HIGHLIGHTS OF PRESCRIBING INFORMATION

VASCEPA ® (icosapent ethyl) Capsules, for oral use 

Initial U.S. Approval: 2012 

These highlights do not include all the information needed to use VASCEPA ® safely and effectively. See full prescribing information for VASCEPA. 

INDICATIONS AND USAGE 

VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) 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 VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. (1)

The effect of VASCEPA on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined. (1)

DOSAGE AND ADMINISTRATION 

The daily dose of VASCEPA is 4 grams per day taken as four 0.5-gram capsules or two 1-gram capsules twice daily with food. (2) 

Patients should be advised to swallow VASCEPA capsules whole. Do not break open, crush, dissolve, or chew VASCEPA. (2) 

DOSAGE FORMS AND STRENGTHS 

Capsules: 0.5-gram and 1-gram (3) 

CONTRAINDICATIONS 

VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components. (4) 

WARNINGS AND PRECAUTIONS 

In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy. (5.1) 

Use with caution in patients with known hypersensitivity to fish and/or shellfish. (5.2) 

ADVERSE REACTIONS 

The most common reported adverse reaction (incidence >2% and greater than placebo) was arthralgia. (6) 

To report SUSPECTED ADVERSE REACTIONS, contact Amarin Pharma Inc. at 1-855-VASCEPA (1-855-827-2372) or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

DRUG INTERACTIONS 

Omega-3 acids may prolong bleeding time. Patients receiving treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically. (7) 

USE IN SPECIFIC POPULATIONS 

Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. (8.1) 

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 2/2017

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE 

2 DOSAGE AND ADMINISTRATION 

3 DOSAGE FORMS AND STRENGTHS 

4 CONTRAINDICATIONS 

5 WARNINGS AND PRECAUTIONS 

5.1 Monitoring: Laboratory Tests 

5.2 Fish Allergy 

6 ADVERSE REACTIONS 

6.1 Clinical Trials Experience 

7 DRUG INTERACTIONS  

7.1 Anticoagulants 

8 USE IN SPECIFIC POPULATIONS 

8.1 Pregnancy 

8.3 Nursing Mothers 

8.4 Pediatric Use 

8.5 Geriatric Use 

9 DRUG ABUSE AND DEPENDENCE 

11 DESCRIPTION 

12 CLINICAL PHARMACOLOGY 

12.1 Mechanism of Action 

12.3 Pharmacokinetics 

13 NONCLINICAL TOXICOLOGY 

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 

14 CLINICAL STUDIES