"The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
Zykadia is an anaplastic lymphoma kinase (ALK)"...
DOSAGE AND ADMINISTRATION
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
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].
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
|Degree of Renal Impairment||Creatinine Clearancea (mL/min)||Dose (mg/m²)/day|
|Moderate||30 - 49||1.5b|
|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. 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.
Additional Hycamtin Capsules Information
- Hycamtin Capsules Drug Interactions Center: topotecan oral
- Hycamtin Capsules Side Effects Center
- Hycamtin Capsules in detail including Side Effects and Drug Images
- Hycamtin Capsules FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
Get the latest treatment options.