Welcome to PS-Mycophenolate Risk Evaluation and Mitigation Strategy (REMS)

What is the PS-Mycophenolate REMS?

The PS-Mycophenolate REMS (Risk Evaluation and Mitigation Strategy) is a drug safety program required by the U.S. Food and Drug Administration (FDA) to ensure the benefits of the Mycophenolate outweigh its risks. 

What are the risks of mycophenolate during pregnancy?

Higher risk of first trimester pregnancy loss (miscarriage).

Higher risk that the baby will be born with birth defects (congenital malformations).

Who should be informed about the PS-Mycophenolate REMS?

Healthcare Providers

Patients

What is the goal of the PS-Mycophenolate REMS?

The goal of the PS-Mycophenolate REMS is to mitigate the risk of embryofetal toxicity associated with the 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 PS-Mycophenolate Pregnancy Registry.
  1. Informing female patients 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.

Healthcare Providers who intend to treat patients with Mycophenolate should review the educational materials and complete the Prescriber Training Confirmation Form.

What medications contain mycophenolate?

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For complete safety information and a comprehensive description of the increased risks associated with Mycophenolate, please refer to the Prescribing Information, including Boxed WARNING and MEDICATION GUIDE.