Label Changes for:

Temodar (temozolomide) capsules and for injection

April 2010

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) – April 2010

ADVERSE REACTIONS

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