Vinca alkaloid cytotoxic Pregnancy: Vinorelbine is CONTRAINDICATED during pregnancy and lactation (§4.3). There are no or limited data in pregnant women; animal studies have shown embryotoxicity and teratogenicity, and vinorelbine is suspected to cause congenital malformations when administered during pregnancy. Women must not become pregnant during treatment; women of childbearing potential must use effective contraception during and for at least 7 months after treatment, and men are advised not to father a child during and for at least 4 months after treatment (sperm conservation should be advised beforehand because of the risk of irreversible infertility). Breast-feeding must be discontinued before starting treatment.

Vinorelbine (Specialist drug)

Brand names: Navelbine

Vinorelbine is a vinca alkaloid cytotoxic, available as intravenous and oral formulations, used in non-small cell lung cancer and advanced breast cancer.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 25 to 30 mg/m² body surface area

Route: Intravenous — slow bolus over 6 to 10 minutes after dilution in 20 to 50 ml of sodium chloride 9 mg/ml (0.9%) or 5% (w/v) glucose solution for injection, always followed by an infusion of at least 250 ml sodium chloride 0.9% to flush the vein. Strictly intravenous administration: intrathecal administration may be fatal.

Frequency: Once weekly

Max: Maximum tolerated dose per administration 35.4 mg/m² body surface area; maximum total dose per administration 60 mg

eMC SPC for Vinorelbine 10 mg/ml Concentrate for solution for infusion. Should be administered under the supervision of a physician experienced in the use of chemotherapy. In combination with other cytostatic agents the exact dose should be taken from the treatment protocol. The 6 to 10 minute infusion time must be followed, as the risk of venous irritation increases if the infusion exposure time is increased. Make sure the cannula is accurately placed in the vein before infusing; if extravasation occurs, stop the infusion immediately, flush the vein with sodium chloride 0.9% and give the rest of the dose in another vein (published data support hyaluronidase and dry heat). MONITORING: close haematological monitoring is required (haemoglobin, leukocytes, granulocytes and platelets before each new injection); the dose-limiting adverse reaction is mainly neutropenia, with a nadir between 7 and 14 days after administration, non-cumulative and rapidly reversible within 5 to 7 days. If the neutrophil count is <1,500/mm³ and/or the platelet count is below 100,000/mm³, treatment should be delayed until recovery and the patient observed (a 1-week delay is expected in about 35% of courses). HEPATIC: pharmacokinetics are not modified in moderate or severe liver impairment, but as a precautionary measure a reduced dose of 20 mg/m² with close monitoring of haematological parameters is recommended in severe liver impairment (note that severe hepatic impairment not related to the tumoural process is a contraindication). ELDERLY: no significant differences in response rate have been detected and age does not modify the pharmacokinetics. PAEDIATRIC: the safety and efficacy in children have not been established and administration is therefore not recommended. Vinorelbine should not be given concomitantly with radiotherapy if the treatment field includes the liver. FORMULATION SCOPE: this is the intravenous concentrate SPC; it does not cover the oral (soft capsule) vinorelbine formulation, whose posology differs and must be sourced separately. eMC §4.5 was not captured in the fetched bundle.

Dose adjustments

Renal

Given the minor renal excretion there is no pharmacokinetic rationale for reducing the vinorelbine dose in patients with impaired kidney function — no dose modification is necessary (§4.2, §4.4).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or other vinca alkaloids, or to any of the excipients (§4.3)
Neutrophil count < 1,500/mm³, or severe current or recent infection (within the last 2 weeks)
Thrombocyte count below 100,000/mm³
Severe hepatic impairment not related to the tumoural process
In combination with yellow fever vaccine
Pregnancy and lactation

Side effects

Bone marrow depression resulting mainly in neutropenia (Grade 3: 24.3%, Grade 4: 27.8% in monotherapy), reversible within 5 to 7 days and non-cumulative; anaemia (Grade 3–4: 7.4%); thrombocytopenia (Grade 3–4: 2.5%) is less common
Neurological disorders (Grade 3: 2.6%, Grade 4: 0.1%) including loss of deep tendon reflexes; weakness of the lower extremities after prolonged chemotherapy, and uncommonly severe paraesthesia with sensory and motor symptoms
Gastrointestinal toxicity — nausea, vomiting, stomatitis and constipation
Transient elevations of liver function tests; alopecia
Local phlebitis at the injection site; infections (bacterial, viral or fungal), with neutropenic sepsis reported (potentially fatal in 1.2% of cases); allergic reactions and SIADH have also been reported

Interactions

Yellow fever vaccine — specifically contraindicated in combination with vinorelbine (§4.3, §4.4)
Strong CYP3A4 inhibitors or inducers — should be administered with caution because of the risk of affecting the vinorelbine concentration (§4.4); the US label likewise advises caution with CYP3A inhibitors, which may cause an earlier onset and/or increased severity of adverse reactions
Itraconazole — generally not recommended in combination (as with all vinca alkaloids) (§4.4)
Phenytoin — generally not recommended in combination (as with all cytotoxics) (§4.4)
Radiotherapy where the treatment field includes the liver — vinorelbine should not be given concomitantly (§4.4). Note: eMC §4.5 was not captured in the fetched bundle

Clinical monograph

How it works

It binds tubulin and inhibits microtubule polymerisation, arresting cells in metaphase and preventing proliferation.

Prescribing in practice

It is for intravenous or oral use only and is fatal if given intrathecally; the injectable form is a vesicant requiring extravasation precautions.
Neutropenia is the principal dose-limiting toxicity and dosing should be guided by the blood count.
Oral and intravenous formulations are not dose-equivalent and must not be interchanged without specialist recalculation.

Monitoring

Check full blood count before each administration and monitor hepatic function and for signs of infection or neuropathy.

Counselling the patient

Report fever or other signs of infection urgently because the white cell count may fall.
Swallow oral capsules whole with food and do not chew or suck them; report any leakage of capsule contents.
Report numbness, tingling, constipation or injection-site pain.

Evidence & guidelines

Its efficacy in non-small cell lung and breast cancer is supported by randomised trials and reflected in NICE-appraised regimens.

Reference: NICE TA181; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Drugs

Pathways