Label Changes for:
Temodar (temozolomide) for Injection; vial and capsules
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2011
- There have been reported cases of hepatotoxicity including elevations of liver enzymes, hyperbillirubinemia, cholestasis, and hepatitis.