These highlights do not include all the information needed to use NAVELBINE safely and effectively. See full prescribing information for NAVELBINE.
NAVELBINE® (vinorelbine tartrate) injection, for intravenous use
Initial U.S. Approval: 1994
WARNING: MYELOSUPPRESSION
See full prescribing information for complete boxed warning.
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Severe myelosuppression resulting in serious infection, septic shock, and death may occur (5.1).
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Decrease the dose or withhold NAVELBINE in accord with recommended dose modifications (2.2).
INDICATIONS AND USAGE
NAVELBINE is a vinca alkaloid indicated:
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In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) (1)
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As a single agent for first-line treatment of patients with metastatic NSCLC (1)
DOSAGE AND ADMINISTRATION
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In combination with cisplatin: 25 to 30 mg/m2 as a single intravenous injection weekly (2.1)
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Single agent: 30 mg/m2 as a single intravenous injection weekly (2.1)
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Adjust the dose in patients with decreased neutrophil counts or elevated serum total bilirubin (2.2)
DOSAGE FORMS AND STRENGTHS
None (4)
WARNINGS AND PRECAUTIONS
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Hepatic toxicity: monitor liver function during treatment (5.2)
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Severe constipation and bowel obstruction including necrosis and perforation can occur. Institute a prophylactic bowel regimen to mitigate potential constipation. Monitor for abdominal pain and severe constipation (5.3)
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Extravasation can result in severe tissue injury, necrosis and/or thrombophlebitis. Immediately stop NAVELBINE and institute recommended management procedures (5.4)
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Neurologic toxicity: severe sensory and motor neuropathies can occur. Monitor patients for new or worsening signs and symptoms of neuropathy (5.5)
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Pulmonary toxicity and respiratory failure can occur with use of NAVELBINE. Monitor patients respiratory disorders: dyspnea and bronchospasm Interrupt NAVELBINE in patients who develop unexplained dyspnea (5.6)
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Embryo-fetal toxicity: can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus (5.7, 8.1)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 20%) are neutropenia, anemia, liver enzyme elevation, nausea, vomiting, asthenia, constipation, injection site reaction, and peripheral neuropathy (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pierre Fabre Pharmaceuticals at 1- 855-PFPHARM (1-855-737-4276) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Inhibitors of CYP3A4: increased severity of adverse reactions (7.1)
USE IN SPECIFIC POPULATIONS
Nursing Mothers: discontinue drug or nursing taking into consideration importance of drug to mother (8.3)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 5/2014
