DOSAGE AND ADMINISTRATION
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.