Icosapent is used together with other medicines (such as statins) to reduce the risk of heart attack, stroke, and some types of heart problems that need hospitalization in adults.

Icosapent is used together with a low-fat and low-cholesterol diet to reduce triglycerides (fats) in adults with severely high triglycerides.

It is not known whether icosapent will lower your risk of pancreatitis (inflammation of your pancreas).

Icosapent may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food.

Swallow the capsule whole and do not crush, chew, break, or open it.

You will need frequent blood tests.

Icosapent is only part of a complete treatment program that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Hypertriglyceridemia:

2 g orally twice a day with food

Comments:
-Limitations of Use: The effect of this drug on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Uses:
-As an adjunct to diet to reduce triglyceride (TG) levels in patients with severe (500 mg/dL or greater) hypertriglyceridemia
-As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in patients with elevated TG levels (150 mg/dL or higher) and: established cardiovascular disease OR diabetes mellitus and at least 2 additional risk factors for cardiovascular disease

Usual Adult Dose for Cardiovascular Risk Reduction:

2 g orally twice a day with food

Comments:
-Limitations of Use: The effect of this drug on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Uses:
-As an adjunct to diet to reduce triglyceride (TG) levels in patients with severe (500 mg/dL or greater) hypertriglyceridemia
-As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in patients with elevated TG levels (150 mg/dL or higher) and: established cardiovascular disease OR diabetes mellitus and at least 2 additional risk factors for cardiovascular disease

You should not use icosapent if you are allergic to it.

Tell your doctor if you have ever had:

• liver disease;

• diabetes;

• a thyroid disorder;

• problems with your pancreas;

• a bleeding or blood-clotting disorder; or

• if you are allergic to fish or shellfish.

It is not known whether icosapent will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Icosapent can pass into breast milk, and may harm your baby. Tell your doctor if you are breastfeeding.

Icosapent is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid eating foods that are high in fat or cholesterol. Icosapent will not be as effective in lowering your cholesterol if you do not follow a cholesterol lowering diet plan.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Icosapent may cause serious side effects. Call your doctor at once if you have:

• fast or irregular heartbeats, dizziness, shortness of breath, chest discomfort, fainting, or if you feel light-headed; or

• serious bleeding.

Common side effects of icosapent may include:

• muscle or joint pain;

• constipation;

• swelling of the hands, legs, or feet.

• gout; or

• chest pressure, racing or pounding heartbeats, fluttering in your chest, feeling short of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• a blood thinner--warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect icosapent, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.