OMEGA-3 ACID CAP,ORAL
Clinical Criteria Summary
Document 120: Omega 3 Acid Ethyl Esters LOVAZA and Generics CFU for Severe Hypertriglyceridemia
Indication
- Severe hypertriglyceridemia
Laboratory Criteria
- Fasting triglyceride level of > 500 mg/dL on two occasions
Pre-treatment Considerations & Warnings
- Secondary causes should be considered and addressed prior to initiation of therapy
- Effect of Lovaza and Lovaza generics on risk for pancreatitis in patients with severe hypertriglyceridemia has not been established
Therapeutic Efficacy & Alternatives
- Evidence does not support a greater triglyceride lowering response between Lovaza, Lovaza generics and icosapent ethyl
- For patients who may be candidates for reducing cardiovascular (CV) risk with icosapent ethyl (established CV disease, on statins with LDL 41-100 mg/dL and fasting TG > 150 mg/dL), refer to CFU for Icosapent Ethyl
Document 843: Omega 3 Acid LOVAZA Generics ESRD on Dialysis April 2026
Exclusion Criteria
- None
Inclusion Criteria
- Provider must be a VA or VA Community Care Nephrologist or locally designed expert in managing patients with end stage renal disease (ESRD) on hemodialysis.
- Patient must have ESRD receiving chronic maintenance hemodialysis.
Clinical Monitoring & Evidence Considerations
- Closely monitor patients during treatment due to an observed increased risk for new onset or hospitalization for atrial fibrillation or flutter.
- The omega-3 fatty acid product used in the PISCES trial is not FDA approved for these patients; Lovaza/generics is the only FDA approved option available in the US.