TRACLEER Enrollment and Access

Because of the risks of liver injury and birth defects associated with treatment, the use of TRACLEER requires participation in the Tracleer Risk Evaluation and Mitigation Strategy (REMS), a restricted distribution program.

To start treatment with TRACLEER, you must review essential safety information with your healthcare provider, complete a TRACLEER Patient Enrollment and Consent Form, and agree to have important monthly tests. Your first step is to 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 or the REMS Program. You must then go for liver function and, if applicable, pregnancy tests. These tests rule out that you are pregnant or that you have liver problems before starting treatment with TRACLEER. This is important because of the risk of liver damage and serious birth defects associated with TRACLEER.

When you’re prescribed TRACLEER, it’s important to understand the possible risks and benefits of treatment.