Approved Risk Evaluation and Mitigation Strategies (REMS)

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The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.

The table below provides links to currently approved individual and shared system REMS.

Information on historical and released REMS: downloadable data files.

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Name Last Updated Medication Guide* Communication Plan ETASU Implementation System Recall Type
Adasuve (loxapine), aerosol, powder
NDA #22549
 		10/19/2016    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Adasuve, loxapine
Addyi (flibanserin), tablet
NDA #022526
 		05/10/2016    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Addyi, flibanserin
Adempas (riociguat), tablet, film coated
NDA #204819
 		10/04/2016
✓
  		 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Medication Guide Adempas, riociguat
Afrezza (insulin human), powder, metered
NDA #022472
 		04/01/2016  
✓
  		    Communication Plan Afrezza, insulin human
Alosetron (alosetron), tablet
ANDA #200652
 		03/24/2016    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU
Androgel 1% (testosterone), gel
NDA #21015
 		05/11/2015
✓
  		      Medication Guide Androgel, testosterone
Androgel 1.62% (testosterone), gel
NDA #22309
 		05/11/2015
✓
  		      Medication Guide Androgel 1.62%, testosterone
Aranesp (darbepoetin alfa), solution
BLA #103951
 		12/31/2013    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Aranesp, darbepoetin alfa
Aveed (testosterone undecanoate), injection
NDA #022219
 		03/05/2014    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU testosterone undecanoate, testosterone undecanoate
Axiron (testosterone), solution
NDA #22504
 		05/11/2015
✓
  		      Medication Guide Axiron, testosterone
Blincyto (blinatumomab), kit
BLA #125557
 		08/30/2016  
✓
  		    Communication Plan Blincyto, blinatumomab
Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)
Shared System REMS 		10/04/2016
✓
  		 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Medication Guide Bunavail, buprenorphine and naloxone, Zubsolv, buprenorphine and naloxone
Bupropion (ANDA 206122) (bupropion hydrochloride), tablet, extended release
ANDA #206122
 		08/17/2016
✓
  		      Medication Guide
Caprelsa (vandetanib), tablet
NDA #22405
 		11/27/2013
✓
 
✓
 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Communication Plan Medication Guide Caprelsa, vandetanib
Chantix (varenicline), kit
NDA #21928
 		08/12/2016
✓
  		      Medication Guide Chantix, varenicline
Clozapine
Shared System REMS 		09/15/2015    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Clozaril, clozapine, Fazaclo ODT, clozapine, Versacloz, clozapine
Entereg (alvimopan), capsule
NDA #21775
 		06/01/2016    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Entereg, alvimopan
Epogen / Procrit (epoetin alfa), solution
BLA #103234
 		12/31/2013    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Epogen / Procrit, epoetin alfa
Extended-Release and Long-Acting (ER/LA) Opioid Analgesics
Shared System REMS 		09/30/2016
✓
  		 
✓
  		  Elements to Assure Safe Use, ETASU Medication Guide Avinza, morphine sulfate, Belbuca, buprenorphine, Butrans, buprenorphine, Dolophine, methadone hydrochloride, Duragesic, fentanyl transdermal system, Embeda, morphine sulfate and naltrexone hydrochloride, Exalgo, hydromorphone hydrochloride, Hysingla ER, hydrocodone bitartrate, Kadian, morphine sulfate, Methadose, methadone hydrochloride, Morphabond, morphine sulfate, MS Contin, morphine sulfate, Nucynta ER, tapentadol, Opana ER, oxymorphone hydrochloride, OxyContin, oxycodone hydrochloride, Targiniq ER, oxycodone and naloxone hydrochloride, Troxyca ER, oxycodone hydrochloride and naloxone hydrochloride, Xtampza, oxycodone, Zohydro ER, hydrocodone
Extraneal (icodextrin), injection, solution
NDA #21321
 		10/24/2016
✓
  		 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Medication Guide Extraneal, icodextrin
Farydak (panobinostat), capsule
NDA #205353
 		02/23/2015  
✓
  		    Communication Plan Farydak, panobinostat
Forteo (teriparatide [rDNA origin]), injection, solution
NDA #021318
 		08/30/2013
✓
 
✓
  		    Communication Plan Medication Guide Forteo, teriparatide [rDNA origin]
Fortesta (testosterone), gel, metered
NDA #21463
 		05/11/2015
✓
  		      Medication Guide Fortesta, testosterone
Gattex (teduglutide [rDNA origin]), injection, powder, for solution
NDA #203441
 		05/27/2016  
✓
 
