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Hycamtin Dosage

Generic name: TOPOTECAN HYDROCHLORIDE 4mg in 4mL
Dosage form: injection, powder, lyophilized, for solution

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Verify dose using body surface area prior to dispensing. Recommended dosage should generally not exceed 4 mg intravenously [see Overdosage (10)].

Ovarian Cancer

Recommended Dose and Schedule

The recommended dose of HYCAMTIN 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.

Small Cell Lung Cancer

Recommended Dose and Schedule

The recommended dose of HYCAMTIN 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.

Cervical Cancer

Recommended Dose and Schedule

The recommended dose of HYCAMTIN 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.

Dose Modifications

Hematologic Toxicities

For single-agent use, dose reduce HYCAMTIN to 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 HYCAMTIN.
platelet counts less than 25,000 cells/mm3 during previous cycle.

For combination use with cisplatin, dose reduce HYCAMTIN to 0.60 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 38.0°C (100.4°F), or administer G‑CSF starting no sooner than 24 hours following the last dose of HYCAMTIN.
platelet counts less than 25,000 cells/mm3 during previous cycle.

Renal Impairment

For single-agent use, dose reduce HYCAMTIN 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 HYCAMTIN [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Preparation and Intravenous Administration

HYCAMTIN is a cytotoxic drug. Follow applicable special handling and disposable procedures.1

Preparation and Administration

Reconstitute each 4-mg vial of HYCAMTIN 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 HYCAMTIN 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 HYCAMTIN diluted for infusion are stable at approximately 20°C to 25°C (68°F to 77°F) and ambient lighting conditions for 24 hours.

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