Hycamtin (Topotecan Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

HYCAMTIN capsules are indicated for the treatment of relapsed small cell lung cancer in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy.

DOSAGE AND ADMINISTRATION

Recommended Dosing

The recommended dose of HYCAMTIN capsules is 2.3 mg/m²/day once daily for 5 consecutive days repeated every 21 days. Round the calculated oral daily dose to the nearest 0.25 mg, and prescribe the minimum number of 1 mg and 0.25 mg capsules. The same number of capsules should be prescribed for each of the 5 dosing days.

HYCAMTIN capsules may be taken with or without food. The capsules must be swallowed whole and must not be chewed, crushed, or divided. If your patient vomits after taking the dose of HYCAMTIN, the patient should not take a replacement dose.

Adjustment of Dose in Special Populations

Renal Function Impairment

No dosage adjustment of HYCAMTIN capsules appears to be required for treating patients with mild renal impairment (CLcr = 50-80 mL/min). A dose adjustment of HYCAMTIN capsules to 1.8 mg/m²/day is predicted to adjust the area under the curve (AUC) to the normal range for patients with moderate renal impairment (CLcr = 30-49 mL/min). Insufficient data are available in patients with severe renal impairment (CLcr <30 mL/min) to provide a dosage recommendation for HYCAMTIN capsules [see Use in Specific Populations].

Dose Modification Guidelines

Patients should not be treated with subsequent courses of HYCAMTIN until neutrophils recover to >1,000 cells/mm³, platelets recover to >100,000 cells/mm³, and hemoglobin levels recover to ≥9.0 g/dL (with transfusion if necessary).

For patients who experience severe neutropenia (neutrophils <500 cells/mm³ associated with fever or infection or lasting for 7 days or more) or neutropenia (neutrophils 500 to 1,000 cells/mm³ lasting beyond day 21 of the treatment course), the HYCAMTIN capsules dose should be reduced by 0.4 mg/m²/day for subsequent courses. Doses should be similarly reduced if the platelet count falls below 25,000 cells/mm³.

For patients who experience Grade 3 or 4 diarrhea, the HYCAMTIN capsules dose should be reduced by 0.4 mg/m²/day for subsequent courses [see Warnings and Precautions]. Patients with Grade 2 diarrhea may need to follow the same dose modification guidelines.

DOSAGE FORMS AND STRENGTHS

HYCAMTIN capsules contain topotecan hydrochloride expressed as topotecan free base. The 0.25 mg capsules are opaque white to yellowish-white and imprinted with HYCAMTIN and 0.25 mg. The 1 mg capsules are opaque pink and imprinted with HYCAMTIN and 1 mg.

HOW SUPPLIED/STORAGE AND HANDLING

The 0.25 mg HYCAMTIN capsules are opaque white to yellowish-white imprinted with HYCAMTIN and 0.25 mg and are available in bottles of 10: NDC 0007-4205-11.

The 1 mg HYCAMTIN capsules are opaque pink imprinted with HYCAMTIN and 1 mg and are available in bottles of 10: NDC 0007-4207-11.

Store refrigerated 2° to 8°C (36° to 46°F). Store the bottles protected from light in the original outer cartons.

Procedures for proper handling and disposal of anticancer drugs should be used. Several guidelines on this subject have been published.^1-4

HYCAMTIN capsules should not be opened or crushed. Direct contact of the capsule contents with the skin or mucous membranes should be avoided. If such contacts occur, wash thoroughly with soap and water or wash the eyes immediately with gently flowing water for at least 15 minutes. Consult the healthcare provider in case of a skin reaction or if the drug gets in the eyes.