2 DOSAGE AND ADMINISTRATION
2.1 Important Safety Information
Verify dosage using body surface area. Do not exceed a single dose of 4 mg intravenously.
2.2 Recommended Dosage for Small Cell Lung Cancer
The recommended dosage of Topotecan Injection is 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day cycle.
2.3 Dosage Modifications for Adverse Reactions
Do not administer subsequent cycles of Topotecan Injection until neutrophils recover to greater than 1,000/mm3, platelets recover to greater than 100,000/mm3, and hemoglobin levels recover to greater than or equal to 9 g/dL (with transfusion if necessary).
Reduce the dose of Topotecan Injection to 1.25 mg/m2/day for:
- neutrophil counts of less than 500/mm3 or administer granulocyte-colony stimulating factor (G-CSF) starting no sooner than 24 hours following the last dose
- platelet counts less than 25,000/mm3 during previous cycle
2.4 Dosage Modification for Renal Impairment
Reduce the dose of Topotecan Injection to 0.75 mg/m2/day for patients with creatinine clearance (CLcr) of 20 to 39 mL/min (calculated with the Cockcroft-Gault method using ideal body weight) [see Clinical Pharmacology (12.3)].
2.5 Preparation and Administration
Topotecan Injection is a cytotoxic drug. Follow applicable special handling and disposable procedures.1
Withdraw the appropriate volume from the vial and discard any unused portion.
Dilute Topotecan Injection in a minimum of 50 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP prior to administration. Infuse diluted Topotecan Injection over 30 minutes.
Store diluted Topotecan Injection at 20°C and 25°C (68°F and 77°F) in ambient lighting conditions for no more than 24 hours. Discard unused portion after 24 hours.
Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if particulate matter or discoloration is observed.