"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)"...
HYCAMTIN is indicated for the treatment of:
- metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy.
- small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase 3 study) or at least 90 days (in the Phase 2 studies) after chemotherapy [see Clinical Studies].
HYCAMTIN in combination with cisplatin is indicated for the treatment of:
DOSAGE AND ADMINISTRATION
Ovarian Cancer And Small Cell Lung Cancer
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.
In the absence of tumor progression, a minimum of 4 courses is recommended because tumor response may be delayed. The median time to response in 3 ovarian clinical trials was 9 to 12 weeks, and median time to response in 4 small cell lung cancer trials was 5 to 7 weeks.
Dosage Modification Guidelines
- In the event of severe neutropenia (defined as < 500 cells/mm³) during any course, reduce the dose by 0.25 mg/m² (to 1.25 mg/m²) for subsequent courses.
- Alternatively, in the event of severe neutropenia, administer G-CSF (granulocyte-colony stimulating factor) following the subsequent course (before resorting to dose reduction) starting from day 6 of the course (24 hours after completion of topotecan administration).
- In the event the platelet count falls below 25,000 cells/mm³, reduce doses by 0.25 mg/m² (to 1.25 mg/m²) for subsequent courses.
The recommended dose of HYCAMTIN is 0.75 mg/m² by intravenous infusion over 30 minutes daily on days 1, 2, and 3; followed by cisplatin 50 mg/m by intravenous infusion on day 1 repeated every 21 days (a 21-day course).
Dosage Modification Guidelines
Dosage adjustments for subsequent courses of HYCAMTIN in combination with cisplatin are specific for each drug. See manufacturer's prescribing information for cisplatin administration and hydration guidelines and for cisplatin dosage adjustment in the event of hematologic toxicity.
- In the event of severe febrile neutropenia (defined as < 1,000 cells/mm with temperature of 38.0°C or 100.4°F), reduce the dose of HYCAMTIN to 0.60 mg/m² for subsequent courses.
- Alternatively, in the event of severe febrile neutropenia, administer G-CSF following the subsequent course (before resorting to dose reduction) starting from day 4 of the course (24 hours after completion of administration of HYCAMTIN).
- If febrile neutropenia occurs despite the use of G-CSF, reduce the dose of HYCAMTIN to 0.45 mg/m² for subsequent courses.
- In the event the platelet count falls below 25,000 cells/mm³, reduce doses to 0.60 mg/m² for subsequent courses.
Dosage Adjustment In Specific Populations
No dosage adjustment of HYCAMTIN appears to be required for patients with mild renal impairment (Clcr 40 to 60 mL/min). Dosage adjustment of HYCAMTIN to 0.75 mg/m² is recommended for patients with moderate renal impairment (20 to 39 mL/min). Insufficient data are available in patients with severe renal impairment to provide a dosage recommendation for HYCAMTIN [see Use In Specific Populations and CLINICAL PHARMACOLOGY].
HYCAMTIN in combination with cisplatin for the treatment of cervical cancer should only be initiated in patients with serum creatinine < 1.5 mg/dL. In the clinical trial, cisplatin was discontinued for a serum creatinine > 1.5 mg/dL. Insufficient data are available regarding continuing monotherapy with HYCAMTIN after cisplatin discontinuation in patients with cervical cancer.
Instructions For Handling, Preparation, And Intravenous Administration
HYCAMTIN is a cytotoxic anticancer drug. Prepare HYCAMTIN under a vertical laminar flow hood while wearing gloves and protective clothing. If HYCAMTIN solution contacts the skin, wash the skin immediately and thoroughly with soap and water. If HYCAMTIN contacts mucous membranes, flush thoroughly with water.
Use procedures for proper handling and disposal of anticancer drugs. Several guidelines on this subject have been published.1-4
Preparation and Administration
Each 4-mg vial of HYCAMTIN is reconstituted with 4 mL Sterile Water for Injection. Then the appropriate volume of the reconstituted solution is diluted in either 0.9% Sodium Chloride Intravenous Infusion or 5% Dextrose Intravenous Infusion prior to administration.
Stability: Unopened vials of HYCAMTIN are stable until the date indicated on the package when stored between 20° and 25°C (68° and 77°F) [see USP] and protected from light in the original package. 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° to 25°C (68° to 77°F) and ambient lighting conditions for 24 hours.
Dosage Forms And Strengths
4-mg (free base) single-dose vial; light yellow to greenish powder.
Storage And Handling
HYCAMTIN for Injection is supplied in 4-mg (free base) single-dose vials.
NDC 0007-4201-01 (package of 1)
Store the vials protected from light in the original cartons at controlled room temperature between 20° and 25°C (68° and 77°F) [see USP].
1. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004-165.
2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm vi/otm vi 2.html
3. American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs. Am JHealth-Syst Pharm. 2006;63:1172-1193.
4. Polovich M, White JM, Kelleher LO (eds.) 2005. Chemotherapy and Biotherapy Guidelines and Recommendations for Practice. (2nd ed) Pittsburgh, PA: Oncology Nursing Society.
GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: Feb 2014
Last reviewed on RxList: 3/18/2014
This monograph has been modified to include the generic and brand name in many instances.
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