children and others for whom it was not prescribed.
- Educating prescribers, pharmacists, and patients on the potential for misuse, abuse, addiction, and overdose of TIRF medicines.
"
"42","Potiga","875","11/25/2015","1","0","0","0","0","0","0","0","0","0","0","0",""
"36","Multaq","876","02/12/2016","1","0","0","0","0","0","0","0","0","0","0","0",""
"67","Vivitrol","877","12/08/2015","0","0","1","1","0","0","0","0","0","0","0","0","The goals of this REMS are:
- To inform patients and healthcare providers about severe injection site reactions associated with the use of VIVITROL.
- To inform healthcare providers about the importance of counseling their patients about severe injection site reactions associated with the use of VIVITROL.
"
"217","Lamictal","878","04/23/2009","0","0","1","0","0","0","0","0","0","0","0","0",""
"29","Lotronex","881","01/07/2016","0","0","0","0","1","0","0","0","0","1","0","0","The goals and objectives of the LOTRONEX REMS are to mitigate the risks of ischemic colitis (IC) and serious complications of constipation (CoC) associated with LOTRONEX and its authorized generic alosetron hydrochloride by:
- Informing prescribers of LOTRONEX/alosetron hydrochloride about:
- the serious risks of IC and serious CoC associated with LOTRONEX/alosetron hydrochloride.
- the importance of understanding that LOTRONEX/alosetron hydrochloride should only be used in severely affected diarrhea-predominant irritable bowel syndrome patients for whom the benefits exceed the risks.
- the important of counseling patients about the risks of IC and serious CoC .
- Informing patients about the risks of IC and CoC and actions to take should they experience early warning signs and symptoms of these risks.
"
"347","Alosetron (moved to shared system, do not use)","882","01/07/2016","0","0","0","0","1","0","0","0","0","1","0","0","The goals and objectives of the Alosetron REMS Program are to mitigate the risks of ischemic colitis (IC) and serious complications of constipation (CoC) associated with alosetron hydrochloride (hereinafter, referred to as alosetron) by:
- Informing prescribers of alosetron about:
- the serious risks of IC and serious CoC associated with alosetron.
- the importance of understanding that alosetron should only be used in severely affected diarrhea-predominant irritable bowel syndrome patients for whom the benefits exceed the risks.
- the importance of counseling patients about the risks of IC and serious CoC.
- Informing patients about the risks of IC and CoC and actions to take should they experience early warning signs and symptoms of these risks.
"
"342","Saxenda","884","02/01/2016","0","0","0","1","0","0","0","0","0","0","0","0","The goal of the SAXENDA REMS is to mitigate the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis (including necrotizing pancreatitis) associated with SAXENDA by:
- Informing healthcare providers about the potential risk of medullary thyroid carcinoma associated with SAXENDA
- Informing healthcare providers about the risk of acute pancreatitis (including necrotizing pancreatitis) associated with SAXENDA.
"
"24","Isotretinoin iPLEDGE","885","02/04/2016","0","0","1","0","1","1","1","1","1","0","0","0","The goals of the isotretinoin risk evaluation and mitigation strategy are:
- To prevent fetal exposure to isotretinoin
- To inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions
"
"69","Xeljanz","886","02/08/2016","1","0","0","0","0","0","0","0","0","0","0","0",""
"76","Opsumit","888","02/22/2016","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the Opsumit Risk Evaluation and Mitigation Strategy (REMS) are:
- To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Opsumit.
- To minimize the risk of fetal exposure and adverse fetal outcomes in females of reproductive potential (FRP) prescribed Opsumit
- Females who are pregnant must not be prescribed Opsumit.
- Females taking Opsumit must not become pregnant.
"
"62","Truvada","889","02/25/2016","0","0","0","0","1","0","0","0","0","1","0","0",""
"59","Tikosyn","890","03/08/2016","1","0","0","0","0","0","0","0","0","0","0","0",""
"62","Truvada","891","03/10/2016","0","0","0","0","1","0","0","0","0","1","0","0","The goals of the REMS for TRUVADA for a Pre-Exposure Prophylaxis (PrEP) Indication are:
- To inform and educate prescribers and uninfected individuals at high risk for acquiring HIV-1 infection about:
- The importance of strict adherence to the recommended dosing regimen
- The importance of regular monitoring of HIV-1 serostatus to avoid continuing to take TRUVADA for a PrEP indication, if seroconversion has occurred, to reduce the risk of development of resistant HIV-1 variants
- The fact that TRUVADA for a PrEP indication must be considered as only part of a comprehensive prevention strategy to reduce the risk of HIV-1 infection and that other preventive measures should also be used
"
"65","Vibativ","892","03/23/2016","0","0","1","1","0","0","0","0","0","0","0","0","The goal of the Vibativ REMS is to mitigate the risks of:
- mortality in patients with pre-existing creatinine clearance of ≤50 mL/min being treated for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) by informing healthcare providers about this risk
- unintended exposure of pregnant women to Vibativ by:
- informing healthcare providers and patients of the potential risk of fetal developmental toxicity if women are exposed to Vibativ while pregnant
- informing healthcare providers that a serum pregnancy test should be performed before initiating therapy with Vibativ in females of reproductive potential
- informing healthcare providers that females of reproductive potential, including those being treated in the outpatient setting, should be counseled about pregnancy prevention and use of effective contraception during Vibativ use
"
"347","Alosetron (moved to shared system, do not use)","893","03/24/2016","0","0","0","0","1","0","0","0","0","1","0","0","The goals and objectives of the Alosetron REMS Program are to mitigate the risks of ischemic colitis (IC) and serious complications of constipation (CoC) associated with alosetron hydrochloride (hereinafter, referred to as alosetron) by:
- Informing prescribers of alosetron about:
- the serious risks of IC and serious CoC associated with alosetron
- the importance of understanding that alosetron should only be used in severely affected diarrhea-predominant irritable bowel syndrome patients for whom the benefits exceed the risks.
- the importance of counseling patients about the risks of IC and serious CoC
- Informing patients about the risks of IC and CoC and actions to take should they experience early warning signs and symptoms of these risks.
"
"35","Mifeprex","894","03/29/2016","0","0","0","0","1","1","1","0","0","0","0","0","The goal of the Mifeprex REMS is to mitigate the risk of serious complications associated with Mifeprex by:
- Requiring healthcare providers who prescribe Mifeprex to be certified in the Mifeprex REMS Program.
- Ensuring that Mifeprex is only dispensed in certain healthcare settings by or under the supervision of a certified prescriber.
- Informing patients about the risk of serious complications associated with Mifeprex
"
"319","Afrezza","895","04/01/2016","0","0","0","1","0","0","0","0","0","0","1","0","The goal of the Afrezza REMS is to mitigate the risk of acute bronchospasm associated with Afrezza by:
- Informing healthcare providers that there is risk of acute bronchospasm associated with AFREZZA in patients with chronic lung disease.
- Informing healthcare providers that acute bronchospasm has been observed with AFREZZA in patients with asthma and COPD.
- Informing healthcare providers that AFREZZA is contraindicated in patients with chronic lung disease.
- Informing healthcare providers of the need to evaluate patients for lung disease before starting on AFREZZA.
"
"350","Addyi","896","04/08/2016","0","0","0","0","1","1","1","1","0","1","0","0","The goal of the Addyi REMS is to mitigate the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol by:
- Ensuring prescribers and pharmacists are educated about the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol and the need to counsel patients about this risk.
- Informing patients of the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol.
"
"340","Lemtrada","897","04/05/2016","0","0","0","1","1","1","1","1","1","1","0","0","The goal of the LEMTRADA REMS is to mitigate the risks of autoimmune conditions, infusion reactions, and malignancies associated with LEMTRADA by:
- Helping to ensure informed decisions about the safe use of LEMTRADA by:
- Informing patients about the serious risks of autoimmune conditions, infusion reactions, and malignancies with LEMTRADA and the need for baseline and periodic monitoring; and
- Informing healthcare providers about the serious risks of autoimmune conditions, infusion reactions, and malignancies with LEMTRADA, the need to counsel patients, and the need for baseline and periodic monitoring.
- Helping to ensure the safe use of LEMTRADA by:
- Ensuring that only certified prescribers prescribe LEMTRADA;
- Ensuring that LEMTRADA is dispensed only in certain healthcare settings, by certified pharmacies, and certified infusion sites, which have on-site access to equipment and personnel trained to manage infusion reactions; and
- Ensuring that only enrolled and authorized patients receive LEMTRADA;
- Ensuring that certified prescribers submit documentation of periodic monitoring of patients who receive LEMTRADA to identify autoimmune conditions and malignancies.
"
"49","Soliris","898","04/13/2016","0","0","1","0","1","0","1","0","0","1","0","0","The goals of the REMS are:
- To mitigate the occurrence and morbidity associated with meningococcal infections
- To mitigate the occurrence and morbidity associated with meningococcal infections
- To mitigate the occurrence and morbidity associated with meningococcal infections
- the early signs of invasive meningococcal infections, and
- the need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections
"
"26","Krystexxa","899","04/11/2016","1","0","0","0","0","0","0","0","0","0","0","0",""
"17","Opioid Analgesic REMS","900","04/20/2016","0","0","1","0","1","0","0","0","0","1","0","0","The goal of this REMS is to reduce serious adverse outcomes resulting from
inappropriate prescribing, misuse, and abuse of extended-release or long-acting (ER/LA)
opioid analgesics while maintaining patient access to pain medications. Adverse
outcomes of concern include addiction, unintentional overdose, and death."
"14","Eliquis","901","03/02/2016","1","0","0","0","0","0","0","0","0","0","0","0",""
"41","Pomalyst","902","04/22/2016","0","0","0","0","1","1","1","0","1","0","0","0","The goals of the POMALYST risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to POMALYST.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for POMALYST.
"
"46","Revlimid","903","04/22/2016","0","0","0","0","1","1","1","0","1","0","0","0","The goals of the REVLIMID risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to REVLIMID.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for REVLIMID.
"
"58","Thalomid","904","04/22/2016","0","0","0","0","1","1","1","0","1","0","0","0","The goals of the THALOMID risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to THALOMID.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for THALOMID.
"
"17","Opioid Analgesic REMS","906","04/26/2016","0","0","1","0","1","0","0","0","0","1","0","0","The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extended-release or long-acting (ER/LA) opioid analgesics while maintaining patient access to pain medications. Adverse outcomes of concern include addiction, unintentional overdose, and death.
Inappropriate prescribing, misuse, and abuse of extended-release or long-acting (ER/LA)
opioid analgesics while maintaining patient access to pain medications. Adverse
outcomes of concern include addiction, unintentional overdose, and death."
"29","Lotronex","907","04/29/2016","0","0","0","0","1","0","0","0","0","1","1","0","The goals and objectives of the LOTRONEX REMS are to mitigate the risks of ischemic colitis (IC) and serious complications of constipation (CoC) associated with LOTRONEX and its authorized generic alosetron hydrochloride by:
- Informing prescribers of LOTRONEX/alosetron hydrochloride about:
- the serious risks of IC and serious CoC associated with LOTRONEX/alosetron hydrochloride.
- the importance of understanding that LOTRONEX/alosetron hydrochloride should only be used in severely affected diarrhea-predominant irritable bowel syndrome patients for whom the benefits exceed the risks.
- the important of counseling patients about the risks of IC and serious CoC .
- Informing patients about the risks of IC and CoC and actions to take should they experience early warning signs and symptoms of these risks.
"
"350","Addyi","908","05/10/2016","0","0","0","0","1","1","1","1","0","1","1","0","The goal of the Addyi REMS is to mitigate the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol by:
- Ensuring prescribers and pharmacists are educated about the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol and the need to counsel patients about this risk.
- Informing patients of the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol.
"
"67","Vivitrol","909","05/17/2016","0","0","1","1","0","0","0","0","0","0","0","0","The goals of this REMS are:
- To inform patients and healthcare providers about severe injection site reactions associated with the use of VIVITROL.
- To inform healthcare providers about the importance of counseling their patients about severe injection site reactions associated with the use of VIVITROL.
"
"15","Entereg","911","05/18/2016","0","0","0","0","1","1","0","1","0","0","0","0","The goal of the E.A.S.E. ENTEREG REMS Program is to mitigate the potential risk of myocardial infarction by:
- Ensuring that ENTEREG (alvimopan) is used only for short-term use (no more than 15 doses) in a hospital inpatient setting.
- Informing healthcare providers about the potential risk of myocardial infarction observed with long-term use of ENTEREG.
"
"356","Probuphine","912","05/26/2016","0","0","1","0","1","1","1","0","0","1","0","0","The goal of the Probuphine REMS is to mitigate the risk of complications of migration, protrusion, expulsion and nerve damage associated with the insertion and removal of Probuphine and the risks of accidental overdose, misuse and abuse by:
- Ensuring that healthcare providers are educated on the following:
- proper insertion and removal of Probuphine
- risk of complications of migration, protrusion, expulsion and nerve damage associated with the insertion and removal of Probuphine
- risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin
- Informing patients about the risks of complications of migration, protrusion, expulsion and nerve damage associated with insertion and removal, as well as the risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin.
"
"357","Zinbryta","913","05/27/2016","0","0","0","1","1","1","1","1","1","1","0","0","To mitigate the risks of severe and fatal hepatic injury and serious immune mediated disorders associated with ZINBRYTA by:
- Ensuring that prescribers are educated on the following:
- the potential risks of severe and fatal hepatic injury and serious immune mediated disorders associated with the use of ZINBRYTA
- the need to counsel patients about these risks and the need for appropriate baseline and monthly monitoring
- Ensuring that prescribers are educated on and adhere to:
- required baseline and monthly monitoring and evaluation of patients who receive ZINBRYTA
- Ensuring that patients are informed about:
- the potential risks of severe and fatal hepatic injury and serious immune mediated disorders associated with the use of ZINBRYTA
- appropriate baseline and monthly monitoring
- Enrollment of all patients in a registry to further support long-term safety and safe use of ZINBRYTA
"
"21","Gattex","914","05/27/2016","0","0","0","1","1","0","0","0","0","1","0","0",""
"15","Entereg","915","06/01/2016","0","0","0","0","1","1","0","1","0","0","1","0","The goal of the E.A.S.E. ENTEREG REMS Program is to mitigate the potential risk of myocardial infarction by:
- Ensuring that ENTEREG (alvimopan) is used only for short-term use (no more than 15 doses) in a hospital inpatient setting.
- Informing healthcare providers about the potential risk of myocardial infarction observed with long-term use of ENTEREG.
"
"356","Probuphine","916","06/14/2016","0","0","1","0","1","1","1","0","0","1","1","0","The goal of the Probuphine REMS is to mitigate the risk of complications of migration, protrusion, expulsion and nerve damage associated with the insertion and removal of Probuphine and the risks of accidental overdose, misuse and abuse by:
- Ensuring that healthcare providers are educated on the following:
- proper insertion and removal of Probuphine
- risk of complications of migration, protrusion, expulsion and nerve damage associated with the insertion and removal of Probuphine
- risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin
- Informing patients about the risks of complications of migration, protrusion, expulsion and nerve damage associated with insertion and removal, as well as the risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin.
"
"48","Sabril","917","06/21/2016","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the SABRIL REMS Program is to mitigate the risk of vision loss associated with SABRIL by:
- Ensuring that healthcare providers are educated about the risk of vision loss, the need to counsel patients about the risk, and the need for periodic visual monitoring.
- Ensuring that SABRIL is only dispensed to patients with documentation that patients are informed about the risk of vision loss associated with SABRIL and the need for periodic visual monitoring.
"
"48","Sabril","918","06/27/2016","0","0","0","0","1","1","1","1","1","1","1","0","The goal of the SABRIL REMS Program is to mitigate the risk of vision loss associated with SABRIL by:
- Ensuring that healthcare providers are educated about the risk of vision loss, the need to counsel patients about the risk, and the need for periodic visual monitoring.
- Ensuring that SABRIL is only dispensed to patients with documentation that patients are informed about the risk of vision loss associated with SABRIL and the need for periodic visual monitoring.
"
"352","Suboxone/Subutex","919","07/07/2016","0","0","1","0","1","1","0","0","0","0","0","0","The goals of the REMS for SUBOXONE sublingual film, SUBOXONE sublingual tablets and SUBUTEX sublingual tablets are to:
- Mitigate the risks of accidental overdose, misuse and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with SUBOXONE sublingual film, SUBOXONE sublingual tablets and SUBUTEX sublingual tablets.
"
"24","Isotretinoin iPLEDGE","921","07/08/2016","0","0","1","0","1","1","1","1","1","0","0","0","The goals of the isotretinoin risk evaluation and mitigation strategy are:
- To prevent fetal exposure to isotretinoin
- To inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions
"
"9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","922","07/07/2016","0","0","1","0","1","1","0","0","0","0","0","0","The goals of the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS are to:
- Mitigate the risks of accidental overdose, misuse, and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with buprenorphine-containing products.
"
"49","Soliris","924","07/12/2016","0","0","1","0","1","0","1","0","0","1","1","0","The goals of the REMS are:
- To mitigate the occurrence and morbidity associated with meningococcal infections
- To educate Healthcare Professionals (HCPs) and Patients (or Caregivers, or Legal Guardians) regarding:
- the increased risk of meningococcal infections with Soliris® (eculizumab)
- the early signs of invasive meningococcal infections, and
- the need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections
"
"9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","925","07/27/2016","0","0","1","0","1","1","0","0","0","0","1","0","The goals of the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS are to:
- Mitigate the risks of accidental overdose, misuse, and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with buprenorphine-containing products.
"
"12","Chantix","926","08/12/2016","0","0","1","0","0","0","0","0","0","0","0","0","to add new language describing a reduce-to-quit regimen and to provide information about the risk of somnambulism so as to furnish adequate information for the safe and effective use of the drug in the Medication Guide."
"358","Xultophy","927","11/21/2016","0","0","0","1","0","0","0","0","0","0","0","0","- The goal of the XULTOPHY 100/3.6 REMS is to mitigate the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis (including necrotizing pancreatitis) associated with XULTOPHY 100/3.6 by:
- Informing healthcare providers about the potential risk of medullary thyroid carcinoma associated with XULTOPHY 100/3.6.
- Informing healthcare providers about the risk of acute pancreatitis (including necrotizing pancreatitis) associated with XULTOPHY 100/3.6.
"
"17","Opioid Analgesic REMS","928","08/19/2016","0","0","1","0","1","0","0","0","0","1","0","0","The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extended-release or long-acting (ER/LA) opioid analgesics while maintaining patient access to pain medications. Adverse outcomes of concern include addiction, unintentional overdose, and death."
"341","Blincyto","929","08/30/2016","0","0","0","1","0","0","0","0","0","0","0","0","The goals of the BLINCYTO REMS are to mitigate the risk of cytokine release syndrome which may be life-threatening or fatal; the risk of neurological toxicities which may be severe, life-threatening, or fatal; and the risk of preparation and administration errors associated with use of BLINCYTO by:
- Informing healthcare providers about the risk of cytokine release syndrome which may be life-threatening or fatal
- Informing healthcare providers about the risk of neurological toxicities which may be severe, life-threatening, or fatal
- Informing pharmacists, who will prepare and dispense BLINCYTO, and nurses, who will administer BLINCYTO, about the risk of preparation and administration errors associated with use of BLINCYTO
"
"66","Victoza","931","09/20/2016","0","0","0","1","0","0","0","0","0","0","0","0","The goal of the VICTOZA REMS is to mitigate the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis (including necrotizing pancreatitis) associated with VICTOZA by:
- Informing healthcare providers about the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis (including necrotizing pancreatitis) associated with VICTOZA.
"
"63","Tysabri","932","09/22/2016","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the Tysabri REMS are:
- To inform prescribers, infusion center healthcare providers, and patients about the risk of progressive multifocal leukoencephalopathy (PML) associated with TYSABRI including the increased risk of PML with longer treatment duration, prior immunosuppressant use and the presence of anti-JCV antibodies.
- To warn against concurrent use with antineoplastic, immunosuppressant, or immunomodulating agents, and in patients who are immunocompromised.
- To promote early diagnosis of PML and timely discontinuation of TYSABRI in the event of suspected PML.
"
"2","Adasuve","933","09/28/2016","0","0","0","0","1","1","0","1","0","0","0","0","The goal of the Adasuve REMS is to mitigate the risk of negative outcomes (respiratory distress or respiratory arrest) associated with Adasuve induced bronchospasm by:
- Ensuring that Adasuve is dispensed only in certified healthcare settings that have immediate access on site to supplies and personnel trained to manage acute bronchospasm and ready access to emergency response services. Healthcare settings must have a short-acting bronchodilator (e.g. albuterol), including a nebulizer and inhalation solution, for the immediate treatment of bronchospasm.
- Informing healthcare professionals about the serious risks associated with Adasuve, that Adasuve is contraindicated in patients with lung diseases and other conditions associated with bronchospasm, and how to monitor patients given Adasuve.
"
"17","Opioid Analgesic REMS","934","09/30/2016","0","0","1","0","1","0","0","0","0","1","0","0","The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extended-release or long-acting (ER/LA) opioid analgesics while maintaining patient access to pain medications. Adverse outcomes of concern include addiction, unintentional overdose, and death."
