INDICATIONS AND USAGE

LOVAZA is a combination of ethyl esters of omega 3 fatty acids, principally EPA and DHA, indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. (1)
 

Limitations of Use: The effect of LOVAZA on cardiovascular mortality and morbidity in patients with elevated triglycerides has not been determined. (1)

DOSAGE AND ADMINISTRATION

• The daily dose of LOVAZA is 4 grams per day taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily). (2)
• Patients should be advised to swallow LOVAZA capsules whole. Do not break open, crush, dissolve or chew LOVAZA. (2)

DOSAGE FORMS AND STRENGTHS

1-gram transparent soft-gelatin capsules. (3)

CONTRAINDICATIONS

LOVAZA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to LOVAZA or any of its components. (4)

WARNINGS AND PRECAUTIONS

• In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy. (5.1)
• LOVAZA may increase levels of LDL. Monitor LDL levels periodically during therapy. (5.1)
• Use with caution in patients with known hypersensitivity to fish and/or shellfish. (5.2)

ADVERSE REACTIONS

The most common adverse events (incidence >3% and greater than placebo) were eructation, infection, flu syndrome, and dyspepsia. (6)