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Pulmonary Hypertension
Pulmonary Hypertension
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Macitentan REMS

A Risk Evaluation and Mitigation Strategy (REMS) is a program required by the Food and Drug Administration (FDA) to manage serious risks associated with a drug product. The Macitentan REMS is for females only. Male patients are not required to enroll in the Macitentan REMS. The goal of the Macitentan REMS is to mitigate the risk of embryo-fetal toxicity associated with macitentan by:

1. Ensuring prescribers are educated on the following:

  • the risks of embryo-fetal toxicity

2. Ensuring prescribers are educated on and adhere to the following:

  • counseling patients about these risks and the need for monthly monitoring
  • enrolling patients in the Macitentan REMS
  • monitoring patients at baseline and monthly

3. Ensuring that pharmacies are educated on the following:

  • the risks of embryo-fetal toxicity

4. Ensuring that pharmacies are educated on and adhere to the following:

  • confirming that the appropriate patient monitoring and counseling has occurred before dispensing macitentan

5. Ensuring that patients are informed about:

  • the risks of embryo-fetal toxicity
  • appropriate baseline and monthly patient monitoring
  • appropriate contraception

Access comprehensive information on the Risk Evaluation and Mitigation Strategy for Macitentan REMS. https://www.macitentanrems.com/