- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
As a single agent or in combination for:
- The first line treatment of stage 3 or 4 non-small cell lung cancer
- The treatment of advanced breast cancer stage 3 and 4 relapsing after or refractory to an anthracycline containing regimen.
Treatment should be initiated under the supervision of a physician qualified in the use of chemotherapy.
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
First three administrations:
The recommended dose is 60mg/metre squared of body surface area (BSA) administered once weekly.
Total dose must not exceed 120mg per week.
After initial three doses, if no significant neutropenia, the recommended dose of vinorelbine is increased to 80mg/metre squared of BSA once weekly.
However, in patients where the neutrophil count dropped below 500/cubic millimetre once, or the neutrophil count fell to between 500/cubic millimetre and 1000/cubic millimetre more than once, during the first three administrations the dosage should be maintained at 60mg/metre squared of BSA for any subsequent administrations.
Total dose must not exceed 160mg per week.
Dose modification for any dose planned at 80mg/metre squared
If the neutrophil count is below 500/cubic millimetre or has fallen to between 500/cubic millimetre and 1000/cubic millimetre more than once, administration should be delayed until recovery. The dose should be reduced to 60mg/metre squared of BSA for the three subsequent administrations.
If the neutrophil count is below 1500/cubic millimetre and/or the platelet count is below 100,000/cubic millimetre, treatment should be delayed until recovery.
It is permitted to re-escalate the dose to 80mg/metre squared of BSA, if the neutrophil count does not drop below 500/cubic millimetre or fall between 500/cubic millimetre and 1000/cubic millimetre during these three additional administrations at 60mg/metre squared.
Dosage regimens should be adapted to the relevant treatment protocol when vinorelbine is used in combination therapy.
Studies have suggested that no dose adjustment is necessary in elderly patients (70 years old or above). Nevertheless, elderly patients have a greater risk of developing myelosuppression and cardiotoxicity when they are treated with cytotoxic agents, caution should be used when increasing doses.
Patients with Renal Impairment
Patients with Hepatic Impairment
Treatment with oral vinorelbine is contraindicated in patients with severe hepatic impairment (bilirubin greater than 3 x upper limit of normal (ULN)).
Mild hepatic impairment (bilirubin less than 1.5 x ULN, and ALT/AST from 1.5 - 2.5 x ULN): Standard dose 60mg/metre squared of BSA per week may be used.
Moderate hepatic impairment (bilirubin from 1.5 to 3 x ULN): A reduced dose of 50mg/metre squared of BSA per week should be used.
The manufacturers of the injection, report that a study of patients with liver metastases due to breast cancer, concluded that a change in clearance was only observed when more than 75% of the liver was involved.
Additional Dosage Information
Required doses for appropriate ranges of body surface area (BSA):
BSA 0.95-1.04 metre squared - Dose at 60mg/metre squared 60mg weekly;
BSA 1.05-1.14metre squared - Dose at 60mg/metre squared 70mg weekly;
BSA 1.15-1.24metre squared - Dose at 60mg/metre squared 70mg weekly;
BSA 1.25-1.34metre squared - Dose at 60mg/metre squared 80mg weekly;
BSA 1.35-1.44metre squared - Dose at 60mg/metre squared 80mg weekly;
BSA 1.45-1.54metre squared - Dose at 60mg/metre squared 90mg weekly;
BSA 1.55-1.64metre squared - Dose at 60mg/metre squared 100mg weekly;
BSA 1.65-1.74metre squared - Dose at 60mg/metre squared 100mg weekly;
BSA 1.75-1.84metre squared - Dose at 60mg/metre squared 110mg weekly;
BSA 1.85-1.94metre squared - Dose at 60mg/metre squared 110mg weekly;
BSA 1.95metre squared or greater - Dose at 60mg/metre squared120mg weekly;
Maximum weekly dosage should never exceed 120mg at 60mg/metre squared
BSA 0.95-1.04 metre squared - Dose at 80mg/metre squared 80mg weekly
BSA 1.05-1.14metre squared - Dose at 80mg/metre squared 90mg weekly
BSA 1.15-1.24metre squared - Dose at 80mg/metre squared 100mg weekly
BSA 1.25-1.34metre squared - Dose at 80mg/metre squared 100mg weekly
BSA 1.35-1.44metre squared - Dose at 80mg/metre squared 110mg weekly
BSA 1.45-1.54metre squared - Dose at 80mg/metre squared 120mg weekly
BSA 1.55-1.64metre squared - Dose at 80mg/metre squared 130mg weekly
BSA 1.65-1.74metre squared - Dose at 80mg/metre squared 140mg weekly
BSA 1.75-1.84metre squared - Dose at 80mg/metre squared 140mg weekly
BSA 1.85-1.94metre squared - Dose at 80mg/metre squared 150mg weekly
BSA 1.95metre squared or greater - Dose at 80mg/metre squared 160mg weekly
Maximum weekly dosage should never exceed 160mg per week at 80mg/metre squared
Comparison with parenteral regimens
Clinical studies have shown that an oral dose of 80mg/metre squared corresponds to 30mg/metre squared given intravenously, and an oral dose of 60mg/metre squared to an intravenous dose of 25mg/metre squared.
For oral administration.
To be swallowed whole with water, preferably with food. Capsule should not be sucked, chewed or dissolved.
