Vascepa is a brand-name prescription drug used as an adjunct to statin treatment to reduce the risk of heart attack, stroke, and other cardiovascular events in people being treated for high triglycerides (fats) and high cholesterol. Vascepa is also prescribed along with diet and exercise to reduce very high triglyceride levels.
The active ingredient in Vascepa is icosapent ethyl, a chemically altered version of the omega-3 fatty acid EPA (eicosapentaenoic acid), a common fat found in cold-water fish and over-the-counter dietary supplements. The body changes icosapent ethyl into EPA when it’s absorbed. EPA decreases the amount of triglycerides and fats made in the liver. As a result, triglyceride levels go down. The daily dose of Vascepa is four grams per day (in divided doses) taken with food by mouth as capsules.
RELATED: Learn more about Vascepa | Get Vascepa discounts
Vascepa is available as capsules in two dosage strengths. However, no matter which dose strength is taken, the daily dose is always four grams per day, in divided doses—unless otherwise directed by your doctor.
Capsules: 0.5 grams, 1 gram
Vascepa is a prescription drug that is very similar to the omega-3 fatty acid, EPA. Vascepa is changed into EPA when absorbed by the body. EPA reduces triglycerides in the bloodstream.
The U.S. Food and Drug Administration (FDA) has approved Vascepa to treat two medical conditions. Vascepa is prescribed to adults with elevated triglycerides who are also taking statins and either have a history of heart disease or have Type 2 diabetes and other risk factors for cardiovascular disease. In these people, Vascepa is used to lower the risk of heart attack, stroke, and other serious cardiovascular problems. Vascepa is also prescribed—in combination with diet—to reduce triglyceride levels in people diagnosed with severe hypertriglyceridemia, or very high triglyceride levels. For either condition, the standard Vascepa dose is four grams per day.
Vascepa dosage chart | |||
---|---|---|---|
Indication | Starting dosage | Standard dosage | Maximum dosage |
Adjunct treatment to reduce cardiovascular disease risk in people with elevated triglycerides | 4 grams per day (4 0.5-gram capsules taken twice per day or 2, 1-gram capsules taken twice per day) | 4 grams per day (4 0.5-gram capsules taken twice per day or 2, 1-gram capsules taken twice per day) | 4 grams per day |
Severe hypertriglyceridemia | 4 grams per day (4 0.5-gram capsules taken twice per day or 2, 1-gram capsules taken twice per day) | 4 grams per day (4 0.5-gram capsules taken twice per day or 2, 1-gram capsules taken twice per day) | 4 grams per day |
Source: Vascepa, PDR
Vascepa is FDA approved as an add-on to a statin to reduce the risk of stroke, heart attack, coronary revascularization, or chest pain (unstable angina) requiring hospitalization in people who have cardiovascular disease or Type 2 diabetes mellitus with risk factors for cardiovascular disease.
High triglycerides and high cholesterol are significant risk factors for cardiovascular disease. Triglycerides are fats (lipids); they are carried around in the blood by substances called low-density lipoproteins, that is, LDL cholesterol. High levels of LDL and VLDL increase the risk for atherosclerosis (fat deposits in the arteries) which can lead to cardiovascular disease. Statins are the principal drugs used to reduce LDL cholesterol, but even when they succeed, there still remains a risk for cardiovascular disease. Vascepa is used with a statin to reduce that residual risk. EPA’s mechanism of action in reducing cardiovascular risk is not well understood.
Taken as prescribed, Vascepa provides high doses of an omega-3 fatty acid called EPA, commonly found in cold-water fish and fish oil supplements. High doses (2–4 g) of omega-3 fatty acids (EPA and/or DHA) are effective at reducing cardiovascular risk in people with elevated triglycerides. However, healthcare professionals have compelling reasons to distrust the quality and safety of over-the-counter omega-3 dietary supplements, so they often turn to more rigorously regulated prescription omega-3 fatty acids as safer and more effective alternatives.
Standard adult dosage for adjunct treatment to reduce cardiovascular risk: 2 g taken twice per day (total of 4 g per day)
Maximum adult dosage for adjunct treatment to reduce cardiovascular risk: 4 g per day
Vascepa is also prescribed as an adjunct to a low-cholesterol, low-fat diet to people who have very high triglyceride levels, or severe hypertriglyceridemia, defined as more than 500 mg/dL . Very high triglyceride levels carry a significant risk of pancreatitis (swelling of the pancreas). Chemically-altered omega-3 fatty acids (called DHA ethyl esters and EPA ethyl esters) have been proven effective at reducing both triglyceride and LDL levels. Vascepa, an EPA ester, reduces triglycerides by about 1/3. EPA works by reducing the liver’s production of triglycerides, increasing the clearance of triglycerides from the blood, and increasing the activity of an enzyme (plasma lipoprotein lipase activity) that breaks down triglycerides and VLDL cholesterol.
Standard adult dosage for hypertriglyceridemia: 2 g taken twice per day (total of 4 g per day)
Maximum adult dosage for hypertriglyceridemia: 4 g per day
Vascepa is not approved for use in children.
As a fish oil, Vascepa has no dosage restrictions. People with renal impairment (kidney disease) or hepatic impairment (liver dysfunction) should consult their healthcare provider about dosage, as Vascepa has not been studied in people with kidney or liver problems. However, Vascepa will not be given to anyone who has had a hypersensitivity reaction to Vascepa, though it is uncertain if it is safe for people with fish or shellfish allergies.
