Label Changes for:

Temodar (temozolomide) for Injection; vial and capsules

June 2011

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

 

ADVERSE REACTIONS

Postmarketing Experience
  • There have been reported cases of hepatotoxicity including elevations of liver enzymes, hyperbillirubinemia, cholestasis, and hepatitis.
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