"343","Natpara","935","09/29/2016","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the NATPARA REMS Program is to mitigate the potential risk of osteosarcoma associated with NATPARA by:
- ensuring that prescribers are educated on the following:
- potential risk of osteosarcoma associated with the use of NATPARA
- appropriate patient selection
- safe-use conditions required for prescribing NATPARA
- ensuring that NATPARA is dispensed only to patients informed about the potential risk of osteosarcoma associated with the use of NATPARA
"
"9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","936","10/04/2016","0","0","1","0","1","1","0","0","0","0","0","0","The goals of the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS are to:
- Mitigate the risks of accidental overdose, misuse, and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with buprenorphine-containing products.
"
"149","Adempas","937","10/04/2016","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the Adempas REMS are:
- To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Adempas.
- To minimize the risk of fetal exposure and adverse fetal outcomes in Females of Reproductive Potential (FRP) prescribed Adempas.
- Females who are pregnant must not be prescribed Adempas.
- Females taking Adempas must not become pregnant.
"
"354","Bupropion (ANDA 206122)","938","08/17/2016","0","0","1","0","0","0","0","0","0","0","0","0","The goal of this REMS is to inform patients about the potential serious risks of neuropsychiatric adverse events associated with the use of Bupropion Hydrochloride Extended-Release Tablets, USP (SR), 150 mg."
"63","Tysabri","939","10/14/2016","0","0","1","0","1","1","1","1","1","1","1","0","The goals of the Tysabri REMS are:
- To inform prescribers, infusion center healthcare providers, and patients about the risk of progressive multifocal leukoencephalopathy (PML) associated with TYSABRI including the increased risk of PML with longer treatment duration, prior immunosuppressant use and the presence of anti-JCV antibodies.
- To warn against concurrent use with antineoplastic, immunosuppressant, or immunomodulating agents, and in patients who are immunocompromised.
- To promote early diagnosis of PML and timely discontinuation of TYSABRI in the event of suspected PML.
"
"18","Extraneal","940","10/24/2016","0","0","1","0","1","1","0","0","0","0","0","0","To mitigate the risk of morbidity and mortality associated with the use of non-specific glucose monitors and test strips in patients using EXTRANEAL by:
- Informing the dialysis clinic staff managing the patient’s treatment (such as peritoneal dialysis nurses) about the drug-device interaction and the potential for falsely elevated blood glucose readings in patients using EXTRANEAL.
- Informing patients of the drug-device interaction and the need to alert health care providers of this interaction whenever they receive treatment outside of a dialysis clinic.
"
"2","Adasuve","941","10/19/2016","0","0","0","0","1","1","0","1","0","0","1","0","The goal of the Adasuve REMS is to mitigate the risk of negative outcomes (respiratory distress or respiratory arrest) associated with Adasuve induced bronchospasm by:
- Ensuring that Adasuve is dispensed only in certified healthcare settings that have immediate access on site to supplies and personnel trained to manage acute bronchospasm and ready access to emergency response services. Healthcare settings must have a short-acting bronchodilator (e.g. albuterol), including a nebulizer and inhalation solution, for the immediate treatment of bronchospasm.
- Informing healthcare professionals about the serious risks associated with Adasuve, that Adasuve is contraindicated in patients with lung diseases and other conditions associated with bronchospasm, and how to monitor patients given Adasuve.
"
"314","Myalept","942","11/07/2016","0","0","0","0","1","1","1","0","0","1","1","0","The goal of the MYALEPT REMS is to mitigate
- the risks of serious adverse sequelae (such as severe infections, excessive weight gain, glucose intolerance, diabetes mellitus) due to the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or MYALEPT, and
- the risk of lymphoma by:
- Educating prescribers about the development of neutralizing anti-metreleptin antibodies, the serious adverse sequelae that may result from these antibodies, and the risk for lymphoma associated with MYALEPT
- Limiting the population exposed to MYALEPT by requiring prescriber certification, pharmacy certification, and prescriber attestation that each patient has a diagnosis consistent with the approved indication
"
"71","Xiaflex","943","11/28/2016","0","0","0","0","1","1","1","1","0","1","0","0","- The goal of the XIAFLEX REMS is to mitigate the risks of corporal rupture (penile fracture) and other serious penile injuries associated with the use of XIAFLEX for Peyronie’s disease by:
- Training healthcare providers in how to properly administer XIAFLEX.
- Informing healthcare providers about the risks of corporal rupture (penile fracture)and other serious injuries to the penis.
- Informing healthcare providers about the need to counsel patients to communicate that risks of corporal rupture and other serious penile injuries are associated with the use of XIAFLEX in treating Peyronie’s disease and that patient adherence to post-injection instructions is important for the drug’s safety and effectiveness.
- Ensuring that XIAFLEX is dispensed only in certified pharmacies or healthcare settings for the treatment of Peyronie’s disease.
- Informing patients about the risks of corporal rupture and other serious penile injuries associated with the use of XIAFLEX in treating Peyronie’s disease and that adherence to post-injection instructions is important for the drug’s safety and effectiveness.
- Ensuring that XIAFLEX is dispensed only in certified pharmacies or healthcare settings for the treatment of Peyronie’s disease.
- Informing patients about the risks of corporal rupture and other serious penile injuries associated with the use of XIAFLEX in treating Peyronie’s disease and that adherence to post-injection instructions is important for the drug’s safety and effectiveness.
"
"186","Iclusig","944","11/28/2016","0","0","0","1","0","0","0","0","0","0","0","0","- Inform prescribers of the indications for Iclusig which are limited to:
- Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated
- Treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL
- Limitations of use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML.
- Inform prescribers of the risks of arterial occlusion and venous thromboembolism associated with Iclusig treatment.
"
"22","Gilenya","945","11/29/2016","1","0","0","0","0","0","0","0","0","0","0","0",""
"314","Myalept","946","11/28/2016","0","0","0","0","1","1","1","0","0","1","1","0","The goal of the MYALEPT REMS is to mitigate
- the risks of serious adverse sequelae (such as severe infections, excessive weight gain, glucose intolerance, diabetes mellitus) due to the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or MYALEPT, and
- the risk of lymphoma by:
- Educating prescribers about the development of neutralizing anti-metreleptin antibodies, the serious adverse sequelae that may result from these antibodies, and the risk for lymphoma associated with MYALEPT
- Limiting the population exposed to MYALEPT by requiring prescriber certification, pharmacy certification, and prescriber attestation that each patient has a diagnosis consistent with the approved indication
"
"313","Aveed","948","12/09/2016","0","0","0","0","1","1","1","1","0","1","0","0","The goals and the objectives of the AVEED REMS are to mitigate the negative outcomes associated with AVEED-induced pulmonary oil microembolism (POME) and anaphylaxis by:
- Ensuring that AVEED is dispensed only in certified healthcare settings that have immediate access on-site to equipment and personnel trained to manage POME and anaphylaxis;
- Informing healthcare providers that AVEED can cause POME and anaphylaxis, which have the potential to lead to serious medical consequences (e.g., respiratory distress and syncope);
- Informing healthcare providers about the safe use of AVEED, including proper administration technique and patient observation; and
- Informing patients about the risks of POME and anaphylaxis associated with AVEED and the importance of remaining at the healthcare setting for 30 minutes after each injection.
"
"28","Letairis","949","12/15/2016","0","0","1","0","1","1","1","0","1","1","0","0","The goals of the Letairis Risk Evaluation and Mitigation Strategy (REMS) Program are:
- To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Letairis.
- To minimize the risk of fetal exposure and adverse fetal outcomes in Females of Reproductive Potential (FRP) prescribed Letairis
- Females who are pregnant must not be prescribed Letairis.
- Females taking Letairis must not become pregnant.
"
"12","Chantix","950","12/16/2016","1","0","0","0","0","0","0","0","0","0","0","0",""
"61","Tracleer","951","12/16/2016","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the Tracleer REMS are:
- To inform prescribers, patients, and pharmacists about the risks of Tracleer
- To minimize the risk of hepatotoxicity in patients who are exposed to Tracleer
- To minimize the risk of fetal exposures in female patients who are exposed to Tracleer
- To educate prescribers, patients, and pharmacies on the safe-use conditions for Tracleer
"
"25","Juxtapid","953","01/03/2017","0","0","0","0","1","1","1","0","0","1","0","0","The goal of the JUXTAPID REMS is to mitigate the risk of hepatotoxicity associated with the use of JUXTAPID by ensuring that:
- Prescribers are educated about the approved indication for JUXTAPID, the risk of hepatotoxicity associated with the use of JUXTAPID; and the need to monitor patients during treatment with JUXTAPID as per product labeling.
- JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
- Patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the need for baseline and periodic monitoring.
"
"321","Zydelig","954","01/04/2017","0","0","0","1","0","0","0","0","0","0","0","0","The goal of the Zydelig REMS is to mitigate the risks of fatal and /or serious hepatotoxicity; fatal and/or serious and severe diarrhea or colitis; fatal and/or serious pneumonitis; fatal and/or serious infections, and fatal and serious intestinal perforation associated with Zydelig treatment by informing healthcare providers of the risks of
- fatal and/or serious hepatotoxicity
- fatal and/or serious and severe diarrhea or colitis
- fatal and/or serious pneumonitis
- fatal and/or serious infections
- fatal and serious intestinal perforation
"
"347","Alosetron (moved to shared system, do not use)","955","11/22/2016","0","1","0","0","0","0","0","0","0","0","0","0",""
"360","Alosetron","956","11/22/2016","0","0","0","0","1","0","0","0","0","1","0","0","The goals and objectives of the Alosetron REMS Program are to mitigate the risks of ischemic colitis (IC) and serious complications of constipation (CoC) associated with alosetron hydrochloride (hereinafter, referred to as alosetron) by:
- Informing prescribers of alosetron about:
- the serious risks of IC and serious CoC associated with alosetron the importance of understanding that alosetron should only be used in severely affected diarrhea-predominant irritable bowel syndrome patients for whom the benefits exceed the risks.
- the importance of counseling patients about the risks of IC and serious CoC.
Informing patients about the risks of IC and CoC and actions to take should they experience early warning signs and symptoms of these risks.
"
"49","Soliris","957","01/13/2017","0","0","1","0","1","0","1","0","0","1","0","0","The goals of the REMS are:
- To mitigate the occurrence and morbidity associated with meningococcal infections
- To educate Healthcare Professionals (HCPs) and Patients (or Caregivers, or Legal Guardians) regarding:
- the increased risk of meningococcal infections with Soliris® (eculizumab)
- the early signs of invasive meningococcal infections, and
- the need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections
"
"149","Adempas","958","01/17/2017","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the Adempas REMS are:
- To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Adempas.
- To minimize the risk of fetal exposure and adverse fetal outcomes in Females of Reproductive Potential (FRP) prescribed Adempas.
- Females who are pregnant must not be prescribed Adempas.
- Females taking Adempas must not become pregnant.
"
"361","Sodium Oxybate","959","01/17/2017","0","0","1","0","1","1","1","1","1","1","0","0","The goal of the Sodium Oxybate REMS Program is to mitigate the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion of sodium oxybate by:
A. Informing prescribers, pharmacists, and patients of:
- The risk of significant CNS and respiratory depression associated with sodium oxybate
- The contraindication of use of sodium oxybate with sedative hypnotics and alcohol
- The potential for abuse, misuse, and overdose associated with sodium oxybate
- The safe use, handling, and storage of sodium oxybate
B. Ensuring that pharmacy controls exist prior to filling prescription for sodium oxybate that:
- Screen for concomitant use of sedative hypnotics and other potentially interacting agents
- Monitor for inappropriate prescribing, misuse, abuse, and diversion of sodium oxybate
- Notify prescribers when patients are receiving concomitant contraindicated medications or there are signs of potential abuse, misuse, or diversion"
"7","Axiron","960","01/23/2017","0","0","1","0","0","0","0","0","0","0","0","0","
To inform patients about the serious risks associated with the use of AXIRON® (testosterone) topical solution and its authorized generic.
"
"9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","961","01/23/2017","0","0","1","0","1","1","0","0","0","0","1","0","
The goals of the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS are to:
- Mitigate the risks of accidental overdose, misuse, and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with buprenorphine-containing products.
"
"341","Blincyto","962","01/30/2017","0","0","0","1","0","0","0","0","0","0","1","0","The goals of the BLINCYTO REMS are to mitigate the risk of cytokine release syndrome which may be life-threatening or fatal; the risk of neurological toxicities which may be severe, life-threatening, or fatal; and the risk of preparation and administration errors associated with use of BLINCYTO by:
- Informing healthcare providers about the risk of cytokine release syndrome which may be life-threatening or fatal
- Informing healthcare providers about the risk of neurological toxicities which may be severe, life-threatening, or fatal
- Informing pharmacists, who will prepare and dispense BLINCYTO, and nurses, who will administer BLINCYTO, about the risk of preparation and administration errors associated with use of BLINCYTO
"
"71","Xiaflex","963","01/25/2017","0","0","0","0","1","1","1","1","0","1","1","0","- The goal of the XIAFLEX REMS is to mitigate the risks of corporal rupture (penile fracture) and other serious penile injuries associated with the use of XIAFLEX for Peyronie’s disease by:
- Training healthcare providers in how to properly administer XIAFLEX.
- Informing healthcare providers about the risks of corporal rupture (penile fracture)and other serious injuries to the penis.
- Informing healthcare providers about the need to counsel patients to communicate that risks of corporal rupture and other serious penile injuries are associated with the use of XIAFLEX in treating Peyronie’s disease and that patient adherence to post-injection instructions is important for the drug’s safety and effectiveness.
- Ensuring that XIAFLEX is dispensed only in certified pharmacies or healthcare settings for the treatment of Peyronie’s disease.
- Informing patients about the risks of corporal rupture and other serious penile injuries associated with the use of XIAFLEX in treating Peyronie’s disease and that adherence to post-injection instructions is important for the drug’s safety and effectiveness.
"
"7","Axiron","964","02/03/2017","0","0","1","0","0","0","0","0","0","0","0","0","To inform patients about the serious risks associated with the use of AXIRON® (testosterone) topical solution and its authorized generic.
"
"362","Siliq","965","02/15/2017","0","0","0","0","1","1","1","1","1","0","0","0","
The goal of the SILIQ REMS Program is to mitigate the observed risk of suicidal ideation and behavior, including completed suicides, which occurred in subjects treated with SILIQ by:
- Ensuring that prescribers are educated about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to counsel patients about this risk.
- Ensuring that patients are informed about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to seek medical attention for manifestations of suicidal thoughts and behavior, new onset or worsening depression, anxiety, or other mood changes.
"
"46","Revlimid","966","02/22/2017","0","0","0","0","1","1","1","0","1","0","0","0","The goals of the REVLIMID risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to REVLIMID.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for REVLIMID.
"
"363","testosterone (ANDA 204255)","967","02/28/2017","0","0","1","0","0","0","0","0","0","0","0","0","To inform patients about the serious risks associated with the use of testosterone topical solution.
"
"25","Juxtapid","968","03/02/2017","0","0","0","0","1","1","1","0","0","1","1","0","The goal of the JUXTAPID REMS is to mitigate the risk of hepatotoxicity associated with the use of JUXTAPID by ensuring that:
- Prescribers are educated about the approved indication for JUXTAPID, the risk of hepatotoxicity associated with the use of JUXTAPID; and the need to monitor patients during treatment with JUXTAPID as per product labeling.
- JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
- Patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the need for baseline and periodic monitoring.
"
"357","Zinbryta","969","03/10/2017","0","0","0","1","1","1","1","1","1","1","1","0","To mitigate the risks of severe and fatal hepatic injury and serious immune mediated disorders associated with ZINBRYTA by:
- Ensuring that prescribers are educated on the following:
- the potential risks of severe and fatal hepatic injury and serious immune mediated disorders associated with the use of ZINBRYTA
- the need to counsel patients about these risks and the need for appropriate baseline and monthly monitoring
- Ensuring that prescribers are educated on and adhere to:
- required baseline and monthly monitoring and evaluation of patients who receive ZINBRYTA
- Ensuring that patients are informed about:
- the potential risks of severe and fatal hepatic injury and serious immune mediated disorders associated with the use of ZINBRYTA
- appropriate baseline and monthly monitoring
- Enrollment of all patients in a registry to further support long-term safety and safe use of ZINBRYTA
"
"21","Gattex","970","03/21/2017","0","0","0","0","1","0","0","0","0","1","0","0","The goals of the GATTEX REMS are to mitigate the risks of possible acceleration of neoplastic growth and enhancement of colon polyp growth, gastrointestinal obstruction, and biliary and pancreatic disorders associated with GATTEX by:
- Informing patients about the risks listed above associated with the use of GATTEX
- Informing healthcare providers about the risks listed above associated with GATTEX
"
"76","Opsumit","971","03/21/2017","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the REMS are:
- To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Opsumit
- To minimize the risk of fetal exposure and adverse fetal outcomes in females of reproductive potential (FRP) prescribed Opsumit:
- Females who are pregnant must not be prescribed Opsumit
- Females taking Opsumit must not become pregnant
"
"320","Symlin","972","03/08/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"346","Ionsys","973","03/29/2017","0","0","0","0","1","1","0","1","0","0","0","0","The goal of the IONSYS REMS is to mitigate the risk of respiratory depression resulting from accidental exposure to persons for whom it is not prescribed by:
- Ensuring dispensing to patients in certified hospitals only; and
- Informing healthcare providers of the serious risk of respiratory depression resulting from accidental exposure.
"
"50","Stelara","975","02/15/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"16","Epogen / Procrit","976","04/13/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"6","Aranesp","977","04/13/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","978","04/11/2017","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the TIRF REMS Access program are to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors by:
- Prescribing and dispensing TIRF medicines only to appropriate patients, which includes use only in opioid-tolerant patients.
- Preventing inappropriate conversion between TIRF medicines.
- Preventing accidental exposure to children and others for whom it was not prescribed.
- Educating prescribers, pharmacists, and patients on the potential for misuse, abuse, addiction, and overdose of TIRF medicines.
"
"356","Probuphine","979","04/19/2017","0","0","1","0","1","1","1","0","0","1","0","0","The goal of the Probuphine REMS is to mitigate the risk of complications of migration, protrusion, expulsion and nerve damage associated with the insertion and removal of Probuphine and the risks of accidental overdose, misuse and abuse by:
- Ensuring that healthcare providers are educated on the following:
- proper insertion and removal of Probuphine
- risk of complications of migration, protrusion, expulsion and nerve damage associated with the insertion and removal of Probuphine
- risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin
- Informing patients about the risks of complications of migration, protrusion, expulsion and nerve damage associated with insertion and removal, as well as the risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin.
"
"62","Truvada","980","04/21/2017","0","0","0","0","1","0","0","0","0","1","0","0","The goals of the REMS for TRUVADA for a Pre-Exposure Prophylaxis (PrEP) Indication are:
To inform and educate prescribers and uninfected individuals at high risk for acquiring HIV-1 infection about:
- The importance of strict adherence to the recommended dosing regimen
- The importance of regular monitoring of HIV-1 serostatus to avoid continuing to take TRUVADA for a PrEP indication, if seroconversion has occurred, to reduce the risk of development of resistant HIV-1 variants
- The fact that TRUVADA for a PrEP indication must be considered as only part of a comprehensive prevention strategy to reduce the risk of HIV-1 infection and that other preventive measures should also be used
"
"48","Sabril","982","04/27/2017","0","1","0","0","0","0","0","0","0","0","0","0",""
"364","Vigabatrin","983","04/27/2017","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Vigabatrin REMS Program is to mitigate the risk of vision loss associated with vigabatrin by:
- Ensuring that healthcare providers are educated about the risk of vision loss, the need to counsel patients about the risk, and the need for periodic visual monitoring.
- Ensuring that vigabatrin is only dispensed to patients with documentation that patients are informed about the risk of vision loss associated with vigabatrin and the need for periodic visual monitoring.
"
"322","Trulicity","984","04/19/2017","0","0","0","1","0","0","0","0","0","0","1","0","The goal of the TRULICITY REMS is to mitigate the potential risk of medullary thyroid carcinoma and the risk of pancreatitis associated with the use of TRULICITY by:
- Informing healthcare providers (HCPs) about the potential risk of medullary thyroid carcinoma associated with TRULICITY.
- Informing HCPs about the risk of pancreatitis associated with TRULICITY.
"
"73","Zyban","985","05/04/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"39","Nulojix","986","05/09/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"19","Forteo","987","04/28/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"11","Caprelsa","988","05/16/2017","0","0","0","0","1","1","1","1","0","1","0","0","The goals of the CAPRELSA REMS Program are to mitigate the serious risks of QT prolongation, Torsades de pointes, and sudden death associated with use of CAPRELSA by:- Educating prescribers on the following:
- Serious risks of QT prolongation, Torsades de pointes, and sudden death associated with use of CAPRELSA.
- The need to monitor for QT prolongation and electrolyte abnormalities.
- Appropriate management of QT prolongation to minimize the occurrence of Torsades de pointes and sudden death associated with use of CAPRELSA.
- Informing patients on the following:
- Serious risks of QT prolongation, Torsades de pointes, and sudden death associated with use of CAPRELSA.
