Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- Infections and infestations: reactivation of infections such as cytomegalovirus and hepatitis B.
- Endocrine disorders: Diabetes insipidus
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
- Cases of interstitial pneumonitis/pneumonitis, alveolitis, and pulmonary fibrosis have been reported.