Vascepa also raises your mood some, but with no side effects like anti-depressants. All rights reserved, This Patient Information has been approved by the U.S. Food and Drug Administration. Praluent, simvastatin, Xarelto, fenofibrate, rosuvastatin, Crestor, ramipril, Trulicity, Victoza, Brilinta. Vascepa is associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization. Patients with other risk factors for cardiovascular disease were defined as being at least 50 years of age with diabetes and at least one additional risk factor. The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. Selected additional baseline risk factors included hypertension (87%), type 2 diabetes mellitus (58%), eGFR < 60 mL/min per 1.73 m2 (22%), congestive heart failure (18%), and current daily cigarette smoking (15%). The mean age was 53 years and the mean body mass index was 31 kg/m2. Some may cause as much as an 11-pound weight gain in 10 weeks. Cytochrome P450-mediated metabolism is a minor pathway of elimination of EPA. Drug-related neoplasms were not observed in female mice. Vascepa may be used alone or with other medications. In a double-blind, randomized, placebo-controlled cardiovascular outcomes trial, 8,179 statin-stabilized patients were randomized to receive Vascepa or placebo and followed for a median of 4.9 years [see Clinical Studies (14.1)]. The effect of Vascepa on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Vascepa is a pregnancy Category C medication. Twenty-five percent of patients were on concomitant statin therapy, 28% were diabetics, and 39% of the patients had TG levels >750 mg/dL. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. In a double-blind, placebo-controlled trial of 8,179 statin-treated subjects with established cardiovascular disease (CVD) or diabetes plus an additional risk factor for CVD, adjudicated atrial fibrillation or atrial flutter requiring hospitalization for 24 or more hours occurred in 127 (3%) patients treated with Vascepa compared to 84 (2%) patients receiving placebo [HR= 1.5 (95% CI 1.14, 1.98)]. Generic Name: icosapent ethyl The study is created by eHealthMe based on reports of 2,092 people who have side effects when taking Vascepa from … have a low thyroid problem (hypothyroidism). Vascepa does not undergo renal excretion. When administered Vascepa in clinical trials, plasma total EPA concentrations did not differ significantly between men and women. Patients should engage in appropriate nutritional intake and physical activity before receiving Vascepa, which should continue during treatment with Vascepa. Do not break open, crush, dissolve, or chew Vascepa. Weight increased is found among people who take Repatha, especially for people who are female, 60+ old, have been taking the drug for 1 - 6 months. 1. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locater Tool Including 24 Hour, Pharmacies. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Overall incidence of hemangiomas and hemangiosarcomas in all vascular tissues did not increase with treatment. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure: Vascepa capsules also contain the following inactive ingredients: tocopherol, gelatin, glycerin, maltitol, sorbitol, and purified water. as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and. A chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells was positive for clastogenicity with and without metabolic activation. EPA inhibits platelet aggregation under some ex vivo conditions. 1 gram. I feel much better when I am taking the 4 G per day. Dublin, Ireland, Vascepa is a registered trademark of the Amarin group of companies, ©2019 Amarin Pharma, Inc. Bridgewater NJ 08807. The recommended dosage is 2 capsules (4 grams) twice daily with food. Consult your doctor before breastfeeding. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Keep Vascepa and all medicine out of the reach of children. Vascepa is associated with an increased risk of bleeding. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. The median baseline TG and LDL-C levels in these patients were 684 mg/dL and 86 mg/dL, respectively. No overall differences in safety or effectiveness were observed between these patients and younger groups. In the two years I have taken Vascepa I have gained about 40 pounds. Overall, 99.8% of patients were followed for vital status until the end of the trial or death. Dark urine general tiredness and weakness light-colored stools upper right abdominal or stomach pain yellow eyes and skin Slight increases in resorbed and dead fetuses were noted in the 1 g/kg/day group, but these were not significantly different from the control group. Some of the dosage forms listed on this page may not apply to the brand name Vascepa. However, if they miss one day of Vascepa, they should not double the dose when they take it. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel, or warfarin. Summary: Gout is found among people who take Vascepa, especially for people who are male, 60+ old, have been taking the drug for < 1 month. are allergic to fish or shellfish. Beta oxidation splits the long carbon chain of EPA into acetyl Coenzyme A, which is converted into energy via the Krebs cycle. