Integrating the FDA Mycophenolate Safety Standards to Prevent Adverse Pregnancy Outcomes

Mycophenolic acid (MPA) products, including mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium, were approved by the FDA in 1995 and 2004, respectively, as immunosuppressants used in preventing rejection of transplanted organs. MPA has become a front-line anti-rejection therapy in combination with calcineurin-inhibitors and corticosteroids. However, use of MPA during pregnancy is associated with increased risk of pregnancy loss, congenital malformations, and low birth weight. The FDA approved the Mycophenolate Shared System Risk Evaluation and Mitigation Strategy (MREMS) in 2012, but despite the information provided to clinicians and patients on the pregnancy risks associated with the use of MPA, pregnancies are still occurring too frequently in patients being treated with MPAs leading to preventable adverse pregnancy outcomes.

Integrating the Mycophenolate Risk Evaluation and Mitigation Strategy (MREMS) into Practice to Prevent Adverse Pregnancy Outcomes will provide HCPs who prescribe MPAs with information on MPA-associated pregnancy risks, the need for counseling female patients of reproductive potential on birth control and planning, and the need for reporting pregnancies to the Mycophenolate Pregnancy Registry. It will also provide information to female patients of reproductive potential who are prescribed MPA about the pregnancy risks and the importance of appropriate planning and birth control.

The patient handout is available in multiple languages for your patients including:

English CLICK HERE to download the Patient Handout.

Spanish HAGA CLIC aquí para descargar la versión en Español.

French CLIQUEZ ICI pour télécharger la version Française.

Chinese Diǎnjī zhèlǐ xiàzài zhōngwén bǎn.

Vietnamese Bấm vào đây để xem phiên bản tiếng Việt.

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SUPPORTER
This activity is supported by an independent educational grant from the Mycophenolate REMS Group. This activity is intended to be fully compliant with the Mycophenolate REMS education requirements issued by the U.S. Food and Drug Administration (FDA).