Risk Evaluation and Mitigation Strategies (REMS) Summary

Goal of the Mycophenolate REMS Program

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:
• 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.

2. 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.

REMS Elements

• Elements to Assure Safe Use

Open the Full REMS Notification

REMS Summary of Terms