Icosapent Ethyl
(Redirected from Vascepa)
What is Icosapent Ethyl?[edit | edit source]
- 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?[edit | edit source]
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?[edit | edit source]
- 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 ?[edit | edit source]
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?[edit | edit source]
- Monitor patients receiving Vascepa and concomitant anticoagulants and/or antiplatelet agents for bleeding.
Is this medicine FDA approved?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
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?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
- Safety and effectiveness in pediatric patients have not been established.
What are the active and inactive ingredients in this medicine?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
- 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.
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