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. Vascepa (icosapent ethyl) is a type of omega-3 fatty acid, a fat found in fish oil. It is used along with a low-fat and low-cholesterol diet, to lower high triglycerides (fats). In two randomized, double-blind, placebo-controlled trials in patients with triglyceride levels between 200 and 2000 mg/dL treated for 12 weeks, adverse reactions reported with Vascepa at an incidence ≥1% more frequent than placebo based on pooled data included arthralgia and oropharyngeal pain. This is not a complete list of side effects and others may occur. ©2019 Amarin Pharma, Inc. Bridgewater NJ, 08807 All rights reserved, Distributed by: Amarin Pharma Inc. Bridgewater, NJ, USA, Manufactured for: Amarin Pharmaceuticals Ireland Limited Dublin, Ireland +1-855-Vascepa (+1-855-827-2372) www.Vascepa.com. If you miss a dose of Vascepa, take it as soon as you remember. The median follow-up duration was 4.9 years. Read the entire detailed patient monograph for Vascepa (Icosapent Ethyl Capsules). Store Vascepa at room temperature between 68° to 77° F (20° to 25° C). The median change in LDL-C from baseline to Year 1 was 2 mg/dL (3%) in the Vascepa group and 7 mg/dL (10%) in the placebo group. Select one or more newsletters to continue. Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions to Vascepa and advise them to discontinue Vascepa and seek medical attention if any reactions occur [see Warnings and Precautions (5.2)]. There were no differences between the icosapent ethyl groups and control group as to the number of corpora lutea, number of implantations, number of surviving fetuses, sex ratio, body weight of female fetuses or placental weight. Anecdotally, some blogs report weight loss with Vascepa, but this tends to correlate with the person experiencing side effects such excessive diarrhea or gastrointestinal discomfort. drugs a-z list Click to see full answer. [see Indications and Usage (1)]. Additional adverse reactions have been identified during post-approval use of Vascepa. Do not break open, crush, dissolve, or chew Vascepa [see Dosage and Administration (2.2)]. Patients with established cardiovascular disease were defined as being at least 45 years of age and having a documented history of coronary artery disease, cerebrovascular or carotid disease, or peripheral artery disease. However, the direct clinical meaning of individual findings is not clear. Patients should engage in appropriate nutritional intake and physical activity before receiving VASCEPA, which should continue during treatment with VASCEPA. Increased EPA lipid composition from carotid plaque specimens and increased circulating EPA/arachidonic acid ratio have been observed following EPA treatment. Vascepa is thought to work by decreasing the amount of triglycerides made by the body. It is used along with a low-fat and low-cholesterol diet, to lower high triglycerides . Copyright © 2021 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Vascepa may cause serious side effects, including: Heart rhythm problems (atrial fibrillation and atrial flutter). The plasma elimination half-life (t1/2) of EPA is approximately 89 hours. In pregnant rabbits given oral gavage doses of 0.1, 0.3, and 1 g/kg/day icosapent ethyl from gestation through organogenesis, a decrease in body weight and food consumption was observed at the high dose of 1 g/kg/day (5 times the human exposure at the maximum dose of 4 g/day, based on body surface area comparisons). The median [Q1, Q3] fasting TG was 216.0 [176.0, 272.5] mg/dL; the mean (SD) was 233.2 (80.1) mg/dL. Greater than 99% of unesterified EPA is bound to plasma proteins. If you are prescribed the 0.5-gram capsules, you should not take more than 8 capsules each day with food. The reduction in TG observed with Vascepa was not associated with elevations in LDL-C levels relative to placebo. The majority of EPA circulating in plasma is incorporated in phospholipids, triglycerides and cholesteryl esters, and <1% is present as the unesterified fatty acid. In animal reproduction studies in pregnant rats, non-dose-related imbalances for some minor developmental findings were observed with oral administration of icosapent ethyl during organogenesis at exposures that were equivalent to the clinical exposure at the human dose of 4 g/day, based on body surface area comparisons. The following important adverse reactions are described below and elsewhere in the labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. How to Lower Your Cholesterol & Save Your Heart, fast or irregular heartbeats, dizziness, shortness of breath, chest discomfort, fainting, or if you feel light-headed; or. Dark urine fever Incidence not known. On stable background lipid-lowering therapy, the median [Q1, Q3] LDL-C at baseline was 75.0 [62.0, 89.0] mg/dL; the mean (SD) was 76.2 (20.3) mg/dL. weight gain Rare. In a drug-drug interaction study of 26 healthy adult subjects, Vascepa 4 g/day at steady-state did not significantly change the steady-state AUCτ or Cmax of atorvastatin, 2-hydroxyatorvastatin, or 4-hydroxyatorvastatin when co-administered with atorvastatin 80 mg/day at steady-state. Common adverse reactions (incidence ≥3% on VASCEPA and ≥1% more frequent than placebo) included musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. If you are prescribed the 1-gram capsules, you should not take more than 4 capsules each day with food. Inform patients that Vascepa may increase their risk for bleeding, especially if they are receiving other antithrombotic agents [see Warnings and Precautions (5.3)]. It is not known if people who are allergic to fish or shellfish are also allergic to Vascepa. It is not known if Vascepa will harm your unborn baby. ... Vascepa)? Do not break, crush, dissolve, or chew Vascepa capsules before swallowing. Monitor patients receiving Vascepa and concomitant anticoagulants and/or antiplatelet agents for bleeding. