Icosapent ethyl


Generic Medicine Info
Indications and Dosage
Oral
Cardiovascular risk reduction
Adult: As an adjunct to statin therapy in patients with triglyceride levels ≥150 mg/dL, established CV disease, or type 2 diabetes mellitus, and at least 1 CV risk factor: 4 g daily taken as 2 g bid. Dosage recommendations may vary among countries or individual products. Refer to specific product guidelines.

Oral
Severe hypertriglyceridaemia
Adult: As an adjunct to diet in patients with triglyceride levels ≥500 mg/dL: 2 g bid. Treatment guidelines may vary among countries or individual products. Refer to specific product guidelines.
Administration
Should be taken with food. Swallow whole, do not break open/crush/dissolve/chew.
Special Precautions
Patient with known allergy or sensitivity to fish and/or shellfish, coagulopathy, history of atrial fibrillation or flutter. Pregnancy and lactation.
Adverse Reactions
Significant: Bleeding, atrial fibrillation or atrial flutter, hypersensitivity (in patients with fish allergy).
Gastrointestinal disorders: Constipation, eructation, diarrhoea, abdominal discomfort.
General disorders and admin site conditions: Peripheral oedema.
Investigations: Increased serum triglycerides.
Metabolism and nutrition disorders: Gout.
Musculoskeletal and connective tissue disorders: Musculoskeletal pain, limb pain, arthralgia.
Respiratory, thoracic and mediastinal disorders: Oropharyngeal pain.
Skin and subcutaneous tissue disorders: Rash.
Monitoring Parameters
Monitor triglycerides and other lipids at baseline and periodically; ALT and AST (in patients with hepatic impairment) periodically during treatment. Monitor for signs and symptoms of bleeding.
Drug Interactions
Increased risk of bleeding with anticoagulants and antiplatelets.
Action
Description: Icosapent ethyl is a stable ethyl ester of eicosapentaenoic acid (EPA). Its mechanisms of action contributing to the reduction of CV events are not fully understood, but are likely multifactorial such as reduction of triglyceride-rich lipoprotein, inhibition of platelet aggregation, increasing EPA composition from carotid plaques, or increasing the circulating EPA/arachidonic acid ratio. Other possible cellular mechanisms include inhibition of acyl CoA:1,2-diacylglycerol acyltransferase, increased hepatic β-oxidation, and decreased hepatic synthesis of triglycerides.
Synonym: ethyl icosapentate; ethyl-eicosapentaenoic acid, ethyl-EPA.
Pharmacokinetics:
Absorption: De-esterified to an active metabolite (EPA), which is absorbed in the small intestine. Time to peak plasma concentration: Approx 5 hours.
Distribution: Volume of distribution: Approx 88 L. Plasma protein binding: >99%.
Metabolism: Metabolised mainly in the liver via β-oxidation (similar to dietary fatty acids).
Excretion: Elimination half-life: Approx 37-89 hours.
Chemical Structure

Chemical Structure Image
Icosapent ethyl

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 9831415, Icosapent ethyl. https://pubchem.ncbi.nlm.nih.gov/compound/Icosapent-ethyl. Accessed Oct. 27, 2021.

Storage
Store below 30°C.
MIMS Class
Dyslipidaemic Agents / Supplements & Adjuvant Therapy
References
Anon. Icosapent Ethyl. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 15/10/2021.

Anon. Icosapent Ethyl. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 15/10/2021.

Buckingham R (ed). Omega-3 Fatty Acids. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/10/2021.

Epadel S900 (Catalent Japan K.K. Kakegawa Plant). MIMS Thailand. http://www.mims.com/thailand. Accessed 15/10/2021.

Vascepa (Amarin Pharma Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 15/10/2021.

Vazkepa 998 mg Soft Capsules (Amarin Pharmaceuticals Ireland Limited). MHRA. https://products.mhra.gov.uk. Accessed 15/10/2021.

Disclaimer: This information is independently developed by MIMS based on Icosapent ethyl from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 MIMS. All rights reserved. Powered by MIMS.com
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