Vinorelbine

What it is and how it works

Mechanism of Action 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.

Indications

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

Dosage and administration (summary)

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 Recommended Dosage In Combination with Cisplatin 100 mg/m 2 The recommended dosage of Vinorelbine Injection is 25 mg/m 2 administered as an intravenous injection or infusion over 6 to 10 minutes on Days 1, 8, 15 and 22 of a 28-day cycle in combination with cisplatin 100 mg/m 2 on Day 1 only of each 28-day cycle.

Contraindications

None None

Warnings and precautions

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. Monitor patients for new or worsening signs and symptoms of neuropathy.

Pregnancy

Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action , vinorelbine can cause fetal harm when administered to a pregnant woman. Available human data are insufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Storage and supply

Storage Conditions Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Protect from light. Retain in carton until time of use. Discard unused portion. Unopened vials of Vinorelbine Injection, USP are stable at 25°C (77°F) for up to 72 hours. Store diluted solutions of Vinorelbine Injection, USP at 5° to 30°C (41° to 86°F) .

Source: Vinorelbine (Vinorelbine) — US FDA prescribing information, 2024-08-16, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.