Drugs List

Therapeutic Indications

Uses

For the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.
Prevention and treatment of post-operative nausea and vomiting in adults

Not all presentations are licensed for all indications.

Administration

To be administered after dilution by intravenous infusion or slow intravenous injection.

Reconstitution

For intravenous injection:
To prepare dose of 1mg, 1ml should be drawn from the ampoule and diluted to 5ml with 0.9% w/v sodium chloride injection. No other diluents should be used.

For intravenous infusion:
Intravenous infusions should be prepared at the time of administration. It must not be used after 24 hours. If it is to be stored after preparation, granisetron infusions must be prepared under appropriate aseptic conditions.

To prepare a dose of 3mg, 3ml is withdrawn from the ampoule and diluted either to 15ml with 0.9% sodium chloride injection (for bolus administration) or in infusion fluid to a total volume of 20 to 50ml in any of the solutions listed below.

To prepare the dose of 20-40 micrograms per kilogram, the appropriate volume is withdrawn and diluted with infusion fluid to a total volume of 10 to 30ml in any of the solutions listed below.

Any one of the following solutions may be used:
sodium chloride injection 0.9% w/v
Sodium chloride 0.18% w/v and glucose 4% w/v injection
glucose injection 5% w/v
sodium lactate compound injection
sodium lactate injection
mannitol injection 10%

No other diluents should be used.

Incompatibilities

Granisetron should not be mixed in solution with other drugs.

Prophylactic administration of granisetron should be completed prior to the start of cytostatic therapy or induction of anaesthesia.

Contraindications

Breastfeeding (see Lactation)

Precautions and Warnings

Patients with subacute intestinal obstruction should be monitored following administration as granisetron may reduce bowel motility.

Cases of ECG modifications including QT prolongation have been reported. The ECG changes were minor and generally not of clinical significance, specifically with no evidence of proarrhythmia.

Patients treated concurrently with drugs known to prolong QT interval, and/or with pre-existing arrhythmias or cardiac conduction disorders, may experience clinical consequences. Use with caution in patients with cardiac co-morbidities, receiving cardio-toxic chemotherapy and/or with concomitant electrolyte abnormalities.

Pregnancy- see Pregnancy section

Not all presentations are licensed for all indications

Do not mix with other drugs or substances unless compatibility known

For children under 18 years see- Dosage Children.

Contains sodium. This should be taken into consideration by patients on a controlled sodium diet.

Pregnancy and Lactation

Pregnancy

At the time of writing there are no reports of the use of granisetron during pregnancy although animal studies have shown no teratogenic effects. Use only where there are compelling clinical reasons.

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 ).

Lactation

At the time of writing there are no reports of the use of granisetron during breastfeeding but its molecular weight is low enough that transfer to milk would be expected. The manufacturer recommends that breast feeding is discontinued during therapy.

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

Headache
Constipation
Hypersensitivity reactions
Anaphylaxis
Allergic reaction
Rash
Increases in serum transaminases (transient)
Dystonia
Dyskinesia
Prolongation of QT interval
Somnolence
Diarrhoea
Asthenia
Agitation
Anxiety
Insomnia
Abnormal vision
Dizziness
Oedema
Hypertension
Hypotension
ECG changes
Urticaria
Extrapyramidal effects
Nausea
Vomiting
Abdominal pain
Drowsiness
Fever
Anorexia
Chest pain
Arrhythmias
Increase of liver transaminases

Presentation

Ampoule containing solution of granisetron hydrochloride equivalent to 1mg granisetron per ml of isotonic solution.

Drugs List

Therapeutic Indications

Uses

For the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.
Prevention and treatment of post-operative nausea and vomiting in adults

Not all presentations are licensed for all indications.

Dosage

Adults

Elderly

Children

Additional Dosage Information

Administration

To be administered after dilution by intravenous infusion or slow intravenous injection.

