Approved Risk Evaluation and Mitigation Strategies (REMS)

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Mycophenolate
Shared System REMS
REMS last update: 11/13/2015

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
Cellcept (mycophenolate mofetil capsules) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 050722 ROCHE PALO 09/25/2012 setid=81ca6530-76d1-46f1-9bf8-0ffac79d2523 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=050722
Cellcept (mycophenolate mofetil injection) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 050758 ROCHE PALO 09/25/2012 setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=050758
Cellcept (mycophenolate mofetil oral suspension) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 050759 ROCHE PALO 09/25/2012 setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=050759
Cellcept (mycophenolate mofetil tablets) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 050723 ROCHE PALO 09/25/2012 setid=ca059bbf-0341-4e9d-8537-8b0c30ff42c7 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=050723
Myfortic (mycophenolate acid delayed-release tablets) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 050791 NOVARTIS 09/25/2012 setid=eed26501-890d-4ff6-88e7-6dbea4726e53 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=050791
mycophenolate acid delayed-release tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 091558 APOTEX INC 09/25/2012 setid=c0efafa6-d249-f44a-fbf3-e6bd3acaf6f0 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=091558
mycophenolate mofetil ( Info at Drugs@FDA ) ANDA 090661 JUBILANT CADISTA 12/15/2014 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090661
mycophenolate mofetil ( Info at Drugs@FDA ) ANDA 090762 JUBILANT CADISTA 12/15/2014 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090762
mycophenolate mofetil ( Info at Drugs@FDA ) ANDA 202720 TEVA PHARMS USA 10/30/2014 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202720
mycophenolate mofetil ( Info at Drugs@FDA ) ANDA 203005 ALKEM LABS LTD 11/14/2014 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203005
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090253 ACCORD HLTHCARE 09/25/2012 setid=741e079a-646b-47ec-84ac-8e12574c2aaf http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090253
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065520 MYLAN 09/25/2012 setid=52907069-4a29-4351-a830-a9ee86b5ff7c http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065520
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 200197 ALKEM LABS LTD 09/27/2013 setid=9f84ea84-2d8b-4d91-a33f-7dfb5df937dc http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=200197
mycophenolate mofetil capsules Info at Drugs@FDA ANDA 204077 ZHEJIANG HISUN PHARM 11/13/2017
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065410 WEST-WARD PHARMS INT 09/25/2012 setid=e94895d9-f040-4a75-9f04-9814238b8f3c http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065410
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065379 SANDOZ 09/25/2012 setid=99b2eb58-8d14-48fc-bbe1-aacb711a783e http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065379
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090055 STRIDES PHARMA 09/25/2012 setid=209efe01-7908-46e4-a964-0665078c0acd http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090055
mycophenolate mofetil capsules ( Info at Drugs@FDA ) ANDA 090419 APOTEX CORP 09/25/2012 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090419
mycophenolate mofetil capsules ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065491 TEVA PHARMS 09/25/2012 setid=b414303f-e6f3-4e22-a537-96be352b59a4 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065491
mycophenolate mofetil capsules ( Info at Drugs@FDA ) ANDA 090111 VINTAGE PHARMS LLC 09/25/2012 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090111
mycophenolate mofetil for injection ( Info at Drugs@FDA ) ANDA 203859 MYLAN LABS LTD 03/31/2017 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203859
mycophenolate mofetil for injection Info at Drugs@FDA ANDA 204473 ZYDUS PHARMS USA INC 08/31/2017
mycophenolate mofetil for injection ( Info at Drugs@FDA ) ANDA 203575 PAR STERILE PRODUCTS 10/28/2016 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=203575
mycophenolate mofetil for injection ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 204043 AKORN INC 02/28/2017 setid=f186e133-1796-4689-9bf5-c074ba21ed30 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=204043
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065521 MYLAN 09/25/2012 setid=74c3a01e-9451-0f2f-6aab-8348047cb1f5 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065521
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065416 ACCORD HLTHCARE 09/25/2012 setid=741e079a-646b-47ec-84ac-8e12574c2aaf http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065416
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 091249 ALKEM LABS LTD 09/25/2012 setid=9f84ea84-2d8b-4d91-a33f-7dfb5df937dc http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=091249
mycophenolate mofetil tablets Info at Drugs@FDA ANDA 204076 ZHEJIANG HISUN PHARM 11/16/2017
mycophenolate mofetil tablets ( Info at Drugs@FDA ) ANDA 090606 VINTAGE PHARMS LLC 09/25/2012 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090606
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065457 TEVA PHARMS 09/25/2012 setid=b414303f-e6f3-4e22-a537-96be352b59a4 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065457
mycophenolate mofetil tablets ( Info at Drugs@FDA ) ANDA 090499 APOTEX 09/25/2012 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090499
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 090456 STRIDES PHARMA 09/25/2012 setid=209efe01-7908-46e4-a964-0665078c0acd http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090456
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065451 SANDOZ 09/25/2012 setid=fa37d1be-c5a5-41c6-88ea-218f551dbbb5 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065451
mycophenolate mofetil tablets ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 065413 WEST-WARD PHARMS INT 09/25/2012 setid=e94895d9-f040-4a75-9f04-9814238b8f3c http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=065413
mycophenolic acid delayed release tablets Info at Drugs@FDA ANDA 202555 ACCORD HLTHCARE 08/23/2017
mycophenolic acid delayed-release ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 091248 MYLAN PHARMS INC 01/08/2014 setid=d7fbf301-0b08-4b19-bfa0-e0c0067cb5ab http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=091248

