VELABINE

What it is

VELABINE contains vinorelbine tartrate in soft capsule formulations of 20 mg, 30 mg and 80 mg strengths. VELABINE soft capsules must be given strictly by the oral route and should be swallowed whole with water without being chewed or sucked.

Approved indications

— First line treatment of advanced non-small cell lung cancer, as a single agent or in combination. — Treatment of advanced breast cancer after failure of standard therapy as a single agent or in combination.

Dosing overview

For single agent therapy in adults, the recommended regimen is 60 mg/m² administered once weekly for the first three administrations, then increased to 80 mg/m² once weekly for subsequent administrations, except in patients whose neutrophil count has dropped below 500/mm³ or more than once between 500 and 1000/mm³ during the initial three doses. In combination with capecitabine for advanced breast cancer, VELABINE is administered on days 1 and 8 of three-week cycles at 60 mg/m² for the first cycle, then increased to 80 mg/m² for subsequent cycles, with capecitabine given at 1000 mg/m² twice daily on days 1–14. For patients with moderate hepatic impairment (serum bilirubin between 1.5 and 3 times the upper limit of normal), the dose should be reduced to 50 mg/m² per week. Patients with mild hepatic impairment (serum bilirubin less than 1.5 times the upper limit of normal and ALT and/or AST between 1.5 and 2.5 times the upper limit of normal) may be administered at the standard dose of 60 mg/m² per week.

Key safety warnings

Neutropenia is dose-limiting, and complete blood counts with differentials should be performed prior to each dose of VELABINE, with patients monitored frequently for myelosuppression during and after therapy. During clinical trials, febrile neutropenia, in some cases fatal, was encountered in about 15% of patients when treatment was initiated at a weekly dose of 80 mg/m², therefore the starting dose should be 60 mg/m² and increased only if tolerated. VELABINE is associated with a higher incidence of nausea and vomiting than the intravenous formulation, and primary prophylaxis with antiemetics is recommended. Constipation is a very common gastrointestinal disorder, and prescription of laxatives may be appropriate for patients with a prior history of constipation and/or those receiving concomitant treatment with opiates. Acute shortness of breath and severe bronchospasm have been reported infrequently along with rare cases of interstitial pneumopathy following VELABINE administration, particularly when combined with mitomycin or in patients with pre-existing pulmonary dysfunction, and these adverse events may require treatment with supplemental oxygen, bronchodilators and/or corticosteroids.

Contraindications

Known hypersensitivity to vinorelbine or to other vinca alkaloids or to any of the excipients. Disease significantly affecting absorption, or previous significant surgical resection of stomach or small bowel. Neutrophil counts below 1500 cells/mm³ or current or recent severe infection due to neutropenia within 2 weeks, or platelet count below 100,000 cells/mm³. Pregnancy and lactation. Patients requiring long-term oxygen therapy. Severe hepatic insufficiency. Concomitant use with yellow fever vaccine.

PBS listing

VELABINE 20 mg capsules and 30 mg capsules are listed on the PBS with authority required restriction. The ex-manufacturer prices are A$38.18 for the 20 mg strength and A$57.59 for the 30 mg strength, with the latest schedule dated 1 May 2026.

Regulatory history

VELABINE vinorelbine 20 mg and 30 mg soft capsules were first registered on the ARTG on 14 February 2023 under licence category RE (Sponsor: Arrotex Pharmaceuticals). The 80 mg formulation was also registered at the same date.