"
"342","Saxenda","989","05/22/2017","0","0","0","1","0","0","0","0","0","0","0","0","The goal of the SAXENDA REMS is to mitigate the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis (including necrotizing pancreatitis) associated with SAXENDA by:
- Informing healthcare providers about the potential risk of medullary thyroid carcinoma associated with SAXENDA
- Informing healthcare providers about the risk of acute pancreatitis (including necrotizing pancreatitis) associated with SAXENDA.
"
"65","Vibativ","990","05/24/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"17","Opioid Analgesic REMS","991","05/26/2017","0","0","1","0","1","0","0","0","0","1","0","0","The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extended-release or long-acting (ER/LA) opioid analgesics while maintaining patient access to pain medications. Adverse outcomes of concern include addiction, unintentional overdose, and death."
"364","Vigabatrin","993","05/24/2017","0","0","0","0","1","1","1","1","1","1","1","0","The goal of the Vigabatrin REMS Program is to mitigate the risk of vision loss associated with vigabatrin by:
- Ensuring that healthcare providers are educated about the risk of vision loss, the need to counsel patients about the risk, and the need for periodic visual monitoring.
- Ensuring that vigabatrin is only dispensed to patients with documentation that patients are informed about the risk of vision loss associated with vigabatrin and the need for periodic visual monitoring.
"
"9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","994","05/23/2017","0","0","1","0","1","1","0","0","0","0","0","0","The goals of the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS are to:
- Mitigate the risks of accidental overdose, misuse, and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with buprenorphine-containing products.
"
"362","Siliq","995","06/08/2017","0","0","0","0","1","1","1","1","1","0","0","0","The goal of the SILIQ REMS Program is to mitigate the observed risk of suicidal ideation and behavior, including completed suicides, which occurred in subjects treated with SILIQ by:
- Ensuring that prescribers are educated about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to counsel patients about this risk.
- Ensuring that patients are informed about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to seek medical attention for manifestations of suicidal thoughts and behavior, new onset or worsening depression, anxiety, or other mood changes.
"
"62","Truvada","996","06/08/2017","0","1","0","0","0","0","0","0","0","0","0","0",""
"365","Emtricitabine/tenofovir disoproxil fumarate","997","06/08/2017","0","0","0","0","1","0","0","0","0","1","0","0","The goals of the REMS for the emtricitabine/tenofovir disoproxil fumarate for a Pre-Exposure Prophylaxis (PrEP) Indication are:
To inform and educate prescribers and uninfected individuals at high risk for acquiring HIV-1 infection about:
- The importance of strict adherence to the recommended dosing regimen
- The importance of regular monitoring of HIV-1 serostatus to avoid continuing to take emtricitabine/tenofovir disoproxil fumarate for a PrEP indication, if seroconversion has occurred, to reduce the risk of development of resistant HIV-1 variants
- The fact that emtricitabine/tenofovir disoproxil fumarate for a PrEP indication must be considered as only part of a comprehensive prevention strategy to reduce the risk of HIV-1 infection and that other preventive measures should also be used
"
"58","Thalomid","998","06/09/2017","0","0","0","0","1","1","1","0","1","0","0","0","The goals of the THALOMID risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to THALOMID.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for THALOMID.
"
"350","Addyi","999","06/16/2017","0","0","0","0","1","1","1","1","0","1","0","0","The goal of the Addyi REMS is to mitigate the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol by:
- Ensuring prescribers and pharmacists are educated about the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol and the need to counsel patients about this risk.
- Informing patients of the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol.
"
"24","Isotretinoin iPLEDGE","1000","06/17/2017","0","0","1","0","1","1","1","1","1","0","0","0","The goals of the isotretinoin risk evaluation and mitigation strategy are:
- To prevent fetal exposure to isotretinoin
- To inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions
"
"58","Thalomid","1001","06/27/2017","0","0","0","0","1","1","1","0","1","0","0","0","The goals of the THALOMID risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to THALOMID.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for THALOMID.
"
"46","Revlimid","1002","06/27/2017","0","0","0","0","1","1","1","0","1","0","0","0","The goals of the REVLIMID risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to REVLIMID.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for REVLIMID.
"
"41","Pomalyst","1003","06/27/2017","0","0","0","0","1","1","1","0","1","0","0","0","The goals of the POMALYST risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to POMALYST.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for POMALYST.
"
"45","Qsymia","1004","07/03/2017","0","0","1","0","1","1","0","1","0","1","1","0","To inform prescribers and females of reproductive potential about:
- the increased risk of congenital malformations, specifically orofacial clefts, in infants exposed to Qsymia during the first trimester of pregnancy
- the importance of pregnancy prevention for females of reproductive potential receiving Qsymia
- the need to discontinue Qsymia immediately if pregnancy occurs.
"
"341","Blincyto","1005","07/12/2017","0","0","0","1","0","0","0","0","0","0","0","0","The goals of the BLINCYTO REMS are to mitigate the risk of cytokine release syndrome which may be life-threatening or fatal; the risk of neurological toxicities which may be severe, life-threatening, or fatal; and the risk of preparation and administration errors associated with use of BLINCYTO by:
- Informing healthcare providers about the risk of cytokine release syndrome which may be life-threatening or fatal
- Informing healthcare providers about the risk of neurological toxicities which may be severe, life-threatening, or fatal
- Informing pharmacists, who will prepare and dispense BLINCYTO, and nurses, who will administer BLINCYTO, about the risk of preparation and administration errors associated with use of BLINCYTO
"
"366","testosterone 1.62% (ANDA 205781)","1006","07/12/2017","0","0","1","0","0","0","0","0","0","0","0","0","To inform patients about the serious risks associated with the use of testosterone gel."
"28","Letairis","1008","07/21/2017","0","0","1","0","1","1","1","0","1","1","0","0","The goals of the Letairis Risk Evaluation and Mitigation Strategy (REMS) Program are:
- To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Letairis.
- To minimize the risk of fetal exposure and adverse fetal outcomes in Females of Reproductive Potential (FRP) prescribed Letairis
- Females who are pregnant must not be prescribed Letairis.
- Females taking Letairis must not become pregnant.
"
"66","Victoza","1009","07/26/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"343","Natpara","1010","08/04/2017","0","0","0","0","1","1","1","1","1","1","1","0","The goal of the NATPARA REMS Program is to mitigate the potential risk of osteosarcoma associated with NATPARA by:
- ensuring that prescribers are educated on the following:
- potential risk of osteosarcoma associated with the use of NATPARA
- appropriate patient selection
- safe-use conditions required for prescribing NATPARA
- ensuring that NATPARA is dispensed only to patients informed about the potential risk of osteosarcoma associated with the use of NATPARA
"
"367","testosterone (ANDA 205328)","1011","08/07/2017","0","0","1","0","0","0","0","0","0","0","0","0","To inform patients about the serious risks associated with the use of testosterone topical solution."
"318","Vogelxo","1012","08/11/2017","0","0","1","0","0","0","0","0","0","0","1","0","The goal of this REMS is to inform patients about the serious risks associated with the use of testosterone gel."
"368","Kymriah","1013","08/30/2017","0","0","0","0","1","1","0","1","0","0","0","0"," The goals of the Kymriah REMS Program are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
- Ensuring that hospitals and their associated clinics that dispense Kymriah are specially certified and have on-site, immediate access to tocilizumab.
- Ensuring those who prescribe, dispense, or administer Kymriah are aware of how to manage the risks of cytokine release syndrome and neurological toxicities.
"
"60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1014","09/07/2017","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the TIRF REMS Access program are to mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors by:
- Prescribing and dispensing TIRF medicines only to appropriate patients, which includes use only in opioid-tolerant patients.
- Preventing inappropriate conversion between TIRF medicines.
- Preventing accidental exposure to children and others for whom it was not prescribed.
- Educating prescribers, pharmacists, and patients on the potential for misuse, abuse, addiction, and overdose of TIRF medicines.
"
"61","Tracleer","1015","09/05/2017","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the Tracleer REMS are:
- To inform prescribers, patients, and pharmacists about the risks of Tracleer
- To minimize the risk of hepatotoxicity in patients who are exposed to Tracleer
- To minimize the risk of fetal exposures in female patients who are exposed to Tracleer
- To educate prescribers, patients, and pharmacies on the safe-use conditions for Tracleer
"
"372","Bupropion (ANDA 075914)","1016","05/13/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"372","Bupropion (ANDA 075914)","1017","06/30/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"370","Bupropion (ANDA 077475)","1018","06/25/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"370","Bupropion (ANDA 077475)","1019","06/30/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"371","Bupropion (ANDA 079094)","1020","04/27/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"371","Bupropion (ANDA 079094)","1021","06/30/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"369","Bupropion (ANDA 091520)","1022","06/09/2011","0","0","1","0","0","0","0","0","0","0","0","0",""
"369","Bupropion (ANDA 091520)","1023","08/25/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"76","Opsumit","1024","08/25/2017","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the REMS are:
- To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Opsumit.
- To minimize the risk of fetal exposure and adverse fetal outcomes in females of reproductive potential (FRP) prescribed Opsumit:
- Females who are pregnant must not be prescribed Opsumit.
- Females taking Opsumit must not become pregnant.
"
"373","testosterone 1% (ANDA 091073)","1028","09/18/2017","0","0","1","0","0","0","0","0","0","0","0","0","The goal of this REMS is to inform patients about the serious risks associated with the use of testosterone gel 1%.
"
"28","Letairis","1029","09/27/2017","0","0","1","0","1","1","1","0","1","1","0","0","
The goals of the Letairis Risk Evaluation and Mitigation Strategy (REMS) Program are:
- To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Letairis.
- To minimize the risk of fetal exposure and adverse fetal outcomes in Females of Reproductive Potential (FRP) prescribed Letairis
- Females who are pregnant must not be prescribed Letairis.
- Females taking Letairis must not become pregnant.
"
"365","Emtricitabine/tenofovir disoproxil fumarate","1030","09/21/2017","0","0","0","0","1","0","0","0","0","1","1","0","The goals of the REMS for the emtricitabine/tenofovir disoproxil fumarate for a Pre-Exposure Prophylaxis (PrEP) Indication are:
To inform and educate prescribers and uninfected individuals at high risk for acquiring HIV-1 infection about:
- The importance of strict adherence to the recommended dosing regimen
- The importance of regular monitoring of HIV-1 serostatus to avoid continuing to take emtricitabine/tenofovir disoproxil fumarate for a PrEP indication, if seroconversion has occurred, to reduce the risk of development of resistant HIV-1 variants
- The fact that emtricitabine/tenofovir disoproxil fumarate for a PrEP indication must be considered as only part of a comprehensive prevention strategy to reduce the risk of HIV-1 infection and that other preventive measures should also be used
"
"352","Suboxone/Subutex","1031","09/19/2017","0","0","1","0","1","1","0","0","0","0","0","0","The goals of the REMS for SUBOXONE sublingual film, SUBOXONE sublingual tablets and SUBUTEX sublingual tablets are to:
- Mitigate the risks of accidental overdose, misuse and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with SUBOXONE sublingual film, SUBOXONE sublingual tablets and SUBUTEX sublingual tablets.
"
"2","Adasuve","1032","10/10/2017","0","0","0","0","1","1","0","1","0","0","1","0","The goal of the Adasuve REMS is to mitigate the risk of negative outcomes (respiratory distress or respiratory arrest) associated with Adasuve induced bronchospasm by:
- Ensuring that Adasuve is dispensed only in certified healthcare settings that have immediate access on site to supplies and personnel trained to manage acute bronchospasm and ready access to emergency response services. Healthcare settings must have a short-acting bronchodilator (e.g. albuterol), including a nebulizer and inhalation solution, for the immediate treatment of bronchospasm.
- Informing healthcare professionals about the serious risks associated with Adasuve, that Adasuve is contraindicated in patients with lung diseases and other conditions associated with bronchospasm, and how to monitor patients given Adasuve.
"
"61","Tracleer","1033","10/20/2017","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the Tracleer REMS are:
- To inform prescribers, patients, and pharmacists about the risks of Tracleer
- To minimize the risk of hepatotoxicity in patients who are exposed to Tracleer
- To minimize the risk of fetal exposures in female patients who are exposed to Tracleer
- To educate prescribers, patients, and pharmacies on the safe-use conditions for Tracleer
"
"364","Vigabatrin","1034","10/23/2017","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Vigabatrin REMS Program is to mitigate the risk of vision loss associated with vigabatrin by:
- Ensuring that healthcare providers are educated about the risk of vision loss, the need to counsel patients about the risk, and the need for periodic visual monitoring.
- Ensuring that vigabatrin is only dispensed to patients with documentation that patients are informed about the risk of vision loss associated with vigabatrin and the need for periodic visual monitoring.
"
"49","Soliris","1035","10/23/2017","0","0","1","0","1","0","1","0","0","1","0","0","The goals of the REMS are:
- To mitigate the occurrence and morbidity associated with meningococcal infections
- To educate Healthcare Professionals (HCPs) and Patients regarding:
- the increased risk of meningococcal infections with Soliris
- the early signs of invasive meningococcal infections, and
- the need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections
"
"374","testosterone (ANDA 208061)","1036","10/23/2017","0","0","1","0","0","0","0","0","0","0","0","0","To inform patients about the serious risks associated with the use of Testosterone Topical Solution, 30 mg/1.5 mL Actuation."
"27","Kynamro","1037","10/25/2017","0","0","0","0","1","1","1","1","1","1","0","1","The goal of the KYNAMRO REMS is to mitigate the risk of hepatotoxicity associated with the use of KYNAMRO by ensuring that:
- prescribers are educated about the approved indication for KYNAMRO, the risk of hepatotoxicity associated with the use of KYNAMRO, and the need to monitor patients during treatment with KYNAMRO as per product labeling
- KYNAMRO is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH)
- patients are informed about the risk of hepatotoxicity associated with the use of KYNAMRO and the need for baseline and periodic monitoring.
"
"375","Yescarta and Tecartus","1038","10/18/2017","0","0","0","0","1","1","0","1","0","0","0","0","The goals of the YESCARTA REMS are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
- Ensuring that hospitals and their associated clinics that dispense YESCARTA are specially certified and have on-site, immediate access to tocilizumab.
- Ensuring those who prescribe, dispense, or administer YESCARTA are aware of how to manage the risks of CRS and neurological toxicities.
"
"357","Zinbryta","1039","11/01/2017","0","0","0","1","1","1","1","1","1","1","0","0","To mitigate the risks of severe and fatal hepatic injury and serious immune mediated disorders associated with ZINBRYTA by:
- Ensuring that prescribers are educated on the following:
- the potential risks of severe and fatal hepatic injury and serious immune mediated disorders associated with the use of ZINBRYTA
- the need to counsel patients about these risks and the need for appropriate baseline and monthly monitoring
- Ensuring that prescribers are educated on and adhere to:
- required baseline and monthly monitoring and evaluation of patients who receive ZINBRYTA
- Ensuring that patients are informed about:
- the potential risks of severe and fatal hepatic injury and serious immune mediated disorders associated with the use of ZINBRYTA
- appropriate baseline and monthly monitoring
- Enrollment of all patients in a registry to further support long-term safety and safe use of ZINBRYTA
"
"7","Axiron","1041","07/13/2017","0","0","1","0","0","0","0","0","0","0","0","1","To inform patients about the serious risks associated with the use of AXIRON® (testosterone) topical solution and its authorized generic.
"
"376","Sublocade","1042","11/30/2017","0","0","0","0","1","1","0","1","0","0","0","0","
The goal of the SUBLOCADE REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration by:
- Ensuring healthcare settings and pharmacies are certified and only dispense SUBLOCADE directly to a healthcare provider for administration by a healthcare provider.
"
"74","Zyprexa Relprevv","1044","11/30/2017","0","0","1","1","1","1","1","1","1","1","0","0","The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS) by:
- ensuring Zyprexa Relprevv is prescribed only by certified prescribers, dispensed only by certified dispensers, and dispensed for use only in certified healthcare facilities with ready access to emergency response services, and dispensed for use only with documentation of safe use conditions;
- informing healthcare providers and patients about the risks and the need for continuous observation of patients for at least 3 hours in certified health care facilities; and
- establishing long-term safety and safe use of Zyprexa Relprevv through periodic monitoring for the risk of PDSS events and by enrolling all patients who receive Zyprexa Relprevv in the Zyprexa Relprevv Patient Care Program Registry.
"
"365","Emtricitabine/tenofovir disoproxil fumarate","1045","12/08/2017","0","0","0","0","1","0","0","0","0","1","0","0","The goals of the REMS for the emtricitabine/tenofovir disoproxil fumarate for a Pre-Exposure Prophylaxis (PrEP) Indication are:
To inform and educate prescribers and uninfected individuals at high risk for acquiring HIV-1 infection about:
- The importance of strict adherence to the recommended dosing regimen
- The importance of regular monitoring of HIV-1 serostatus to avoid continuing to take emtricitabine/tenofovir disoproxil fumarate for a PrEP indication, if seroconversion has occurred, to reduce the risk of development of resistant HIV-1 variants
- The fact that emtricitabine/tenofovir disoproxil fumarate for a PrEP indication must be considered as only part of a comprehensive prevention strategy to reduce the risk of HIV-1 infection and that other preventive measures should also be used
"
"314","Myalept","1046","12/11/2017","0","0","0","1","1","1","1","0","0","1","0","0","The goal of the MYALEPT REMS is to mitigate
- the risks of serious adverse sequelae (such as severe infections, excessive weight gain, glucose intolerance, diabetes mellitus) due to the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or MYALEPT, and
- the risk of lymphoma by:
- Educating prescribers about the development of neutralizing anti-metreleptin antibodies,the serious adverse sequelae that may result from these antibodies, and the risk for lymphoma associated with MYALEPT
- Limiting the population exposed to MYALEPT by requiring prescriber certification, pharmacy certification, and prescriber attestation that each patient has a diagnosis consistent with the approved indication.
"
"322","Trulicity","1047","12/12/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"316","Tanzeum","1048","12/12/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"358","Xultophy","1049","12/12/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"354","Bupropion (ANDA 206122)","1050","06/30/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"377","bupropion (ANDA 090941)","1051","05/03/2010","0","0","1","0","0","0","0","0","0","0","0","0",""
"377","bupropion (ANDA 090941)","1052","06/30/2017","1","0","0","0","0","0","0","0","0","0","0","0",""
"362","Siliq","1053","01/26/2018","0","0","0","0","1","1","1","1","1","0","0","0","The goal of the SILIQ REMS Program is to mitigate the observed risk of suicidal ideation and behavior, including completed suicides, which occurred in subjects treated with SILIQ by:
- Ensuring that prescribers are educated about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to counsel patients about this risk.
- Ensuring that patients are informed about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to seek medical attention for manifestations of suicidal thoughts and behavior, new onset or worsening depression, anxiety, or other mood changes.
"
"321","Zydelig","1054","01/26/2018","0","0","0","1","0","0","0","0","0","0","0","0","The goal of the Zydelig REMS is to mitigate the risks of fatal and /or serious hepatotoxicity; fatal and/or serious and severe diarrhea or colitis; fatal and/or serious pneumonitis; fatal and/or serious infections, and fatal and serious intestinal perforation associated with Zydelig treatment by informing healthcare providers of the risks of
- fatal and/or serious hepatotoxicity
- fatal and/or serious and severe diarrhea or colitis
- fatal and/or serious pneumonitis
- fatal and/or serious infections
- fatal and serious intestinal perforation
"
"321","Zydelig","1055","02/06/2018","0","0","0","1","0","0","0","0","0","0","0","0","The goal of the Zydelig REMS is to mitigate the risks of fatal and /or serious hepatotoxicity; fatal and/or serious and severe diarrhea or colitis; fatal and/or serious pneumonitis; fatal and/or serious infections, and fatal and serious intestinal perforation associated with Zydelig treatment by informing healthcare providers of the risks of
- fatal and/or serious hepatotoxicity
- fatal and/or serious and severe diarrhea or colitis
- fatal and/or serious pneumonitis
- fatal and/or serious infections
- fatal and serious intestinal perforation
"
"378","testosterone (ANDA 209533)","1056","01/30/2018","0","0","1","0","0","0","0","0","0","0","0","0","To inform patients about the serious risks associated with the use of testosterone topical solution.
To inform patients about the serious risks associated with the use of testosterone topical solution."
"376","Sublocade","1057","02/09/2018","0","0","0","0","1","1","0","1","0","0","1","0","The goal of the SUBLOCADE REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration by:
- Ensuring healthcare settings and pharmacies are certified and only dispense SUBLOCADE directly to a healthcare provider for administration by a healthcare provider.
"
"376","Sublocade","1059","03/08/2018","0","0","0","0","1","1","0","1","0","0","1","0","The goal of the SUBLOCADE REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration by:
- Ensuring healthcare settings and pharmacies are certified and only dispense SUBLOCADE directly to a healthcare provider for administration by a healthcare provider.
