• Myelosuppression is dose-limiting, especially neutropenia – check full blood count before every dose
• For intravenous use only – fatal outcomes reported with intrathecal administration
• Contraindicated in pregnancy and breastfeeding – teratogenic and embryotoxic
• Avoid live vaccines (especially yellow fever) due to risk of severe infection
• Use with caution in hepatic impairment
• Risk of severe infection and sepsis – any fever during treatment is a medical emergency
• Risk of thromboembolism and cardiac ischaemia – caution in patients with cardiovascular disease
• Extravasation risk – ensure secure IV access and monitor infusion site closely
Generic name: Vinorelbine (vinorelbine tartrate)
Drug class: Vinca alkaloid (antimitotic chemotherapy)
Formulation: Concentrate for solution for intravenous infusion
Strengths:
• 10 mg per 1 mL
• 50 mg per 5 mL
Mechanism of action:
Inhibits microtubule assembly by binding to tubulin, leading to mitotic arrest and tumour cell death.
Non-small cell lung cancer (NSCLC):
• Treatment of non-small cell lung cancer, used alone or in combination with other anticancer agents
Breast cancer:
• Advanced breast cancer that has not responded to other treatments
• Advanced breast cancer that has relapsed within 6 months of prior chemotherapy
Route: Intravenous infusion only
Administration:
• Administered by trained healthcare professionals
• Must never be given intrathecally
Typical dose:
• 25–30 mg per square metre once weekly
Dose depends on indication, combination therapy, patient condition, and blood counts.
• Delay treatment in neutropenia or thrombocytopenia until recovery
• Withhold treatment in severe infection or sepsis
• Dose reduction may be required in hepatic impairment
• Discontinue if severe or persistent toxicity occurs
• Hypersensitivity to vinorelbine or other vinca alkaloids
• Pregnancy or breastfeeding
• Severe hepatic impairment
• Severe neutropenia or thrombocytopenia
• Concomitant or recent yellow fever vaccination
• Full blood count before each dose
• Monitor closely for signs of infection
• Liver function tests at baseline and periodically
• Monitor cardiac symptoms in patients with heart disease
• Observe infusion site for extravasation
Very common and common:
• Neutropenia, leukopenia, anaemia, thrombocytopenia
• Nausea, vomiting
• Constipation or diarrhoea (may be severe)
• Fatigue and weakness
• Alopecia
• Peripheral neuropathy
• Injection site reactions
Serious:
• Febrile neutropenia
• Sepsis and severe infections
• Pulmonary embolism
• Myocardial infarction, angina, heart failure
• Severe liver toxicity
• Posterior reversible encephalopathy syndrome
• Other myelosuppressive therapies
• CYP3A inhibitors (e.g. azole antifungals, macrolides)
• CYP3A inducers (e.g. rifampicin, phenytoin)
• Anticoagulants – monitor INR
• Live vaccines (contraindicated)
• Pregnancy: Contraindicated
• Breastfeeding: Contraindicated
• Women of childbearing potential: Effective contraception required during treatment and for 7 months after
• Men: Avoid fathering a child during treatment and for 4 months after
• Elderly: No routine dose adjustment but close monitoring required
• Renal impairment: No specific dose adjustment required
Continue treatment until disease progression or unacceptable toxicity.
Permanently discontinue if:
• Life-threatening infection or sepsis
• Persistent severe myelosuppression
• Serious cardiac or neurological toxicity
• Inability to safely resume treatment after dose delays
https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2025/08/Sandoz-Vinorelbine-Final-PIL.pdf
| Trade Name | |
|---|---|
| Drug Class | Alkylating Agents |
| Cost | |
| Company | |
|---|---|
| Drug Rep | Admin |
| Indications | Breast Cancer, Lung Cancer |
| Dosage |