Drugs List

Therapeutic Indications

Uses

Chemotherapy induced nausea and vomiting

Administration

The transdermal patch should be applied to clean, dry, intact healthy skin on the upper arm. If it is not possible to apply the transdermal patch to the upper arm, it can be applied to the abdomen.

The transdermal patch should only be applied whole. Do not cut into pieces.

If the transdermal patch becomes completely or partially detached, the original transdermal patch should be reattached in the same position using medical tape (if necessary). If reattachment is not possible or the transdermal patch is damaged, a new transdermal patch should be applied in the same position as the original transdermal patch. If this is not possible, a new transdermal patch should be applied on the opposite arm. The newly applied transdermal patch should be removed in line with the timing recommended above.

The transdermal patch can be worn in everyday situations, including during bathing or in the shower though activities such as swimming, strenuous exercise or using a sauna should be avoided.

The transdermal patch application site most be covered e.g. with clothing, to protect it from natural and artificial sun light during treatment and for 10 days following its removal.

The transdermal patch should not be exposed to any external heat sources e.g. hot water bottles or heat pads.

Dispose of used patches safely by folding in half, adhesive side inwards and then discard out of reach of children.

Contraindications

Children under 18 years
Breastfeeding

Precautions and Warnings

Elderly
Family history of long QT syndrome
Cardiac arrhythmias
Hepatic impairment
History of torsade de pointes
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Long QT syndrome
Pregnancy
Renal impairment
Subacute gastrointestinal obstruction

Avoid exposing application site to direct external heat
Discard used patches safely - fold with adhesive edges together
Do not apply to broken or denuded skin
Dry skin thoroughly before application
Ensure application site is covered during treatment and for 10 days after
Perform ECG before treatment
Monitor patients for signs and symptoms of Serotonin Syndrome
Monitor patients with signs of sub-acute intestinal obstruction
Discontinue if severe skin reaction occurs
Advise patients to avoid strenuous exercise, swimming and sauna use

Cases of ECG modifications including QT prolongation have been reported in other formulations. 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 and Lactation

Pregnancy

Granisetron transdermal patches should be used with caution in pregnancy.

There is highly limited data on the use of granisetron in pregnant women, although animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity or teratogenic effects. There for the manufacture recommends avoidance of the product in pregnancy.

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

Granisetron transdermal patches are contraindicated in breastfeeding.

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

Anaphylaxis
Application site reaction
Arthralgia
Constipation
Decreased appetite
Dry mouth
Dyskinesia
Dystonia
Flushing
Headache
Hypersensitivity reactions
Increase of liver transaminases
Irritation at application site
Itching at application site
Localised and generalised rash
Nausea
Oedema
Pain at application site
Prolongation of QT interval
Rash
Retching
Urticaria
Vertigo

Presentation

Transdermal patch containing granisetron

Drugs List

Therapeutic Indications

Uses

Chemotherapy induced nausea and vomiting

Dosage

The transdermal patch should only be applied to patients whose chemotherapy treatment is unlikely to be delayed.

The transdermal patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen.

The transdermal patch should be removed a minimum of 24 hours after completion of chemotherapy.

Adults

Elderly

Administration

The transdermal patch should be applied to clean, dry, intact healthy skin on the upper arm. If it is not possible to apply the transdermal patch to the upper arm, it can be applied to the abdomen.

The transdermal patch should only be applied whole. Do not cut into pieces.

If the transdermal patch becomes completely or partially detached, the original transdermal patch should be reattached in the same position using medical tape (if necessary). If reattachment is not possible or the transdermal patch is damaged, a new transdermal patch should be applied in the same position as the original transdermal patch. If this is not possible, a new transdermal patch should be applied on the opposite arm. The newly applied transdermal patch should be removed in line with the timing recommended above.

The transdermal patch can be worn in everyday situations, including during bathing or in the shower though activities such as swimming, strenuous exercise or using a sauna should be avoided.

The transdermal patch application site most be covered e.g. with clothing, to protect it from natural and artificial sun light during treatment and for 10 days following its removal.

The transdermal patch should not be exposed to any external heat sources e.g. hot water bottles or heat pads.

Dispose of used patches safely by folding in half, adhesive side inwards and then discard out of reach of children.

Contraindications

Children under 18 years
Breastfeeding

Precautions and Warnings

Elderly
Family history of long QT syndrome
Cardiac arrhythmias
Hepatic impairment
History of torsade de pointes
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Long QT syndrome
Pregnancy
Renal impairment
Subacute gastrointestinal obstruction

Avoid exposing application site to direct external heat
Discard used patches safely - fold with adhesive edges together
Do not apply to broken or denuded skin
Dry skin thoroughly before application
Ensure application site is covered during treatment and for 10 days after
Perform ECG before treatment
Monitor patients for signs and symptoms of Serotonin Syndrome
Monitor patients with signs of sub-acute intestinal obstruction
Discontinue if severe skin reaction occurs
Advise patients to avoid strenuous exercise, swimming and sauna use

Cases of ECG modifications including QT prolongation have been reported in other formulations. 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 and Lactation

Pregnancy

Granisetron transdermal patches should be used with caution in pregnancy.

There is highly limited data on the use of granisetron in pregnant women, although animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity or teratogenic effects. There for the manufacture recommends avoidance of the product in pregnancy.

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

Granisetron transdermal patches are contraindicated in breastfeeding.

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

Anaphylaxis
Application site reaction
Arthralgia
Constipation
Decreased appetite
Dry mouth
Dyskinesia
Dystonia
Flushing
Headache
Hypersensitivity reactions
Increase of liver transaminases
Irritation at application site
Itching at application site
Localised and generalised rash
Nausea
Oedema
Pain at application site
Prolongation of QT interval
Rash
Retching
Urticaria
Vertigo

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 2013

Reference Sources

British National Formulary, 66th Edition (September 2013-March 2014) Pharmaceutical Press, London.

BNF for Children (2013-2014) Pharmaceutical Press, London.

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: Sancuso 3.1mg/24 hours transdermal patch. ProStrakan. Revised May 2014.