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.