• Vascepa is a brand (trade) name for icosapent ethyl, a high purity eicosapentaenoic acid (EPA), which is an ethyl ester of omega-3 fatty acid and is obtained from the oil of fish. Vascepa is a prescription omega-3 fatty acid that is similar to fish oil but not exactly the same.
• Vascepa is thought to work by reducing the production of triglycerides by the liver and enhancing their clearance from lipid particles, via several different mechanisms. This decreases triglyceride levels in the body. Triglycerides are a type of fat in the blood (called a lipid). People with high triglyceride levels are more at risk of developing heart disease. The most common causes of high triglycerides are obesity, high carbohydrate or high-sugar diets, excessive alcohol intake, physical inactivity, and poorly controlled diabetes. Triglyceride levels are normally less than 150 milligrams per deciliter.
• Vascepa belongs to the class of medicines known as miscellaneous antihyperlipidemic agents. It may also be called an omega-3 fatty acid.

• May be used in addition to statin therapy to reduce the risk of a heart attack, stroke, coronary revascularization, and unstable angina that may require admission to hospital in adults with high triglyceride levels (≥ 150 mg/dL) and established cardiovascular disease.
• May also be given to people with diabetes mellitus and 2 or more additional risk factors for cardiovascular disease (eg, high blood pressure, smoking, inactivity, obesity, family or personal history).
• May be given in addition to diet to adults with extremely high triglyceride levels (≥ 500 mg/dL) in addition to dietary changes aimed at reducing cholesterol intake.
• Vascepa only contains eicosapentaenoic acid (EPA), whereas most other fish oils (including prescription fish oils) contain both EPA and docosahexaenoic acid (DHA). By only containing EPA, Vascepa reduces high triglycerides without raising levels of “bad” cholesterol or LDL-C.
• Vascepa is also a lot stronger than most over-the-counter (OTC) fish oils (up to four times the strength).
• Vascepa is the only prescription omega-3 approved for cardiovascular risk reduction alongside diet modification.
• In clinical trials, over 45% of trial participants were aged 65 years and over. No overall differences in safety or effectiveness were observed between these patients and younger groups.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Muscle and joint pain, swelling of the hands, legs, or feet, constipation, mouth or throat pain, or gout, are the most common side effects of Vascepa. Diarrhea, abdominal discomfort, and pain in the extremities have also been reported.
• Vascepa is also associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization (occurs in 3% of patients taking Vascepa compared with 2% of those taking placebo). The risk of atrial fibrillation is greater in those with a previous history of atrial fibrillation or atrial flutter.
• There is a possibility that people who are allergic to fish or shellfish may also be allergic to Vascepa.
• Vascepa can increase the risk of bleeding (thin the blood). One trial showed that 12% of people receiving Vascepa experienced a bleeding event and in 3% of people, this bleeding event was severe. The incidence of bleeding events in people receiving a placebo (an inactive pill) in the same trial was 10% with 2% of these being severe. The risk of bleeding is higher in people receiving Vascepa who also take other medications that increase the risk of bleeding, such as aspirin, clopidogrel, dabigatran, warfarin, or NSAIDs, such as ibuprofen or diclofenac. Some supplements, such as feverfew, ginkgo, garlic, ginseng, and Dong Quai can also increase a person’s bleeding risk.
• Before initiating Vascepa, assess the person's lipid levels and try to identify other causes of high triglycerides such as diabetes, hypothyroidism, or medications and manage as appropriate.
• Vascepa is much more expensive than OTC fish oils, costing around $300 per month without insurance.
• Because it is prescription-strength, it is only available on a prescription written by a doctor to people with abnormally high triglyceride levels. This is because it is more likely to cause heart rhythm disturbances, thin the blood, or increase the risk of bleeding than supplemental varieties. There is also more data to support the effectiveness and safety of prescription-strength fish oils compared with OTC varieties.
• There are no documented reports that Vascepa helps with weight loss. Anecdotally, some blogs report weight loss with Vascepa, but this tends to correlate with the person experiencing excessive diarrhea or gastrointestinal discomfort as a side effect, which can be intolerable in some people, forcing discontinuation of Vascepa. Weight loss can also occur due to diet modification (Vascepa should be taken alongside a low-fat, low-cholesterol diet) and increased physical activity.
• There is insufficient data to determine the risk of administering Vascepa to pregnant women, and there is no data about its effects on a newborn when breastfeeding. In animal studies, there were no clinically relevant adverse developmental effects noted when rabbits were given the equivalent of 5 times the recommended dose. Omega-3 fatty acids, including EPA, have been detected in human milk.
• In people with liver disease, monitor levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels regularly during Vascepa treatment.
• The safety of Vascepa in children has not been established.
• There is currently no generic version of Vascepa.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Tell your doctor before taking Vascepa if you have ever had an allergic reaction to fish or shellfish. There is a possibility you may be at risk of a similar reaction if you take Vascepa. If you do experience an allergic reaction after taking Vascepa, discontinue it immediately, and seek immediate medical attention.
• Vascepa is available in two strengths: 0.5 gram capsules and 1 gram capsules. The usual dosage 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.
• Swallow Vascepa capsules whole. Do not break open, crush, dissolve, or chew. Vascepa may be taken with or without food.
• If you miss a dose of Vascepa, take it as soon as you remember. However, if it is only a few hours until your next dose, do not double the dose, just go back to your regular dosing schedule.
• In addition to taking Vascepa, modify your diet to try to lose some weight if you are overweight or obese. Dropping just 5% to 10% of your body weight can help drive your triglycerides down to a normal range.
• Move every day. Physical activity and regular exercise lowers triglycerides
• Choose your carbohydrates wisely. Avoid white bread, white rice, chips, and sugar-laden foods and drinks. Replace these instead with vegetables and whole grains.
• Cut back on meat, milk, and other dairy products that contain saturated fats, which can elevate triglycerides. Unsaturated fats and oils from plants and fish bring down triglycerides.
• Reduce your alcohol intake. Alcohol increases triglycerides so avoid excessive drinking and have several alcohol-free days per week.
• Always talk to your doctor or pharmacist before taking any other medications or supplements with Vascepa, including those brought over the counter from a drugstore, health store, pharmacy, or supermarket. If you notice any unusual bruising or bleeding; lightheadedness; red or dark, tarry feces; or you cough or vomit up fresh blood or your sputum looks like it contains coffee grounds, seek immediate medical attention.