Neutrophil count below 1,500/cubic millimetre
Platelet count below 100,000/cubic millimetre
Severe current or recent infection (within previous 2 weeks)
Patients requiring long-term oxygen therapy
Current disease that may significantly affect absorption
Previous significant surgical resection of the stomach or small bowel
Severe hepatic impairment (bilirubin greater than 3 x ULN)
Hereditary fructose intolerance
Pregnancy (See Pregnancy)
Breastfeeding (See Lactation)
Children under 18 years of age
Precautions and Warnings
Treatment should be initiated under the supervision of a physician qualified in the use of chemotherapy.
Whilst the doses stated are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
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 neutrophil count is less than 1,500/cubic millimetre and/ or platelet count is less than 100,000/cubic millimetre, delay treatment until recovery (see Dosage - Adult ). A higher incidence of granulocytopenia has been reported in patients receiving combination therapy with vinorelbine and cisplatin than in those receiving vinorelbine monotherapy.
If the patient presents signs or symptoms suggestive of infection, a prompt investigation should be carried out.
Use with caution in hepatic impairment. Moderate hepatic impairment (bilirubin from 1.5 to 3 x ULN) dose reduction is recommended (see Dosage - Hepatic Impairment). Vinorelbine capsules should not be administered concurrently with radiotherapy if the treatment field includes the liver.
Caution is advised when administering vinorelbine to patients with a history of, or current, ischaemic heart disease or a poor performance status.
If vomiting occurs within a few hours of administration, the dose should not be re-administered. Prophylaxis with antiemetics (e.g. metoclopramide or a 5-HT3 antagonist) and administration with food is recommended, and has been shown to reduce the incidence of nausea and vomiting. The incidence of nausea and vomiting is higher with the capsule than the intravenous formulation.
Patients receiving concomitant morphine or opioid analgesics: laxatives and careful monitoring of bowel mobility are recommended. Prescription of laxatives may be appropriate in patients with prior history of constipation.
To avoid the risk of bronchospasm - especially in combination therapy with mitomycin C appropriate prophylaxis may be considered. Outpatients should be informed that in case of dyspnoea a doctor has to be informed.
It is not recommended to use live vaccines during therapy as there is a risk of generalised vaccine disease which may be fatal.
Vinorelbine has genotoxic effects. All patients should ensure adequate contraception during treatment and for 3 months afterwards. Prior to treatment male patients should be advised to consider conserving sperm due to the chance of irreversible infertility as a consequence of treatment with vinorelbine
Vinorelbine capsules should be swallowed whole with water, and preferably with food. If the patient accidentally chews or sucks the capsule, the mouth should be washed out with water or preferably a normal saline solution.
The liquid content of vinorelbine capsules is an irritant and may cause damage if in contact with the skin, mucosa or eyes. If accidental contact does occur, the area should be washed thoroughly with normal saline solution or water.
Damaged capsules should not be taken and should be returned to the pharmacy or doctor for proper disposal.
Vinorelbine capsules contain sorbitol.
The side effects of vinorelbine may affect the patient's ability to drive or operate machinery.
Advise patient to avoid grapefruit products during therapy due to risk of increased plasma concentration of vinorelbine.
Advise patient not to use products containing St John's Wort during therapy due to risk of decreased plasma concentration and clinical effects of Vinorelbine.
Pregnancy and Lactation
Vinorelbine is contraindicated in pregnancy.
Vinorelbine is suspected to cause serious birth effects when administered during pregnancy. According to Briggs (2008), due to the heavy molecular weight of vinorelbine, it is thought that placental transfer would 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 the majority of the children had no abnormalities. It is recommended that should vinorelbine treatment occur during pregnancy, genetic counselling should be offered to the patient.
Animal (mice and rabbit) studies have shown embryo- and foetotoxicity with intrauterine growth retardation and delayed ossification.
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
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 https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Effects on Ability to Drive and Operate Machinery
Effects on the ability to drive and operate machinery have not been established but vinorelbine may cause neuromotor and neurosensory disorders so caution should be exercised.
Vinorelbine capsules should be swallowed whole with water, and preferably with food.
If vomiting occurs within a few hours of a dose, the dose should not be re-administered.
All patients should use effective contraception during and for 3 months following treatment.
Advise men regarding sperm storage and the risk of infertility.
Advise the patients that the side effects of vinorelbine may affect their ability to drive or operate machinery.
Patients should be advised to report any signs or symptoms of infection or dyspnoea to their doctor immediately.
Advise patient to avoid grapefruit products during therapy.
Advise patient not to use products containing St John's Wort during therapy.
Loss of deep tendon reflexes
Hypersensitivity reactions including anaphylaxis
Inappropriate secretion of antidiuretic hormone
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.
Drugs in Pregnancy and Lactation: A Reference Guide for Fetal and Neonatal Risk, 8th Edition. ed. Briggs, Freeman & Yaffe; Lippincott Williams & Wilkins, Philadelphia 2008.
Drugs during Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd Edition, ed. Schaefer, Peters & Miller, Elsevier Academic Press, London 2007.
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 20mg soft capsules. Pierre Fabre Ltd. Revised September 2010
Summary of Product Characteristics: Navelbine 30mg soft capsules. Pierre Fabre Ltd. Revised September 2010
Summary of Product Characteristics: Navelbine 80mg soft capsules. Pierre Fabre Ltd. Revised September 2010
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