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Hycamtin Capsules

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Hycamtin Capsules

Hycamtin Capsules

INDICATIONS

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 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.
Diarrhea

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.

HOW SUPPLIED

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

REFERENCES

1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

GlaxoSmithKline, Research Triangle Park, NC 27709. June 2014

Last reviewed on RxList: 7/7/2014
This monograph has been modified to include the generic and brand name in many instances.

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