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Omega-3 Fatty Acid (Purified EPA — Eicosapentaenoic Acid Ethyl Ester)

Icosapent Ethyl (Omega-3 — Cardiovascular Risk Reduction)

Brand names: Vascepa

Icosapent ethyl is a highly purified omega-3 fatty acid ester (an ethyl ester of eicosapentaenoic acid, EPA) taken orally to reduce cardiovascular risk in selected statin-treated patients with raised triglycerides.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 4 grams per day, taken as either four 0.5 gram capsules twice daily with food, or two 1 gram capsules twice daily with food (i.e. 2 g per dose, twice daily).
Route: Oral — capsules swallowed whole: 'Do not break open, crush, dissolve, or chew icosapent ethyl capsules.' Indication scope: this is the label's single lipid-management dose; §2.1 directs that lipid levels be assessed and other causes of high triglyceride levels identified and managed before initiation. (The label's INDICATIONS AND USAGE section was not part of the fetched bundle, so the exact indication wording is not quoted here.)
Frequency: Twice daily with food.
Max: Maximum 4 g per day. The label gives one fixed total daily dose and no titration step or higher dose — §2.2 verbatim: 'The daily dose of icosapent ethyl capsules are 4 grams per day taken as either: four 0.5 gram capsules twice daily with food; or as two 1 gram capsules twice daily with food.'
Verbatim §2.1: 'Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. Patients should engage in appropriate nutritional intake and physical activity before receiving icosapent ethyl capsules, which should continue during treatment.' Capsule strengths supplied: 0.5 gram and 1 gram. This bundle carries US labelling only — no UK SPC was retrieved — so the regimen is stated as it appears on the US label. Elderly: '45% were 65 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger groups' (§8.5). PAEDIATRICS: §8.4 'Safety and effectiveness in pediatric patients have not been established' — hence paedDose is null.

Dose adjustments

Renal

Not stated — the fetched sections (DOSAGE AND ADMINISTRATION, DOSAGE FORMS AND STRENGTHS, Pediatric Use, Geriatric Use, Pregnancy, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, ADVERSE REACTIONS) contain no renal-impairment dosing statement.

Hepatic

Not stated — the fetched sections contain no hepatic-impairment dosing statement.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components (§4)

Side effects

  • Common adverse reactions (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation (§6.1)
  • Common adverse reactions in the hypertriglyceridemia trials (incidence ≥1% more frequent than placebo): arthralgia and oropharyngeal pain
  • Atrial fibrillation or atrial flutter requiring hospitalization — 'The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter' (§5.1)
  • Bleeding — 'associated with an increased risk of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin' (§5.3)
  • Potential for allergic reactions in patients with fish allergy — the product 'contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish'; it is not known whether patients allergic to fish and/or shellfish are at increased risk (§5.2)

Monitoring

  • Assess lipid levels before initiating therapy and identify/manage other causes of high triglyceride levels (§2.1).
  • Monitor for atrial fibrillation or atrial flutter, especially in patients with a previous history of AF/flutter (§5.1).
  • Monitor patients receiving concomitant anticoagulants and/or antiplatelet agents for bleeding (§5.3, §7.1) — 'Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time.' Advise patients with known fish/shellfish hypersensitivity about the potential for allergic reactions and to discontinue and seek medical attention if any reactions occur (§5.2).

Clinical monograph

How it works

EPA lowers triglycerides and is thought to exert additional anti-inflammatory, antithrombotic and plaque-stabilising effects, though the precise cardiovascular mechanism is not fully defined.

Prescribing in practice

  • It increases the risk of atrial fibrillation or flutter and of bleeding, so use with caution in patients with prior atrial fibrillation or on antithrombotic therapy.
  • Used as an adjunct to statin therapy in high cardiovascular-risk patients with elevated triglycerides, not as a substitute for statins.
  • Use caution in patients with known sensitivity to fish or shellfish, as the product is derived from fish oil.

Monitoring

Monitor triglycerides and remain alert for new palpitations or symptoms suggesting atrial fibrillation or unusual bleeding.

Counselling the patient

  • Take the capsules whole with food and do not crush or chew them.
  • Report palpitations or an irregular heartbeat to your doctor.

Evidence & guidelines

The REDUCE-IT trial showed reduced cardiovascular events in high-risk statin-treated patients with raised triglycerides, and it is recommended in NICE guidance for eligible patients.

Reference: REDUCE-IT Trial (Bhatt et al. NEJM 2018); FDA Prescribing Information Vascepa; MHRA Drug Safety Update 2021 (AF risk); ESC Dyslipidaemia Guidelines 2019; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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