1 INDICATIONS AND USAGE Omega-3-acid ethyl esters capsules, are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia.

Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules.

Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters.

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 omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined.

The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined.

Omega-3-acid ethyl esters capsules are 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 omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined.

(1) The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined.

(1)

6 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 Strides Pharma, Inc.

at 1-877-244-9825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

Adverse reactions reported in at least 3% of subjects treated with omega-3-acid ethyl esters capsules and at a greater rate than placebo based on pooled data across 23 clinical trials are listed in Table 1.

Table 1.

Adverse Reactions Occurring at Incidence ≥3% and Greater than Placebo in Clinical Trials of Omega-3-Acid Ethyl Esters Capsules a Trials included subjects with hypertriglyceridemia and severe hypertriglyceridemia.

Adverse Reaction a Omega-3-Acid Ethyl Esters Capsules (n=655) Placebo (n=370) n % n % Eructation Dyspepsia Taste perversion 29 22 27 4 3 4 5 6 1 1 2 <1 Additional adverse reactions from clinical trials are listed below: Digestive System Constipation, gastrointestinal disorder, and vomiting.

Metabolic and Nutritional Disorders Increased ALT and increased AST.

Skin Pruritus and rash.

6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the events described below have been identified during post-approval use of omega-3-acid ethyl esters capsules.

Because these events are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or to always establish a causal relationship to drug exposure.

The following events have been reported: anaphylactic reaction, hemorrhagic diathesis, urticaria.