Reconstitution

For intravenous injection:
To prepare dose of 1mg, 1ml should be drawn from the ampoule and diluted to 5ml with 0.9% w/v sodium chloride injection. No other diluents should be used.

For intravenous infusion:
Intravenous infusions should be prepared at the time of administration. It must not be used after 24 hours. If it is to be stored after preparation, granisetron infusions must be prepared under appropriate aseptic conditions.

To prepare a dose of 3mg, 3ml is withdrawn from the ampoule and diluted either to 15ml with 0.9% sodium chloride injection (for bolus administration) or in infusion fluid to a total volume of 20 to 50ml in any of the solutions listed below.

To prepare the dose of 20-40 micrograms per kilogram, the appropriate volume is withdrawn and diluted with infusion fluid to a total volume of 10 to 30ml in any of the solutions listed below.

Any one of the following solutions may be used:
sodium chloride injection 0.9% w/v
Sodium chloride 0.18% w/v and glucose 4% w/v injection
glucose injection 5% w/v
sodium lactate compound injection
sodium lactate injection
mannitol injection 10%

No other diluents should be used.

Incompatibilities

Granisetron should not be mixed in solution with other drugs.

Prophylactic administration of granisetron should be completed prior to the start of cytostatic therapy or induction of anaesthesia.

Contraindications

Breastfeeding (see Lactation)

Precautions and Warnings

Patients with subacute intestinal obstruction should be monitored following administration as granisetron may reduce bowel motility.

Cases of ECG modifications including QT prolongation have been reported. The ECG changes were minor and generally not of clinical significance, specifically with no evidence of proarrhythmia.

Patients treated concurrently with drugs known to prolong QT interval, and/or with pre-existing arrhythmias or cardiac conduction disorders, may experience clinical consequences. Use with caution in patients with cardiac co-morbidities, receiving cardio-toxic chemotherapy and/or with concomitant electrolyte abnormalities.

Pregnancy- see Pregnancy section

Not all presentations are licensed for all indications

Do not mix with other drugs or substances unless compatibility known

For children under 18 years see- Dosage Children.

Contains sodium. This should be taken into consideration by patients on a controlled sodium diet.

Pregnancy and Lactation

Pregnancy

At the time of writing there are no reports of the use of granisetron during pregnancy although animal studies have shown no teratogenic effects. Use only where there are compelling clinical reasons.

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 ).

Lactation

At the time of writing there are no reports of the use of granisetron during breastfeeding but its molecular weight is low enough that transfer to milk would be expected. The manufacturer recommends that breast feeding is discontinued during therapy.

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

Adverse effects such a somnolence may affect the patient's ability to drive or operate machinery.

Counselling

If the patient feels drowsy after treatment with granisetron they should be advised not to drive or operate machinery.

Side Effects

Headache
Constipation
Hypersensitivity reactions
Anaphylaxis
Allergic reaction
Rash
Increases in serum transaminases (transient)
Dystonia
Dyskinesia
Prolongation of QT interval
Somnolence
Diarrhoea
Asthenia
Agitation
Anxiety
Insomnia
Abnormal vision
Dizziness
Oedema
Hypertension
Hypotension
ECG changes
Urticaria
Extrapyramidal effects
Nausea
Vomiting
Abdominal pain
Drowsiness
Fever
Anorexia
Chest pain
Arrhythmias
Increase of liver transaminases

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 ).

Shelf Life and Storage

Do not store above 25 degrees C
Protect from light
Do not freeze
Keep container in outer carton

After reconstitution:
After dilution or when the container is opened for the first time, the shelf life is 24 hours when stored at room temperature in normal indoor illumination protected from direct sunlight. It must not be used after 24 hours.

Further Information

Last Full Review Date: September 2012

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.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com [Accessed on [May 19, 2014]].

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications https://www.medicinescomplete.com [Accessed on [May 19, 2014]].

Summary of Product Characteristics: Granisetron 1mg/ml concentrate for solution for injection or infusion. Hameln Pharmaceuticals Ltd. May 2013.