This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Vinorelbine intravenous

Updated 2 Feb 2023 | Vinca alkaloids and etoposide


Vinorelbine (as tartrate) parenteral formulations

Drugs List

  • NAVELBINE 10mg/1ml concentrate for solution for infusion
  • NAVELBINE 50mg/5ml concentrate for solution for infusion
  • vinorelbine 10mg/1ml concentrate for solution for infusion
  • vinorelbine 50mg/5ml concentrate for solution for infusion
  • Therapeutic Indications


    Advanced/metastatic breast cancer resistant to anthracycline chemotherapy
    First line treatment of stage 3 or 4 non-small cell lung cancer


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.

    This preparation is for intravenous use only. Fatal if given by other routes.


    Consider the use of anti-emetics before and during therapy.

    Usually 25 to 30 mg/square metre once weekly.

    Combination therapy
    The usual dose in combination is 25 to 30 mg/square metre on day 1 and 5 every third week or day 1 and 8 every third week. Refer to local cancer network protocols.

    Breast Cancer
    Usually 25 to 30 mg/square metre once weekly.
    Maximum tolerated dose is 35.4 mg/square metre

    Patients with Hepatic Impairment

    A reduced dose of 20 mg/square metre and close haematological monitoring is recommended in patients with severe hepatic impairment.

    A change in clearance was observed in patients with liver metastases due to breast cancer when more than 75% of the liver was involved.


    For intravenous use only. Fatal if given by other routes.

    The NPSA issued the following guidance in August 2008

    When vinca alkaloids are prescribed, dispensed or administered in adult or adolescent units:

    - Doses in syringes should no longer be used.

    - The prescribed dose should be supplied from the hospital pharmacy ready to administer in a 50ml minibag of sodium chloride 0.9% (or 5% glucose).

    - The following warning should be prominently displayed on the label of all vinca alkaloid doses 'For Intravenous Use Only - Fatal if Administered by Other Routes'

    - There should be judicious use of colour and design on the label, outer packaging and delivery bags to further differentiate minibags containing vinca alkaloids from other minibag infusions.

    - The vinca alkaloid should be infused intravenously over 5 to 10 minutes and the patient closely monitored for signs of extravasation. Incidents of extravasation should be reported and shared via the National Extravasation Information Service ( )

    NB. The use of minibags to administer vinca alkaloids to children in paediatric units is not recommended. Local protocols should be consulted for information regarding the volume and method of administration in such patients.

    The majority of manufacturers recommend that administration should always be followed by at least 250ml of sodium chloride 0.9% infusion to flush the vein.


    Children under 18 years
    Infection within the last 2 weeks
    Neutrophil count below 1.5 x 10 to the power of 9 / L
    Platelet count below 100 x 10 to the power of 9/ L

    Precautions and Warnings

    Females of childbearing potential
    Hepatic metastases
    History of ischaemic heart disease
    Ischaemic heart disease
    Severe hepatic impairment

    Administration of live vaccines is not recommended
    Avoid concurrent liver radiotherapy
    Advise ability to drive/operate machinery may be affected by side effects
    Give pre-treatment counselling and consideration of sperm cryopreservation
    Treatment to be prescribed under the supervision of a specialist
    Consult local policy on the safe use of anti-cancer drugs
    Dilute and use as an infusion
    For intravenous use only
    If extravasation occurs follow local policy & seek expert help immediately
    Staff: Not to be handled by pregnant staff
    Investigate signs and symptoms suggesting an infection
    Monitor hepatic function
    Monitor platelets, leucocytes and granulocytes before each dose
    Advise patient to report breathlessness or cough immediately
    Advise patient to report symptoms of infection immediately
    Consider the use of anti-emetics before and during therapy
    Suspend treatment if neutrophil count is less than 1,500/cubic mm
    Suspend treatment if platelets fall below 100,000/cubic mm
    Consider dose reduction in severe hepatic impairment
    Advise patient not to take St John's wort concurrently
    Female: Contraception required during and for 3 months after treatment
    Male: Contraception required during and for 6 months after treatment

    Close haematological checks are necessary during treatment (measurement of haemoglobin level, leucocyte, neutrophil and platelet counts before each administration). Treatment limiting toxicity is mainly neutropenia. This effect is non-cumulative, having its nadir between 7 and 14 days after the administration and is rapidly reversible within 5 to 7 days.

    If extravasation occurs, administration should be stopped, the vein flushed with 0.9 % sodium chloride solution and the remaining dose administered in another vein. Always follow local protocols for the management of extravasation. The appropriate management of such events is contentious but may include glucocorticosteroid to reduce risk of phlebitis.

    To avoid the risk of bronchospasm - especially in combination therapy with mitomycin C appropriate prophylaxis may be considered.

    Pregnancy and Lactation


    Vinorelbine is contraindicated in pregnancy.

    There is insufficient evidence of safety in humans, vinorelbine is suspected to cause serious birth defects when administered during pregnancy. It is unclear if vinorelbine crosses the placental barrier, molecular weight suggests that transmission may be inhibited but not prevented. There have been a small number of cases in which vinorelbine was used and from these, oligohydramnios (attributed to a concomitant cytotoxic) and transient neonatal anaemia have been reported.

    However, Briggs concludes that as the indications can be fatal, if a woman requires treatment with this agent and informed consent is obtained, treatment should not be withheld because of pregnancy. If an inadvertent pregnancy occurs, the woman should be advised of the possible risk for severe adverse effects in the embryo and foetus.

    Animal (mice and rabbit) studies have shown embryo- and foetotoxicity with intrauterine growth retardation and delayed ossification.

    The effect of concurrent therapies must also be considered.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Vinorelbine is contraindicated in breastfeeding.

    At the time of writing there are no data on the excretion of vinorelbine into breast milk. Due to the potential for serious adverse reactions in the nursing infant, it should not be given to nursing mothers. Schaefer (2007) advises that breastfeeding should not take place until 30 days after the treatment has stopped, due to the long and variable half life of vinorelbine.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Angina pectoris
    Burning pain at injection site
    Cardiac disorders
    Chest pain
    ECG changes
    Erythema at injection site
    Febrile neutropenia
    Guillain-Barre syndrome
    Hypersensitivity reactions including anaphylaxis
    Inappropriate secretion of antidiuretic hormone
    Increase in alkaline phosphatase
    Increase in creatinine
    Increase in serum ALT/AST
    Injection site reactions
    Interstitial pneumopathies
    Jaw pain
    Loss of deep tendon reflexes
    Motor disturbances
    Myocardial infarction
    Necrosis (injection site)
    Neurological disorders
    Neutropenic sepsis
    Paralytic ileus
    Peripheral coldness
    Phlebitis (injection site)
    Respiratory insufficiency
    Sensory disturbances
    Serum bilirubin increased
    Skin reactions
    Tumour pain
    Vein discolouration
    Weakness of legs


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: July 2014

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Drugs during Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd Edition, ed. Schaefer, Peters & Miller, Elsevier Academic Press, London 2007.

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [Accessed on May 23, 2014].

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

    Summary of Product Characteristics: Navelbine. Pierre Fabre Ltd. Revised July 2011.
    Summary of Product Characteristics: Vinorelbine. Medac GmbH. Revised February 2014.
    Summary of Product Characteristics: Vinorelbine. Actavis. Revised April 2014.

    NPSA Rapid Response Report 11 August 2008. Using Vinca Alkaloid Minibags (Adult/Adolescent Units).
    Available at:
    Last accessed: 18 July 2014.

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.