✓
  		  Elements to Assure Safe Use, ETASU Communication Plan Gattex, teduglutide [rDNA origin]
Gilenya (fingolimod), capsule
NDA #22527
 		05/14/2015  
✓
  		    Communication Plan Gilenya, fingolimod
Iclusig (ponatinib), tablet, film coated
NDA #203469
 		12/20/2013  
✓
  		    Communication Plan Iclusig, ponatinib
Ionsys (fentanyl iontophoretic transdermal system), patch
NDA #021338
 		11/12/2015    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Ionsys, fentanyl iontophoretic transdermal system
Isotretinoin iPLEDGE
Shared System REMS 		07/08/2016
✓
  		 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Medication Guide Absorica, isotretinoin, Accutane, isotretinoin, Amnesteem, isotretinoin, Claravis, isotretinoin, Myorisan, isotretinoin, Sotret, isotretinoin, Zenatane, isotretinoin
Juxtapid (lomitapide), capsule
NDA #203858
 		08/13/2013    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Juxtapid, lomitapide
Kynamro (mipomersen sodium), injection, solution
NDA #203568
 		07/28/2015    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Kynamro, mipomersen sodium
Lemtrada (alemtuzumab), injection, solution, concentrate
BLA #103948
 		04/05/2016  
✓
 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Communication Plan Lemtrada, alemtuzumab
Letairis (ambrisentan), tablet, film coated
NDA #22081
 		10/02/2015
✓
  		 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Medication Guide Letairis, ambrisentan
Lotronex (alosetron hydrochloride), tablet
NDA #21107
 		04/29/2016    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Lotronex, alosetron hydrochloride
Mifeprex (mifepristone), tablet
NDA #20687
 		03/29/2016    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Mifeprex, mifepristone
Myalept (metreleptin), injection, powder, lyophilized, for solution
BLA #125390
 		08/27/2015    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Myalept, metreleptin
Mycophenolate
Shared System REMS 		11/13/2015    
✓
  		  Elements to Assure Safe Use, ETASU Cellcept, mycophenolate mofetil capsules, Cellcept, mycophenolate mofetil injection, Cellcept, mycophenolate mofetil oral suspension, Cellcept, mycophenolate mofetil tablets, Myfortic, mycophenolate acid delayed-release tablets
Natpara (parathyroid hormone), injection, powder, lyophilized, for solution
BLA #125511
 		09/29/2016    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Natpara, parathyroid hormone
Nplate (romiplostim), injection, powder, lyophilized, for solution
BLA #125268
 		12/06/2011  
✓
  		    Communication Plan Nplate, romiplostim
Nulojix (belatacept), injection, powder, lyophilized, for solution
BLA #125288
 		06/15/2011
✓
 
✓
  		    Communication Plan Medication Guide Nulojix, belatacept
Omontys (peginesatide), injection
NDA #202799
 		03/27/2012  
✓
  		    Communication Plan Omontys, peginesatide
Opsumit (macitentan), tablet, film coated
NDA #204410
 		02/22/2016
✓
  		 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Medication Guide Opsumit, macitentan
Pomalyst (pomalidomide), capsule
NDA #204026
 		04/22/2016    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Pomalyst, pomalidomide
Probuphine (buprenorphine hydrochloride), implant
NDA #204442
 		06/14/2016
✓
  		 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Medication Guide Probuphine, buprenorphine hydrochloride
Prolia (denosumab), injection
BLA #125320
 		05/21/2015
✓
 
✓
  		    Communication Plan Medication Guide Prolia, denosumab
Qsymia (phentermine and topiramate), capsule, extended release
NDA #22580
 		09/26/2014
✓
  		 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Medication Guide Qsymia, phentermine and topiramate
Revlimid (lenalidomide), capsule
NDA #21880
 		04/22/2016    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Revlimid, lenalidomide
Sabril (vigabatrin), powder, for solution; tablet, film coated
NDA #20427
NDA #22006
 		06/27/2016    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Sabril, vigabatrin
Saxenda (liraglutide), injection, solution
NDA #206321
 		02/01/2016  
✓
  		    Communication Plan Saxenda, liraglutide
Soliris (eculizumab), injection, solution, concentrate
BLA #125166
 		07/12/2016
✓
  		 
