Label Changes for:
Hycamtin (topotecan) capsules
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
USE IN SPECIFIC POPULATIONS
- The systemic exposure to both topotecan lactone and total topotecan increased in patients with renal impairment compared with that in patients with normal renal function. No dosage adjustment is recommended for patients with mild renal impairment (CLcr = 50-79 mL/min). Adjust the dose of Hycamtin capsules in patients with moderate (CLcr = 30-49 mL/min) and severe (CLcr <30 mL/min) renal impairment.
- ...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.