Drugs List

Therapeutic Indications

Uses

For the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.

Administration

Oral administration

Contraindications

Breastfeeding (see Lactation section)
Children under 12 years
Galactosaemia

Precautions and Warnings

Granisetron may reduce bowel motility. Monitor patients with signs of sub-acute intestinal obstruction and advise them to report bowel dysfunction immediately.

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

The tablets contain lactose and should not be used by patients with galactose intolerance or glucose-galactose malabsorption.

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

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

Presentation

Oral formulations of granisetron.

Drugs List

Therapeutic Indications

Uses

For the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.

Dosage

Adults

Children

Additional Dosage Information

Administration

Oral administration

Contraindications

Breastfeeding (see Lactation section)
Children under 12 years
Galactosaemia

Precautions and Warnings

Granisetron may reduce bowel motility. Monitor patients with signs of sub-acute intestinal obstruction and advise them to report bowel dysfunction immediately.

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

The tablets contain lactose and should not be used by patients with galactose intolerance or glucose-galactose malabsorption.

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

None known

Counselling

Advise patient to report signs of bowel dysfunction promptly.

Side Effects

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

No special requirements.

Further Information

Last Full Review Date: September 2012

Reference Sources

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

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.

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

Summary of Product Characteristics: Kytril Tablets 1 mg. Roche Products Ltd. Revised April 2017.
Summary of Product Characteristics: Kytril Tablets 2 mg. Roche Products Ltd. Revised April 2017.