NAVELBINE is indicated as a single agent or in combination with cisplatin for the treatment of ambulatory patients with advanced, unresectable non-small cell lung cancer.
The use of NAVELBINE is contraindicated in patients with a pre-treatment granulocyte count of less than 1000 cells/cubic mm.
Dosage and Administration
Preparation and Administration
Exercise caution in handling and preparing NAVELBINE solution. As with other toxic compounds, skin reactions may occur with accidental exposure. Use of gloves is recommended. If NAVELBINE solution contacts skin or mucosa, immediately wash thoroughly with soap and water. If accidental contamination of the eye occurs, flush the eye with water immediately and thoroughly.
Injection Site Reactions
Like other vinca alkaloids, NAVELBINE is a moderate vesicant and an irritant to the vein. Some patients may experience erythema, pain at injection site, vein discoloration, and/or chemical phlebitis along the vein proximal to injection site. Proper administration technique is important. If an extravasation occurs, treat according to institutional guidelines.
The major dose-limiting toxicity of NAVELBINE is hematologic, specifically granulocytopenia, which is predictable at 7-10 days, generally reversible and not cumulative over time, usually does not require growth factor support, and can be managed by a modification in the dose.
Nonhematologic adverse effects are usually mild or moderate and include injection site reactions, nausea/vomiting, constipation, fatigue, peripheral neuropathy, diarrhea, and alopecia. Fatigue and injection site reactions were the only nonhematologic events that were of Grade 3-4 intensity in >5% of patients.
Patients should be informed that the major acute toxicities of NAVELBINE are related to bone marrow toxicity, specifically granulocytopenia with increased susceptibility to infection. They should report fever or chills immediately.
50 mg/5 mL single-use vial (NDC 0081-0656-44)
10 mg/1 mL single-use vial (NDC 0081-0656-01)
Store vials at 2° to 8°C (36° to 46°F) and protect
Do not freeze.
For further information, call Glaxo Wellcome Inc. Drug Information Service at 1-800-443-6763.