"
"321","Zydelig","1060","03/22/2018","0","0","0","1","0","0","0","0","0","0","0","0","The goal of the Zydelig REMS is to mitigate the risks of fatal and /or serious hepatotoxicity; fatal and/or serious and severe diarrhea or colitis; fatal and/or serious pneumonitis; fatal and/or serious infections, and fatal and serious intestinal perforation associated with Zydelig treatment by informing healthcare providers of the risks of
- fatal and/or serious hepatotoxicity
- fatal and/or serious and severe diarrhea or colitis
- fatal and/or serious pneumonitis
- fatal and/or serious infections
- fatal and serious intestinal perforation
"
"341","Blincyto","1061","03/29/2018","0","0","0","1","0","0","0","0","0","0","0","0","The goals of the BLINCYTO REMS are to mitigate the risk of cytokine release syndrome which may be life-threatening or fatal; the risk of neurological toxicities which may be severe, life-threatening, or fatal; and the risk of preparation and administration errors associated with use of BLINCYTO by:
- Informing healthcare providers about the risk of cytokine release syndrome which may be life-threatening or fatal
- Informing healthcare providers about the risk of neurological toxicities which may be severe, life-threatening, or fatal
- Informing pharmacists, who will prepare and dispense BLINCYTO, and nurses, who will administer BLINCYTO, about the risk of preparation and administration errors associated with use of BLINCYTO
"
"341","Blincyto","1062","04/10/2018","0","0","0","1","0","0","0","0","0","0","0","0","The goals of the BLINCYTO REMS are to mitigate the risk of cytokine release syndrome which may be life-threatening or fatal; the risk of neurological toxicities which may be severe, life-threatening, or fatal; and the risk of preparation and administration errors associated with use of BLINCYTO by:
- Informing healthcare providers about the risk of cytokine release syndrome which may be life-threatening or fatal
- Informing healthcare providers about the risk of neurological toxicities which may be severe, life-threatening, or fatal
- Informing pharmacists, who will prepare and dispense BLINCYTO, and nurses, who will administer BLINCYTO, about the risk of preparation and administration errors associated with use of BLINCYTO
"
"63","Tysabri","1063","04/18/2018","0","0","1","0","1","1","1","1","1","1","0","0","
The goals of the Tysabri REMS are:
- To inform prescribers, infusion center healthcare providers, and patients about the risk of progressive multifocal leukoencephalopathy (PML) associated with TYSABRI including the increased risk of PML with longer treatment duration, prior immunosuppressant use and the presence of anti-JCV antibodies.
- To warn against concurrent use with antineoplastic, immunosuppressant, or immunomodulating agents, and in patients who are immunocompromised.
- To promote early diagnosis of PML and timely discontinuation of TYSABRI in the event of suspected PML.
"
"319","Afrezza","1064","04/24/2018","1","0","0","0","0","0","0","0","0","0","0","0",""
"380","Jynarque","1065","04/23/2018","0","0","0","1","1","1","1","1","1","1","0","0","The goal of the JYNARQUE REMS is to mitigate the risk of serious and potentially fatal liver injury by:
- Ensuring that healthcare providers are educated on the following:
- the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- the need to counsel patients about the risk of serious and potentially fatal liver injury and the
need for monitoring at baseline and periodic monitoring as described in the Prescribing
Information
- Ensuring that healthcare providers adhere to:
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- Ensuring that patients are informed about:
- the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- Enrollment of all patients in a registry to further support long term safety and safe use of JYNARQUE
"
"17","Opioid Analgesic REMS","1066","","0","0","0","0","0","0","0","0","0","0","0","0",""
"24","Isotretinoin iPLEDGE","1067","04/23/2018","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the isotretinoin risk evaluation and mitigation strategy are:
- To prevent fetal exposure to isotretinoin
- To inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions
"
"63","Tysabri","1068","04/30/2018","0","0","1","0","1","1","1","1","1","1","1","0","
The goals of the Tysabri REMS are:
- To inform prescribers, infusion center healthcare providers, and patients about the risk of progressive multifocal leukoencephalopathy (PML) associated with TYSABRI including the increased risk of PML with longer treatment duration, prior immunosuppressant use and the presence of anti-JCV antibodies.
- To warn against concurrent use with antineoplastic, immunosuppressant, or immunomodulating agents, and in patients who are immunocompromised.
- To promote early diagnosis of PML and timely discontinuation of TYSABRI in the event of suspected PML.
"
"368","Kymriah","1069","05/01/2018","0","0","0","0","1","1","0","1","0","0","0","0"," The goals of the Kymriah REMS Program are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
- Ensuring that hospitals and their associated clinics that dispense Kymriah are specially certified and have on-site, immediate access to tocilizumab.
- Ensuring those who prescribe, dispense, or administer Kymriah are aware of how to manage the risks of cytokine release syndrome and neurological toxicities.
"
"186","Iclusig","1070","05/07/2018","0","0","0","1","0","0","0","0","0","0","1","0","- Inform prescribers of the indications for Iclusig which are limited to:
- Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated
- Treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL
- Limitations of use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase CML.
- Inform prescribers of the risks of arterial occlusion and venous thromboembolism associated with Iclusig treatment.
"
"350","Addyi","1071","05/09/2018","0","0","0","0","1","1","1","1","0","1","1","0","The goal of the Addyi REMS is to mitigate the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol by:
- Ensuring prescribers and pharmacists are educated about the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol and the need to counsel patients about this risk.
- Informing patients of the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol.
"
"365","Emtricitabine/tenofovir disoproxil fumarate","1073","05/15/2018","0","0","0","0","1","0","0","0","0","1","0","0","The goals of the REMS for the emtricitabine/tenofovir disoproxil fumarate for a Pre-Exposure Prophylaxis (PrEP) Indication are:
To inform and educate prescribers and uninfected adults and adolescents at risk for acquiring HIV-1 infection about:
- The importance of strict adherence to the recommended dosing regimen
- The importance of regular monitoring of HIV-1 serostatus to avoid continuing to take emtricitabine/tenofovir disoproxil fumarate for a PrEP indication, if seroconversion has occurred, to reduce the risk of development of resistant HIV-1 variants
- The fact that emtricitabine/tenofovir disoproxil fumarate for a PrEP indication must be considered as only part of a comprehensive prevention strategy to reduce the risk of HIV-1 infection and that other preventive measures should also be used
"
"381","Palynziq","1074","05/24/2018","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the PALYNZIQ (pegvaliase-pqpz) REMS is to mitigate the risk of anaphylaxis associated with PALYNZIQ by:
- Ensuring that prescribers are educated on the risk of anaphylaxis associated with the use of PALYNZIQ
- Ensuring that prescribers are educated and adhere to the following:
- Counsel patients on how to recognize and respond to signs and symptoms of anaphylaxis
- Enroll patients in the PALYNZIQ REMS
- Prescribe auto-injectable epinephrine with PALYNZIQ
- Ensuring that PALYNZIQ is only dispensed to patients with documentation of safe use conditions
- Patient education and enrollment in the PALYNZIQ REMS
- Having auto-injectable epinephrine available at all times
- Ensuring that patients are educated on the following:
- How to recognize and respond to signs and symptoms of anaphylaxis
- The need to carry auto-injectable epinephrine with them at all times
"
"186","Iclusig","1075","05/29/2018","1","0","0","0","0","0","0","0","0","0","0","0",""
"380","Jynarque","1076","05/29/2018","0","0","0","1","1","1","1","1","1","1","1","0","The goal of the JYNARQUE REMS is to mitigate the risk of serious and potentially fatal liver injury by:
- Ensuring that healthcare providers are educated on the following:
- the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- the need to counsel patients about the risk of serious and potentially fatal liver injury and the
need for monitoring at baseline and periodic monitoring as described in the Prescribing
Information
- Ensuring that healthcare providers adhere to:
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- Ensuring that patients are informed about:
- the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- Enrollment of all patients in a registry to further support long term safety and safe use of JYNARQUE
"
"25","Juxtapid","1077","06/04/2018","0","0","0","0","1","1","1","1","0","1","0","0","The goal of the JUXTAPID REMS is to mitigate the risk of hepatotoxicity associated with the use of JUXTAPID by ensuring that:
- Prescribers are educated about the approved indication for JUXTAPID, the risk of hepatotoxicity associated with the use of JUXTAPID; and the need to monitor patients during treatment with JUXTAPID as per product labeling.
- JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
- Patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the need for baseline and periodic monitoring.
"
"352","Suboxone/Subutex","1079","06/11/2018","0","0","1","0","1","1","0","0","0","0","0","0","The goals of the REMS for SUBOXONE sublingual film, Authorized Generic of SUBOXONE sublingual film, SUBOXONE sublingual tablets, and SUBUTEX sublingual tablets are to:
- Mitigate the risks of accidental overdose, misuse and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with SUBOXONE sublingual film, Authorized Generic of SUBOXONE sublingual film, SUBOXONE sublingual tablets, and SUBUTEX sublingual tablets.
"
"25","Juxtapid","1080","06/18/2018","0","0","0","0","1","1","1","1","0","1","1","0","The goal of the JUXTAPID REMS is to mitigate the risk of hepatotoxicity associated with the use of JUXTAPID by ensuring that:
- Prescribers are educated about the approved indication for JUXTAPID, the risk of hepatotoxicity associated with the use of JUXTAPID; and the need to monitor patients during treatment with JUXTAPID as per product labeling.
- JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
- Patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the need for baseline and periodic monitoring.
"
"71","Xiaflex","1081","07/10/2018","0","0","0","0","1","1","1","1","0","1","1","0","- The goal of the XIAFLEX REMS is to mitigate the risks of corporal rupture (penile fracture) and other serious penile injuries associated with the use of XIAFLEX for Peyronie’s disease by:
- Training healthcare providers in how to properly administer XIAFLEX.
- Informing healthcare providers about the risks of corporal rupture (penile fracture)and other serious injuries to the penis.
- Informing healthcare providers about the need to counsel patients to communicate that risks of corporal rupture and other serious penile injuries are associated with the use of XIAFLEX in treating Peyronie’s disease and that patient adherence to post-injection instructions is important for the drug’s safety and effectiveness.
- Ensuring that XIAFLEX is dispensed only in certified pharmacies or healthcare settings for the treatment of Peyronie’s disease.
- Informing patients about the risks of corporal rupture and other serious penile injuries associated with the use of XIAFLEX in treating Peyronie’s disease and that adherence to post-injection instructions is important for the drug’s safety and effectiveness.
"
"365","Emtricitabine/tenofovir disoproxil fumarate","1082","07/10/2018","0","0","0","0","1","0","0","0","0","1","1","0","The goals of the REMS for the emtricitabine/tenofovir disoproxil fumarate for a Pre-Exposure Prophylaxis (PrEP) Indication are:
To inform and educate prescribers and uninfected adults and adolescents at risk for acquiring HIV-1 infection about:
- The importance of strict adherence to the recommended dosing regimen
- The importance of regular monitoring of HIV-1 serostatus to avoid continuing to take emtricitabine/tenofovir disoproxil fumarate for a PrEP indication, if seroconversion has occurred, to reduce the risk of development of resistant HIV-1 variants
- The fact that emtricitabine/tenofovir disoproxil fumarate for a PrEP indication must be considered as only part of a comprehensive prevention strategy to reduce the risk of HIV-1 infection and that other preventive measures should also be used
"
"380","Jynarque","1083","07/30/2018","0","0","0","1","1","1","1","1","1","1","0","0","The goal of the JYNARQUE REMS is to mitigate the risk of serious and potentially fatal liver injury by:
- Ensuring that healthcare providers are educated on the following:
- the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- the need to counsel patients about the risk of serious and potentially fatal liver injury and the
need for monitoring at baseline and periodic monitoring as described in the Prescribing
Information
- Ensuring that healthcare providers adhere to:
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- Ensuring that patients are informed about:
- the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- Enrollment of all patients in a registry to further support long term safety and safe use of JYNARQUE
"
"49","Soliris","1084","07/25/2018","0","0","0","0","1","0","1","0","0","1","0","0","The goals of the REMS are:
- To mitigate the occurrence and morbidity associated with meningococcal infections
- To educate Healthcare Professionals (HCPs) and Patients regarding:
- the increased risk of meningococcal infections with Soliris
- the early signs of invasive meningococcal infections, and
- the need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections
"
"313","Aveed","1085","09/01/2018","0","0","0","0","1","1","1","1","0","1","0","0","The goals and the objectives of the AVEED REMS are to mitigate the negative outcomes associated with AVEED-induced pulmonary oil microembolism (POME) and anaphylaxis by:
- Ensuring that AVEED is dispensed only in certified healthcare settings that have immediate access on-site to equipment and personnel trained to manage POME and anaphylaxis;
- Informing healthcare providers that AVEED can cause POME and anaphylaxis, which have the potential to lead to serious medical consequences (e.g., respiratory distress and syncope);
- Informing healthcare providers about the safe use of AVEED, including proper administration technique and patient observation; and
- Informing patients about the risks of POME and anaphylaxis associated with AVEED and the importance of remaining at the healthcare setting for 30 minutes after each injection.
"
"9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1086","09/07/2018","0","0","1","0","1","1","0","0","0","0","0","0","The goals of the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS are to:
- Mitigate the risks of accidental overdose, misuse, and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with buprenorphine-containing products.
"
"17","Opioid Analgesic REMS","1087","09/18/2018","0","0","1","0","1","0","0","0","0","1","0","0","The goal of the Opioid Analgesic REMS is to educate prescribers and other healthcare providers (including pharmacists and nurses) on the treatment and monitoring of patients with pain. The education provided through the REMS program is based on the Opioid Analgesic REMS Education Blueprint for Health Care
Providers Involved in the Treatment and Monitoring of Patients with Pain (“FDA Blueprint”). Through better education, the healthcare team will have an improved understanding of how to manage pain and the role of opioid analgesics along with nonpharmacologic and non-opioid analgesics in pain management. The education will also provide information about the risks of opioids and use of other therapies which is intended to assist healthcare providers in reducing adverse outcomes of addiction, unintentional overdose, and death resulting from inappropriate prescribing, abuse, and misuse. The REMS will accomplish this goal by:
- Ensuring that training based on the FDA Blueprint is effective in educating prescribers and other
healthcare providers involved in the treatment and monitoring of patients in pain (including pharmacists and nurses) about recommended pain management practices and appropriate use of opioid analgesics.
- Informing patients about their roles and responsibilities regarding their pain treatment plan, including the risks of opioid analgesics and how to use and store them safely, as outlined in the Medication Guides and Patient Counseling Guide for opioid analgesics.
"
"382","Copiktra","1088","09/24/2018","0","0","0","1","0","0","0","0","0","0","0","0","The goal of the COPIKTRA REMS is to mitigate the risks of fatal and/or serious toxicities including
infections, diarrhea or colitis, cutaneous reactions, and pneumonitis associated with the use of COPIKTRA
by informing healthcare providers of these risks."
"71","Xiaflex","1089","09/26/2018","0","0","0","0","1","1","1","1","0","1","0","0","- The goal of the XIAFLEX REMS is to mitigate the risks of corporal rupture (penile fracture) and other serious penile injuries associated with the use of XIAFLEX for Peyronie’s disease by:
- Training healthcare providers in how to properly administer XIAFLEX.
- Informing healthcare providers about the risks of corporal rupture (penile fracture)and other serious injuries to the penis.
- Informing healthcare providers about the need to counsel patients to communicate that risks of corporal rupture and other serious penile injuries are associated with the use of XIAFLEX in treating Peyronie’s disease and that patient adherence to post-injection instructions is important for the drug’s safety and effectiveness.
- Ensuring that XIAFLEX is dispensed only in certified pharmacies or healthcare settings for the treatment of Peyronie’s disease.
- Informing patients about the risks of corporal rupture and other serious penile injuries associated with the use of XIAFLEX in treating Peyronie’s disease and that adherence to post-injection instructions is important for the drug’s safety and effectiveness.
"
"346","Ionsys","1090","10/03/2018","0","0","0","0","1","1","0","1","0","0","0","1","The goal of the IONSYS REMS is to mitigate the risk of respiratory depression resulting from accidental exposure to persons for whom it is not prescribed by:
- Ensuring dispensing to patients in certified hospitals only; and
- Informing healthcare providers of the serious risk of respiratory depression resulting from accidental exposure.
"
"362","Siliq","1091","10/09/2018","0","0","0","0","1","1","1","1","1","0","0","0","The goal of the SILIQ REMS Program is to mitigate the observed risk of suicidal ideation and behavior, including completed suicides, which occurred in subjects treated with SILIQ by:
- Ensuring that prescribers are educated about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to counsel patients about this risk.
- Ensuring that patients are informed about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to seek medical attention for manifestations of suicidal thoughts and behavior, new onset or worsening depression, anxiety, or other mood changes.
"
"76","Opsumit","1093","10/16/2018","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Opsumit REMS Program is to mitigate the risk of embryo-fetal toxicity associated with
Opsumit by:
- Ensuring prescribers are educated on the following:
- the risks of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about these risks and the need for monthly monitoring
- enrolling patients in the Opsumit REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risks of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before
dispensing Opsumit
- Ensuring that patients are informed about:
- the risks of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"383","Tegsedi","1094","10/05/2018","0","0","0","0","1","1","1","1","1","1","1","0","The goal of the Tegsedi REMS is to mitigate the risk of serious bleeding with severe thrombocytopenia and
the risk of glomerulonephritis associated with Tegsedi by:
- Ensuring prescribers are educated on the risk of serious bleeding with severe thrombocytopenia
and the risk of glomerulonephritis associated with Tegsedi.
- Ensuring prescribers are educated and adhere to the following:
- Counsel patients on how to recognize and respond to signs and symptoms of serious
bleeding and glomerulonephritis.
- Enroll patients in the Tegsedi REMS Program.
- Submit documentation that periodic monitoring of patients is being done to identify severe
thrombocytopenia, serious bleeding with severe thrombocytopenia, and glomerulonephritis.
- Ensuring patients are informed on the following:
- How to recognize and respond to signs and symptoms of serious bleeding and
glomerulonephritis.
- The need to have their platelet count and renal function monitored.
- Enrollment of all patients in a registry to further support long-term safety and safe use of Tegsedi.
"
"352","Suboxone/Subutex","1096","10/26/2018","0","0","1","0","1","1","0","0","0","0","0","0","The goals of the REMS for SUBOXONE sublingual film, Authorized Generic of SUBOXONE sublingual film, SUBOXONE sublingual tablets, and SUBUTEX sublingual tablets are to:
- Mitigate the risks of accidental overdose, misuse and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with SUBOXONE sublingual film, Authorized Generic of SUBOXONE sublingual film, SUBOXONE sublingual tablets,
and SUBUTEX sublingual tablets.
"
"345","Xywav and Xyrem","1097","10/26/2018","0","0","1","0","1","1","1","1","1","1","0","0","The goal of the XYREM REMS is to mitigate the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion of XYREM by:
- Informing prescribers, pharmacists, and patients of:
- The risk of significant CNS and respiratory depression associated with XYREM.
- The contraindication of use of XYREM with sedative hypnotics and alcohol.
- The potential for abuse, misuse, and overdose associated with XYREM.
- The safe use, handling, and storage of XYREM.
- Ensuring that pharmacy controls exist prior to filling prescriptions for XYREM that:
- Screen for concomitant use of sedative hypnotics and other potentially interacting agents.
- Monitor for inappropriate prescribing, misuse, abuse, and diversion of XYREM.
- Notify prescribers when patients are receiving concomitant contraindicated medications or there are signs of potential abuse, misuse, or diversion.
"
"9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1098","10/31/2018","0","0","1","0","1","1","0","0","0","0","0","0","The goals of the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS are to:
- Mitigate the risks of accidental overdose, misuse, and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with buprenorphine-containing products.
"
"384","Dsuvia","1099","11/02/2018","0","0","0","0","1","1","0","1","0","0","0","0","The goal of the DSUVIA REMS is to mitigate the risk of respiratory depression resulting from
accidental exposure by ensuring that DSUVIA is dispensed only to patients in certified medically supervised
healthcare settings."
"71","Xiaflex","1100","10/30/2018","0","0","0","0","1","1","0","0","0","0","1","0","- The goal of the XIAFLEX REMS is to mitigate the risks of corporal rupture (penile fracture) and other serious penile injuries associated with the use of XIAFLEX for Peyronie’s disease by:
- Training healthcare providers in how to properly administer XIAFLEX.
- Informing healthcare providers about the risks of corporal rupture (penile fracture)and other serious injuries to the penis.
- Informing healthcare providers about the need to counsel patients to communicate that risks of corporal rupture and other serious penile injuries are associated with the use of XIAFLEX in treating Peyronie’s disease and that patient adherence to post-injection instructions is important for the drug’s safety and effectiveness.
- Ensuring that XIAFLEX is dispensed only in certified pharmacies or healthcare settings for the treatment of Peyronie’s disease.
- Informing patients about the risks of corporal rupture and other serious penile injuries associated with the use of XIAFLEX in treating Peyronie’s disease and that adherence to post-injection instructions is important for the drug’s safety and effectiveness.
"
"340","Lemtrada","1101","11/28/2018","0","0","0","1","1","1","1","1","1","1","0","0","The goal of the LEMTRADA REMS is to mitigate the risks of autoimmune conditions, infusion reactions, and malignancies associated with LEMTRADA by:
- Helping to ensure informed decisions about the safe use of LEMTRADA by:
- Informing patients about the serious risks of autoimmune conditions, infusion reactions, and malignancies with LEMTRADA and the need for baseline and periodic monitoring; and
- Informing healthcare providers about the serious risks of autoimmune conditions, infusion reactions, and malignancies with LEMTRADA, the need to counsel patients, and the need for baseline and periodic monitoring.