✓
  		  Elements to Assure Safe Use, ETASU Medication Guide Soliris, eculizumab
Stelara (ustekinumab), injection, solution
BLA #125261
 		09/20/2013  
✓
  		    Communication Plan Stelara, ustekinumab
Suboxone/Subutex (buprenorphine and naloxone/buprenorphine), film, soluble; tablet
NDA #20732
NDA #20733
NDA #22410
 		07/07/2016
✓
  		 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Medication Guide Suboxone, buprenorphine and naloxone/buprenorphine, Subutex, buprenorphine and naloxone/buprenorphine
Symlin (pramlintide), injection
NDA #021332
 		09/18/2015  
✓
  		    Communication Plan Symlin, pramlintide
Tanzeum (albiglutide), injection, powder, lyophilized, for solution
BLA #125431
 		07/27/2015  
✓
  		    Communication Plan Tanzeum, albiglutide
Testim (testosterone), gel
NDA #21454
 		05/11/2015
✓
  		      Medication Guide Testim, testosterone
testosterone (ANDA 076744) (testosterone), gel
ANDA #076744
 		09/25/2015
✓
  		      Medication Guide
testosterone (ANDA 204571) (testosterone), gel, metered
ANDA #204571
 		08/05/2015
✓
  		      Medication Guide
testosterone (NDA 202763) (testosterone), gel
NDA #202763
 		07/01/2015
✓
  		      Medication Guide Testosterone Gel, testosterone
testosterone (NDA 203098) (testosterone), gel
NDA #203098
 		05/11/2015
✓
  		      Medication Guide
testosterone 1% (ANDA 076737) (testosterone), gel
ANDA #076737
 		11/05/2015
✓
  		      Medication Guide
testosterone 1.62% (ANDA 204268) (testosterone), gel
ANDA #204268
 		08/04/2015
✓
  		      Medication Guide
Thalomid (thalidomide), capsule
NDA #20785
 		04/22/2016    
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Thalomid, thalidomide
Tracleer (bosentan), tablet, film coated
NDA #21290
 		12/04/2015
✓
  		 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Medication Guide Tracleer, bosentan
Transmucosal Immediate-Release Fentanyl (TIRF) Products
Shared System REMS 		12/21/2015
✓
  		 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Medication Guide Abstral, fentanyl citrate, Actiq, fentanyl citrate, Fentora, fentanyl citrate, Lazanda, fentanyl citrate, Onsolis, fentanyl citrate, Subsys, fentanyl
Trulicity (dulaglutide), injection, solution
BLA #125469
 		07/27/2015  
✓
  		    Communication Plan Trulicity, dulaglutide
Truvada (emtricitabine and tenofovir disoproxil fumarate), tablet, film coated
NDA #21752
 		03/10/2016    
✓
  		  Elements to Assure Safe Use, ETASU Truvada, emtricitabine and tenofovir disoproxil fumarate
Tysabri (natalizumab), injection
BLA #125104
 		10/14/2016
✓
  		 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Medication Guide Tysabri, natalizumab
Vibativ (telavancin), injection, powder, lyophilized, for solution
NDA #022407
NDA #22110
 		03/23/2016
✓
 
✓
  		    Communication Plan Medication Guide Vibativ, telavancin
Victoza (liraglutide), injection, solution
NDA #22341
 		09/20/2016  
✓
  		    Communication Plan Victoza, liraglutide
Vivitrol (naltrexone), kit
NDA #21897
 		05/17/2016
✓
 
✓
  		    Communication Plan Medication Guide Vivitrol, naltrexone
Vogelxo (testosterone), gel
NDA #204399
 		05/11/2015
✓
  		      Medication Guide Vogelxo, testosterone
Xiaflex (collagenase clostridium histolyticum), kit
BLA #125338
 		10/20/2014  
✓
 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Communication Plan Xiaflex, collagenase clostridium histolyticum
Xyrem (Sodium oxybate), solution
NDA #021196
 		07/15/2015
✓
  		 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Medication Guide Xyrem, Sodium oxybate
Zinbryta (daclizumab), injection
BLA #761029
 		05/27/2016  
✓
 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Communication Plan Zinbryta, daclizumab
Zyban (bupropion hydrochloride), tablet, film coated
NDA #20711
 		03/27/2014
✓
  		      Medication Guide Zyban, bupropion hydrochloride
Zydelig (idelalisib), tablet, film coated
NDA #205858
NDA #206545
 		07/23/2014  
✓
  		    Communication Plan Zydelig, idelalisib
Zyprexa Relprevv (olanzapine), kit
NDA #22173
 		10/30/2014
✓
 
✓
 
✓
 
✓
  		Implementation System Elements to Assure Safe Use, ETASU Communication Plan Medication Guide Zyprexa Relprevv, olanzapine

*Many products within these REMS programs have Medication Guides not part of the REMS program. For a full list of Medication Guides click here.

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