NAVELBINE

What it is

NAVELBINE is a concentrated injection containing vinorelbine tartrate, supplied as 10 mg per 1 mL or 50 mg per 5 mL. The injection is a clear, colourless to pale yellow solution.

Approved indications

— Treatment of advanced breast cancer after failure of standard therapy, as a single agent or in combination. — First line treatment for advanced non-small cell lung cancer, as a single agent or in combination. — Treatment in combination with cisplatin of patients with completely resected non-small cell lung cancer of stage IB or greater.

Dosing overview

For advanced breast cancer and non-small cell lung cancer, single agent treatment is usually given at 25–30 mg/m² weekly intravenously. In combination chemotherapy the dose may be the same and the frequency of administration reduced, for example day 1 and 8 or day 1 and 5 every 3 weeks. For resected non-small cell lung cancer (stage IB or greater) in combination with cisplatin, NAVELBINE may be administered at an initial dose of 25–30 mg/m² intravenously at weekly intervals for 16 weeks. The dose of cisplatin is 100 mg/m² administered intravenously over 1 hour, on days 1, 29, 57 and 85. NAVELBINE should be administered either by infusion over 6 to 10 minutes after dilution in 50 mL of normal saline solution or by infusion over 20 to 30 minutes after dilution in 125 mL of normal saline solution, followed by at least 250 mL normal saline infusion to flush the vein and prevent phlebitis. Neutrophil counts should be ≥ 1 × 10⁹ cells/L prior to the administration of NAVELBINE. For patients with severe liver impairment (bilirubin > 2 × UNL and/or transaminases > 5 × UNL), a dose reduction of 33% is suggested with close monitoring of haematological parameters.

Key safety warnings

NAVELBINE is a moderate vesicant, and leakage into surrounding tissue during intravenous administration may cause considerable irritation, local tissue necrosis, and/or thrombophlebitis. It is extremely important that the intravenous needle or catheter be properly positioned before any NAVELBINE is infused. Insertion of a central venous line may be necessary. Patients treated with NAVELBINE should be frequently monitored for myelosuppression both during and after therapy. Neutropenia is dose-limiting, with neutrophil nadirs occurring between 5 and 10 days after dosing, depending on whether NAVELBINE is used as single agent or in combination, with neutrophil count recovery usually within 7 to 14 days after administration. Complete blood counts with differentials should be performed and results reviewed prior to administering each dose of NAVELBINE. Pulmonary toxicity, including severe acute bronchospasm, interstitial pneumonitis, and acute respiratory distress syndrome occurring with NAVELBINE has been reported, with mean time to onset of ARDS being one week. The infusion must be immediately interrupted in patients who develop unexplained dyspnea or evidence of pulmonary toxicity, and NAVELBINE must be permanently discontinued for confirmed interstitial pneumonitis. Peripheral neuropathy effects are dose dependent but usually reversible when treatment is discontinued.

Contraindications

— Known hypersensitivity to vinorelbine or to any of the excipients or to other vinca alkaloids. — Neutrophil count < 1500 cells/mm³, or severe infection, current or recent (within 2 weeks). — Platelet count < 100,000 cells/mm³. — Severe hepatic insufficiency. — Pregnancy. — Lactation. — In combination with yellow fever vaccine.

Regulatory history

NAVELBINE vinorelbine 10 mg/mL injection and 50 mg/5 mL injection were first listed on the ARTG on 16 February 1998. NAVELBINE ORAL vinorelbine 20 mg and 30 mg capsules were first listed on the ARTG on 31 May 2005.