Vascepa does interfere with the body’s ability to form blood clots, so bleeding is a common side effect (12% incidence in clinical trials compared to 10% incidence taking a placebo). Healthcare providers will be cautious or reluctant to prescribe Vascepa to people with bleeding problems, at risk for bleeding, or taking a blood thinner such as warfarin or clopidogrel.
People taking Vascepa should also tell the prescribing healthcare provider if they have an underactive thyroid (hypothyroidism) or pancreas problems.
To get the maximum benefit from Vascepa in reducing triglycerides and cholesterol, take the recommended dose twice per day. Always take Vascepa with a meal.
Take Vascepa as directed by a healthcare provider. Do not take more capsules than prescribed.
Vascepa comes with a patient information guide with important details about taking Vascepa safely and possible side effects to watch out for. If the drug information package insert is not included with the medicine, ask the pharmacist for a copy.
Take Vascepa twice per day with food as directed.
Swallow the Vascepa capsule whole with a glass of water. Do not crush, break, chew, or dissolve it.
Rigorously follow the diet prescribed or advised by a healthcare provider when taking Vascepa.
Store Vascepa in a closed container at room temperature (68°F to 77°F) out of the reach of children.
Regular blood tests may be required to measure cholesterol levels (HDL, LDL, and VLDL), triglycerides, and liver enzymes (ALT and AST).
Vascepa is a long-term treatment. Taking daily doses of Vascepa produces a significant reduction (almost 30%) in triglycerides and a slight reduction in LDL (about 5%) in the first 12 weeks of daily dosing. In reducing cardiovascular disease risk, it takes at least one year for Vascepa to show a difference between people taking Vascepa and people not taking Vascepa. It will take almost five years of treatment to show a significant difference between these two groups.
Vascepa is an omega-3 fatty acid with a half-life of 89 hours. So, if a person takes four grams of Vascepa, two grams of the EPA in the dose will be eliminated in 89 hours (about four days). It will take almost three weeks for the body to clear a dose of Vascepa. Fortunately, the possible side effects of Vascepa tend to be minimal and infrequently experienced.
Take a missed dose as soon as it’s remembered. However, if an entire day of Vascepa is missed, do not take extra doses the next day. Just take the next doses as scheduled.
Vascepa is intended for long-term and even lifelong treatment. Clinical studies have shown that Vascepa does not make a difference in cardiovascular outcomes until two years of treatment and does not produce a substantial difference until five or six years of treatment.
Vascepa is a fatty acid found in fish oil. It can be discontinued at any time without causing problems.
Even though EPA, the active ingredient in Vascepa, is commonly found in fish and dietary supplements, some people may need to stop taking Vascepa. A healthcare provider will immediately tell anyone who has an allergic reaction to Vascepa to stop taking the medicine. Other people may experience serious side effects such as atrial fibrillation, atrial flutter, or bleeding episodes. Finally, some people may want to stop taking Vascepa because of less serious adverse reactions such as constipation, muscle pain, or joint pain (arthralgia).
There are alternative triglyceride treatments for people not taking Vascepa. Of course, there are over-the-counter supplements with DHA and EPA, but these may not be safe or effective. The supplement industry is unregulated, so consumers don’t completely know what they’re purchasing in terms of quality of safety. Another omega-3 fatty acid prescription brand name available is called Lovaza, which contains DHA and EPA ethyl esters. Statins such as Lipitor (atorvastatin), fibrates such as gemfibrozil, and niacin are also effective treatments for reducing triglycerides.
People taking Vascepa should not take more than four grams per day.
Vascepa is a fish oil. However, it is prescribed to people with serious health issues, so if too much Vascepa is taken, always call a poison helpline or get medical attention. Vascepa does increase the risk for serious medical conditions such as severe bleeding or atrial fibrillation.
With Vascepa, there is an increased risk of bleeding. Vascepa blocks platelets from clumping together to form blood clots. The most serious Vascepa drug interactions, then, involve drugs that also interfere with blood clotting. These include drugs that, like Vascepa, have antiplatelet activities or drugs that block some steps in the blood clotting process. At the top of the list are anticoagulants (blood thinners), drugs containing aspirin, and nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen.
Vascepa does not interact with alcohol. However, many people taking Vascepa will also be under strict diets that limit fats, cholesterol, calories, carbohydrates, sugar, and possibly alcohol. Make sure to follow the healthcare provider’s advice about drinking alcohol.
The safety of taking Vascepa while pregnant or breastfeeding has not been determined. Women who are pregnant, planning to be pregnant, or breastfeeding should get medical advice from the prescribing healthcare provider about the risks and benefits of taking Vascepa while pregnant or breastfeeding.
Hypertriglyceridemia, StatPearls
Icosapent ethyl drug summary, Prescriber’s Digital Reference
Triglyceride lowering drugs, Endotext
Vascepa, Epocrates
Vascepa prescribing information, U.S. National Library of Medicine
Vascepa (icosapent ethyl), Amarin
After receiving her doctorate from the University of Pittsburgh School of Pharmacy, Karen Berger, Pharm.D., has worked in both chain and independent community pharmacies. She currently works at an independent pharmacy in New Jersey. Dr. Berger enjoys helping patients understand medical conditions and medications—both in person as a pharmacist, and online as a medical writer and reviewer.
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