May 23, 2017
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Hycamtin Capsules

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Hycamtin Capsules

How Supplied


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.


Recommended Dosing

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

Take HYCAMTIN capsules with or without food. Swallow capsules whole. Do not chew, crush, or divide the capsules. Do not prescribe a replacement dose for emesis.

Dose Modification Guidelines

Hematologic Toxicities

Do not administer subsequent courses of HYCAMTIN capsules until neutrophils recover to greater than 1,000 cells/mm³, platelets recover to greater than 100,000 cells/mm³, hemoglobin levels recover to greater than or equal to 9.0 g/dL (with transfusion if necessary).

  • Dose reduce HYCAMTIN capsules by 0.4 mg/m²/day for:
    • neutrophil counts of less than 500 cells/mm³ associated with fever or infection or lasting for 7 days or more;
    • neutrophil counts of 500 to 1,000 cells/mm³ lasting beyond day 21 of the treatment course;
    • platelet counts less than 25,000 cells/mm³.

Do not administer HYCAMTIN capsules to patients with Grade 3 or 4 diarrhea. After recovery to Grade 1 or less, reduce the dose of HYCAMTIN by 0.4 mg/m²/day for subsequent courses [see WARNINGS AND PRECAUTIONS].

Renal Impairment

The recommended starting doses of HYCAMTIN capsules in patients with moderate and severe renal impairment are as follows:

Table 1: Dose Reduction Guidelines for Renal Impairment

Degree of Renal Impairment Creatinine Clearancea (mL/min) Dose (mg/m²)/day
Moderate 30 - 49 1.5b
Severe < 30 0.6b
a Calculated with the Cockroft-Gault method using ideal body weight.
b Dose can be increased after the first course by 0.4 mg/m²/day if no severe hematologic or gastrointestinal toxicities occur.


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 and0.25 mg. The 1-mg capsules are opaque pink and imprinted with HYCAMTIN and 1 mg.

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

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


1. “OSHA Hazardous Drugs.” OSHA.

GlaxoSmithKline, Research Triangle Park, NC 27709. June 2014

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/8/2016

How Supplied

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