- Helping to ensure the safe use of LEMTRADA by:
- Ensuring that only certified prescribers prescribe LEMTRADA;
- Ensuring that LEMTRADA is dispensed only in certain healthcare settings, by certified pharmacies, and certified healthcare facilities administering the infusion, which have on-site access to equipment and personnel trained to manage infusion reactions; and
- Ensuring that only enrolled and authorized patients receive LEMTRADA;
- Ensuring that certified prescribers submit documentation of periodic monitoring of patients who receive LEMTRADA to identify autoimmune conditions and malignancies.
"
"28","Letairis","1102","11/30/2018","0","0","0","0","1","1","1","1","1","1","0","0","The goals of the Letairis Risk Evaluation and Mitigation Strategy (REMS) Program are:
- To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Letairis.
- To minimize the risk of fetal exposure and adverse fetal outcomes in Females of Reproductive Potential (FRP) prescribed Letairis
- Females who are pregnant must not be prescribed Letairis.
- Females taking Letairis must not become pregnant.
"
"380","Jynarque","1103","12/01/2018","0","0","0","1","1","1","1","1","1","1","0","0","The goal of the JYNARQUE REMS is to mitigate the risk of serious and potentially fatal liver injury by:
- Ensuring that healthcare providers are educated on the following:
- the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- the need to counsel patients about the risk of serious and potentially fatal liver injury and the
need for monitoring at baseline and periodic monitoring as described in the Prescribing
Information
- Ensuring that healthcare providers adhere to:
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- Ensuring that patients are informed about:
- the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- Enrollment of all patients in a registry to further support long term safety and safe use of JYNARQUE
"
"149","Adempas","1105","12/06/2018","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Adempas REMS Program is to mitigate the risk of embryo-fetal toxicity associated with Adempas by:
- Ensuring prescribers are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about the risk and the need for monthly monitoring
- enrolling patients in the Adempas REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before dispensing Adempas
- Ensuring that patients are informed about:
- the risk of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"342","Saxenda","1106","12/04/2018","1","0","0","0","0","0","0","0","0","0","0","0",""
"356","Probuphine","1107","11/01/2018","0","0","1","0","1","1","1","1","0","1","0","1","
The goal of the Probuphine REMS is to mitigate the risk of complications of migration, protrusion, expulsion and nerve damage associated with the insertion and removal of Probuphine and the risks of accidental overdose, misuse and abuse by:
- Ensuring that healthcare providers are educated on the following:
- proper insertion and removal of Probuphine
- risk of complications of migration, protrusion, expulsion and nerve damage associated with the insertion and removal of Probuphine
- risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin
- Ensuring pharmacies are certified and only provide Probuphine to healthcare settings in which a certified prescriber is practicing
- Informing patients about the risks of complications of migration, protrusion, expulsion and nerve damage associated with insertion and removal, as well as the risk of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin.
"
"313","Aveed","1108","12/19/2018","0","0","0","0","1","1","1","1","0","1","0","0","The goals and the objectives of the AVEED REMS are to mitigate the negative outcomes associated with AVEED-induced pulmonary oil microembolism (POME) and anaphylaxis by:
- Ensuring that AVEED is dispensed only in certified healthcare settings that have immediate access on-site to equipment and personnel trained to manage POME and anaphylaxis;
- Informing healthcare providers that AVEED can cause POME and anaphylaxis, which have the potential to lead to serious medical consequences (e.g., respiratory distress and syncope);
- Informing healthcare providers about the safe use of AVEED, including proper administration technique and patient observation; and
- Informing patients about the risks of POME and anaphylaxis associated with AVEED and the importance of remaining at the healthcare setting for 30 minutes after each injection.
"
"314","Myalept","1109","12/21/2018","0","0","0","1","1","1","1","1","0","1","0","0","The goal of the MYALEPT REMS is to mitigate
- the risks of serious adverse sequelae (such as severe infections, excessive weight gain, glucose intolerance, diabetes mellitus) due to the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or MYALEPT, and
- the risk of lymphoma by:
- Educating prescribers about the development of neutralizing anti-metreleptin antibodies,the serious adverse sequelae that may result from these antibodies, and the risk for lymphoma associated with MYALEPT
- Limiting the population exposed to MYALEPT by requiring prescriber certification, pharmacy certification, and prescriber attestation that each patient has a diagnosis consistent with the approved indication
"
"21","Gattex","1110","12/18/2018","0","0","0","0","1","0","0","0","0","1","0","0","The goals of the GATTEX REMS are to mitigate the risks of possible acceleration of neoplastic growth and enhancement of colon polyp growth, gastrointestinal obstruction, and biliary and pancreatic disorders associated with GATTEX by:
- Informing patients about the risks listed above associated with the use of GATTEX
- Informing healthcare providers about the risks listed above associated with GATTEX
"
"385","Ultomiris","1111","12/21/2018","0","0","0","0","1","0","1","0","0","0","0","0","The goals of the REMS are:- To mitigate the occurrence and morbidity associated with meningococcal infections
- To educate healthcare providers and patients regarding:
- the increased risk of meningococcal infections with Ultomiris
- the early signs of invasive meningococcal infections, and
- the need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections
"
"275","Treximet","1112","09/23/2011","1","0","0","0","0","0","0","0","0","0","0","0",""
"351","Clozapine","1113","01/16/2019","0","0","0","0","1","1","1","1","0","1","0","0","The goal of the Clozapine REMS Program is to mitigate the risk of severe neutropenia associated with the use of clozapine by:
- Educating prescribers and pharmacists about the risk of severe neutropenia and appropriate monitoring requirements.
- Informing patients about the risk of severe neutropenia and appropriate monitoring requirements.
- Ensuring compliance with the monitoring schedule for absolute neutrophil count (ANC) prior to dispensing clozapine.
- Ensuring the prescriber documents a risk-benefit assessment when ANC falls below the acceptable range as described in the Prescribing Information.
- Establishing long-term safety and safe use of clozapine by enrolling all patients who receive clozapine in the registry.
"
"76","Opsumit","1114","02/01/2019","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Opsumit REMS Program is to mitigate the risk of embryo-fetal toxicity associated with
Opsumit by:
- Ensuring prescribers are educated on the following:
- the risks of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about these risks and the need for monthly monitoring
- enrolling patients in the Opsumit REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risks of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before
dispensing Opsumit
- Ensuring that patients are informed about:
- the risks of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"341","Blincyto","1115","02/05/2019","0","0","0","1","0","0","0","0","0","0","1","0","The goals of the BLINCYTO REMS are to mitigate the risk of cytokine release syndrome which may be life-threatening or fatal; the risk of neurological toxicities which may be severe,
life-threatening, or fatal; and the risk of preparation and administration errors associated with use of BLINCYTO by:
- Informing healthcare providers about the risk of cytokine release syndrome which may be life-threatening or fatal
- Informing healthcare providers about the risk of neurological toxicities which may be severe, life-threatening, or fatal
- Informing pharmacists, who will prepare and dispense BLINCYTO, and nurses, who will administer BLINCYTO, about the risk of preparation and administration errors associated
with use of BLINCYTO
"
"40","Omontys","1116","02/13/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"386","Spravato","1117","03/05/2019","0","0","0","0","1","1","0","1","1","1","0","0","The goal of the REMS is to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO administration, and abuse and misuse of SPRAVATO by:
- Ensuring that SPRAVATO is only dispensed and administered to patients in a medically supervised healthcare setting that monitors these patients
- Ensuring pharmacies and healthcare settings that dispense SPRAVATO are certified
- Ensuring that each patient is informed about the serious adverse outcomes resulting from sedation and dissociation and need for monitoring
- Enrollment of all patients in a registry to further characterize the risks and support safe use
"
"380","Jynarque","1118","03/04/2019","0","0","0","1","1","1","1","1","1","1","1","0","The goal of the JYNARQUE REMS is to mitigate the risk of serious and potentially fatal liver injury by:
- Ensuring that healthcare providers are educated on the following:
- the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- the need to counsel patients about the risk of serious and potentially fatal liver injury and the
need for monitoring at baseline and periodic monitoring as described in the Prescribing
Information
- Ensuring that healthcare providers adhere to:
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- Ensuring that patients are informed about:
- the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- Enrollment of all patients in a registry to further support long term safety and safe use of JYNARQUE
"
"387","Zulresso","1119","03/19/2019","0","0","0","0","1","1","0","1","1","0","0","0","The goal of the ZULRESSO REMS Program is to mitigate the risk of serious harm resulting from excessive
sedation and sudden loss of consciousness during the ZULRESSO infusion by:
- Ensuring that ZULRESSO is administered only to patients in a medically supervised setting that
provides monitoring while ZULRESSO is administered.
- Ensuring pharmacies and healthcare settings that dispense ZULRESSO are certified.
- Ensuring that each patient is informed of the adverse events of excessive sedation and loss of
consciousness and the need for monitoring while ZULRESSO is administered.
- Enrollment of all patients in a registry to characterize the risks and support safe use.
"
"388","PS-Ambrisentan","1120","03/28/2019","0","0","0","0","1","1","1","1","1","0","0","0","The goal of the PS-Ambrisentan REMS Program is to mitigate the risk of embryo-fetal toxicity associated
with ambrisentan by:
- Ensuring prescribers are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about the risk and the need for monthly monitoring
- enrolling patients in the PS-Ambrisentan REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before dispensing ambrisentan
- Ensuring that patients are informed about:
- the risk of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"28","Letairis","1121","03/28/2019","0","1","0","0","0","0","0","0","0","0","0","0","
with ambrisentan by:
- Ensuring prescribers are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about the risk and the need for monthly monitoring
- enrolling patients in the Ambrisentan REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before dispensing ambrisentan
- Ensuring that patients are informed about:
- the risk of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"350","Addyi","1122","04/02/2019","0","0","0","0","1","1","1","1","0","1","0","0","The goal of the Addyi REMS is to mitigate the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol by:
- Ensuring prescribers and pharmacists are educated about the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol and the need to counsel patients about this risk.
- Informing patients of the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol.
"
"74","Zyprexa Relprevv","1124","04/11/2019","0","0","1","1","1","1","1","1","1","1","0","0","The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS) by:
- ensuring Zyprexa Relprevv is prescribed only by certified prescribers, dispensed only by certified dispensers, and dispensed for use only in certified healthcare facilities with ready access to emergency response services, and dispensed for use only with documentation of safe use conditions;
- informing healthcare providers and patients about the risks and the need for continuous observation of patients for at least 3 hours in certified health care facilities; and
- establishing long-term safety and safe use of Zyprexa Relprevv through periodic monitoring for the risk of PDSS events and by enrolling all patients who receive Zyprexa Relprevv in the Zyprexa Relprevv Patient Care Program Registry.
"
"35","Mifeprex","1125","04/11/2019","0","1","0","0","0","0","0","0","0","0","0","0",""
"390","Mifepristone","1126","04/11/2019","0","0","0","0","1","1","1","0","0","0","0","0","The goal of the REMS for mifepristone is to mitigate the risk of serious complications associated with
mifepristone by:
- Requiring healthcare providers who prescribe mifepristone to be certified in the Mifepristone
REMS Program.
- Ensuring that mifepristone is only dispensed in certain healthcare settings by or under the
supervision of a certified prescriber.
- Informing patients about the risk of serious complications associated with mifepristone.
"
"391","testosterone (ANDA 208620)","1127","04/10/2019","0","0","1","0","0","0","0","0","0","0","0","0","To inform patients about the serious risks associated with the use of testosterone gel 1.62%."
"392","testosterone (ANDA 208560)","1128","04/10/2019","0","0","1","0","0","0","0","0","0","0","0","0","To inform patients about the serious risks associated with the use of testosterone gel 1.62%."
"393","testosterone (ANDA 207373)","1129","04/10/2019","0","0","1","0","0","0","0","0","0","0","0","0","To inform patients about the serious risks associated with the use of testosterone gel 1.62%."
"394","testosterone (ANDA 204570)","1130","04/10/2019","0","0","1","0","0","0","0","0","0","0","0","0","To inform patients about the serious risks associated with the use of testosterone gel 1.62%."
"341","Blincyto","1131","04/18/2019","0","0","0","1","0","0","0","0","0","0","1","0","The goals of the BLINCYTO REMS are to mitigate the risk of cytokine release syndrome which may be life-threatening or fatal; the risk of neurological toxicities which may be severe,
life-threatening, or fatal; and the risk of preparation and administration errors associated with use of BLINCYTO by:
- Informing healthcare providers about the risk of cytokine release syndrome which may be life-threatening or fatal
- Informing healthcare providers about the risk of neurological toxicities which may be severe, life-threatening, or fatal
- Informing pharmacists, who will prepare and dispense BLINCYTO, and nurses, who will administer BLINCYTO, about the risk of preparation and administration errors associated
with use of BLINCYTO
"
"340","Lemtrada","1132","04/23/2019","0","0","0","1","1","1","1","1","1","1","0","0","
The goal of the LEMTRADA REMS is to mitigate the risks of autoimmune conditions, infusion reactions, stroke, and malignancies associated with LEMTRADA by:
- Helping to ensure informed decisions about the safe use of LEMTRADA by:
- Informing patients about the serious risks of autoimmune conditions, infusion reactions, stoke, and malignancies with LEMTRADA and the need for baseline and periodic monitoring; and
- Informing healthcare providers about the serious risks of autoimmune conditions, infusion reactions, stroke, and malignancies with LEMTRADA, the need to counsel patients, and the need for baseline and periodic monitoring.
- Helping to ensure the safe use of LEMTRADA by:
- Ensuring that only certified prescribers prescribe LEMTRADA;
- Ensuring that LEMTRADA is dispensed only in certain healthcare settings, by certified pharmacies, and certified healthcare facilities administering the infusion, which have on-site access to equipment and personnel trained to manage infusion reactions; and
- Ensuring that only enrolled and authorized patients receive LEMTRADA;
- Ensuring that certified prescribers submit documentation of periodic monitoring of patients who receive LEMTRADA to identify autoimmune conditions and malignancies.
"
"61","Tracleer","1133","04/26/2019","0","1","0","0","0","0","0","0","0","0","0","0",""
"395","Bosentan","1134","04/26/2019","0","0","0","0","1","1","1","1","1","0","0","0","The goal of the Bosentan REMS Program is to mitigate the risk of hepatotoxicity and embryofetal
toxicity associated with bosentan by:
- Ensuring prescribers are educated on the following:
- the risks of hepatotoxicity and embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about these risks and the need for monthly monitoring
- enrolling patients in the Bosentan REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risks of hepatotoxicity and embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before dispensing bosentan
- Ensuring that patients are informed about:
- the risks of hepatotoxicity and embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"375","Yescarta and Tecartus","1135","04/19/2019","0","0","0","0","1","1","0","1","0","0","0","0","The goals of the YESCARTA REMS are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
- Ensuring that hospitals and their associated clinics that dispense YESCARTA are specially certified and have on-site, immediate access to tocilizumab.
- Ensuring those who prescribe, dispense, or administer YESCARTA are aware of how to manage the risks of CRS and neurological toxicities.
"
"149","Adempas","1136","05/08/2019","0","0","0","0","1","1","1","1","1","1","1","0","The goal of the Adempas REMS Program is to mitigate the risk of embryo-fetal toxicity associated with Adempas by:
- Ensuring prescribers are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about the risk and the need for monthly monitoring
- enrolling patients in the Adempas REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before dispensing Adempas
- Ensuring that patients are informed about:
- the risk of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"341","Blincyto","1137","05/16/2019","0","0","0","1","0","0","0","0","0","0","1","0","The goals of the BLINCYTO REMS are to mitigate the risk of cytokine release syndrome which may be life-threatening or fatal; the risk of neurological toxicities which may be severe,
life-threatening, or fatal; and the risk of preparation and administration errors associated with use of BLINCYTO by:
- Informing healthcare providers about the risk of cytokine release syndrome which may be life-threatening or fatal
- Informing healthcare providers about the risk of neurological toxicities which may be severe, life-threatening, or fatal
- Informing pharmacists, who will prepare and dispense BLINCYTO, and nurses, who will administer BLINCYTO, about the risk of preparation and administration errors associated
with use of BLINCYTO
"
"387","Zulresso","1138","05/17/2019","0","0","0","0","1","1","0","1","1","1","0","0","The goal of the ZULRESSO REMS Program is to mitigate the risk of serious harm resulting from excessive
sedation and sudden loss of consciousness during the ZULRESSO infusion by:
- Ensuring that ZULRESSO is administered only to patients in a medically supervised setting that
provides monitoring while ZULRESSO is administered.
- Ensuring pharmacies and healthcare settings that dispense ZULRESSO are certified.
- Ensuring that each patient is informed of the adverse events of excessive sedation and loss of
consciousness and the need for monitoring while ZULRESSO is administered.
- Enrollment of all patients in a registry to characterize the risks and support safe use.
"
"46","Revlimid","1139","05/28/2019","0","0","0","0","1","1","1","0","1","0","0","0","The goals of the REVLIMID risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to REVLIMID.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for REVLIMID.
"
"4","Androgel 1%","1140","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"318","Vogelxo","1141","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"56","Testim","1142","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"20","Fortesta","1143","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"5","Androgel 1.62%","1144","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"363","testosterone (ANDA 204255)","1145","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"353","testosterone (ANDA 076744)","1146","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"394","testosterone (ANDA 204570)","1147","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"349","testosterone (ANDA 204571)","1148","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"367","testosterone (ANDA 205328)","1149","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"393","testosterone (ANDA 207373)","1150","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"374","testosterone (ANDA 208061)","1151","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"392","testosterone (ANDA 208560)","1152","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"391","testosterone (ANDA 208620)","1153","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"378","testosterone (ANDA 209533)","1154","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"57","testosterone (NDA 202763)","1155","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"317","testosterone (NDA 203098)","1156","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"355","testosterone 1% (ANDA 076737)","1157","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"373","testosterone 1% (ANDA 091073)","1158","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"348","testosterone 1.62% (ANDA 204268)","1159","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"366","testosterone 1.62% (ANDA 205781)","1160","05/30/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"395","Bosentan","1161","05/20/2019","0","0","0","0","1","1","1","1","1","0","1","0","The goal of the Bosentan REMS Program is to mitigate the risk of hepatotoxicity and embryofetal
toxicity associated with bosentan by:
- Ensuring prescribers are educated on the following:
- the risks of hepatotoxicity and embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about these risks and the need for monthly monitoring
- enrolling patients in the Bosentan REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risks of hepatotoxicity and embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before dispensing bosentan
- Ensuring that patients are informed about:
- the risks of hepatotoxicity and embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"364","Vigabatrin","1162","05/30/2019","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Vigabatrin REMS Program is to mitigate the risk of vision loss associated with vigabatrin by:
- Ensuring that healthcare providers are educated about the risk of vision loss, the need to counsel patients about the risk, and the need for periodic visual monitoring.
- Ensuring that vigabatrin is only dispensed to patients with documentation that patients are informed about the risk of vision loss associated with vigabatrin and the need for
periodic visual monitoring.
"
"149","Adempas","1163","05/30/2019","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Adempas REMS Program is to mitigate the risk of embryo-fetal toxicity associated with Adempas by:
- Ensuring prescribers are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about the risk and the need for monthly monitoring
- enrolling patients in the Adempas REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before dispensing Adempas
- Ensuring that patients are informed about:
- the risk of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"21","Gattex","1164","05/16/2019","0","0","0","0","1","0","0","0","0","1","0","0","The goals of the GATTEX REMS are to mitigate the risks of possible acceleration of neoplastic growth and enhancement of colon polyp growth, gastrointestinal obstruction, and biliary and pancreatic disorders associated with GATTEX by:
- Informing patients about the risks listed above associated with the use of GATTEX
- Informing healthcare providers about the risks listed above associated with GATTEX
"
"76","Opsumit","1165","06/10/2019","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Opsumit REMS Program is to mitigate the risk of embryo-fetal toxicity associated with
Opsumit by:
- Ensuring prescribers are educated on the following:
- the risks of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about these risks and the need for monthly monitoring
- enrolling patients in the Opsumit REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risks of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before
dispensing Opsumit
- Ensuring that patients are informed about:
- the risks of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"67","Vivitrol","1166","06/07/2019","0","0","1","1","0","0","0","0","0","0","0","0","The goals of this REMS are:
- To inform patients and healthcare providers about severe injection site reactions associated with the use of VIVITROL.
- To inform healthcare providers about the importance of counseling their patients about severe injection site reactions associated with the use of VIVITROL.
"
"25","Juxtapid","1168","06/13/2019","0","0","0","0","1","1","1","1","0","1","1","0","The goal of the JUXTAPID REMS is to mitigate the risk of hepatotoxicity associated with the use of JUXTAPID by ensuring that:
- Prescribers are educated about the approved indication for JUXTAPID, the risk of hepatotoxicity associated with the use of JUXTAPID; and the need to monitor patients during treatment with JUXTAPID as per product labeling.
- JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
- Patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the need for baseline and periodic monitoring.
"
"387","Zulresso","1169","06/17/2019","0","0","0","0","1","1","0","1","1","1","1","0","The goal of the ZULRESSO REMS Program is to mitigate the risk of serious harm resulting from excessive
sedation and sudden loss of consciousness during the ZULRESSO infusion by:
- Ensuring that ZULRESSO is administered only to patients in a medically supervised setting that
provides monitoring while ZULRESSO is administered.
- Ensuring pharmacies and healthcare settings that dispense ZULRESSO are certified.
- Ensuring that each patient is informed of the adverse events of excessive sedation and loss of
consciousness and the need for monitoring while ZULRESSO is administered.
- Enrollment of all patients in a registry to characterize the risks and support safe use.
"
"386","Spravato","1170","06/25/2019","0","0","0","0","1","1","0","1","1","1","0","0","The goal of the REMS is to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO administration, and abuse and misuse of SPRAVATO by:
- Ensuring that SPRAVATO is only dispensed and administered to patients in a medically supervised healthcare setting that monitors these patients
- Ensuring pharmacies and healthcare settings that dispense SPRAVATO are certified
- Ensuring that each patient is informed about the serious adverse outcomes resulting from sedation and dissociation and need for monitoring
- Enrollment of all patients in a registry to further characterize the risks and support safe use
"
"362","Siliq","1171","06/27/2019","0","0","0","0","1","1","1","1","1","0","1","0","The goal of the SILIQ REMS Program is to mitigate the observed risk of suicidal ideation and behavior, including completed suicides, which occurred in subjects treated with SILIQ by:
- Ensuring that prescribers are educated about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to counsel patients about this risk.
- Ensuring that patients are informed about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to seek medical attention for manifestations of suicidal thoughts and behavior, new onset or worsening depression, anxiety, or other mood changes.
"
"365","Emtricitabine/tenofovir disoproxil fumarate","1172","07/01/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"368","Kymriah","1173","06/20/2019","0","0","0","0","1","1","0","1","0","0","0","0"," The goals of the Kymriah REMS Program are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
- Ensuring that hospitals and their associated clinics that dispense Kymriah are specially certified and have on-site, immediate access to tocilizumab.
- Ensuring those who prescribe, dispense, or administer Kymriah are aware of how to manage the risks of cytokine release syndrome and neurological toxicities.
"
"389","Turalio","1174","08/02/2019","0","0","0","1","1","1","1","1","1","1","0","0","The goal of the TURALIO REMS is to mitigate the risk of serious and potentially fatal liver injury by:
- Ensuring that prescribers are educated on the following:
- approved indication for TURALIO
- the risk of serious and potentially fatal liver injury associated with the use of TURALIO
- the need for liver monitoring at baseline and periodically during treatment with dose modifications as described in the Prescribing Information
- the need to counsel patients about the risk of serious and potentially fatal liver injury, liver
monitoring at baseline and periodically during treatment with TURALIO as described in the Patient Guide and to report signs and/or symptoms of liver injury to the prescriber during therapy
- Ensuring that prescribers adhere to the requirement of baseline and periodic monitoring as described in the Prescribing Information
- Enrollment of all patients in a registry to further assess the safe use and acute, chronic and irreversible hepatotoxicity of TURALIO.
"
"360","Alosetron","1175","08/05/2019","0","0","0","0","1","0","0","0","0","1","1","0","The goals and objectives of the Alosetron REMS Program are to mitigate the risks of ischemic colitis (IC) and serious complications of constipation (CoC) associated with alosetron hydrochloride (hereinafter, referred to as alosetron) by:
- Informing prescribers of alosetron about:
- the serious risks of IC and serious CoC associated with alosetron the importance of understanding that alosetron should only be used in severely affected diarrhea-predominant irritable bowel syndrome patients for whom the benefits exceed the risks.
- the importance of counseling patients about the risks of IC and serious CoC.
Informing patients about the risks of IC and CoC and actions to take should they experience early warning signs and symptoms of these risks.
"
"396","Ambrisentan Shared System","1178","03/28/2019","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Ambrisentan REMS Program is to mitigate the risk of embryo-fetal toxicity associated
with ambrisentan by:
- Ensuring prescribers are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about the risk and the need for monthly monitoring
- enrolling patients in the Ambrisentan REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before dispensing ambrisentan
- Ensuring that patients are informed about:
- the risk of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"375","Yescarta and Tecartus","1180","08/02/2019","0","0","0","0","1","1","0","1","0","1","0","0","The goals of the YESCARTA REMS are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
- Ensuring that hospitals and their associated clinics that dispense YESCARTA are specially certified and have on-site, immediate access to tocilizumab.
- Ensuring those who prescribe, dispense, or administer YESCARTA are aware of how to manage the risks of CRS and neurological toxicities.
"
"389","Turalio","1181","08/20/2019","0","0","0","1","1","1","1","1","1","1","1","0","The goal of the TURALIO REMS is to mitigate the risk of serious and potentially fatal liver injury by:
- Ensuring that prescribers are educated on the following:
- approved indication for TURALIO
- the risk of serious and potentially fatal liver injury associated with the use of TURALIO
- the need for liver monitoring at baseline and periodically during treatment with dose modifications as described in the Prescribing Information
- the need to counsel patients about the risk of serious and potentially fatal liver injury, liver
monitoring at baseline and periodically during treatment with TURALIO as described in the Patient Guide and to report signs and/or symptoms of liver injury to the prescriber during therapy
- Ensuring that prescribers adhere to the requirement of baseline and periodic monitoring as described in the Prescribing Information
- Enrollment of all patients in a registry to further assess the safe use and acute, chronic and irreversible hepatotoxicity of TURALIO.
"
"364","Vigabatrin","1182","09/12/2019","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Vigabatrin REMS Program is to mitigate the risk of vision loss associated with vigabatrin by:
- Ensuring that healthcare providers are educated about the risk of vision loss, the need to counsel patients about the risk, and the need for periodic visual monitoring.
- Ensuring that vigabatrin is only dispensed to patients with documentation that patients are informed about the risk of vision loss associated with vigabatrin and the need for
periodic visual monitoring.
"
"49","Soliris","1183","06/27/2019","0","0","0","0","1","0","1","0","0","1","0","0","The goals of the REMS are:
- To mitigate the occurrence and morbidity associated with meningococcal infections
- To educate Healthcare Professionals (HCPs) and Patients regarding:
- the increased risk of meningococcal infections with Soliris
- the early signs of invasive meningococcal infections, and
- the need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections
"
"387","Zulresso","1184","09/30/2019","0","0","0","0","1","1","0","1","1","1","0","0","The goal of the ZULRESSO REMS Program is to mitigate the risk of serious harm resulting from excessive
sedation and sudden loss of consciousness during the ZULRESSO infusion by:
- Ensuring that ZULRESSO is administered only to patients in a medically supervised setting that
provides monitoring while ZULRESSO is administered.
- Ensuring pharmacies and healthcare settings that dispense ZULRESSO are certified.
- Ensuring that each patient is informed of the adverse events of excessive sedation and loss of
consciousness and the need for monitoring while ZULRESSO is administered.
- Enrollment of all patients in a registry to characterize the risks and support safe use.
"
"350","Addyi","1185","10/09/2019","0","0","1","0","0","0","0","0","0","0","0","1","The goal of the Addyi REMS is to inform patients about the increased risk of hypotension and syncope associated with Addyi
due to an interaction with alcohol."
"385","Ultomiris","1186","10/18/2019","0","0","0","0","1","0","1","0","0","0","0","0","The goals of the REMS are:- To mitigate the occurrence and morbidity associated with meningococcal infections
- To educate healthcare providers and patients regarding:
- the increased risk of meningococcal infections with Ultomiris
- the early signs of invasive meningococcal infections, and
- the need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections
"
"340","Lemtrada","1187","10/29/2019","0","0","0","1","1","1","1","1","1","0","0","0","The goal of the LEMTRADA REMS is to mitigate the risks of autoimmune conditions, infusion reactions, stroke, and malignancies associated with LEMTRADA by:
- Helping to ensure informed decisions about the safe use of LEMTRADA by:
- Informing patients about the serious risks of autoimmune conditions, infusion reactions, stoke, and malignancies with LEMTRADA and the need for baseline and periodic monitoring; and
- Informing healthcare providers about the serious risks of autoimmune conditions, infusion reactions, stroke, and malignancies with LEMTRADA, the need to counsel patients, and the need for baseline and periodic monitoring.
- Helping to ensure the safe use of LEMTRADA by:
- Ensuring that only certified prescribers prescribe LEMTRADA;
- Ensuring that LEMTRADA is dispensed only in certain healthcare settings, by certified pharmacies, and certified healthcare facilities administering the infusion, which have on-site access to equipment and personnel trained to manage infusion reactions; and
- Ensuring that only enrolled and authorized patients receive LEMTRADA;
- Ensuring that certified prescribers submit documentation of periodic monitoring of patients who receive LEMTRADA to identify autoimmune conditions and malignancies.
"
"376","Sublocade","1188","11/07/2019","0","0","0","0","1","1","0","1","0","0","1","0","The goal of the SUBLOCADE REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration by:
- Ensuring healthcare settings and pharmacies are certified and only dispense SUBLOCADE directly to a healthcare provider for administration by a healthcare provider.
"
"351","Clozapine","1189","11/12/2019","0","0","0","0","1","1","1","1","0","1","1","0","The goal of the Clozapine REMS Program is to mitigate the risk of severe neutropenia associated with the use of clozapine by:
- Educating prescribers and pharmacists about the risk of severe neutropenia and appropriate monitoring requirements.
- Informing patients about the risk of severe neutropenia and appropriate monitoring requirements.
- Ensuring compliance with the monitoring schedule for absolute neutrophil count (ANC) prior to dispensing clozapine.
- Ensuring the prescriber documents a risk-benefit assessment when ANC falls below the acceptable range as described in the Prescribing Information.
- Establishing long-term safety and safe use of clozapine by enrolling all patients who receive clozapine in the registry.
"
"375","Yescarta and Tecartus","1191","11/12/2019","0","0","0","0","1","1","0","1","0","1","0","0","The goals of the YESCARTA REMS are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
- Ensuring that hospitals and their associated clinics that dispense YESCARTA are specially certified and have on-site, immediate access to tocilizumab.
- Ensuring those who prescribe, dispense, or administer YESCARTA are aware of how to manage the risks of CRS and neurological toxicities.
"
"389","Turalio","1192","11/19/2019","0","0","0","1","1","1","1","1","1","1","0","0","The goal of the TURALIO REMS is to mitigate the risk of serious and potentially fatal liver injury by:
- Ensuring that prescribers are educated on the following:
- approved indication for TURALIO
- the risk of serious and potentially fatal liver injury associated with the use of TURALIO
- the need for liver monitoring at baseline and periodically during treatment with dose modifications as described in the Prescribing Information
- the need to counsel patients about the risk of serious and potentially fatal liver injury, liver
monitoring at baseline and periodically during treatment with TURALIO as described in the Patient Guide and to report signs and/or symptoms of liver injury to the prescriber during therapy
- Ensuring that prescribers adhere to the requirement of baseline and periodic monitoring as described in the Prescribing Information
- Enrollment of all patients in a registry to further assess the safe use and acute, chronic and irreversible hepatotoxicity of TURALIO.
"
"17","Opioid Analgesic REMS","1193","11/14/2019","0","0","1","0","1","0","0","0","0","1","0","0","The goal of the Opioid Analgesic REMS is to educate prescribers and other healthcare providers (including pharmacists and nurses) on the treatment and monitoring of patients with pain. The education provided through the REMS program is based on the Opioid Analgesic REMS Education Blueprint for Health Care
Providers Involved in the Treatment and Monitoring of Patients with Pain (“FDA Blueprint”). Through better education, the healthcare team will have an improved understanding of how to manage pain and the role of opioid analgesics along with nonpharmacologic and non-opioid analgesics in pain management. The education will also provide information about the risks of opioids and use of other therapies which is intended to assist healthcare providers in reducing adverse outcomes of addiction, unintentional overdose, and death resulting from inappropriate prescribing, abuse, and misuse. The REMS will accomplish this goal by:
- Ensuring that training based on the FDA Blueprint is effective in educating prescribers and other
healthcare providers involved in the treatment and monitoring of patients in pain (including pharmacists and nurses) about recommended pain management practices and appropriate use of opioid analgesics.
- Informing patients about their roles and responsibilities regarding their pain treatment plan, including the risks of opioid analgesics and how to use and store them safely, as outlined in the Medication Guides and Patient Counseling Guide for opioid analgesics.
"
"380","Jynarque","1194","12/03/2019","0","0","0","1","1","1","1","1","1","1","0","0","The goal of the JYNARQUE REMS is to mitigate the risk of serious and potentially fatal liver injury by:
- Ensuring that healthcare providers are educated on the following:
- the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- the need to counsel patients about the risk of serious and potentially fatal liver injury and the
need for monitoring at baseline and periodic monitoring as described in the Prescribing
Information
- Ensuring that healthcare providers adhere to:
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- Ensuring that patients are informed about:
- the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- Enrollment of all patients in a registry to further support long term safety and safe use of JYNARQUE
"
"18","Extraneal","1195","12/04/2019","1","0","0","0","0","0","0","0","0","0","0","0",""
"387","Zulresso","1196","12/13/2019","0","0","0","0","1","1","0","1","1","1","0","0","The goal of the ZULRESSO REMS Program is to mitigate the risk of serious harm resulting from excessive
sedation and sudden loss of consciousness during the ZULRESSO infusion by:
- Ensuring that ZULRESSO is administered only to patients in a medically supervised setting that
provides monitoring while ZULRESSO is administered.
- Ensuring pharmacies and healthcare settings that dispense ZULRESSO are certified.
- Ensuring that each patient is informed of the adverse events of excessive sedation and loss of
consciousness and the need for monitoring while ZULRESSO is administered.
- Enrollment of all patients in a registry to characterize the risks and support safe use.
"
"362","Siliq","1197","12/13/2019","0","0","0","0","1","1","1","1","1","0","1","0","The goal of the SILIQ REMS Program is to mitigate the observed risk of suicidal ideation and behavior, including completed suicides, which occurred in subjects treated with SILIQ by:
- Ensuring that prescribers are educated about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to counsel patients about this risk.
- Ensuring that patients are informed about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to seek medical attention for manifestations of suicidal thoughts and behavior, new onset or worsening depression, anxiety, or other mood changes.
"
"15","Entereg","1198","12/19/2019","0","1","0","0","0","0","0","0","0","0","0","0",""
"397","Alvimopan Shared System REMS","1199","12/19/2019","0","0","0","0","1","1","0","1","0","0","0","0","The goal of the Alvimopan REMS Program is to mitigate the potential risk of myocardial infarction by:
- Ensuring that alvimopan is used only for short-term use (no more than 15 doses) in a hospital inpatient setting.
"
"24","Isotretinoin iPLEDGE","1201","01/24/2020","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the isotretinoin risk evaluation and mitigation strategy are:
- To prevent fetal exposure to isotretinoin
- To inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions
"
"364","Vigabatrin","1202","01/24/2020","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Vigabatrin REMS Program is to mitigate the risk of vision loss associated with vigabatrin by:
- Ensuring that healthcare providers are educated about the risk of vision loss, the need to counsel patients about the risk, and the need for periodic visual monitoring.
- Ensuring that vigabatrin is only dispensed to patients with documentation that patients are informed about the risk of vision loss associated with vigabatrin and the need for
periodic visual monitoring.
The goal of the Vigabatrin REMS Program is to mitigate the risk of vision loss associated with vigabatrin by:
- Ensuring that healthcare providers are educated about the risk of vision loss, the need to counsel patients about the risk, and the need for periodic visual monitoring.
- Ensuring that vigabatrin is only dispensed to patients with documentation that patients are informed about the risk of vision loss associated with vigabatrin and the need for
periodic visual monitoring.
"
"352","Suboxone/Subutex","1203","01/24/2020","0","0","1","0","1","1","0","0","0","0","1","0","The goals of the REMS for SUBOXONE sublingual film, Authorized Generic of SUBOXONE sublingual film, SUBOXONE sublingual tablets, and SUBUTEX sublingual tablets are to:
- Mitigate the risks of accidental overdose, misuse and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with SUBOXONE sublingual film, Authorized Generic of SUBOXONE sublingual film, SUBOXONE sublingual tablets,
and SUBUTEX sublingual tablets.
"
"351","Clozapine","1204","","0","0","0","0","0","0","0","0","0","0","0","0",""
"376","Sublocade","1205","01/28/2020","0","0","0","0","1","1","0","1","0","0","1","0","The goal of the SUBLOCADE REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration by:
- Ensuring healthcare settings and pharmacies are certified and only dispense SUBLOCADE directly to a healthcare provider for administration by a healthcare provider.
"
"398","Palforzia","1206","01/31/2020","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the PALFORZIA REMS Program is to mitigate the risk of anaphylaxis associated with PALFORZIA by:
- Ensuring that healthcare providers who prescribe and healthcare settings that dispense and administer PALFORZIA are educated on the following:
- the risk of anaphylaxis associated with the use of PALFORZIA
- the Initial Dose Escalation and first dose of each Up-Dosing level must only be administered to patients in a healthcare setting equipped to monitor patients, and to identify and manage anaphylaxis.
- Ensuring that the Initial Dose Escalation and the first dose of each Up-Dosing level of PALFORZIA are only dipsensed and distributed to certified healthcare sttings and only administered to patients in healthcare settings
- Ensuring that PALFORZIA is only dispensed and administered to patients who are informed, by enrolling in the PALFORZIA REMS Program, of the need to have injectable epinephrine available for immediate use at all times, the need for monitoring with the Initial Dose Escalation and first dose of each Up-Dosing level, the need for continued dietary peanut avoidance, and how to recognize the signs and symptoms of anaphylaxis.
"
"149","Adempas","1207","02/10/2020","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Adempas REMS Program is to mitigate the risk of embryo-fetal toxicity associated with Adempas by:
- Ensuring prescribers are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about the risk and the need for monthly monitoring
- enrolling patients in the Adempas REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before dispensing Adempas
- Ensuring that patients are informed about:
- the risk of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"43","Prolia","1208","04/30/2019","0","0","1","1","0","0","0","0","0","0","0","0","The goal of the PROLIA REMS is to mitigate the risks of hypocalcemia, osteonecrosis of the jaw, atypical femoral fractures, serious infections, and dermatologic reactions by:
- informing healthcare providers and patients about the risks of (1) hypocalcemia, (2) osteonecrosis of the jaw, (3) atypical femoral fractures, (4) serious infections, and (5) dermatologic reactions associated with PROLIA
- informing healthcare providers they should counsel patients about the risks associated with PROLIA.
"
"43","Prolia","1209","10/01/2019","0","0","1","1","0","0","0","0","0","1","0","0","The goal of the PROLIA REMS is to mitigate the risks of hypocalcemia, osteonecrosis of the jaw, atypical femoral fractures, serious infections, and dermatologic reactions by:
- informing healthcare providers and patients about the risks of (1) hypocalcemia, (2) osteonecrosis of the jaw, (3) atypical femoral fractures, (4) serious infections, and (5) dermatologic reactions associated with PROLIA
- informing healthcare providers they should counsel patients about the risks associated with PROLIA.
"
"341","Blincyto","1210","02/14/2020","0","0","0","1","0","0","0","0","0","0","1","0","The goals of the BLINCYTO REMS are to mitigate the risk of cytokine release syndrome which may be life-threatening or fatal; the risk of neurological toxicities which may be severe,
life-threatening, or fatal; and the risk of preparation and administration errors associated with use of BLINCYTO by:
- Informing healthcare providers about the risk of cytokine release syndrome which may be life-threatening or fatal
- Informing healthcare providers about the risk of neurological toxicities which may be severe, life-threatening, or fatal
- Informing pharmacists, who will prepare and dispense BLINCYTO, and nurses, who will administer BLINCYTO, about the risk of preparation and administration errors associated
with use of BLINCYTO
"
"352","Suboxone/Subutex","1211","03/02/2020","0","0","1","0","1","1","0","0","0","0","0","0","The goals of the REMS for SUBOXONE sublingual film, Authorized Generic of SUBOXONE sublingual film, SUBOXONE sublingual tablets, and SUBUTEX sublingual tablets are to:
- Mitigate the risks of accidental overdose, misuse and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with SUBOXONE sublingual film, Authorized Generic of SUBOXONE sublingual film, SUBOXONE sublingual tablets,
and SUBUTEX sublingual tablets.
"
"344","Farydak","1212","03/13/2020","0","0","0","1","0","0","0","0","0","0","1","1","The goal of the FARYDAK REMS is to mitigate the risks of severe diarrhea and cardiac toxicities (severe and fatal cardiac ischemic events, severe arrhythmias, and ECG changes) associated with FARYDAK treatment
- by informing healthcare providers about the risks of severe diarrhea and cardiac toxicities associated with FARYDAK.
