Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Amarin Pharmaceuticals Ireland Limited, 88 Harcourt Street, Dublin 2, D02DK18, Ireland
Vazkepa is indicated to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL [≥1.7 mmol/L]) and
For study details including cardiovascular risk factors and results with respect to effects on cardiovascular events see section 5.1.
The recommended daily oral dose is 4 capsules taken as two 998 mg capsules twice daily.
If a dose is missed, patients should take it as soon as they remember. However, if one daily dose is missed, the next dose should not be doubled.
No dose adjustment is necessary based on age (see section 5.2).
No dose reduction is recommended (see also section 5.2).
No dose reduction is recommended (see also sections 4.4 and 5.2).
There is no relevant use of icosapent ethyl in children aged <18 years of age in reducing the risk of cardiovascular events in statin-treated patients at high cardiovascular risk with elevated triglycerides and other risk factors for cardiovascular disease.
Oral use.
Vazkepa should be taken with or following a meal.
To ensure the full intended dose is received, patients should be advised to swallow the capsules whole and not to break, crush, dissolve, or chew them.
There is no specific treatment for icosapent ethyl overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
4 years.
Store below 30°C.
Bottle: keep the bottle tightly closed in order to protect from moisture.
Blister: store in the original package in order to protect from moisture.
High density polyethylene (HDPE) bottles with a child-resistant polypropylene heat induction sealed closure containing 120 soft capsules.
Pack size of one bottle or three bottles per carton.
PVC/PCTFE/Al perforated unit dose blisters containing 4x2 soft capsules.
Not all pack sizes may be marketed.
No special requirements for disposal.
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