Label Changes for:
Tracleer (bosentan) 62.5 and 125 mg tablets
August 2009
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009
MEDICATION GUIDE (new)
REMS Goals
The goals of the Tracleer risk evaluation and mitigation strategy are as follows:
1. To enable informed risk-benefit decisions for treating patients with Tracleer.
2. To minimize the risk of hepatotoxicity in patients who are exposed to
Tracleer.
3. To minimize the risk of fetal exposures in female patients who are exposed to
Tracleer.
4. To educate prescribers, patients, and pharmacies on the safe-use conditions for
Tracleer.
