Icosapent Ethyl

What is Icosapent Ethyl?

• Icosapent Ethyl (Vascepa) is an ethyl ester of eicosapentaenoic acid (EPA) used to treat dyslipidemia and hypertriglyceridemia.
• It is made from the omega-3 fatty acid eicosapentaenoic acid (EPA).

What are the uses of this medicine?

Vascepa is a prescription medicine used:

• along with certain medicines (statins) to reduce the risk of heart attack, stroke, and certain types of heart issues requiring hospitalization in adults with heart (cardiovascular) disease, or diabetes and 2 or more additional risk factors for heart disease.
• along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults.

Limitations of Use:

• It is not known if Vascepa changes your risk of having inflammation of your pancreas (pancreatitis).
• It is not known if Vascepa is safe and effective in children.

How does this medicine work?

• Studies suggest that EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles.
• Potential mechanisms of action include increased β-oxidation; inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity.
• The mechanisms of action contributing to reduction of cardiovascular events with Vascepa (icosapent ethyl) are not completely understood but are likely multi-factorial.
• Increased EPA lipid composition from carotid plaque specimens and increased circulating EPA/arachidonic acid ratio have been observed following EPA treatment.
• EPA inhibits platelet aggregation under some ex vivo conditions.
• However, the direct clinical meaning of individual findings is not clear.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components

What drug interactions can this medicine cause?

• Monitor patients receiving Vascepa and concomitant anticoagulants and/or antiplatelet agents for bleeding.

Is this medicine FDA approved?

• On 13 December 2019, the FDA also approved Vascepa as the first drug specifically "to reduce cardiovascular risk among people with elevated triglyceride levels".

How should this medicine be used?

• Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate.
• Patients should engage in appropriate nutritional intake and physical activity before receiving Vascepa, which should continue during treatment with Vascepa.

Recommended dosage:

• The daily dose of Vascepa is 4 grams per day taken as either:
• four 0.5 gram capsules twice daily with food; or as
• two 1 gram capsules twice daily with food.

Administration:

• Take Vascepa exactly as your doctor tells you to take it.
• Do not change your dose or stop taking Vascepa without talking to your doctor.
• Do not take more capsules than what is prescribed by your doctor.
• If you are prescribed the 0.5-gram capsules, you should not take more than 8 capsules each day with food.
• If you are prescribed the 1-gram capsules, you should not take more than 4 capsules each day with food.
• Take Vascepa capsules whole. Do not break, crush, dissolve, or chew Vascepa capsules before swallowing.
• If you miss a dose of Vascepa, take it as soon as you remember. However, if you miss one day of Vascepa, do not double your dose when you take it.
• Your doctor may start you on a diet that is low in saturated fat, cholesterol, carbohydrates, and low in added sugars before giving you Vascepa. Stay on this diet while taking Vascepa.
• Your doctor may do blood tests to check your triglyceride and other lipid levels while you take Vascepa.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 0.5 gram and 1 gram

This medicine is available in fallowing brand namesː

• Vascepa

What side effects can this medication cause?

The most common side effects of this medicine include:

• Muscle and joint pain.
• Swelling of the hands, legs, or feet.
• Constipation
• Gout
• Heart rhythm problems (atrial fibrillation)

Vascepa may cause serious side effects, including:

• Heart rhythm problems (atrial fibrillation and atrial flutter)
• Possible allergic reactions if you are allergic to fish or shellfish
• Bleeding

What special precautions should I follow?

• Vascepa was associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
• Vascepa contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish. It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to Vascepa. Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions and advise them to discontinue Vascepa and seek medical attention if any reactions occur.
• Vascepa was associated with an increased risk of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• The available data from published case reports and the pharmacovigilance database on the use of Vascepa in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: icosapent ethyl
• Inactive ingredients: tocopherol, gelatin, glycerin, maltitol, sorbitol, and purified water

Vascepa is a registered trademark of the Amarin group of companies.

Who manufactures and distributes this medicine?

• Distributed by: Amarin Pharma Inc. Bridgewater, NJ, USA
• Manufactured for: Amarin Pharmaceuticals Ireland Limited Dublin, Ireland

What should I know about storage and disposal of this medication?

• Store Vascepa at room temperature between 68° to 77° F (20° to 25° C).
• Safely throw away medicine that is out of date or no longer needed.
• Keep Vascepa and all medicine out of the reach of children.

• Dailymed label info on Icosapent Ethyl
• FDA Icosapent Ethyl

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