It is a vinca alkaloid indicated: ? In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) ? As a single agent for first-line treatment of patients with metastatic NSCLC
Vinorelbine is a vinca alkaloid that interferes with microtubule assembly. The antitumor activity of vinorelbine is thought to be due primarily to inhibition of mitosis at metaphase through its interaction with tubulin. Vinorelbine may also interfere with: 1) amino acid, cyclic AMP and glutathione metabolism, 2) calmodulin-dependent Ca2+ transport ATPase activity, 3) cellular respiration, and 4) nucleic acid and lipid biosynthesis. Vinorelbine inhibited mitotic microtubule formation in intact mouse embryo tectal plates at a concentration of 2 µM inducing a blockade of cells at metaphase, but produced depolymerization of axonal microtubules at a concentration 40 µM, suggesting a modest selectivity of vinorelbine for mitotic microtubules.
In combination with cisplatin: 25 to 30 mg/m2 as a single intravenous injection weekly ? Single agent: 30 mg/m2 as a single intravenous injection weekly . ? Adjust the dose in patients with decreased neutrophil counts or elevated serum total bilirubin In combination with cisplatin: 25 to 30 mg/m2 as a single intravenous injection weekly . ? Single agent: 30 mg/m2 as a single intravenous injection weekly . ? Adjust the dose in patients with decreased neutrophil counts or elevated serum total bilirubin .
Exercise caution in patients concurrently taking drugs known to inhibit CYP3A. Concurrent administration of Vinorelbine Tartrate with a CYP3A inhibitor may cause an earlier onset and/or an increased severity of adverse reactions.
Neutropenia, anemia, liver enzyme elevation, nausea, vomiting, asthenia, constipation, injection site reaction, and peripheral neuropathy
Nursing Mothers: discontinue drug or nursing taking into consideration importance of drug to mother
There is no known antidote for overdoses of NAVELBINE. Overdoses involving quantities up to
10 times the recommended dose (30 mg/m2
) have been reported. The adverse reactions described
were consistent with those listed in the ADVERSE REACTIONS section, including paralytic
ileus, stomatitis and esophagitis. Bone marrow aplasia, sepsis and paresis have also been
reported. Fatalities have occurred following overdose of NAVELBINE. If overdosage occurs,
general supportive measures together with appropriate blood transfusions, growth factors and
antibiotics should be instituted as deemed necessary by the physician.
Store the vials at 2° to 8°C in the carton. Protect from light. DO NOT FREEZE. Unopened vials of Vinorelbine Tartrate are stable at 25°C for up to 72 hours. Store diluted solutions of NAVELBINE at 5° to 30°C.
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