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U.S. Department of Health and Human Services

Safety

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Temodar (temozolomide) capsules and for injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

 

May 2014

Summary View

5 WARNINGS AND PRECAUTIONS

5.5 Hepatotoxicity...section added
  • Fatal and severe hepatotoxicity have been reported in patients receiving TEMODAR. Perform liver function tests at baseline, midway through the first cycle, prior to each subsequent cycle, and approximately two to four weeks after the last dose of TEMODAR.
6.2 Postmarketing Experience ... section edited

 

April 2010

Summary View 

ADVERSE REACTIONS

Postmarketing Experience
  • Cases of interstitial pneumonitis/pneumonitis, alveolitis, and pulmonary fibrosis have been reported.