Omega 3 Acid Ethyl Esters — 1 Gram — Generic For Lovaza — Epic Pharma

These highlights do not include all the information needed to use OMEGA-3-ACID ETHYL ESTERS CAPSULES safely and effectively. See full prescribing information for OMEGA-3-ACID ETHYL ESTERS CAPSULES.

Initial U.S. Approval: 2004

Indications And Usage

Omega-3-acid ethyl esters capsules are 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 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)

Dosage And Administration

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

2)

Dosage Forms And Strengths

Capsules: 1 gram (

3)

Contraindications

Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components. (

4)

Warnings And Precautions

• In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy. ( 5.1)
• Omega-3-acid ethyl esters 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 omega-3-acid ethyl esters 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)

• In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy. ( 5.1)
• Omega-3-acid ethyl esters 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 omega-3-acid ethyl esters 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)

In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy. (

5.1)

Omega-3-acid ethyl esters 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 omega-3-acid ethyl esters 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)

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[Epic Pharma LLC at 1-888-374-2791]or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch.

Drug Interactions

Omega-3-acids may prolong bleeding time. Patients taking omega-3-acid ethyl esters and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically. (

7.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 1/2021