Vinflunine Ditartrate

What it is and how it works

Vinflunine is a bi-fluorinated semi-synthetic vinca alkaloid that binds to tubulin at or near the vinca-binding site, inhibiting microtubule polymerisation and mitotic spindle formation. This arrests cells in mitosis (G2/M) and induces apoptosis.

Indications

Monotherapy for advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen.

Dosage and administration (summary)

By intravenous infusion over 20 minutes, usually 320 mg/m² every 3 weeks; a lower starting dose (280 mg/m²) is used in patients with poorer performance status, prior pelvic irradiation, older age or renal or hepatic impairment, with adjustment for toxicity.

Contraindications

Hypersensitivity to vinflunine or other vinca alkaloids; recent (within 2 weeks) or current severe infection; baseline neutrophil count below 1500/mm³ (or platelets below 100,000/mm³) before the first infusion; breast-feeding.

Warnings and precautions

Neutropenia is the main dose-limiting toxicity; monitor blood counts before each cycle. Constipation and paralytic ileus are frequent, so prophylactic laxatives and dietary measures are recommended. QT prolongation, hyponatraemia, posterior reversible encephalopathy syndrome and injection-site reactions may occur; it must be given intravenously only, as intrathecal administration of vinca alkaloids is fatal.

Pregnancy

Can cause fetal harm; should not be used in pregnancy unless clearly necessary, and effective contraception is required during and after treatment.

Storage and supply

Store refrigerated at 2–8 °C in the original carton to protect from light; do not freeze.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.