What is the purpose of the REMS?

The goal of the Mycophenolate REMS is to mitigate the risk of embryofetal toxicity associated with use of mycophenolate during pregnancy by:

  1. Educating healthcare providers on the following:
    1. The increased risks of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy.
    2. The need to counsel females of reproductive potential on the importance of pregnancy prevention and planning when taking mycophenolate.
    3. The need to report pregnancies to the Mycophenolate Pregnancy Registry.
  2. Informing females of reproductive potential who are prescribed mycophenolate about:
    1. The increased risks of first trimester pregnancy loss and congenital malformations when taking mycophenolate during pregnancy.
    2. The importance of pregnancy prevention and planning when taking mycophenolate.

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe mycophenolate-containing products

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Mycophenolate REMS, see the DailyMed link on the Products tab.

Material Name Material Name Link
Brochure for Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Healthcare_Provider_Brochure.pdf
Center Training Confirmation Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Center_Training_Confirmation_Form.pdf
DHCP Introductory Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Dear_Healthcare_Provider_Letter.pdf
DHCP Letter for Centers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_DHCP_Letter_for_Centers.pdf
Obstetrician/Gynecologist Referral Template Letter for Contraception Counseling (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Obstetrician_Gynecologist_Referral_Template_Letter_for_Contraception_Counseling.pdf
Obstetrician/Gynecologist Referral Template Letter for Preconception Counseling (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Obstetrician_Gynecologist_Referall_Template_Letter_for_Preconception_Counseling.pdf
Patient Brochure: What You Need to Know About Mycophenolate (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Patient_Brochure_What_You_Need_To_Know_About_Mycophenolate.pdf
Patient-Prescriber Acknowledgement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Patient_Prescriber_Acknowledgement_Form.pdf
Prescriber Training Confirmation Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Prescriber_Training_Confirmation_Form.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_REMS_Full.pdf
REMS Program Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mycophenolate_2015-11-13_Mycophenolate_REMS_Program_Website_Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
11/13/2015 Modified to:

  1. Address the knowledge and behavior gaps identified in the prescriber and patient surveys from the Year 2 REMS assessment, increase exposure of both healthcare providers and patients to the important safe use messages, and reinforce the importance of healthcare provider-patient dialogue in the modified and new REMS materials
  2. Modify the goals.
  3. Remove the Medication Guide as an element of the REMS.
09/27/2013 Modified to include information about the risk of reactivation of hepatitis B and hepatitis C virus in the Medication Guide, the shared Important Safety Information (ISI) included in the Dear Healthcare Provider (DHCP) Introductory Letter and DHCP Letter to Centers, and the Mycophenolate REMS website.
09/25/2012 Approval of the REMS.

Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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