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 (omega-3-acid ethyl esters) and should continue this diet during treatment with LOVAZA (omega-3-acid ethyl esters) .

Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting LOVAZA (omega-3-acid ethyl esters) 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 (omega-3-acid ethyl esters) on cardiovascular mortality and morbidity in patients with elevated triglycerides has not been determined.

• Assess triglyceride levels carefully before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate, [see INDICATIONS].
• Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA (omega-3-acid ethyl esters) , and should continue this diet during treatment with LOVAZA (omega-3-acid ethyl esters) . In clinical studies, LOVAZA (omega-3-acid ethyl esters) was administered with meals.

The daily dose of LOVAZA (omega-3-acid ethyl esters) 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 (omega-3-acid ethyl esters) capsules whole. Do not break open, crush, dissolve or chew LOVAZA (omega-3-acid ethyl esters) .

Dosage Forms and Strengths

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 (omega-3-acid ethyl esters) .

Bottles of 60: NDC 0173-0783-01
Bottles of 120: NDC 0173-0783-02

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children.

Manufactured for GlaxoSmithKline by: Catalent Pharma Solutions 2725 Scherer Drive St. Petersburg, FL 33716-1016.
Accucaps Industries Limited 2125 Ambassador Drive Windsor, Ontario, Canada N9B 3R5
Banner Pharmaceuticals Inc. Premier Drive High Point, NC 27265.
Distributed by: GlaxoSmithKline Research Triangle Park, NC 27709.

Last reviewed on RxList: 2/10/2011
This monograph has been modified to include the generic and brand name in many instances.