Lovaza

LOVAZA (omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. LOVAZA is a combination of ethyl esters of omega 3 fatty acids, principally eicosapentaenoic acid (EPA) and docosahexaenoic acid (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 the risk for pancreatitis has not been determined. ( 1 ) The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined. ( 1 ) 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 therapy with LOVAZA.

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 TG-lowering drug therapy.

Limitations of Use: The effect of LOVAZA on the risk for pancreatitis has not been determined. The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined.

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

In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy. ( 5.1 ) LOVAZA may increase levels of low-density lipoprotein (LDL). Monitor LDL levels periodically during therapy. ( 5.1 ) Use with caution in patients with known hypersensitivity to fish and/or shellfish. ( 5.2 ) There is a possible association between LOVAZA and more frequent recurrences of symptomatic atrial fibrillation or flutter in patients with paroxysmal or persistent atrial fibrillation, particularly within the first months of initiating therapy.