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Most patients were taking moderate-intensity (63%) or high-intensity (31%) statin therapy at baseline. Take Vascepa exactly as your doctor tells you to take it. Learn more about Zetia (Ezetimibe) at EverydayHealth.com. Applies to icosapent: oral capsule liquid filled. are breastfeeding or plan to breastfeed. Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components. For more information about Vascepa, go to www.Vascepa.com or call 1-855-Vascepa (1-855-827-2372). In an oral gavage rat fertility study, ethyl-EPA, administered at doses of 0.3, 1, and 3 g/kg/day to male rats for 9 weeks before mating and to female rats for 14 days before mating through day 7 of gestation, increased anogenital distance in female pups and increased cervical ribs were observed at 3 g/kg/day (7 times human systemic exposure with 4 g/day clinical dose based on a body surface area comparison). are pregnant, or planning to become pregnant. General information about the safe and effective use of Vascepa. Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. The following important adverse reactions are described below and elsewhere in the labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Some foods that have omega-3 fatty acids naturally are fatty fish like albacore tuna, halibut, herring, mackerel, lake trout, salmon, and sardines. However, if you miss one day of Vascepa, do not double your dose when you take it. chest pressure, racing or pounding heartbeats, fluttering in your chest, feeling short of breath. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. Weight loss can also occur due to diet modification (Vascepa should be taken alongside a low-fat, low-cholesterol diet) and increased … Lovaza vs. Vascepa - what's the difference between them? Some side effects of Vascepa can also be serious, such as vomiting of blood, vision changes, or a severe headache. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 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. Our Vascepa (icosapent ethyl) Side Effects Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. The phase IV clinical study is created by eHealthMe based on reports of 2,333 people who have side effects when taking Vascepa from … Weight gain and even obesity are among the possible physical side effects. There are no data on the effects of omega-3 fatty acid ethyl esters on the breastfed infant or on milk production. Blood in the urine 2. body aches or pain 3. chills 4. cough or cough producing mucus 5. difficulty with breathing 6. ear congestion 7. fever 8. headache 9. loss of voice 10. nasal congestion 11. runny nose 12. sneezing 13. sore throat 14. tightness in the chest 15. unusual tiredness or weakness two 1 gram capsules twice daily with food. Heart rhythm problems (atrial fibrillation). Read the entire FDA prescribing information for Vascepa (Icosapent Ethyl Capsules). Vascepa 4 grams per day reduced median TG, VLDL-C, and Apo B levels from baseline relative to placebo. The daily dose of Vascepa is 4 grams per day taken as either: four 0.5 gram capsules twice daily with food; or as. Vascepa was administered with or following a meal in all clinical studies; no food effect studies were performed. The effects of Vascepa 4 grams per day were assessed in a randomized, placebo-controlled, double-blind, parallel-group study of adult patients (76 on Vascepa, 75 on placebo) with severe hypertriglyceridemia. Vascepa contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish. Lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of omega-3 fatty acids in human milk. Patients whose baseline TG levels were between 500 and 2,000 mg/dL were enrolled in this study for 12 weeks. Vascepa is a prescription medicine used to treat the symptoms of severely high triglycerides (Severe Hypertriglyceridemia). In a study in pregnant rabbits orally administered icosapent ethyl during organogenesis, there were no clinically relevant adverse developmental effects at exposures that were 5 times the clinical exposure, based on body surface area comparisons (see Data). Available for Android and iOS devices. Your doctor may do blood tests to check your triglyceride and other lipid levels while you take Vascepa. In a drug-drug interaction study with 25 healthy adult subjects, Vascepa 4 g/day at steady-state did not significantly change the single dose AUC or Cmax of R- and S-warfarin or the anti-coagulation pharmacodynamics of warfarin when co-administered as racemic warfarin at 25 mg. as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. In pregnant rats given icosapent ethyl from gestation day 17 through lactation day 20 at 0.3, 1, 3 g/kg/day no adverse maternal or developmental effects were observed. Icosapent is only part of a complete treatment program that may also include diet, exercise, and weight control. Capsules