"
"314","Myalept","1213","03/13/2020","0","0","0","1","1","1","1","1","0","1","1","0","The goal of the MYALEPT REMS is to mitigate
- the risks of serious adverse sequelae (such as severe infections, excessive weight gain, glucose intolerance, diabetes mellitus) due to the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or MYALEPT, and
- the risk of lymphoma by:
- Educating prescribers about the development of neutralizing anti-metreleptin antibodies,the serious adverse sequelae that may result from these antibodies, and the risk for lymphoma associated with MYALEPT
- Limiting the population exposed to MYALEPT by requiring prescriber certification, pharmacy certification, and prescriber attestation that each patient has a diagnosis consistent with the approved indication
"
"25","Juxtapid","1214","03/13/2020","0","0","0","0","1","1","1","1","0","1","1","0","The goal of the JUXTAPID REMS is to mitigate the risk of hepatotoxicity associated with the use of JUXTAPID by ensuring that:
- Prescribers are educated about the approved indication for JUXTAPID, the risk of hepatotoxicity associated with the use of JUXTAPID; and the need to monitor patients during treatment with JUXTAPID as per product labeling.
- JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
- Patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the need for baseline and periodic monitoring.
"
"49","Soliris","1215","04/07/2020","0","0","0","0","1","0","1","0","0","1","0","0","The goals of the REMS are:
- To mitigate the occurrence and morbidity associated with meningococcal infections
- To educate Healthcare Professionals (HCPs) and Patients regarding:
- the increased risk of meningococcal infections with Soliris
- the early signs of invasive meningococcal infections, and
- the need for immediate medical evaluation of signs and symptoms consistent with possible meningococcal infections
"
"76","Opsumit","1216","04/08/2020","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Opsumit REMS Program is to mitigate the risk of embryo-fetal toxicity associated with
Opsumit by:
- Ensuring prescribers are educated on the following:
- the risks of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about these risks and the need for monthly monitoring
- enrolling patients in the Opsumit REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risks of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before
dispensing Opsumit
- Ensuring that patients are informed about:
- the risks of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"388","PS-Ambrisentan","1217","04/20/2020","0","1","0","0","0","0","0","0","0","0","0","0",""
"74","Zyprexa Relprevv","1218","04/22/2020","0","0","1","1","1","1","1","1","1","1","0","0","The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS) by:
- ensuring Zyprexa Relprevv is prescribed only by certified prescribers, dispensed only by certified dispensers, and dispensed for use only in certified healthcare facilities with ready access to emergency response services, and dispensed for use only with documentation of safe use conditions;
- informing healthcare providers and patients about the risks and the need for continuous observation of patients for at least 3 hours in certified health care facilities; and
- establishing long-term safety and safe use of Zyprexa Relprevv through periodic monitoring for the risk of PDSS events and by enrolling all patients who receive Zyprexa Relprevv in the Zyprexa Relprevv Patient Care Program Registry.
"
"63","Tysabri","1219","04/21/2020","0","0","1","0","1","1","1","1","1","1","0","0","
The goals of the Tysabri REMS are:
- To inform prescribers, infusion center healthcare providers, and patients about the risk of progressive multifocal leukoencephalopathy
(PML) associated with TYSABRI including the increased risk of PML with longer treatment duration, prior immunosuppressant use and the presence of anti-JCV antibodies.
- To warn against concurrent use with antineoplastic, immunosuppressant, or immunomodulating agents, and in patients who are immunocompromised.
- To promote early diagnosis of PML and timely discontinuation of TYSABRI in the event of suspected PML.
"
"63","Tysabri","1220","04/27/2020","0","0","1","0","1","1","1","1","1","1","1","0","The goals of the Tysabri REMS are:
- To inform prescribers, infusion center healthcare providers, and patients about the risk of progressive multifocal leukoencephalopathy
(PML) associated with TYSABRI including the increased risk of PML with longer treatment duration, prior immunosuppressant use and the presence of anti-JCV antibodies.
- To warn against concurrent use with antineoplastic, immunosuppressant, or immunomodulating agents, and in patients who are immunocompromised.
- To promote early diagnosis of PML and timely discontinuation of TYSABRI in the event of suspected PML.
"
"385","Ultomiris","1221","04/30/2020","0","0","0","0","1","0","1","0","0","0","0","0","The goals of the REMS are:- To mitigate the occurrence and morbidity associated with meningococcal infections
"
"383","Tegsedi","1222","05/11/2020","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Tegsedi REMS is to mitigate the risk of serious bleeding with severe thrombocytopenia and
the risk of glomerulonephritis associated with Tegsedi by:
- Ensuring prescribers are educated on the risk of serious bleeding with severe thrombocytopenia
and the risk of glomerulonephritis associated with Tegsedi.
- Ensuring prescribers are educated and adhere to the following:
- Counsel patients on how to recognize and respond to signs and symptoms of serious
bleeding and glomerulonephritis.
- Enroll patients in the Tegsedi REMS Program.
- Submit documentation that periodic monitoring of patients is being done to identify severe
thrombocytopenia, serious bleeding with severe thrombocytopenia, and glomerulonephritis.
- Ensuring patients are informed on the following:
- How to recognize and respond to signs and symptoms of serious bleeding and
glomerulonephritis.
- The need to have their platelet count and renal function monitored.
- Enrollment of all patients in a registry to further support long-term safety and safe use of Tegsedi.
"
"41","Pomalyst","1223","05/14/2020","0","0","0","0","1","1","1","0","1","0","0","0","The goals of the POMALYST risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to POMALYST.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for POMALYST.
"
"343","Natpara","1224","06/05/2020","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the NATPARA REMS Program is to mitigate the potential risk of osteosarcoma associated with NATPARA by:
- ensuring that prescribers are educated on the following:
- potential risk of osteosarcoma associated with the use of NATPARA
- appropriate patient selection
- safe-use conditions required for prescribing NATPARA
- ensuring that NATPARA is dispensed only to patients informed about the potential risk of osteosarcoma associated with the use of NATPARA
"
"376","Sublocade","1225","06/15/2020","0","0","0","0","1","1","0","1","0","0","0","0","The goal of the SUBLOCADE REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration by:
- Ensuring healthcare settings and pharmacies are certified and only dispense SUBLOCADE directly to a healthcare provider for administration by a healthcare provider.
"
"400","Fintepla","1227","06/25/2020","0","0","0","1","1","1","1","1","1","1","0","0","The goal of the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program is to mitigate the risk of valvular heart disease and pulmonary arterial hypertension associated with FINTEPLA, by:
- Ensuring prescribers are educated on:
- The risk of valvular heart disease and pulmonary arterial hypertension associated with FINTEPLA.
- The need to counsel patients on how to recognize and respond to signs and symptoms of valvular heart disease and pulmonary arterial hypertension.
- The need to enroll patients in the FINTEPLA REMS.
- The need to submit documentation of baseline and periodic cardiac monitoring of patients to identify valvular heart disease and pulmonary arterial hypertension.
- Ensuring prescribers adhere to the following:
- Enroll patients in the FINTEPLA REMS.
- Submit documentation of baseline cardiac monitoring.
- Submit documentation of periodic cardiac monitoring.
- Ensuring patients are educated on the following:
- How to recognize and respond to signs and symptoms of valvular heart disease and pulmonary arterial hypertension.
- The need to have baseline and periodic cardiac monitoring.
- Enrolling of all patients in a registry to further support the long-term safety and safe use of FINTEPLA.
"
"314","Myalept","1228","07/13/2020","0","0","0","1","1","1","1","1","0","1","0","0","The goal of the MYALEPT REMS is to mitigate
- the risks of serious adverse sequelae (such as severe infections, excessive weight gain, glucose intolerance, diabetes mellitus) due to the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or MYALEPT, and
- the risk of lymphoma by:
- Educating prescribers about the development of neutralizing anti-metreleptin antibodies,the serious adverse sequelae that may result from these antibodies, and the risk for lymphoma associated with MYALEPT
- Limiting the population exposed to MYALEPT by requiring prescriber certification, pharmacy certification, and prescriber attestation that each patient has a diagnosis consistent with the approved indication
"
"63","Tysabri","1229","07/07/2020","0","0","1","0","1","1","1","1","1","1","1","0","The goals of the Tysabri REMS are:
- To inform prescribers, infusion center healthcare providers, and patients about the risk of progressive multifocal leukoencephalopathy
(PML) associated with TYSABRI including the increased risk of PML with longer treatment duration, prior immunosuppressant use and the presence of anti-JCV antibodies.
- To warn against concurrent use with antineoplastic, immunosuppressant, or immunomodulating agents, and in patients who are immunocompromised.
- To promote early diagnosis of PML and timely discontinuation of TYSABRI in the event of suspected PML.
"
"21","Gattex","1230","07/14/2020","0","0","0","0","1","0","0","0","0","1","0","0","The goals of the GATTEX REMS are to mitigate the risks of possible acceleration of neoplastic growth and enhancement of colon polyp growth, gastrointestinal obstruction,
and biliary and pancreatic disorders associated with GATTEX by:- Informing patients about the risks listed above associated with the use of GATTEX
- Informing healthcare providers about the risks listed above associated with GATTEX
"
"398","Palforzia","1231","07/17/2020","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the PALFORZIA REMS Program is to mitigate the risk of anaphylaxis associated with PALFORZIA by:
- Ensuring that healthcare providers who prescribe and healthcare settings that dispense and administer PALFORZIA are educated on the following:
- the risk of anaphylaxis associated with the use of PALFORZIA
- the Initial Dose Escalation and first dose of each Up-Dosing level must only be administered to patients in a healthcare setting equipped to monitor patients, and to identify and manage anaphylaxis.
- Ensuring that the Initial Dose Escalation and the first dose of each Up-Dosing level of PALFORZIA are only dipsensed and distributed to certified healthcare sttings and only administered to patients in healthcare settings
- Ensuring that PALFORZIA is only dispensed and administered to patients who are informed, by enrolling in the PALFORZIA REMS Program, of the need to have injectable epinephrine available for immediate use at all times, the need for monitoring with the Initial Dose Escalation and first dose of each Up-Dosing level, the need for continued dietary peanut avoidance,
and how to recognize the signs and symptoms of anaphylaxis.
"
"345","Xywav and Xyrem","1232","07/21/2020","0","0","1","0","1","1","1","1","1","1","0","0","The goal of the XYWAV and XYREM REMS is to mitigate the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and
diversion of XYWAV and XYREM by:
- Informing prescribers, pharmacists, and patients of:
- The risk of significant CNS and respiratory depression associated with XYWAV and XYREM.
- The contraindication of use of XYREM with sedative hypnotics and alcohol.
- The potential for abuse, misuse, and overdose associated with XYWAV and XYREM.
- The safe use, handling, and storage of XYWAV and XYREM.
- Ensuring that pharmacy controls exist prior to filling prescriptions for XYWAV and XYREM that:
- Screen for concomitant use of sedative hypnotics and other potentially interacting agents.
- Monitor for inappropriate prescribing, misuse, abuse, and diversion of XYWAV and XYREM.
- Notify prescribers when patients are receiving concomitant contraindicated medications or there are signs of potential abuse, misuse, or diversion.
"
"375","Yescarta and Tecartus","1234","07/24/2020","0","0","0","0","1","1","0","1","0","1","0","0","The goals of the YESCARTA and TECARTUS REMS are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
- Ensuring that hospitals and their associated clinics that dispense YESCARTA and/or TECARTUS are specially certified and have on-site, immediate access to tocilizumab.
- Ensuring those who prescribe, dispense, or administer YESCARTA and/or TECARTUS are aware of how to manage the risks of CRS and neurological toxicities.
"
"386","Spravato","1235","07/31/2020","0","0","0","0","1","1","0","1","1","1","0","0","The goal of the REMS is to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO administration, and abuse and misuse of SPRAVATO by:
- Ensuring that SPRAVATO is only dispensed and administered to patients in a medically supervised healthcare setting that monitors these patients
- Ensuring pharmacies and healthcare settings that dispense SPRAVATO are certified
- Ensuring that each patient is informed about the serious adverse outcomes resulting from sedation and dissociation and need for monitoring
- Enrolling all patients who receive treatment in an outpatient healthcare setting in a registry to further characterize the risks and support safe use
"
"389","Turalio","1236","08/04/2020","0","0","0","1","1","1","1","1","1","1","0","0","The goal of the TURALIO REMS is to mitigate the risk of serious and potentially fatal liver injury by:
- Ensuring that prescribers are educated on the following:
- approved indication for TURALIO
- the risk of serious and potentially fatal liver injury associated with the use of TURALIO
- the need for liver monitoring at baseline and periodically during treatment with dose modifications as described in the Prescribing Information
- the need to counsel patients about the risk of serious and potentially fatal liver injury, liver
monitoring at baseline and periodically during treatment with TURALIO as described in the Patient Guide and to report signs and/or symptoms of liver injury to the prescriber during therapy
- Ensuring that prescribers adhere to the requirement of baseline and periodic monitoring as described in the Prescribing Information
- Enrollment of all patients in a registry to further assess the safe use and acute, chronic and irreversible hepatotoxicity of TURALIO.
"
"403","Blenrep","1237","08/05/2020","0","0","0","1","1","1","1","1","1","1","0","0"," The goal of the BLENREP REMS is to manage the risk of ocular toxicity by:
- Ensuring that healthcare providers are educated on the risk of ocular toxicity associated with the use of BLENREP
- Ensuring that healthcare providers are educated and adhere to the following:
- submit documentation that ophthalmic exams are being done at baseline and prior to each dose to identify ocular toxicity
- counsel patients on the risk of ocular toxicity and the requirement for monitoring via ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms as described in the Prescribing Information
- Ensuring safe use of BLENREP by:
- Ensuring that BLENREP is infused in certified healthcare settings only after verification of ophthalmic exams
- Ensuring that patients are informed about:
- the risk of ocular toxicity associated with the use of BLENREP
- the requirement for ophthalmic exams at baseline, prior to each dose and promptly for worsening symptoms, as described in the Prescribing Information
"
"403","Blenrep","1238","09/10/2020","0","0","0","1","1","1","1","1","1","1","1","0"," The goal of the BLENREP REMS is to manage the risk of ocular toxicity by:
- Ensuring that healthcare providers are educated on the risk of ocular toxicity associated with the use of BLENREP
- Ensuring that healthcare providers are educated and adhere to the following:
- submit documentation that ophthalmic exams are being done at baseline and prior to each dose to identify ocular toxicity
- counsel patients on the risk of ocular toxicity and the requirement for monitoring via ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms as described in the Prescribing Information
- Ensuring safe use of BLENREP by:
- Ensuring that BLENREP is infused in certified healthcare settings only after verification of ophthalmic exams
- Ensuring that patients are informed about:
- the risk of ocular toxicity associated with the use of BLENREP
- the requirement for ophthalmic exams at baseline, prior to each dose and promptly for worsening symptoms, as described in the Prescribing Information
"
"46","Revlimid","1239","09/24/2020","0","0","0","0","1","1","1","0","1","0","0","0","The goals of the REVLIMID risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to REVLIMID.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for REVLIMID.
"
"364","Vigabatrin","1240","10/02/2020","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Vigabatrin REMS Program is to mitigate the risk of vision loss associated with vigabatrin by:
- Ensuring that healthcare providers are educated about the risk of vision loss, the need to counsel patients about the risk, and the need for periodic visual monitoring.
- Ensuring that vigabatrin is only dispensed to patients with documentation that patients are informed about the risk of vision loss associated with vigabatrin and the need for
periodic visual monitoring.
"
"381","Palynziq","1241","10/06/2020","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the PALYNZIQ (pegvaliase-pqpz) REMS is to mitigate the risk of anaphylaxis associated with PALYNZIQ by:
- Ensuring that prescribers are educated on the risk of anaphylaxis associated with the use of PALYNZIQ
- Ensuring that prescribers are educated and adhere to the following:
- Counsel patients on how to recognize and respond to signs and symptoms of anaphylaxis
- Enroll patients in the PALYNZIQ REMS
- Prescribe auto-injectable epinephrine with PALYNZIQ
- Ensuring that PALYNZIQ is only dispensed to patients with documentation of safe use conditions
- Patient education and enrollment in the PALYNZIQ REMS
- Having auto-injectable epinephrine available at all timesM/li>
- Ensuring that patients are educated on the following:
- How to recognize and respond to signs and symptoms of anaphylaxis
- The need to carry auto-injectable epinephrine with them at all times
"
"63","Tysabri","1242","10/05/2020","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the Tysabri REMS are:
- To inform prescribers, infusion center healthcare providers, and patients about the risk of progressive multifocal leukoencephalopathy
(PML) associated with TYSABRI including the increased risk of PML with longer treatment duration, prior immunosuppressant use and the presence of anti-JCV antibodies.
- To warn against concurrent use with antineoplastic, immunosuppressant, or immunomodulating agents, and in patients who are immunocompromised.
- To promote early diagnosis of PML and timely discontinuation of TYSABRI in the event of suspected PML.
"
"352","Suboxone/Subutex","1243","10/01/2020","0","0","1","0","1","1","0","0","0","0","1","0","The goals of the REMS for SUBOXONE sublingual film, Authorized Generic of SUBOXONE sublingual film, SUBOXONE sublingual tablets, and SUBUTEX sublingual tablets are to:
- Mitigate the risks of accidental overdose, misuse and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with SUBOXONE sublingual film, Authorized Generic of SUBOXONE sublingual film, SUBOXONE sublingual tablets,
and SUBUTEX sublingual tablets.
"
"387","Zulresso","1244","10/14/2020","0","0","0","0","1","1","0","1","1","1","1","0","The goal of the ZULRESSO REMS Program is to mitigate the risk of serious harm resulting from excessive
sedation and sudden loss of consciousness during the ZULRESSO infusion by:
- Ensuring that ZULRESSO is administered only to patients in a medically supervised setting that
provides monitoring while ZULRESSO is administered.
- Ensuring pharmacies and healthcare settings that dispense ZULRESSO are certified.
- Ensuring that each patient is informed of the adverse events of excessive sedation and loss of
consciousness and the need for monitoring while ZULRESSO is administered.
- Enrollment of all patients in a registry to characterize the risks and support safe use.
"
"314","Myalept","1245","10/15/2020","0","0","0","1","1","1","1","1","0","1","1","0","The goal of the MYALEPT REMS is to mitigate
- the risks of serious adverse sequelae (such as severe infections, excessive weight gain, glucose intolerance, diabetes mellitus) due to the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or MYALEPT, and
- the risk of lymphoma by:
- Educating prescribers about the development of neutralizing anti-metreleptin antibodies,the serious adverse sequelae that may result from these antibodies, and the risk for lymphoma
associated with MYALEPT
- Limiting the population exposed to MYALEPT by requiring prescriber certification, pharmacy certification, and prescriber attestation that each patient has a diagnosis consistent
with the approved indication
"
"25","Juxtapid","1246","05/18/2020","0","0","0","0","1","1","1","1","0","1","1","0","The goal of the JUXTAPID REMS is to mitigate the risk of hepatotoxicity associated with the use of JUXTAPID by ensuring that:
- Prescribers are educated about the approved indication for JUXTAPID, the risk of hepatotoxicity associated with the use of JUXTAPID; and the need to monitor patients during treatment with JUXTAPID as per product labeling.
- JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
- Patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the need for baseline and periodic monitoring.
"
"25","Juxtapid","1247","10/21/2020","0","0","0","0","1","1","1","1","0","1","1","0","The goal of the JUXTAPID REMS is to mitigate the risk of hepatotoxicity associated with the use of JUXTAPID by ensuring that:
- Prescribers are educated about the approved indication for JUXTAPID, the risk of hepatotoxicity associated with the use of JUXTAPID; and the need to monitor patients during treatment with JUXTAPID as per product labeling.
- JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
- Patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the need for baseline and periodic monitoring.
"
"404","Pomalidomide","1248","10/30/2020","0","0","0","0","1","1","1","1","1","1","0","1","The goals of the Pomalidomide REMS are as follows:
- To prevent the risk of embryo-fetal exposure to pomalidomide.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for pomalidomide.
"
"403","Blenrep","1249","11/20/2020","0","0","0","1","1","1","1","1","1","1","0","0"," The goal of the BLENREP REMS is to manage the risk of ocular toxicity by:
- Ensuring that healthcare providers are educated on the risk of ocular toxicity associated with the use of BLENREP
- Ensuring that healthcare providers are educated and adhere to the following:
- submit documentation that ophthalmic exams are being done at baseline and prior to each dose to identify ocular toxicity
- counsel patients on the risk of ocular toxicity and the requirement for monitoring via ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms as described in the Prescribing Information
- Ensuring safe use of BLENREP by:
- Ensuring that BLENREP is infused in certified healthcare settings only after verification of ophthalmic exams
- Ensuring that patients are informed about:
- the risk of ocular toxicity associated with the use of BLENREP
- the requirement for ophthalmic exams at baseline, prior to each dose and promptly for worsening symptoms, as described in the Prescribing Information
"
"380","Jynarque","1250","11/25/2020","0","0","0","1","1","1","1","1","1","1","0","0","The goal of the JYNARQUE REMS is to mitigate the risk of serious and potentially fatal liver injury by:
- Ensuring that healthcare providers are educated on the following:
- the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- the need to counsel patients about the risk of serious and potentially fatal liver injury and the
need for monitoring at baseline and periodic monitoring as described in the Prescribing
Information
- Ensuring that healthcare providers adhere to:
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- Ensuring that patients are informed about:
- the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
- the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
- Enrollment of all patients in a registry to further support long term safety and safe use of JYNARQUE
"
"149","Adempas","1251","11/30/2020","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Adempas REMS Program is to mitigate the risk of embryo-fetal toxicity associated with Adempas by:
- Ensuring prescribers are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about the risk and the need for monthly monitoring
- enrolling patients in the Adempas REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before dispensing Adempas
- Ensuring that patients are informed about:
- the risk of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"376","Sublocade","1252","12/02/2020","0","0","0","0","1","1","0","1","0","0","1","0","The goal of the SUBLOCADE REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration by:
- Ensuring healthcare settings and pharmacies are certified and only dispense SUBLOCADE directly to a healthcare provider for administration by a healthcare provider.
