Verify dose using body surface area prior to dispensing. Recommended dosage should generally not exceed 4 mg intravenously [see Overdosage (10)].
2.1 Ovarian Cancer
Recommended Dose and Schedule
The recommended dose of topotecan hydrochloride for 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 course.
2.2 Small Cell Lung Cancer
Recommended Dose and Schedule
The recommended dose of topotecan hydrochloride for 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 course.
2.3 Cervical Cancer
Recommended Dose and Schedule
The recommended dose of topotecan hydrochloride for injection is 0.75 mg/m2 by intravenous infusion over 30 minutes daily on Days 1, 2, and 3 in combination with cisplatin 50 mg/m2 on Day 1, repeated every 21 days.
2.4 Dose Modifications
Hematologic Toxicities
For single-agent use, dose reduce topotecan hydrochloride for injectionto 1.25 mg/m2 for:
neutrophil counts of less than 500 cells/mm3, or administer granulocyte-colony stimulating factor (G-CSF) starting no sooner than 24 hours following the last dose of topotecan hydrochloride for injection.
platelet counts less than 25,000 cells/mm3 during previous cycle.
For combination use with cisplatin, dose reduce topotecan hydrochloride for injectionto 0.6 mg/m2 (and further to 0.45 mg/m2 if necessary) for:
febrile neutropenia (defined as neutrophil counts less than 1,000 cells/mm3 with temperature of greater than or equal to 38°C (100.4°F), or administer G-CSF starting no sooner than 24 hours following the last dose of topotecan hydrochloride for injection.
platelet counts less than 25,000 cells/mm3 during previous cycle.
Renal Impairment
For single-agent use, dose reduce topotecan hydrochloride for injection to 0.75 mg/m2 in patients with moderate renal impairment (creatinine clearance [Clcr] = 20 to 39 mL/min). Insufficient data are available in patients with severe renal impairment (Clcr less than 20 mL/min) to provide a dosage recommendation for topotecan hydrochloride for injection[see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.5 Preparation and Intravenous Administration
Topotecan hydrochloride for injection is a cytotoxic drug. Follow applicable special handling and disposable procedures.1
Preparation and Administration
Reconstitute each 4-mg vial of topotecan hydrochloride for injection with 4 mL Sterile Water for Injection, USP. Dilute the appropriate volume of the reconstituted solution in either 0.9% Sodium Chloride Intravenous Infusion, USP or 5% Dextrose in Water Injection, USP prior to administration.
Stability
Unopened vials of topotecan hydrochloride for injection are stable until the date indicated on the package when stored between 20°C and 25°C (68°F and 77°F) [see USP] and protected from light in the original carton. Because the vials contain no preservative, contents should be used immediately after reconstitution.
Reconstituted vials of topotecan hydrochloride for injection diluted for infusion are stable at approximately 20°C to 25°C (68°F to 77°F) and ambient lighting conditions for 24 hours.