Omega-3 Fatty Acid Formulations

DOSAGE AND ADMINISTRATION:
• The dosage of EPANOVA is 2 grams (2 capsules) or 4 grams (4 capsules) once
daily. Individualize therapy according to patient response and tolerability. In
clinical trials, EPANOVA was administered without regard to meals.

• Patients should be advised to swallow EPANOVA capsules whole. Do not break
open, crush, dissolve or chew EPANOVA.

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

WARNINGS AND PRECAUTIONS:
• In some patients, EPANOVA increases LDL-C levels. LDL-C levels should be
monitored periodically during therapy with EPANOVA.
• In patients with hepatic impairment, monitor ALT and AST levels periodically
during therapy.
• EPANOVA should be used with caution in patients with known hypersensitivity
to fish and/or shellfish.

ADVERSE REACTIONS:
Most common adverse reactions (incidence ≥3% and greater than placebo) are
diarrhea, nausea, abdominal pain or discomfort, and eructation.

To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at
1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:
Omega-3 fatty acids may prolong bleeding time. Patients receiving treatment
with EPANOVA and other drugs affecting coagulation (e.g., anti-platelet agents)
should be monitored periodically.

USE IN SPECIFIC POPULATIONS:
Pregnancy: Use during pregnancy only if the potential benefit justifies the
potential risk to the fetus

See package insert for PATIENT COUNSELING INFORMATION [and FDA-approved patient
labeling].

DOSAGE FORMS AND STRENGTHS:
Soft gelatin capsules: 1 gram

SOURCE:
Package insert data: Accessed June 2014.
Manufactured by: Catalent Germany GmbH, Eberbach and Schorndorf, Germany
Manufactured for: AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
EPANOVA is a registered trademark licensed to the AstraZeneca group of companies.
©AstraZeneca 2014
Rev. 5/14 2985402 5/14

Limitations of Use:
The effect of OMTRYG on the risk for pancreatitis has not been determined.

The effect of OMTRYG on cardiovascular mortality and morbidity has not been determined.

DOSAGE AND ADMINISTRATION:
The daily dose of OMTRYG is 4 capsules per day taken as a single dose or as 2 capsules given twice daily. OMTRYG should be taken with meals.

Patients should be advised to swallow OMTRYG capsules whole. Do not break open, crush, dissolve or chew OMTRYG.

CONTRAINDICATIONS:
Patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any component of OMTRYG.

WARNINGS AND PRECAUTIONS:
•In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
•OMTRYG may increase levels of LDL. Monitor LDL levels periodically during therapy.
•Use with caution in patients with known hypersensitivity to fish and/or shellfish.
•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.

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

To report SUSPECTED ADVERSE REACTIONS, contact Trygg Pharma at 1-855-3-OMTRYG (1-855-366-8794) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:
Omega-3-acids may prolong bleeding time. Patients taking OMTRYG and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.

USE IN SPECIFIC POPULATIONS:
Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

DOSAGE FORMS AND STRENGTHS:
Capsules: 1.2 grams.

SOURCE:
Package insert data: accessed: June 2014
Trygg Pharma, Inc.
1001 North 19th St.
Suite 1200
Arlington, VA 22209
Approved: 04/2014