• It takes approximately one year for Vascepa to start reducing cardiovascular risk and up to almost five years for the full effects to be seen; however, levels of triglycerides are significantly lower after 12 weeks of treatment.
• In the REDUCE-IT trial, Vascepa significantly reduced the risk of cardiovascular events, such as cardiovascular death, heart attack, stroke, coronary revascularization, or hospitalization for unstable angina by about 25% after approximately 4.9 years. In those with atherosclerotic cardiovascular disease (ASCVD), the risk of events decreased by 35% after 4.9 years.
• Laboratory results showed that the average starting levels of triglycerides and LDL-C were similar between the Vascepa and placebo groups, but after one year of taking Vascepa, there was a significant difference between these values between the two groups. The median change in triglycerides from baseline in the Vascepa group after one year was -39 mg/dL (or a drop of 18%) and 5 mg/dL in the placebo group (an increase of 2%). The median change in LDL-C from baseline after one year was 2 mg/dL (an increase of 3%) in the Vascepa group and 7 mg/dL (an increase of 10%) in the placebo group.
• If Vascepa is taken alongside a Mediterranean-style, low-carbohydrate diet that reduces body weight by 5% to 10% and contains no trans fats in addition to a regular exercise regimen, then triglyceride levels are expected to reduce by up to 50%.
• In the REDUCE-IT trial, Vascepa significantly reduced the risk of cardiovascular events, such as cardiovascular death, heart attack, stroke, coronary revascularization, or hospitalization for unstable angina by about 25%. In those with atherosclerotic cardiovascular disease (ASCVD), the risk of events decreased by 35%.

Medicines that interact with Vascepa may either decrease its effect, affect how long it works for, increase side effects, or have less of an effect when taken with Vascepa. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Vascepa include:

• aspirin
• alteplase
• antithrombin
• apixaban
• cangrelor
• clopidogrel
• dabigatran
• dalteparin or enoxaparin
• dextran
• glycoprotein platelet inhibitors such as abciximab or tirofiban
• heparin
• mifepristone
• NSAIDs, such as ibuprofen, diclofenac, etodolac, and naproxen
• prasugrel
• streptokinase or urokinase
• ticlopidine
• tinzaparin
• warfarin.

In general, any medicine that can increase the risk of bleeding (such as clopidogrel, SSRI antidepressants [eg, citalopram, duloxetine, fluoxetine, venlafaxine], fish oils) may interact with Vascepa.

Note that this list is not all-inclusive and includes only common medications that may interact with Vascepa. You should refer to the prescribing information for Vascepa for a complete list of interactions.