Icosapent Ethyl (eye-KOE-sa-pent ETH-il)

Treats high levels of triglycerides (fat-like substances) in your blood. This medicine is used together with diet, exercise, and weight loss to help control triglyceride levels.

Brand Name(s):

Vascepa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid Filled Capsule

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• It is best to take this medicine with food or milk.
• Swallow the capsule whole. Do not crush, break, chew, dissolve, or open it.
• Carefully follow your doctor's instructions about any special diet.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using aspirin, clopidogrel (Plavix), certain blood pressure medicines (such as atenolol, metoprolol, propranolol, Bystolic, Tenormin), a diuretic (water pill, such as hydrochlorothiazide), or any medicine that contains estrogen (including birth control pills and hormone replacement therapy).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease, diabetes, pancreas problems, or an underactive thyroid. Tell your doctor if are allergic to fish or shellfish, or if you drink alcohol.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Joint or muscle pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088