Drugs List

Therapeutic Indications

Uses

Chemotherapy induced nausea and vomiting

Prevention of nausea and vomiting associated with moderately emetogenic and highly emetogenic cancer chemotherapy.

Administration

Adults:
For intravenous injection only.

Children (aged 1 month to 18 years):
For intravenous infusion only.

Contraindications

Neonates under 1 month
Breastfeeding
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Children under 2 years
Constipation
Family history of long QT syndrome
Bradyarrhythmia
Cardiac conduction defects
Congestive cardiac failure
Electrolyte imbalance
End stage renal disease
History of torsade de pointes
Pregnancy
Subacute gastrointestinal obstruction

Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
Consider monitoring ECG in patients at risk of QT prolongation
Monitor patients for signs and symptoms of Serotonin Syndrome
Monitor serum electrolytes

Use with caution in children aged 1 month to 2 years as experience is limited.

Use with caution in patients with end stage renal disease undergoing haemodialysis as experience is limited. No dose adjustments are necessary.

As palonosetron may increase large bowel transit time, patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration.

Palonosetron must only be used as a preventative treatment, given prior to chemotherapy. It should not be used to treat, or prevent further episodes of, nausea and vomiting in the days following chemotherapy administration unless further doses of chemotherapy are scheduled.

Pregnancy and Lactation

Pregnancy

Use palonosetron with caution during pregnancy.

At the time of writing, there is limited published data regarding the use of palonosetron during pregnancy. Animal studies have not indicated direct or indirect harmful effects. There is no published experience of palonosetron during human pregnancy. The manufacturer advises palonosetron should not be used during pregnancy unless it is considered essential by the physician.

Transfer across the placenta is unknown. The molecular weight of the free base, moderate protein binding and metabolism and extended plasma-half life suggest substantial amounts of active drug will be at the maternal-foetal interface for prolonged periods.

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

Palonosetron is contraindicated during breastfeeding.

At the time of writing, there is limited published information available regarding the use of palonosetron during breast feeding. Transfer into breast milk is unknown however the molecular weight of the free base, moderate protein binding and metabolism and extended plasma-half life suggests excretion is likely. Effects on exposed infants are unknown but as palonosetron is only used for short periods, the risk of toxicity is likely to be remote. The manufacturer advises that breast feeding is discontinued.

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
Allergic dermatitis
Amblyopia
Anaphylactic reaction
Anaphylactoid reaction
Anaphylaxis
Anorexia
Anxiety
Arthralgia
Asthenia
Bradycardia
Constipation
Cough
Decreased appetite
Diarrhoea
Dizziness
Dry mouth
Dyskinesia
Dyspepsia
Dyspnoea
Epistaxis
Euphoria
Extrasystoles
Eye irritation
Fatigue
Flatulence
Glucosuria
Headache
Hiccups
Hot flushes
Hyperbilirubinaemia
Hyperglycaemia
Hyperkalaemia
Hypersensitivity reactions
Hypersomnia
Hypertension
Hypocalcaemia
Hypokalaemia
Hypotension
Increase in serum transaminases
Influenza-like symptoms
Injection site reactions
Insomnia
Local pain (injection site)
Metabolic disorders
Motion sickness
Myocardial ischaemia
Pain
Paraesthesia
Peripheral neuropathy
Prolongation of QT interval
Pruritic rash
Pyrexia
Shock
Sinus arrhythmia
Sinus tachycardia
Skin disorder
Somnolence
Tachycardia
Tinnitus
Urinary retention
Urticaria
Vein discolouration
Vein distended
Ventricular extrasystoles

Presentation

Injections of palonosetron.

Drugs List

Therapeutic Indications

Uses

Chemotherapy induced nausea and vomiting

Prevention of nausea and vomiting associated with moderately emetogenic and highly emetogenic cancer chemotherapy.

Dosage

Efficacy may be enhanced by concomitant administration of a corticosteroid.

Adults

Children

Administration

Adults:
For intravenous injection only.

Children (aged 1 month to 18 years):
For intravenous infusion only.

Contraindications

Neonates under 1 month
Breastfeeding
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Children under 2 years
Constipation
Family history of long QT syndrome
Bradyarrhythmia
Cardiac conduction defects
Congestive cardiac failure
Electrolyte imbalance
End stage renal disease
History of torsade de pointes
Pregnancy
Subacute gastrointestinal obstruction

Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
Consider monitoring ECG in patients at risk of QT prolongation
Monitor patients for signs and symptoms of Serotonin Syndrome
Monitor serum electrolytes

Use with caution in children aged 1 month to 2 years as experience is limited.

Use with caution in patients with end stage renal disease undergoing haemodialysis as experience is limited. No dose adjustments are necessary.

As palonosetron may increase large bowel transit time, patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration.

Palonosetron must only be used as a preventative treatment, given prior to chemotherapy. It should not be used to treat, or prevent further episodes of, nausea and vomiting in the days following chemotherapy administration unless further doses of chemotherapy are scheduled.

Pregnancy and Lactation

Pregnancy

Use palonosetron with caution during pregnancy.

At the time of writing, there is limited published data regarding the use of palonosetron during pregnancy. Animal studies have not indicated direct or indirect harmful effects. There is no published experience of palonosetron during human pregnancy. The manufacturer advises palonosetron should not be used during pregnancy unless it is considered essential by the physician.

Transfer across the placenta is unknown. The molecular weight of the free base, moderate protein binding and metabolism and extended plasma-half life suggest substantial amounts of active drug will be at the maternal-foetal interface for prolonged periods.

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

Palonosetron is contraindicated during breastfeeding.

At the time of writing, there is limited published information available regarding the use of palonosetron during breast feeding. Transfer into breast milk is unknown however the molecular weight of the free base, moderate protein binding and metabolism and extended plasma-half life suggests excretion is likely. Effects on exposed infants are unknown but as palonosetron is only used for short periods, the risk of toxicity is likely to be remote. The manufacturer advises that breast feeding is discontinued.

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
Allergic dermatitis
Amblyopia
Anaphylactic reaction
Anaphylactoid reaction
Anaphylaxis
Anorexia
Anxiety
Arthralgia
Asthenia
Bradycardia
Constipation
Cough
Decreased appetite
Diarrhoea
Dizziness
Dry mouth
Dyskinesia
Dyspepsia
Dyspnoea
Epistaxis
Euphoria
Extrasystoles
Eye irritation
Fatigue
Flatulence
Glucosuria
Headache
Hiccups
Hot flushes
Hyperbilirubinaemia
Hyperglycaemia
Hyperkalaemia
Hypersensitivity reactions
Hypersomnia
Hypertension
Hypocalcaemia
Hypokalaemia
Hypotension
Increase in serum transaminases
Influenza-like symptoms
Injection site reactions
Insomnia
Local pain (injection site)
Metabolic disorders
Motion sickness
Myocardial ischaemia
Pain
Paraesthesia
Peripheral neuropathy
Prolongation of QT interval
Pruritic rash
Pyrexia
Shock
Sinus arrhythmia
Sinus tachycardia
Skin disorder
Somnolence
Tachycardia
Tinnitus
Urinary retention
Urticaria
Vein discolouration
Vein distended
Ventricular extrasystoles

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: February 2018

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Aloxi 250 micrograms solution for injection. Chugai Pharma UK Ltd. Revised February 2015.

Summary of Product Characteristics: Palonosetron Accord 250 micrograms solution for injection. Accord Healthcare Ltd. Revised May 2016.