Icosapent Ethyl

Icosapent ethyl is used together with lifestyle changes (diet, weight loss, exercise) to reduce the amount of triglycerides (a fat-like substance) in the blood. It is also used along with cholesterol-lowering medications (statins) to decrease the risk of a heart attack, a stroke, or other heart problems that require hospitalization in certain adults with high triglyceride levels and heart disease or diabetes with 2 or more other heart disease risk factors. Icosapent ethyl is in a class of medications called antilipemic or lipid-regulating agents. Icosapent ethyl may work by decreasing the amount of triglycerides and other fats made in the liver.

Icosapent ethyl comes as a liquid-filled gel capsule to take by mouth. It is usually taken with food two times a day. Take icosapent ethyl at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take icosapent ethyl exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, crush, or dissolve them.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking icosapent ethyl,

• tell your doctor and pharmacist if you are allergic to icosapent ethyl; fish, including shellfish (clams, scallops, shrimp, lobster, crayfish, crab, oyster, mussels, others); any other medications; or any of the ingredients in icosapent ethyl capsules. Ask your pharmacist or check the patient information for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); antiplatelet medications such as cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, in Aggrenox), prasugrel (Effient), and ticlopidine (Ticlid); aspirin or aspirin-containing products; beta-blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); diuretics ('water pills'); estrogen-containing contraceptives (birth control pills, patches, rings, and injections); or estrogen replacement therapy. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had diabetes, irregular heartbeat or heart rhythm problems, or heart, liver, thyroid, or pancreatic disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking icosapent ethyl, call your doctor.

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

Take the missed dose as soon as you remember it. However, if you miss 1 day of icosapent ethyl, continue your regular dosing schedule. Do not take a double dose to make up for a dose missed on the previous day.

• Icosapent ethyl may cause side effects. Tell your doctor if this symptom is severe or does not go away:

  • muscle or joint pain

  • constipation

  • swelling of legs, ankles, or feet

• Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

  • fast and irregular heartbeat, lightheadedness, dizziness, shortness of breath, chest discomfort, or feeling faint

  • pain, redness, or swelling in the joints, especially in the big toe

  • rash, hives, itching, or difficulty breathing or swallowing

  • unusual bruising or bleeding

• Icosapent ethyl may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to icosapent ethyl.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.