Patients
What is the Bosentan REMS (Risk Evaluation and Mitigation Strategy) Program?
The Bosentan REMS Program tells patients and healthcare providers about the risks of liver damage and serious birth defects when taking bosentan.
This program is required by the Food and Drug Administration (FDA). All patients must enroll in the Bosentan REMS Program to receive bosentan.

How do I enroll in the Bosentan REMS Program?
You must complete the following steps to enroll in the Bosentan REMS Program:
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1. READ

READ the Medication Guide and the Bosentan REMS Program Guide for Patients

2. ASK

ASK your healthcare provider any questions you have about taking bosentan and the Bosentan REMS Program

3. UNDERSTAND

MAKE SURE YOU UNDERSTAND
  • The benefits and risks of bosentan
  • How to enroll and take part in the Bosentan REMS Program

4. COMPLETE AND SIGN

COMPLETE AND SIGN the Bosentan REMS Program Patient Enrollment Form with your healthcare provider. Your healthcare provider will fill out most of the enrollment form for you. You must read and agree to the requirements, then sign to show you understand and will follow the rules of the program. Your healthcare provider will then send the form to the Bosentan REMS Program. A parent/legal guardian may sign the form for you. You do not need to set up an account on the Bosentan REMS Program Website.

For additional information about the Bosentan REMS Program, please call 1-866-359-2612.