Amarin Pharma, Inc. Learn about side effects, warnings, dosage, and more. (icosapent ethyl) Patients were randomly assigned 1:1 to receive either Vascepa (4 grams daily) or placebo. Figure 1. Drug class: miscellaneous antihyperlipidemic agents, Cardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE), Cardiovascular death, myocardial infarction, stroke (3-point MACE), Emergent or urgent coronary revascularization, amber-colored soft-gelatin capsules imprinted with V500, amber-colored soft-gelatin capsules imprinted with Vascepa. Published studies have detected omega-3 fatty acids, including EPA, in human milk. Vascepa (icosapent ethyl) is a type of omega-3 fatty acid, a fat found in fish oil. Constipation is found among people who take Vascepa, especially for people who are female, 60+ old, have been taking the drug for < 1 month. 0.5 gram amber-colored, oval, soft-gelatin capsules imprinted with V500, 1 gram amber-colored, oblong, soft-gelatin capsules imprinted with Vascepa, Potential for Allergic Reactions in Patients with Fish Allergy. Inform patients that Vascepa may increase their risk for atrial fibrillation or atrial flutter [see Warnings and Precautions (5.1)]. If a dose is missed, patients should take it as soon as they remember. Median baseline HDL-C level was 27 mg/dL. 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 papillomas were considered to develop secondary to chronic irritation of the proximal tail associated with fecal excretion of oil and therefore not clinically relevant. Call your doctor for medical advice about side effects. Common adverse reactions (incidence ≥3% on Vascepa and ≥1% more frequent than placebo) included musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. Vascepa® Summary: Weight decreased is found among people who take Vascepa, especially for people who are female, 60+ old, have been taking the drug for < 1 month. The results of the primary, key secondary, and other secondary efficacy endpoints in the prespecified testing hierarchy to control for type 1 error are shown in Table 1. It is not known whether patients with allergies to fish and/or shellfish are at increased risk of an allergic reaction to Vascepa. Find patient medical information for Vascepa oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Depression. REDUCE-IT (NCT01492361) was a multinational, double-blind, randomized, placebo-controlled, event-driven trial in 8,179 (4,089 Vascepa, 4,090 placebo) statin-treated adult patients enrolled with LDL-C >40 mg/dL and ≤100 mg/dL and elevated TG levels (90% of enrolled patients had TG ≥ 150 mg/dL and <500 mg/dL) and either established cardiovascular disease (71%) or diabetes and other risk factors for cardiovascular disease (29%). Vascepa® (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet and exercise regimen before receiving Vascepa and should continue this diet and exercise regimen with Vascepa.Attempts should be made to control any medical problems such … Icosapent ethyl was not mutagenic with or without metabolic activation in the bacterial mutagenesis (Ames) assay or in the in vivo mouse micronucleus assay. Clinical trials on Vascepa have shown that joint pain was the most commonly reported problem in people who took this drug, occurring in 2.3 percent of people. Amarin Pharmaceuticals Ireland Limited Pups from high dose treated dams exhibited decreased copulation rates, delayed estrus, decreased implantations and decreased surviving fetuses (F2) suggesting potential multigenerational effects of icosapent ethyl at 7 times human systemic exposure following 4 g/day dose based on body surface area comparisons across species. Instruct patients to take Vascepa as prescribed. The Kaplan-Meier estimates of the cumulative incidence of the primary composite endpoints over time are shown in Figure 1. After oral administration, Vascepa is de-esterified during the absorption process and the active metabolite EPA is absorbed in the small intestine and enters the systemic circulation mainly via the thoracic duct lymphatic system. Side effects requiring immediate medical attention. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. In a drug-drug interaction study with 28 healthy adult subjects, Vascepa 4 g/day at steady-state did not significantly change the single dose AUC or Cmax of rosiglitazone at 8 mg. Taking this medicine does not replace a healthy lifestyle. The changes in the major lipoprotein lipid parameters for the groups receiving Vascepa or placebo are shown in Table 2. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Vascepa and any potential adverse effects on the breastfed child from Vascepa or from the underlying maternal condition. Follow your diet, medication, and exercise routines very closely. The total plasma clearance of EPA at steady state is 684 mL/hr. Medically reviewed by Drugs.com. The pharmacokinetics of Vascepa have not been studied in pediatric patients. In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with Vascepa. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown. In a 6-month carcinogenicity study in Tg.rasH2 transgenic mice with oral gavage doses of 0.5, 1, 2, and 4.6 g/kg/day icosapent ethyl, drug-related incidences of benign squamous cell papilloma in the skin and subcutis of the tail was observed in high dose male mice. