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Navelbine Indications, Dosage, Storage, Stability - Vinorelbine Tartrate
Navelbine Indications, Dosage, Storage, Stability - Vinorelbine Tartrate
INDICATIONS AND USAGE
NAVELBINE is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced nonsmall cell lung cancer (NSCLC). In patients with Stage IV NSCLC, NAVELBINE is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, NAVELBINE is indicated in combination with cisplatin.
DOSAGE AND ADMINISTRATION
Single-Agent NAVELBINE
The usual initial dose of single-agent NAVELBINE is 30 mg/m2 administered weekly. The recommended method of administration is an intravenous injection over 6 to 10 minutes. In controlled trials, single-agent NAVELBINE was given weekly until progression or dose-limiting toxicity.
NAVELBINE in Combination with Cisplatin
NAVELBINE may be administered weekly at a dose of 25 mg/m2 in combination with cisplatin given every 4 weeks at a dose of 100 mg/m2.
Blood counts should be checked weekly to determine whether dose reductions of NAVELBINE and/or cisplatin are necessary. In the SWOG study, most patients required a 50% dose reduction of NAVELBINE at day 15 of each cycle and a 50% dose reduction of cisplatin by cycle 3.
NAVELBINE may also be administered weekly at a dose of 30 mg/m2 in combination with cisplatin, given on days 1 and 29, then every 6 weeks at a dose of 120 mg/m2.
Dose Modifications for NAVELBINE
The dosage should be adjusted according to hematologic toxicity or hepatic insufficiency, whichever results in the lower dose for the corresponding starting dose of NAVELBINE (see Table 5).
Dose Modifications for Hematologic Toxicity: Granulocyte counts should be ³1,000 cells/mm3 prior to the administration of NAVELBINE. Adjustments in the dosage of NAVELBINE should be based on granulocyte counts obtained on the day of treatment according to Table 5.
|
Table 5. Dose Adjustments Based on Granulocyte Counts
|
Granulocytes on Day of Treatment (cells/mm3) |
Percentage of Starting Dose of NAVELBINE |
³1,500 |
100% |
1,000 to 1,499 |
50% |
<1,000 |
Do not administer. Repeat granulocyte count in 1 week. If 3 consecutive weekly doses are held because granulocyte count is <1,000 cells/mm3, discontinue NAVELBINE. |
Note: For patients who, during treatment with NAVELBINE, experienced fever and/or sepsis while granulocytopenic or had 2 consecutive weekly doses held due to granulocytopenia, subsequent doses of NAVELBINE should be: |
³1,500 |
75% |
1,000 to 1,499 |
37.5% |
<1,000 |
See above |
Dose Modifications for Hepatic Insufficiency: NAVELBINE should be administered with caution to patients with hepatic insufficiency. In patients who develop hyperbilirubinemia during treatment with NAVELBINE, the dose should be adjusted for total bilirubin according to Table 6.
|
Table 6. Dose Modification Based on Total Bilirubin
|
Total Bilirubin (mg/dL) |
Percentage of Starting Dose of NAVELBINE |
£2.0 |
100% |
2.1 to 3.0 |
50% |
>3.0 |
25% |
Dose Modifications for Concurrent Hematologic Toxicity and Hepatic Insufficiency: In patients with both hematologic toxicity and hepatic insufficiency, the lower of the doses based on the corresponding starting dose of NAVELBINE determined from Table 5 and Table 6 should be administered.
Dose Modifications for Renal Insufficiency: No dose adjustments for NAVELBINE are required for renal insufficiency. Appropriate dose reductions for cisplatin should be made when NAVELBINE is used in combination.
Dose Modifications for Neurotoxicity: If Grade ³2 neurotoxicity develops, NAVELBINE should be discontinued.
Administration Precautions
Caution - NAVELBINE must be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any NAVELBINE is injected. Leakage into surrounding tissue during intravenous administration of NAVELBINE may cause considerable irritation, local tissue necrosis, and/or thrombophlebitis. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Since there are no established guidelines for the treatment of extravasation injuries with NAVELBINE, institutional guidelines may be used. The ONS Chemotherapy Guidelines provide additional recommendations for the prevention of extravasation injuries.1
As with other toxic compounds, caution should be exercised in handling and preparing the solution of NAVELBINE. Skin reactions may occur with accidental exposure. The use of gloves is recommended. If the solution of NAVELBINE contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water. Severe irritation of the eye has been reported with accidental contamination of the eye with another vinca alkaloid. If this happens with NAVELBINE, the eye should be flushed with water immediately and thoroughly.
Procedures for proper handling and disposal of anticancer drugs should be used. Several guidelines on this subject have been published.2-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
NAVELBINE Injection is a clear, colorless to pale yellow solution. Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. If particulate matter is seen, NAVELBINE should not be administered.
Preparation for Administration
NAVELBINE Injection must be diluted in either a syringe or IV bag using one of the recommended solutions. The diluted NAVELBINE should be administered over 6 to 10 minutes into the side port of a free-flowing IV closest to the IV bag followed by flushing with at least 75 to 125 mL of one of the solutions. Diluted NAVELBINE may be used for up to 24 hours under normal room light when stored in polypropylene syringes or polyvinyl chloride bags at 5° to 30°C (41° to 86°F).
Syringe: The calculated dose of NAVELBINE should be diluted to a concentration between 1.5 and 3.0 mg/mL. The following solutions may be used for dilution:
5% Dextrose Injection, USP
0.9% Sodium Chloride Injection, USP
IV Bag: The calculated dose of NAVELBINE should be diluted to a concentration between 0.5 and 2 mg/mL. The following solutions may be used for dilution:
5% Dextrose Injection, USP
0.9% Sodium Chloride Injection, USP
0.45% Sodium Chloride Injection, USP
5% Dextrose and 0.45% Sodium Chloride Injection, USP
Ringer's Injection, USP
Lactated Ringer's Injection, USP
Stability
Unopened vials of NAVELBINE are stable until the date indicated on the package when stored under refrigeration at 2° to 8°C (36° to 46°F) and protected from light in the carton. Unopened vials of NAVELBINE are stable at temperatures up to 25°C (77°F) for up to 72 hours. This product should not be frozen.
HOW SUPPLIED
NAVELBINE Injection is a clear, colorless to pale yellow solution in Water for Injection, containing 10 mg vinorelbine per mL. NAVELBINE Injection is available in single-use, clear glass vials with elastomeric stoppers and royal blue caps, individually packaged in a carton in the following vial sizes:
10 mg/1 mL Single-Use Vial, Carton of 1 (NDC 0173-0656-01).
50 mg/5 mL Single-Use Vial, Carton of 1 (NDC 0173-0656-44).
Store the vials under refrigeration at 2° to 8°C (36° to 46°F) in the carton. Protect from light. DO NOT FREEZE.
REFERENCES
1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, Pa: Oncology Nursing Society; 1999:32-41.
2. Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety, National Institutes of Health; 1983. US Dept of Health and Human Services, Public Health Service publication NIH 83-2621.
3. AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985;253:1590-1591.
4. National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.
5. Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia. 1983;1:426-428.
6. Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA-A Cancer J for Clin. 1983;33:258-263.
7. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033-1049.
8. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines.) Am J Health-Syst Pharm. 1996;53:1669-1685.
Manufactured by Pierre Fabre Médicament Production, 64320 Idron, FRANCE for GlaxoSmithKline, Research Triangle Park, NC 27709, Under license of Pierre Fabre Médicament, ©2003, GlaxoSmithKline. All rights reserved., April 2003, RL-2005.
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