Label Changes for:
Temodar (temozolomide) capsules and for injection
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
- Cases of interstitial pneumonitis/pneumonitis, alveolitis, and pulmonary fibrosis have been reported.