Vinorelbine

Vinorelbine Injection is 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 the treatment of patients with metastatic NSCLC Vinorelbine Injection 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 Ca++-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/m 2 as an intravenous injection or infusion once weekly. Single agent: 30 mg/m 2 as intravenously once a week. Adjust dose in patients with decreased neutrophil counts or elevated serum total bilirubin

None None

Boxed warning (myelosuppression): Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death can occur. Decrease the dose or withhold vinorelbine in accord with recommended dose modifications. Severe myelosuppression resulting in serious infection, septic shock, and death can occur. Hepatic Toxicity: Monitor hepatic function prior to initiation and during treatment. Severe constipation and bowel obstruction, including necrosis and perforation, occur. Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction and/or paralytic ileus. Extravasation can result in severe tissue injury, local tissue necrosis and/or thrombophlebitis. Immediately stop vinorelbine and institute recommended management procedures. Neurologic Toxicity: Severe sensory and motor neuropathies occur.

The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression Hepatic Toxicity Severe Constipation and Bowel Obstruction Extravasation and Tissue Injury Neurologic Toxicity Pulmonary Toxicity and Respiratory Failure Most common adverse reactions (incidence ≥ 20%) are leukopenia, neutropenia, anemia, increased aspartate aminotransferase, nausea, vomiting, constipation, asthenia, injection site reaction and peripheral neuropathy

Inhibitors of CYP3A4: May cause earlier onset and/or increased severity of adverse reactions CYP3A Inhibitors Exercise caution in patients concurrently taking drugs known to inhibit CYP3A. Concurrent administration of vinorelbine with a CYP3A inhibitor may cause an earlier onset and/or an increased severity of adverse reactions.

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours. Protect from light. Store diluted solutions of Vinorelbine Injection, USP at 5° to 30°C (41° to 86°F).