These highlights do not include all the information needed to use LOVAZA safely and effectively. See full prescribing information for LOVAZA. LOVAZA (omega-3-acid ethyl esters) CapsulesInitial U.S. Approval: 2004
LOVAZA (omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA and should continue this diet during treatment with LOVAZA.
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting LOVAZA therapy. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
Limitations of Use: The effect of LOVAZA on cardiovascular mortality and morbidity in patients with elevated triglycerides has not been determined.
The daily dose of LOVAZA is 4 grams per day. The daily dose may be taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily).
Patients should be advised to swallow LOVAZA capsules whole. Do not break open, crush, dissolve or chew LOVAZA.
LOVAZA (omega-3-acid ethyl esters) capsules are supplied as 1-gram transparent soft-gelatin capsules filled with light-yellow oil and bearing the designation LOVAZA.
LOVAZA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to LOVAZA or any of its components.
In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with LOVAZA. In some patients, increases in ALT levels without a concurrent increase in AST levels were observed.

In some patients, LOVAZA increases LDL-C levels. LDL-C levels should be monitored periodically during therapy with LOVAZA.

Laboratory studies should be performed periodically to measure the patient’s TG levels during therapy with LOVAZA.

LOVAZA contains ethyl esters of omega-3 fatty acids (EPA and DHA) obtained from the oil of several fish sources. It is not known whether patients with allergies to fish and/or shellfish, are at increased risk of an allergic reaction to LOVAZA. LOVAZA should be used with caution in patients with known hypersensitivity to fish and/or shellfish.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse reactions reported in at least 3% and at a greater rate than placebo for patients treated with LOVAZA based on pooled data across 23 clinical studies are listed in Table 1.

  Studies included subjects with HTG and severe HTG.

Additional adverse reactions from clinical studies are listed below:

Digestive System: Constipation, gastrointestinal disorder and vomiting.

Metabolic and Nutritional Disorders: Increased ALT a