Monograph Details
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Neoplasms
> Antimicrotubule agents
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NAVELBINE |
| Manufacturer |
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Pierre Fabre Pharmaceuticals, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Antimicrotubule agent |
| Generic Name |
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Vinorelbine (as tartrate) 10mg/mL; soln for IV inj after dilution; preservative-free. |
| Indications |
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First-line treatment of ambulatory patients with unresectable, advanced non-small cell lung cancer (NSCLC), as a single agent or in combination with cisplatin. In Stage III NSCLC, use in combination with cisplatin. |
| Children |
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Not recommended. |
| Adults |
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See literature. Give by IV inj over 6–10 minutes. Monotherapy: 30mg/m2 once weekly. Combination therapy: 25mg/m2 once weekly with cisplatin given every 4 weeks; or 30mg/m2 once weekly with cisplatin given on Days 1 and 29, then every 6 weeks. Dose adjustment for toxicities, hepatic impairment: see literature. |
| Contraindications |
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Pretreatment granulocyte counts <1000 cells/mm3. |
| Precautions |
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IV use only; fatal if given intrathecally. Discontinue if neurotoxicity ≥grade 2. Pre-existing pulmonary dysfunction or neuropathy. Prior irradiation or chemotherapy. Cardiovascular disease. Monitor for myelosuppression, infection, and/or fever; obtain CBCs with differentials prior to each dose. Avoid contamination of the eyes or injecting into an extremity with poor circulation (thrombosis possible). Hepatic injury or impairment. Avoid extravasation. Pregnancy (Cat.D), nursing mothers: not recommended. |
| Interactions |
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May be potentiated by CYP3A inhibitors. Acute pulmonary reactions possible with mitomycin. Increased risk of granulocytopenia with cisplatin. May increase risk of neurotoxicity with paclitaxel. Prior or concomitant radiation therapy; may result in radiosensitizing effects. |
| Adverse Reactions |
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Myelosuppression (esp. granulocytopenia), inj site reactions, elevated liver enzymes, chest pain, fatigue, GI upset, alopecia, jaw pain, myalgia, arthralgia, rash, severe constipation, paralytic ileus, intestinal obstruction, necrosis, and/or perforation; dyspnea, severe bronchospasm. |
| How Supplied |
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Single-use vial (1mL, 5mL)—1 |
| Additional Resources |
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• Related Prescribing Note |
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