Talk to your healthcare provider about the risks and benefits of using this product during pregnancy (see Vascepa and Pregnancy for more information). Advise patients to swallow Vascepa capsules whole. The median baseline TG and LDL-C levels in these patients were 684 mg/dL and 86 mg/dL, respectively. The trial population was 90% White, 5% Asian, 2% Black; 4% identified as Hispanic ethnicity. Vascepa (icosapent ethyl) is a type of omega-3 fatty acid, a fat found in fish oil. EPA is mainly metabolized by the liver via beta-oxidation similar to dietary fatty acids. as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. 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. People taking them for a long time may gain more. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. The recommended dosage is 2 capsules (4 grams) twice daily with food. 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. 1. Dosage Form: capsule. Vascepa (icosapent ethyl) is a type of omega-3 fatty acid, a fat found in fish oil. Vascepa® Follow your diet, medication, and exercise routines very closely. 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 phase IV clinical study is created by eHealthMe based on reports of 2,333 people who have side effects when taking Vascepa from … Published studies have detected omega-3 fatty acids, including EPA, in human milk. Your doctor may do blood tests to check your triglyceride and other lipid levels while you take Vascepa. 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. See additional information. 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). Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high triglyceride levels and manage as appropriate. The median TG and LDL-C baseline values were similar between the Vascepa group and placebo group. Read the entire FDA prescribing information for Vascepa (Icosapent Ethyl Capsules). Atrial Fibrillation or Atrial Flutter [see, Potential for Allergic Reactions in Patients with Fish Allergy [see. Chills fever hoarseness sore throat swelling of the mouth, hands, or feet trouble with swallowing or breathing (sudden) Incidence not known. 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. 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. [2] Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization. Do not break open, crush, dissolve, or chew Vascepa [see Dosage and Administration (2.2)]. Medically reviewed by Drugs.com. Overall, 99.8% of patients were followed for vital status until the end of the trial or death. are allergic to fish or shellfish. 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. The median age at baseline was 64 years, 29% were women, 90% White, 5% Asian, 2% were Black, and 4% identified as Hispanic ethnicity. 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. 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. Data sources include IBM Watson Micromedex (updated 2 Feb 2021), Cerner Multum™ (updated 3 Feb 2021), ASHP (updated 29 Jan 2021) and others. Instruct patients to take Vascepa as prescribed. Call your doctor for medical advice about side effects. 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. Select one or more newsletters to continue. drugs a-z list No overall differences in safety or effectiveness were observed between these patients and younger groups. Assess lipid levels before initiating therapy. Dark urine fever Incidence not known. 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. Additional variations consisting of early incisor eruption and increased percent cervical ribs were observed at the same exposures. 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%). (icosapent ethyl) The median age at baseline was 64 years, 29% were women, 90% White, 5% Asian, 2% were Black, and 4% identified as Hispanic ethnicity. Vascepa does not undergo renal excretion. Constipation is found among people who take Vascepa, especially for people who are female, 60+ old, have been taking the drug for < 1 month. Vascepa is associated with an increased risk of atrial fibrillation or atrial flutter requiring hospitalization. See additional information. Read the entire detailed patient monograph for Vascepa (Icosapent Ethyl Capsules). Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Take Vascepa capsules whole. Patients were randomly assigned 1:1 to receive either Vascepa (4 grams daily) or placebo. The Kaplan-Meier estimates of the cumulative incidence of the primary composite endpoints over time are shown in Figure 1. two 1 gram capsules twice daily with food. For the Consumer. Find everything you need to know about Zetia (Ezetimibe), including what it is used for, warnings, reviews, side effects, and interactions. ... Vascepa)? Vascepa, a lipid-regulating agent, is supplied as either a 0.5 gram or a 1 gram amber-colored, liquid-filled soft gelatin capsule for oral use. Vascepa is a prescription medicine used to treat the symptoms of severely high triglycerides (Severe Hypertriglyceridemia). In a double-blind, placebo-controlled cardiovascular outcomes trial of 8,179 patients, 482 (12%) patients receiving Vascepa experienced a bleeding event compared to 404 (10%) patients receiving placebo. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. It is used along with a low-fat and low-cholesterol diet, to lower high triglycerides (fats). Capsules For more information about Vascepa, go to www.Vascepa.com or call 1-855-Vascepa (1-855-827-2372). 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. Rosuvastatin (Crestor) is used to treat several types of high cholesterol, and to prevent heart disease. 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. Common adverse reactions (incidence ≥3% on VASCEPA and ≥1% more frequent than placebo) included musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. The phase IV clinical study is created by eHealthMe based on reports of 2,333 people who have side effects when taking Vascepa from … Advise patients to swallow Vascepa capsules whole. Do not change your dose or stop taking Vascepa without talking to your doctor. 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)]. Take Vascepa exactly as your doctor tells you to take it. If a dose is missed, patients should take it as soon as they remember. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. Additional adverse reactions have been identified during post-approval use of VASCEPA. The changes in the major lipoprotein lipid parameters for the groups receiving Vascepa or placebo are shown in Table 2. The mean volume of distribution at steady state of EPA is approximately 88 liters. Vascepa belongs to a class of drugs called Lipid-Lowering Agents, Other. Keep out of reach of children. Figure 1. The median age at baseline was 64 years and 29% were women. