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IMPORTANT SAFETY INFORMATION AND INDICATIONS

Select Safety Information for LOVAZA® (omega-3-acid ethyl esters)

LOVAZA®, along with diet, helps to lower very high triglycerides (≥500 mg/dL) in adult patients. Tell your doctor if you are allergic to fish or shellfish as LOVAZA® may not be right for you. Talk to your doctor about any medical conditions you have and any medications you are taking, especially those that may increase your risk of bleeding. In some patients, LDL-cholesterol levels may increase. Your healthcare provider should do blood tests before and during treatment with LOVAZA® to check your cholesterol and triglyceride levels. If you have liver disease, you may require additional monitoring. Possible side effects include burping, infection, flu-like symptoms, upset stomach and change in sense of taste.

INDICATIONS AND USAGE

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)

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)

WARNINGS AND PRECAUTIONS

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. (5.3)

CONTRAINDICATIONS

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

ADVERSE REACTIONS

The most common adverse reactions (incidence >3% and greater than placebo) were eructation, dyspepsia, and taste perversion. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Woodward Pharma Services LLC at 1-844-700-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full LOVAZA Product Information