Drugs List

Therapeutic Indications

Uses

Inoperable carcinoma of breast
Leukaemia - acute lymphoblastic
Leukaemia - chronic myeloid
Melanoma

Administration

For Intravenous use only. Fatal if given by all 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%.

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 ( www.extravasation.org.uk )

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.

Contraindications

Severe infection
Breastfeeding
Demyelinating Charcot-Marie-Tooth syndrome
Drug induced neutropenia with cell count below 1.5 x 10 to the power of 9/L
Pregnancy
Severe thrombocytopenia

Precautions and Warnings

Hepatic impairment
Neuromuscular disorder

Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of anti-cancer drugs
For intravenous use only
If extravasation occurs follow local policy & seek expert help immediately
Staff: Not to be handled by pregnant staff
Monitor for constipation; give laxatives as required
Monitor patients for symptoms of neuropathy
Advise patient to report any abdominal or pelvic pain
Advise patients to seek medical attention if signs of neurotoxicity occur
Consider dose reduction in hepatic impairment
Advise patient not to take St John's wort concurrently
Advise patient grapefruit products may increase plasma level
Male & female: Ensure adequate contraception during treatment

If acute abdominal pain presents, careful monitoring is required due to the risk of paralytic ileus presenting when further doses are administered. Prophylactic measures should be taken to prevent constipation.

Pregnancy and Lactation

Pregnancy

Vindesine sulfate is contraindicated in pregnancy.

The safety of this product during pregnancy has not been established in humans.

Animal studies have reported teratogenic effects.

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 to 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 ).

Lactation

Vindesine sulfate is contraindicated in lactation.

At the time of writing there is insufficient information to assess the safety of vindesine sulfate on the breastfeeding infant. The related compound vincristine is known to be excreted in breast milk.

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

Side Effects

Abdominal pain
Alopecia
Anaemia
Anorexia
Asthenia
Cellulitis
Chills
Constipation
Convulsions
Cortical blindness
Deafness
Depression
Diarrhoea
Dizziness
Dyspepsia
Dysphagia
Dyspnoea
Fever
Foot drop
Granulocytopenia
Headache
Ileus
Jaw pain
Loss of deep tendon reflexes
Maculopapular rash
Malaise
Musculoskeletal pain
Myelosuppression
Nausea
Necrosis (injection site)
Neuropathy
Nystagmus
Paraesthesia
Perforating duodenal ulcer
Peripheral neuritis
Phlebitis (injection site)
Severe bronchospasm
Shortness of breath
Stomatitis
Thrombocytopenia
Thrombocytosis
Vertigo
Vesiculation
Vomiting

Presentation

Infusions of vindesine sulfate

Drugs List

Therapeutic Indications

Uses

Inoperable carcinoma of breast
Leukaemia - acute lymphoblastic
Leukaemia - chronic myeloid
Melanoma

Dosage

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

Vindesine sulfate is for intravenous administration only. Fatal if given by other routes.

Adults

Elderly

Children

Administration

For Intravenous use only. Fatal if given by all 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%.

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 ( www.extravasation.org.uk )

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.

Contraindications

Severe infection
Breastfeeding
Demyelinating Charcot-Marie-Tooth syndrome
Drug induced neutropenia with cell count below 1.5 x 10 to the power of 9/L
Pregnancy
Severe thrombocytopenia

Precautions and Warnings

Hepatic impairment
Neuromuscular disorder

Treatment to be initiated and supervised by a specialist
Consult local policy on the safe use of anti-cancer drugs
For intravenous use only
If extravasation occurs follow local policy & seek expert help immediately
Staff: Not to be handled by pregnant staff
Monitor for constipation; give laxatives as required
Monitor patients for symptoms of neuropathy
Advise patient to report any abdominal or pelvic pain
Advise patients to seek medical attention if signs of neurotoxicity occur
Consider dose reduction in hepatic impairment
Advise patient not to take St John's wort concurrently
Advise patient grapefruit products may increase plasma level
Male & female: Ensure adequate contraception during treatment

If acute abdominal pain presents, careful monitoring is required due to the risk of paralytic ileus presenting when further doses are administered. Prophylactic measures should be taken to prevent constipation.

Pregnancy and Lactation

Pregnancy

Vindesine sulfate is contraindicated in pregnancy.

The safety of this product during pregnancy has not been established in humans.

Animal studies have reported teratogenic effects.

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 to 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 ).

Lactation

Vindesine sulfate is contraindicated in lactation.

At the time of writing there is insufficient information to assess the safety of vindesine sulfate on the breastfeeding infant. The related compound vincristine is known to be excreted in breast milk.

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

Side Effects

Abdominal pain
Alopecia
Anaemia
Anorexia
Asthenia
Cellulitis
Chills
Constipation
Convulsions
Cortical blindness
Deafness
Depression
Diarrhoea
Dizziness
Dyspepsia
Dysphagia
Dyspnoea
Fever
Foot drop
Granulocytopenia
Headache
Ileus
Jaw pain
Loss of deep tendon reflexes
Maculopapular rash
Malaise
Musculoskeletal pain
Myelosuppression
Nausea
Necrosis (injection site)
Neuropathy
Nystagmus
Paraesthesia
Perforating duodenal ulcer
Peripheral neuritis
Phlebitis (injection site)
Severe bronchospasm
Shortness of breath
Stomatitis
Thrombocytopenia
Thrombocytosis
Vertigo
Vesiculation
Vomiting

Overdosage

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 ).

Further Information

Last Full Review Date: September 2014

Reference Sources

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 10 September, 2014.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

NPSA Rapid Response Report 11 August 2008. Using Vinca Alkaloid Minibags (Adult/Adolescent Units).
Available at: https://www.nrls.npsa.nhs.uk/alerts/?entryid45=59890
Last accessed: 9 September 2014.

Summary of Product Characteristics: Eldisine powder for solution for injection. Genus Pharmaceuticals Ltd. Revised June 2014.