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. Some may cause as much as an 11-pound weight gain in 10 weeks. Increased EPA lipid composition from carotid plaque specimens and increased circulating EPA/arachidonic acid ratio have been observed following EPA treatment. Store Vascepa at room temperature between 68° to 77° F (20° to 25° C). Selected from data included with permission and copyrighted by First Databank, Inc. are pregnant, or planning to become pregnant. Vascepa is a pregnancy Category C medication. 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. We comply with the HONcode standard for trustworthy health information -. 1 gram. In a multigenerational developmental study in pregnant rats given doses of 0.3, 1, 3 g/kg/day icosapent ethyl by oral gavage from gestation day 7-17, icosapent ethyl did not affect viability in fetuses (F1 or F2). Some contraceptives have been shown to cause weight gain, and Dr. Agarwal says the birth control shot (Depo-Provera) is chief among them. Most patients at baseline were taking at least one other cardiovascular medication, including anti-platelet agents (79%) or anti-hypertensives (95%), including beta blockers (71%), angiotensin converting enzyme (ACE) inhibitors (52%), or angiotensin receptor blockers (ARB; 27%). Taking this medicine does not replace a healthy lifestyle. 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). The phase IV clinical study is created by eHealthMe based on reports of 90,509 people who have side effects when taking Repatha from the FDA, and is updated regularly. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. Do not take more capsules than what is prescribed by your doctor. It is used along with a low-fat and low-cholesterol diet, to lower high triglycerides (fats).Vascepa. 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. The pharmacokinetics of Vascepa have not been studied in pediatric patients. Consult your doctor before breastfeeding. 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. The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. Kaplan-Meier Estimated Cumulative Incidence of Primary Composite Endpoint in REDUCE-IT. chest pressure, racing or pounding heartbeats, fluttering in your chest, feeling short of breath. Store at 20° to 25° C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86°F) [see USP Controlled Room Temperature]. If you are prescribed the 0.5-gram capsules, you should not take more than 8 capsules each day with food. Vascepa can pass into your breast milk, and may harm your baby. Click to see full answer. Vascepa (icosapent ethyl) capsules are supplied as. In pregnant rats given oral gavage doses of 0.3, 1 and 2 g/kg/day icosapent ethyl from gestation through organogenesis all drug treated groups had non-dose-related imbalances in visceral and skeletal findings, including 13th reduced ribs, additional liver lobes, testes medially displaced and/or not descended, at human systemic exposures following a maximum oral dose of 4 g/day based on body surface comparisons. 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. 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 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. And it seems to curb your appetite a bit. 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. Icosapent is only part of a complete treatment program that may also include diet, exercise, and weight control. Greater than 99% of unesterified EPA is bound to plasma proteins. [1] Includes adjudicated cardiovascular deaths and deaths of undetermined causality. In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with Vascepa. If you are pregnant, only take Vascepa if the potential benefit outweighs the potential risk to the fetus. Weight loss can also occur due to diet modification (Vascepa should be taken alongside a low-fat, low-cholesterol diet) and increased … along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults. Vascepa is associated with an increased risk of bleeding. The plasma elimination half-life (t1/2) of EPA is approximately 89 hours. Do not break, crush, dissolve, or chew Vascepa capsules before swallowing. Vascepa was administered with or following a meal in all clinical studies; no food effect studies were performed. Vascepa is a registered trademark of the Amarin group of companies. The mean age was 53 years and the mean body mass index was 31 kg/m2. Last updated on July 1, 2020. 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. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locater Tool Including 24 Hour, Pharmacies. Vascepa may be used alone or with other medications. 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. 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. Twenty-five percent of patients were on concomitant statin therapy, 28% were diabetics, and 39% of the patients had TG levels >750 mg/dL. 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. 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%). are breastfeeding or plan to breastfeed. Vascepa passes into breast milk. Continue reading Stay on this diet while taking Vascepa. 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. Some foods that have omega-3 fatty acids naturally are fatty fish like albacore tuna, halibut, herring, mackerel, lake trout, salmon, and sardines. Advise the patient to read the FDA-approved patient labeling before starting Vascepa (Patient Information). Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in those studies has not exceeded normal limits and did not produce clinically significant bleeding episodes. Vascepa is thought to work by decreasing the amount of triglycerides made by the body. Of the total number of patients in well-controlled clinical studies of Vascepa, 45% were 65 years of age and over. 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. General information about the safe and effective use of Vascepa. Vascepa contains ethyl esters of the omega-3 fatty acid, eicosapentaenoic acid (EPA), obtained from the oil of fish. Cytochrome P450-mediated metabolism is a minor pathway of elimination of EPA. 