Label Changes for:
Hycamtin (topotecan) Capsules
Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2011
- ...should not be used in patients with severe bone marrow depression
WARNINGS AND PRECAUTIONS
Interstitial lung disease
- interstitial lung disease..... added
- Respiratory, thoracic, and mediastinal disorders: Interstitial lung disease.