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Approved Risk Evaluation and Mitigation Strategies (REMS)

PS-Mycophenolate
Shared System REMS
REMS last update: 06/01/2023

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
mycophenolate (Info at Drugs@FDA) ANDA 214283 BPI LABS 06/01/2023
mycophenolate (Info at Drugs@FDA) ANDA 217031 SKG PHARMA 11/29/2023

What is the purpose of the REMS?

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

  1. 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 PS-Mycophenolate Pregnancy Registry.
  2. 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.

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 that prescribe mycophenolate-containing products:

  • Receive training provided by the applicant or accredited CE provider.
  • For training provided by applicants: review the educational material for prescribers: Healthcare Provider Guide.
  • For training provided by accredited CE providers: complete the REMS-compliant training, including the knowledge assessment.
  • Report the completion of training to the applicant using the Prescriber Training Confirmation Form.

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.

Material Name Material Name Link
Prescriber Training Confirmation Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_Prescriber_Training_Confirmation_Form.pdf
Center Training Confirmation Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_Center_Training_Confirmation_Form.pdf
FDA Blueprint for Mycophenolate REMS Education (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_10_03_FDA_Blueprint_for_Mycophenolate_REMS_Education.pdf
Healthcare Provider Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/ PS_Mycophenolate_2023_06_01_Healthcare_ Provider_Guide.pdf
Patient Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_Patient_Guide.pdf
PS-Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_PS-Mycophenolate_Pregnancy_Registry_Frequently_Asked_Questions_for_Patients.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Full.pdf
REMS Letter for Healthcare Providers 1 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Letter_for _Healthcare_Providers_1.pdf
REMS Letter for Healthcare Providers 2 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Letter_for _Healthcare_Providers_2.pdf
REMS Letter for Transplant Center Directors 1 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Letter _for_Transplant_Center_Directors_1.pdf
REMS Letter for Transplant Center Directors 2 (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Letter _for_Transplant_Center_Directors_2.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Website_Screenshot.pdf
Website Banner (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/PS_Mycophenolate_2023_06_01_REMS_Website_Banner_Screenshot.pdf

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
06/01/2023 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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