The Tracleer® (bosentan) REMS (Risk Evaluation
and Mitigation Strategy) Program

Information for Patients

What is the Tracleer REMS (Risk Evaluation and Mitigation Strategy) Program?

The Tracleer REMS is a program to tell patients and healthcare providers about the risks of liver damage and serious birth defects when taking Tracleer. This program is required by the Food and Drug Administration (FDA). All patients must enroll in the Tracleer REMS Program to receive Tracleer. REMS stands for Risk Evaluation and Mitigation Strategy.

How do I enroll in the Tracleer REMS Program?

There are several steps you must take:
  • Read the Tracleer REMS Guide for Patients and the Tracleer Medication Guide (which comes with your medicine)
  • Ask your healthcare provider any questions you have about taking Tracleer and the Tracleer REMS Program
  • Make sure you understand:
    • The benefits and risks of Tracleer
    • How to enroll and take part in the Tracleer REMS Program
  • Complete and sign the Tracleer REMS Patient Enrollment and Consent Form with your healthcare provider. Your healthcare provider will fill out most of the enrollment form for you and will send the form to Actelion Pathways®. Actelion Pathways runs the Tracleer REMS Program