September 1, 2015
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Hycamtin

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Hycamtin




Indications
Dosage
How Supplied

INDICATIONS

Ovarian Cancer

HYCAMTIN for injection, as a single agent, is indicated for the treatment of patients with metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy.

Small Cell Lung Cancer

HYCAMTIN for injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy.

Cervical Cancer

HYCAMTIN for injection in combination with cisplatin is indicated for the treatment of patients with Stage IV-B, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment.

DOSAGE AND ADMINISTRATION

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

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, CLINICAL PHARMACOLOGY].

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.

HOW SUPPLIED

Dosage Forms And Strengths

For injection: 4 mg (topotecan free base) lyophilized powder in single-use vial for reconstitution; light yellow to greenish powder.

HYCAMTIN for injection is supplied as a sterile, lyophilized, buffered, light yellow to greenish powder. HYCAMTIN for Injection is supplied in 4-mg (free base) single-dose vials.

NDC 0007-4201-01 (package of 1)

Storage And Handling

Store at controlled room temperature between 20°C and 25°C (68°F and 77°F) [see USP]. Protect from light in original carton. Handle and dispose of HYCAMTIN for injection consistent with recommendations for the handling and disposal of hazardous drugs1 .

REFERENCES

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

Glaxo SmithKline, Research Triangle Park, NC 27709. Revised: June 2015

Last reviewed on RxList: 6/19/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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