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 2) Weight loss benefits In addition to helping to control blood sugar, Jardiance has been found to help with weight loss. Keep out of reach of children. Any weight loss is more likely to be due to diet modification and increased physical activity which are both recommended when taking Vascepa. Vascepa (icosapent ethyl) is a type of omega-3 fatty acid, a fat found in fish oil. Data sources include IBM Watson Micromedex (updated 2 Feb 2021), Cerner Multum™ (updated 3 Feb 2021), ASHP (updated 29 Jan 2021) and others. The median TG and LDL-C baseline values were similar between the Vascepa group and placebo group. Additionally, Vascepa increases the removal of triglycerides from VLDL particles that are circulating in your blood. is thought to work by decreasing the amount of triglycerides made by the body.. does vascepa really work? home However, complete litter loss (not dose-related) was noted in 2/23 litters at the low dose and 1/23 mid-dose dams by post-natal day 4 at human exposures at a maximum dose of 4 g/day, based on body surface area comparisons. Along with its needed effects, icosapent (the active ingredient contained in Vascepa) may cause some unwanted effects. You may report side effects to FDA at 1-800-FDA-1088. Inform patients with known hypersensitivity to fish and/or shellfish about the potential for allergic reactions to Vascepa and advise them to discontinue Vascepa and seek medical attention if any reactions occur. “Thanks to … In a 12-week, dose-ranging study in patients with severe hypertriglyceridemia and in the event-driven REDUCE-IT® trial, Vascepa 4 grams per day reduced median TG from baseline relative to placebo [see Clinical Studies (14)]. Safely throw away medicine that is out of date or no longer needed. Vascepa significantly reduced the risk for the primary composite endpoint (time to first occurrence of cardiovascular death, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina; p<0.0001) and the key secondary composite endpoint (time to first occurrence of cardiovascular death, myocardial infarction, or stroke; p<0.0001). Beside this, does vascepa help with weight loss? Vascepa can pass into your breast milk, and may harm your baby. Black, tarry stools bleeding gums bloating bloody urine chills clay-colored stools constipation cough general feeling of tiredness or weakness headache hives, itching, skin rash hoarseness indigestion irritation joint swelling Tell your doctor all medications and supplements you take. Vascepa may interact with other drugs affecting coagulation (e.g., anti-platelet agents). VASCEPA may cause serious side effects, including: Heart rhythm problems (atrial fibrillation and atrial flutter). In a drug-drug interaction study with 28 healthy adult subjects, Vascepa 4 g/day at steady-state did not significantly change the steady-state AUCτ or Cmax of omeprazole when co-administered at 40 mg/day to steady-state. [2] Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization. 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. Advise patients to swallow Vascepa capsules whole. Vascepa is thought to work by decreasing the amount of triglycerides made by the body. Vascepa has not been studied in patients with renal or hepatic impairment. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. Vascepa(Icosapent Ethyl Capsules) side effects drug center, Medical Editor: John P. Cunha, DO, FACOEP. The median age at baseline was 64 years and 29% were women. The mean volume of distribution at steady state of EPA is approximately 88 liters. Of the total number of patients in well-controlled clinical studies of Vascepa, 45% were 65 years of age and over. Additional adverse reactions have been identified during post-approval use of VASCEPA. Selected from data included with permission and copyrighted by First Databank, Inc. Non-dose-related imbalances in findings of absent optic nerves and unilateral testes atrophy at human exposures based on the maximum dose of 4 g/day and on body surface area comparisons. The trial population was 90% White, 5% Asian, 2% Black; 4% identified as Hispanic ethnicity. Stay on this diet while taking Vascepa. EPA is mainly metabolized by the liver via beta-oxidation similar to dietary fatty acids. Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). Find everything you need to know about Vascepa (Icosapent), including what it is used for, warnings, reviews, side effects, and interactions. Mood stabilizers cause your appetite to turn on and stay on. In a double-blind, randomized, placebo-controlled cardiovascular outcomes trial, 8,179 statin-stabilized patients were randomized to receive VASCEPA or placebo and followed for a median of 4.9 years [see Clinical Studies]. Before taking Vascepa, tell your doctor about all of your medical conditions, including if you: What are the possible side effects of Vascepa? Vascepa is a registered trademark of the Amarin group of companies. Bridgewater, NJ, USA, Manufactured for: What Is Crestor? unexplained weight loss unusual tiredness or weakness vomiting Rare. Do not take more capsules than what is prescribed by your doctor. Even seemingly harmless natural foods can cause an untoward reaction; so it’s best to check with your doctor if are veering off your regular diet.
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