"
"352","Suboxone/Subutex","1253","12/02/2020","0","0","1","0","1","1","0","0","0","0","1","0","The goals of the REMS for SUBOXONE sublingual film, Authorized Generic of SUBOXONE sublingual film, SUBOXONE sublingual tablets, and SUBUTEX sublingual tablets are to:
- Mitigate the risks of accidental overdose, misuse and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with SUBOXONE sublingual film, Authorized Generic of SUBOXONE sublingual film, SUBOXONE sublingual tablets,
and SUBUTEX sublingual tablets.
"
"9","Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)","1254","10/30/2020","0","0","1","0","1","1","0","0","0","0","1","0","The goals of the Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) REMS are to:
- Mitigate the risks of accidental overdose, misuse, and abuse.
- Inform prescribers, pharmacists, and patients of the serious risks associated with buprenorphine-containing products.
"
"24","Isotretinoin iPLEDGE","1255","12/09/2020","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the isotretinoin risk evaluation and mitigation strategy are:
- To prevent fetal exposure to isotretinoin
- To inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions
"
"396","Ambrisentan Shared System","1256","12/22/2020","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Ambrisentan REMS Program is to mitigate the risk of embryo-fetal toxicity associated
with ambrisentan by:
- Ensuring prescribers are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about the risk and the need for monthly monitoring
- enrolling patients in the Ambrisentan REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before dispensing ambrisentan
- Ensuring that patients are informed about:
- the risk of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"60","Transmucosal Immediate-Release Fentanyl (TIRF) Products","1257","12/23/2020","0","0","1","0","1","1","1","1","1","1","0","0","The goals of the TIRF REMS are to:
- Mitigate the risk of overdose by:
- Requiring documentation of opioid tolerance with every TIRF prescription for outpatient use.
- Requiring inpatient pharmacies to develop policies and procedures to verify opioid tolerance in inpatients who require TIRF medicines while hospitalized.
- Educating prescribers, pharmacists and patients that the safe use of TIRF medicines requires patients to be opioid-tolerant throughout treatment.
- Mitigate the risk of accidental exposure by educating prescribers, pharmacists and patients about proper storage and disposal of TIRF medicines.
- Monitor for accidental exposure, misuse, abuse, addiction, and overdose by enrolling all patients who receive a TIRF medicine for outpatient use into a registry and using surveillance systems and other data sources.
"
"375","Yescarta and Tecartus","1258","12/09/2020","0","0","0","0","1","1","0","1","0","1","0","0","The goals of the YESCARTA and TECARTUS REMS are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
- Ensuring that hospitals and their associated clinics that dispense YESCARTA and/or TECARTUS are specially certified and have on-site, immediate access to tocilizumab.
- Ensuring those who prescribe, dispense, or administer YESCARTA and/or TECARTUS are aware of how to manage the risks of CRS and neurological toxicities.
"
"37","Mycophenolate","1259","01/15/2021","0","0","0","0","1","0","0","0","0","1","0","0","The goal of the Mycophenolate REMS is to mitigate the risk of embryofetal toxicity associated with use of mycophenolate during pregnancy by:
- Educating healthcare providers on the following:
- The increased risks of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy.
- The need to counsel females of reproductive potential on the importance of pregnancy prevention and planning when taking mycophenolate.
- The need to report pregnancies to the Mycophenolate Pregnancy Registry.
- Informing females of reproductive potential who are prescribed mycophenolate about:
- The increased risks of pregnancy loss (miscarriage) and birth defects.
- The importance of pregnancy prevention and planning when taking mycophenolate.
"
"362","Siliq","1261","01/22/2021","0","0","0","0","1","1","1","1","1","0","0","0","The goal of the SILIQ REMS Program is to mitigate the observed risk of suicidal ideation and behavior, including completed suicides, which occurred in subjects treated with SILIQ by:
- Ensuring that prescribers are educated about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to counsel patients about this risk.
- Ensuring that patients are informed about the risk of suicidal ideation and behavior observed with SILIQ therapy and the need to seek medical attention for manifestations of suicidal thoughts and behavior, new onset or worsening depression, anxiety, or other mood changes.
"
"38","Nplate","1262","01/29/2021","1","0","0","0","0","0","0","0","0","0","0","0",""
"405","Breyanzi","1263","02/05/2021","0","0","0","0","1","1","0","1","0","1","0","0","The goals of the BREYANZI REMS are to mitigate the risks of cytokine release syndrome (CRS) and
neurological toxicities by:
- Ensuring that hospitals and associated clinics that dispense BREYANZI are specially certified and have
on-site immediate access to tocilizumab.
- Ensuring that those who prescribe, dispense, or administer BREYANZI are aware of how to manage the
risks of CRS and neurological toxicities.
"
"21","Gattex","1264","02/11/2021","0","0","0","0","1","0","0","0","0","1","0","0","The goals of the GATTEX REMS are to mitigate the risks of possible acceleration of neoplastic growth and enhancement of colon polyp growth, gastrointestinal obstruction,
and biliary and pancreatic disorders associated with GATTEX by:- Informing patients about the risks listed above associated with the use of GATTEX
- Informing healthcare providers about the risks listed above associated with GATTEX
"
"345","Xywav and Xyrem","1265","02/11/2021","0","0","1","0","1","1","1","1","1","1","0","0","The goal of the XYWAV and XYREM REMS is to mitigate the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and
diversion of XYWAV and XYREM by:
- Informing prescribers, pharmacists, and patients of:
- The risk of significant CNS and respiratory depression associated with XYWAV and XYREM.
- The contraindication of use of XYREM with sedative hypnotics and alcohol.
- The potential for abuse, misuse, and overdose associated with XYWAV and XYREM.
- The safe use, handling, and storage of XYWAV and XYREM.
- Ensuring that pharmacy controls exist prior to filling prescriptions for XYWAV and XYREM that:
- Screen for concomitant use of sedative hypnotics and other potentially interacting agents.
- Monitor for inappropriate prescribing, misuse, abuse, and diversion of XYWAV and XYREM.
- Notify prescribers when patients are receiving concomitant contraindicated medications or there are signs of potential abuse, misuse, or diversion.
"
"351","Clozapine","1266","02/18/2021","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Clozapine REMS Program is to mitigate the risk of severe neutropenia associated with the use of clozapine by:
- Educating prescribers and pharmacists about the risk of severe neutropenia and appropriate monitoring requirements.
- Informing patients about the risk of severe neutropenia and appropriate monitoring requirements.
- Ensuring compliance with the monitoring schedule for absolute neutrophil count (ANC) prior to dispensing clozapine.
- Ensuring the prescriber documents a risk-benefit assessment when ANC falls below the acceptable range as described in the Prescribing Information.
- Establishing long-term safety and safe use of clozapine by enrolling all patients who receive clozapine in the registry.
"
"341","Blincyto","1267","03/11/2021","0","0","0","1","0","0","0","0","0","0","0","0","The goals of the BLINCYTO REMS are to mitigate the risk of cytokine release syndrome which may be life-threatening or fatal; the risk of neurological toxicities which may be severe,
life-threatening, or fatal; and the risk of preparation and administration errors associated with use of BLINCYTO by:
- Informing healthcare providers about the risk of cytokine release syndrome which may be life-threatening or fatal
- Informing healthcare providers about the risk of neurological toxicities which may be severe, life-threatening, or fatal
- Informing pharmacists, who will prepare and dispense BLINCYTO, and nurses, who will administer BLINCYTO, about the risk of preparation and administration errors associated
with use of BLINCYTO
"
"375","Yescarta and Tecartus","1268","03/05/2021","0","0","0","0","1","1","0","1","0","1","0","0","The goals of the YESCARTA and TECARTUS REMS are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
"
"340","Lemtrada","1269","03/12/2021","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the LEMTRADA REMS is to mitigate the risks of autoimmune conditions, infusion reactions, stroke, and malignancies associated with LEMTRADA by:
- Helping to ensure informed decisions about the safe use of LEMTRADA by:
- Informing patients about the serious risks of autoimmune conditions, infusion reactions, stoke, and malignancies with LEMTRADA and the need for baseline and periodic monitoring; and
- Informing healthcare providers about the serious risks of autoimmune conditions, infusion reactions, stroke, and malignancies with LEMTRADA, the need to counsel patients, and the need for baseline and periodic monitoring.
- Helping to ensure the safe use of LEMTRADA by:
- Ensuring that only certified prescribers prescribe LEMTRADA;
- Ensuring that LEMTRADA is dispensed only in certain healthcare settings, by certified pharmacies, and certified healthcare facilities administering the infusion, which have on-site access to equipment and personnel trained to manage infusion reactions; and
- Ensuring that only enrolled and authorized patients receive LEMTRADA;
- Ensuring that certified prescribers submit documentation of periodic monitoring of patients who receive LEMTRADA to identify autoimmune conditions and malignancies.
"
"406","Abecma","1270","03/26/2021","0","0","1","0","1","1","0","1","0","1","0","0","The goals of the ABECMA REMS are to mitigate the risks of cytokine release syndrome (CRS) and neurologic toxicities by: - Ensuring that hospitals and their associated clinics that dispense ABECMA are specially certified and have on-site immediate access to tocilizumab.
- Ensuring that those who prescribe, dispense, or administer ABECMA are aware of how to manage the risks of CRS and neurologic toxicities."
"45","Qsymia","1271","03/31/2021","0","0","1","0","1","1","0","1","0","1","0","0","
To inform prescribers and patients of reproductive potential about:
- the increased risk of congenital malformations, specifically orofacial clefts, in infants exposed to Qsymia during the first trimester of pregnancy
- the importance of pregnancy prevention for patients of reproductive potential receiving Qsymia
- the need to discontinue Qsymia immediately if pregnancy occurs.
"
"76","Opsumit","1272","04/06/2021","0","1","0","0","0","0","0","0","0","0","0","0",""
"407","Macitentan-Containing Products","1273","04/06/2021","0","0","1","0","1","1","1","1","1","1","0","0","The goal of the Macitentan REMS Program is to mitigate the risk of embryo-fetal toxicity associated with
macitentan by:
- Ensuring prescribers are educated on the following:
- the risks of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about these risks and the need for monthly monitoring
- enrolling patients in the Macitentan REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risks of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before
dispensing macitentan
- Ensuring that patients are informed about:
- the risks of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"375","Yescarta and Tecartus","1274","04/22/2021","0","0","0","0","1","1","0","1","0","1","0","0","The goals of the YESCARTA and TECARTUS REMS are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
- Ensuring that hospitals and their associated clinics that dispense YESCARTA and/or TECARTUS are specially certified and have on-site, immediate access to tocilizumab
- Ensuring those who prescribe, dispense, or administer YESCARTA and/or TECARTUS are aware of how to manage the risks of CRS and neurological toxicities
"
"375","Yescarta and Tecartus","1275","","0","0","0","0","0","0","0","0","0","0","0","0",""
"37","Mycophenolate","1276","04/21/2021","0","0","0","0","1","0","0","0","0","1","0","0","The goal of the Mycophenolate REMS is to mitigate the risk of embryofetal toxicity associated with use of mycophenolate during pregnancy by:
- Educating healthcare providers on the following:
- The increased risks of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy.
- The need to counsel females of reproductive potential on the importance of pregnancy prevention and planning when taking mycophenolate.
- The need to report pregnancies to the Mycophenolate Pregnancy Registry.
- Informing females of reproductive potential who are prescribed mycophenolate about:
- The increased risks of pregnancy loss (miscarriage) and birth defects.
- The importance of pregnancy prevention and planning when taking mycophenolate.
"
"74","Zyprexa Relprevv","1277","04/28/2021","0","0","1","1","1","1","1","1","1","1","0","1","The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS) by:
- ensuring Zyprexa Relprevv is prescribed only by certified prescribers, dispensed only by certified dispensers, and dispensed for use only in certified healthcare facilities with ready access to emergency response services, and dispensed for use only with documentation of safe use conditions;
- informing healthcare providers and patients about the risks and the need for continuous observation of patients for at least 3 hours in certified health care facilities; and
- establishing long-term safety and safe use of Zyprexa Relprevv through periodic monitoring for the risk of PDSS events and by enrolling all patients who receive Zyprexa Relprevv in the Zyprexa Relprevv Patient Care Program Registry.
"
"67","Vivitrol","1278","05/06/2021","1","0","0","0","0","0","0","0","0","0","0","0",""
"390","Mifepristone","1279","05/14/2021","0","0","0","0","1","1","1","0","0","0","1","0","The goal of the REMS for mifepristone is to mitigate the risk of serious complications associated with
mifepristone by:
- Requiring healthcare providers who prescribe mifepristone to be certified in the Mifepristone
REMS Program.
- Ensuring that mifepristone is only dispensed in certain healthcare settings by or under the
supervision of a certified prescriber.
- Informing patients about the risk of serious complications associated with mifepristone.
"
"409","Empaveli","1281","05/14/2021","0","0","0","0","1","1","1","1","0","1","0","1","The goal of the REMS is to mitigate the occurrence and morbidity associated with encapsulated bacteria infections (Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y and B and Haemophilus influenzae Type B) by educating healthcare providers and patients about: - the potential risk of infections caused by encapsulated bacteria with Empaveli
- the need for vaccination and antibiotic prophylaxis, if required,
- the early signs of invasive encapsulated bacteria infections, and
- the need for immediate medical evaluation of signs and symptoms consistent with possible
encapsulated bacteria infections
"
"25","Juxtapid","1282","05/27/2021","0","0","0","0","1","1","1","1","0","1","0","0","The goal of the JUXTAPID REMS is to mitigate the risk of hepatotoxicity associated with the use of JUXTAPID by ensuring that:
- Prescribers are educated about the approved indication for JUXTAPID, the risk of hepatotoxicity associated with the use of JUXTAPID; and the need to monitor patients during treatment with JUXTAPID as per product labeling.
- JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
- Patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the need for baseline and periodic monitoring.
"
"398","Palforzia","1283","05/26/2021","0","0","0","0","1","1","1","1","1","1","0","1","The goal of the PALFORZIA REMS Program is to mitigate the risk of anaphylaxis associated with PALFORZIA by:
- Ensuring that healthcare providers who prescribe and healthcare settings that dispense and administer PALFORZIA are educated on the following:
- the risk of anaphylaxis associated with the use of PALFORZIA
- the Initial Dose Escalation and first dose of each Up-Dosing level must only be administered to patients in a healthcare setting equipped to monitor patients, and to identify and manage anaphylaxis.
- Ensuring that the Initial Dose Escalation and the first dose of each Up-Dosing level of PALFORZIA are only dispensed and distributed to certified healthcare settings and only administered to patients in healthcare settings
- Ensuring that PALFORZIA is only dispensed and administered to patients who are informed, by enrolling in the PALFORZIA REMS Program, of the need to have injectable epinephrine available for immediate use at all times, the need for monitoring with the Initial Dose Escalation and first dose of each Up-Dosing level, the need for continued dietary peanut avoidance,
and how to recognize the signs and symptoms of anaphylaxis.
"
"46","Revlimid","1284","05/21/2021","0","1","0","0","0","0","0","0","0","0","0","0",""
"410","Lenalidomide","1285","05/21/2021","0","0","0","0","1","1","1","1","1","0","0","0","The goals of the Lenalidomide risk evaluation and mitigation strategy are as follows:
"
"396","Ambrisentan Shared System","1286","06/08/2021","0","0","0","0","1","1","1","1","1","1","0","1","The goal of the Ambrisentan REMS Program is to mitigate the risk of embryo-fetal toxicity associated
with ambrisentan by:
- Ensuring prescribers are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring prescribers are educated on and adhere to the following:
- counseling patients about the risk and the need for monthly monitoring
- enrolling patients in the Ambrisentan REMS Program
- monitoring patients at baseline and monthly
- Ensuring that pharmacies are educated on the following:
- the risk of embryo-fetal toxicity
- Ensuring that pharmacies are educated on and adhere to the following:
- confirming that the appropriate patient monitoring and counseling has occurred before dispensing ambrisentan
- Ensuring that patients are informed about:
- the risk of embryo-fetal toxicity
- appropriate baseline and monthly patient monitoring
- appropriate contraception
"
"314","Myalept","1287","06/09/2021","0","0","0","1","1","1","1","1","0","1","0","0","The goal of the MYALEPT REMS is to mitigate
- the risks of serious adverse sequelae (such as severe infections, excessive weight gain, glucose intolerance, diabetes mellitus) due to the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or MYALEPT, and
- the risk of lymphoma by:
- Educating prescribers about the development of neutralizing anti-metreleptin antibodies,the serious adverse sequelae that may result from these antibodies, and the risk for lymphoma
associated with MYALEPT
- Limiting the population exposed to MYALEPT by requiring prescriber certification, pharmacy certification, and prescriber attestation that each patient has a diagnosis consistent
with the approved indication
"
"368","Kymriah","1288","06/11/2021","0","0","0","0","1","1","0","1","0","0","0","0"," The goals of the Kymriah REMS Program are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
- Ensuring that hospitals and their associated clinics that dispense Kymriah are specially certified and have on-site, immediate access to tocilizumab.
- Ensuring those who prescribe, dispense, or administer Kymriah are aware of how to manage the risks of cytokine release syndrome and neurological toxicities.
"
"375","Yescarta and Tecartus","1290","07/14/2021","0","0","0","0","1","1","0","1","0","1","0","0","The goals of the YESCARTA and TECARTUS REMS are to mitigate the risks of cytokine release syndrome (CRS) and neurological toxicities by:
- Ensuring that hospitals and their associated clinics that dispense YESCARTA and/or TECARTUS are specially certified and have on-site, immediate access to tocilizumab
- Ensuring those who prescribe, dispense, or administer YESCARTA and/or TECARTUS are aware of how to manage the risks of CRS and neurological toxicities
"
"313","Aveed","1291","06/28/2021","0","0","0","0","1","1","1","1","0","1","0","0","The goals and the objectives of the AVEED REMS are to mitigate the negative outcomes associated with AVEED-induced pulmonary oil microembolism (POME) and anaphylaxis by:
- Ensuring that AVEED is dispensed only in certified healthcare settings that have immediate access on-site to equipment and personnel trained to manage POME and anaphylaxis;
- Informing healthcare providers that AVEED can cause POME and anaphylaxis, which have the potential to lead to serious medical consequences (e.g., respiratory distress and syncope);
- Informing healthcare providers about the safe use of AVEED, including proper administration technique and patient observation; and
- Informing patients about the risks of POME and anaphylaxis associated with AVEED and the importance of remaining at the healthcare setting for 30 minutes after each injection.
"
"351","Clozapine","1292","07/29/2021","0","0","0","0","1","1","1","1","1","1","0","0","The goal of the Clozapine REMS Program is to mitigate the risk of severe neutropenia associated with the use of clozapine by:
- Educating prescribers and pharmacists about the risk of severe neutropenia and appropriate monitoring requirements.
- Informing patients about the risk of severe neutropenia and appropriate monitoring requirements.
- Ensuring prescribers submit documentation that periodic monitoring of patients is performed to identify severe neutropenia
- Ensuring the prescriber documents a risk-benefit assessment when ANC falls below the acceptable range as described in the Prescribing Information.
- Establishing long-term safety and safe use of clozapine by enrolling all patients who receive clozapine in the registry.
"
"41","Pomalyst","1293","08/05/2021","0","0","0","0","1","1","1","0","1","0","0","0","The goals of the POMALYST risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to POMALYST.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for POMALYST.
"
"58","Thalomid","1294","08/05/2021","0","0","0","0","1","1","1","1","1","0","0","0","The goals of the THALOMID risk evaluation and mitigation strategy are as follows:
- To prevent the risk of embryo-fetal exposure to THALOMID.
- To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for THALOMID.
"
"37","Mycophenolate","1295","08/11/2021","0","0","0","0","1","0","0","0","0","1","0","0","The goal of the Mycophenolate REMS is to mitigate the risk of embryofetal toxicity associated with use of mycophenolate during pregnancy by:
- Educating healthcare providers on the following:
- The increased risks of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy.
- The need to counsel females of reproductive potential on the importance of pregnancy prevention and planning when taking mycophenolate.
- The need to report pregnancies to the Mycophenolate Pregnancy Registry.
- Informing females of reproductive potential who are prescribed mycophenolate about:
- The increased risks of pregnancy loss (miscarriage) and birth defects.
- The importance of pregnancy prevention and planning when taking mycophenolate.
"
"410","Lenalidomide","1296","08/05/2021","0","0","0","0","1","1","1","1","1","0","0","0","