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. Patients whose baseline TG levels were between 500 and 2,000 mg/dL were enrolled in this study for 12 weeks. Do not break open, crush, dissolve, or chew Vascepa. There are no data on the effects of omega-3 fatty acid ethyl esters on the breastfed infant or on milk production. Monitor patients receiving Vascepa and concomitant anticoagulants and/or antiplatelet agents for bleeding. Weight gain and even obesity are among the possible physical side effects. Depression. % Change= Median Percent Change from Baseline, Difference= Median of [Vascepa % Change – Placebo % Change] (Hodges-Lehmann Estimate), *p-value < 0.001 (primary efficacy endpoint), **p-value < 0.05 (key secondary efficacy endpoints determined to be statistically significant according to the pre-specified multiple comparison procedure). Most patients were taking moderate-intensity (63%) or high-intensity (31%) statin therapy at baseline. 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. Patients should engage in appropriate nutritional intake and physical activity before receiving VASCEPA, which should continue during treatment with VASCEPA. Additional adverse reactions have been identified during post-approval use of Vascepa. The mechanisms of action contributing to reduction of cardiovascular events with Vascepa (icosapent ethyl) are not completely understood but are likely multi-factorial. Vascepa (icosapent ethyl) is a type of omega-3 fatty acid, a fat found in fish oil. Amarin Pharma, Inc. Serious bleeding events occurred in 111 (3%) of patients on Vascepa vs. 85 (2%) of patients receiving placebo. The exact manner by which Vascepa does this is not known, although there have been several mechanisms proposed. What Is Crestor? There were no treatment-related malformations or skeletal anomalies. 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. diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. EPA inhibits platelet aggregation under some ex vivo conditions. When administered Vascepa in clinical trials, plasma total EPA concentrations did not differ significantly between men and women. 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. Additionally, Vascepa increases the removal of triglycerides from VLDL particles that are circulating in your blood. The effect of Vascepa on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. It is used along with a low-fat and low-cholesterol diet, to lower high triglycerides . Beta oxidation splits the long carbon chain of EPA into acetyl Coenzyme A, which is converted into energy via the Krebs cycle. Median baseline HDL-C level was 27 mg/dL. The majority of EPA circulating in plasma is incorporated in phospholipids, triglycerides and cholesteryl esters, and <1% is present as the unesterified fatty acid. 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. A chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells was positive for clastogenicity with and without metabolic activation. Patients should engage in appropriate nutritional intake and physical activity before receiving Vascepa, which should continue during treatment with Vascepa. Keep Vascepa and all medicine out of the reach of children. Hemangiomas and hemangiosarcomas of the mesenteric lymph node, the site of drug absorption, were observed in females at clinically relevant exposures based on body surface area comparisons across species relative to the maximum clinical dose of 4 g/day. Dark urine general tiredness and weakness light-colored stools upper right abdominal or stomach pain yellow eyes and skin Inform patients that Vascepa may increase their risk for bleeding, especially if they are receiving other antithrombotic agents [see Warnings and Precautions (5.3)]. Dublin, Ireland, Vascepa is a registered trademark of the Amarin group of companies, ©2019 Amarin Pharma, Inc. Bridgewater NJ 08807. Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components. Icosapent ethyl was not mutagenic with or without metabolic activation in the bacterial mutagenesis (Ames) assay or in the in vivo mouse micronucleus assay. 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 median follow-up duration was 4.9 years. In a 2-year rat carcinogenicity study with oral gavage doses of 0.09, 0.27, and 0.91 g/kg/day icosapent ethyl, respectively, males did not exhibit drug-related neoplasms. 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. Please see enclosed full Prescribing Information for more information on Vascepa®. All rights reserved, This Patient Information has been approved by the U.S. Food and Drug Administration. VASCEPA may cause serious side effects, including: Heart rhythm problems (atrial fibrillation and atrial flutter). Praluent, simvastatin, Xarelto, fenofibrate, rosuvastatin, Crestor, ramipril, Trulicity, Victoza, Brilinta. 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)]. © Vascepa Patient Information is supplied by Cerner Multum, Inc. and Vascepa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights. Vascepa(Icosapent Ethyl Capsules) side effects drug center, Medical Editor: John P. Cunha, DO, FACOEP. And NOW the muscle and joint pain. 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). It is not known if Vascepa is safe and effective in children. Lovaza vs. Vascepa - what's the difference between them? Find patient medical information for Vascepa oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown. Vascepa works by reducing the amount of triglycerides made in the liver. Find everything you need to know about Vascepa (Icosapent), including what it is used for, warnings, reviews, side effects, and interactions. The study is created by eHealthMe based on reports of 2,092 people who have side effects when taking Vascepa from … 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. Available for Android and iOS devices. You may report side effects to FDA at 1-800-FDA-1088. 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 easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. In the two years I have taken Vascepa I have gained about 40 pounds. Common adverse reactions (incidence ≥3% on Vascepa and ≥1% more frequent than placebo) included musculoskeletal pain, peripheral edema, constipation, gout, and atrial fibrillation. Talk to your doctor about the best way to feed your baby if you take Vascepa. 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)]. 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]. 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. However, if you miss one day of Vascepa, do not double your dose when you take it. 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 …

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