INFORM: Information Needed for Optimal Regulation of Mycophenolate- A REMS Activity

Target Audience
The target audience for this initiative includes obstetricians, gynecologists, primary care physicians, physician assistants, nurse practitioners, pharmacists, and care team members involved in the treatment of women across their reproductive lifespan who may have been prescribed mycophenolate products.

Program Overview
Clinicians who work with women of childbearing age who are, or will be, taking mycophenolate must ensure that their patients receive appropriate counseling about the teratogenic effects of mycophenolate and the need for use of contraceptives during the time they are taking the drug. This interactive course is based on the FDA’s Mycophenolate REMS Education Blueprint.

Learning Objectives
Upon completion of this activity, participants should be better able to:

The increased risks of first trimester pregnancy loss and congenital malformations associated with mycophenolate
Importance of educating women of reproductive potential about the increased risk of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy
Importance of prescribers providing or facilitating patient education about pregnancy prevention and planning, including acceptable methods of contraception during mycophenolate treatment
When treating a pregnant patient or a patient who is considering pregnancy, consider alternative immunosuppressants with less potential for embryofetal toxicity
Importance of reporting to the Mycophenolate Pregnancy Registry any pregnancies that occur during mycophenolate treatment or within 6 weeks following discontinuation of treatment
Importance of encouraging pregnant patients to participate in the Mycophenolate Pregnancy Registry