What is the recommended dose and frequency of Vascepa (icosapent ethyl)?

Vascepa (Icosapent Ethyl) Dosage and Administration

The recommended dosage of Vascepa (icosapent ethyl) is 2 grams twice daily with food, for a total daily dose of 4 grams per day. 1

Indications and Dosing Details

Vascepa is FDA-approved for two main indications, each with the same dosing regimen:

1. For Cardiovascular Risk Reduction:

   • Dosage: 2 g twice daily with food (4 g/day total)
   • Indicated as an adjunct to statin therapy in patients with established cardiovascular disease or diabetes plus additional risk factors who have elevated triglycerides (135-499 mg/dL) and controlled LDL-C 1

2. For Severe Hypertriglyceridemia:

   • Dosage: 2 g twice daily with food (4 g/day total)
   • Indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL) 1, 2

Clinical Evidence Supporting This Dosage

The 4 g/day dosage (2 g twice daily) is supported by robust clinical evidence:

• The REDUCE-IT trial, which demonstrated a 25% relative risk reduction in cardiovascular events, used this dosage 3, 1
• This dosage resulted in significant reductions in:
  • Cardiovascular death (20% reduction)
  • Composite of cardiovascular death, nonfatal MI, or nonfatal stroke (26% reduction) 1
  • Triglyceride levels (approximately 20-33% reduction compared to placebo) 2

Administration Guidelines

• Vascepa should be taken with food to enhance absorption 1
• The daily dose should be divided into two doses (morning and evening) 1
• Maximum effects on lipid levels typically occur after 4-12 weeks of treatment 1

Monitoring Recommendations

When prescribing Vascepa, monitor for:

• Atrial fibrillation symptoms (increased risk of 5.3% vs. 3.9% with placebo) 1
• Bleeding events, especially in patients taking anticoagulants or antiplatelet therapies 1
• Lipid levels to assess treatment efficacy 1

Important Considerations

• Unlike some omega-3 products that contain both EPA and DHA, Vascepa contains ≥96% EPA ethyl ester and does not contain DHA 2
• Vascepa does not increase LDL-C levels, which is an advantage over some other triglyceride-lowering therapies 2, 4
• The tolerability profile is generally similar to placebo in clinical trials 1, 2

Potential Adverse Effects

• Atrial fibrillation/flutter (5.3% vs. 3.9% in placebo)
• Peripheral edema (6.5% vs. 5.0%)
• Constipation (5.4% vs. 3.6%)
• Potential increased bleeding risk 1

Vascepa represents an important therapeutic option for cardiovascular risk reduction and management of severe hypertriglyceridemia, with a straightforward dosing regimen of 2 grams twice daily with food.