The Bosentan REMS is a single shared REMS program for brand and generic approved bosentan medications for the treatment of pulmonary arterial hypertension (PAH). Due to the risks of hepatotoxicity and embryo-fetal toxicity, bosentan is only available through the Bosentan REMS Program.

Due to the risks of hepatotoxicity and embryo-fetal toxicity, bosentan is only available through a single shared system required and approved by the Food and Drug Administration (FDA), called the Bosentan REMS. The Bosentan REMS is a shared program including all brand and generic bosentan products.

The goal of the Bosentan Risk Evaluation and Mitigation Strategy (REMS) is to mitigate the risk of hepatotoxicity and embryo-fetal toxicity associated with bosentan by:

• 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 Bosentan REMS
  • monitoring patients at baseline and monthly

• Ensuring that pharmacies are educated on the following:
  • the risks of hepatotoxicity and embryo-fetal toxicity

• Ensuring that pharmacies are educated on and adhere to the following:
  • confirming that the appropriate patient monitoring and counseling has occurred before dispensing bosentan

• Ensuring that patients are informed about:
  • the risks of hepatotoxicity and embryo-fetal toxicity
  • appropriate baseline and monthly patient monitoring
  • appropriate contraception

Access comprehensive information on Risk Evaluation and Mitigation Strategies for Bosentan. https://bosentanremsprogram.com/#Main