Icosapent ethyl oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of icosapent ethyl.
Drugs List
Therapeutic Indications
Uses
Prevention of cardiovascular events in high risk patients
To reduce the risk of cardiovascular events in statin-treated patients at high cardiovascular risk, with elevated triglycerides (greater than or equal to 150 mg/dL [greater than or equal to 1.7mmol/l]) and:
Cardiovascular disease
OR
Diabetes, and at least one other cardiovascular risk factor.
Dosage
Adults
1.996g (2 x 998mg capsules), twice daily.
Additional Dosage Information
Missed dose
If a dose is missed, the patient must take it as soon as they remember. If more than one dose is missed, the next dose must not be doubled.
Contraindications
Children under 18 years
Breastfeeding
Hereditary fructose intolerance
Precautions and Warnings
Fish allergy
Hypersensitivity to shellfish
Atrial fibrillation
Atrial flutter
Hepatic impairment
Pregnancy
Hepatic impairment: Monitor ALT and AST before and during treatment
Contains maltitol: unsuitable in hereditary fructose intolerance
Contains soya or soya derivative
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Capsules should not be opened or crushed
Monitor for atrial fibrillation
Monitor patients receiving concurrent anticoagulants
Monitor patients receiving concurrent antiplatelets
Pregnancy and Lactation
Pregnancy
Use icosapent ethyl with caution during pregnancy.
The manufacturer does not recommend using icosapent ethyl during pregnancy. At the time of writing there is limited published information regarding the use of icosapent ethyl during pregnancy. Potential risks are unknown, therefore the manufacturer states that icosapent ethyl should be avoided unless the therapeutic benefit outweighs the risk to the foetus.
Lactation
Icosapent ethyl is contraindicated during breastfeeding.
The manufacturer states that a decision must be made for the patient to either discontinue icosapent ethyl or discontinue breastfeeding. Literature shows that the active metabolite eicosapentaenoic acid is present in human breast milk at concentrations similar to maternal levels.
Effects on exposed infants are unknown.
Side Effects
Abdominal discomfort
Arrhythmias
Arthralgia
Atrial fibrillation
Atrial flutter
Bleeding
Constipation
Diarrhoea
Dysgeusia
Eructation
Fishy taste
Gout
Hypersensitivity reactions
Musculoskeletal pain
Pain
Peripheral oedema
Pharyngeal oedema
Rash
Skin reactions
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: December 2021
Reference Sources
Summary of Product Characteristics: Vazkepa 998mg capsules. Amarin Pharmaceuticals Ireland Ltd. Revised April 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 26 July 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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