The recommended dosage of Nexletol, in combination with maximally tolerated statin therapy, is 180 mg administered orally once daily. At the time of randomization, all patients were receiving statin therapy and 50% were receiving high-intensity statin therapy. heterozygous familial hypercholesterolemia (HeFH). At the time of randomization, 90% of patients were receiving statin therapy, 53% were receiving high-intensity statin therapy, and 0.3% were receiving PCSK9 inhibitors. Lab and/or medical tests (such as kidney/liver function, uric acid levels, complete blood count, cholesterol levels) should be done while you are taking this medication. List Nexletol 180 Mg Tablet Antihyperlipidemic - ATP-Citrate Lyase (ACLY) Inhibitor side effects by likelihood and severity. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Take this medication regularly to get the most benefit from it. For additional results see Table 3 and Figure 1. In a 2-year mice carcinogenicity study, CD-1 mice were given oral doses of bempedoic acid at 25, 75 and 150 mg/kg/day. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. Elevated blood uric acid may lead to the development of gout. Consult your doctor before breast-feeding. The difference between Nexletol and placebo in mean percent change in LDL-C from baseline to Week 12 was -17 % (95% CI: -21%, -14%; p < 0.001). In clinical trials, 26% of Nexletol-treated patients with normal baseline uric acid values (versus 9.5% placebo) experienced hyperuricemia one or more times, and 3.5% of patients experienced clinically significant hyperuricemia reported as an adverse reaction (versus 1.1% placebo). Bempedoic acid does not partition into blood cells. Mean plasma AUC metabolite/parent drug ratio for ESP15228 following repeat-dose administration was 18% and remained constant over time. Background statin: atorvastatin, simvastatin, rosuvastatin, pravastatin, fluvastatin, pitavastatin, and lovastatin. Do not store in the bathroom. Efficacy of Nexletol was evaluated at Week 12. If you take too much Nexletol, call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away. Northumberland NE61 3YA Nexletol, or bempedoic acid, is the first approved drug in a new class of cholesterol medications known as ATP citrate lyase (ACL) inhibitors. These elevations are not clinically meaningful and do not impact dosing recommendations. Pravastatin: Administration of pravastatin 40 mg with steady-state bempedoic acid 240 mg in healthy subjects resulted in 99% (2-fold) and 104% (2-fold) increases in pravastatin acid AUC and Cmax, respectively [see Drug Interactions (7)]. Medically reviewed by Drugs.com. Remember to use it at the same time each day. White to off white and oval, debossed with "180" on one side and "ESP" on the other side, Bottle of 30 tablets with child-resistant cap, Bottle of 90 tablets with child-resistant cap, This Patient Package Insert has been approved by the U.S. Food and Drug Administration. Nexletol is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. Maximally tolerated lipid lowering therapy was defined as a maximally tolerated statin dose alone or in combination with other lipid-lowering therapies. Relative to those with normal renal function, mean bempedoic acid AUCs were higher in patients with moderate (n = 5) or severe (n = 5) renal impairment by 2.3-fold and 2.4-fold, respectively. Maximally tolerated lipid lowering therapy was defined as a maximally tolerated statin dose alone or in combination with other lipid-lowering therapies. Increases in ALT occurred with similar incidence between Nexletol- and placebo-treated patients. The trial included 2230 patients randomized 2:1 to receive either Nexletol (n = 1488) or placebo (n = 742) as add-on to a maximally tolerated lipid lowering therapy. Keep all medical and lab appointments. Nexletol is used for this purpose, and its approval gives providers a new tool in their toolbox. You should not do both. Your risk for tendon problems is greater if you are over 60 years of age, if you are taking corticosteroids (such as prednisone) or fluoroquinolones (such as ciprofloxacin), or if you have kidney or tendon problems. Are you considering switching to Nexletol 180 Mg Tablet Antihyperlipidemic - ATP-Citrate Lyase (ACLY) Inhibitor? It works by reducing the amount of cholesterol made by the liver. Canada residents can call a provincial poison control center. Concomitant food administration had no effect on the oral bioavailability of bempedoic acid. There were no time-dependent changes in bempedoic acid pharmacokinetics following repeat administration at the recommended dosage, and bempedoic acid steady-state was achieved after 7 days. Administration of bempedoic acid 180 mg with steady-state probenecid resulted in a 1.7- and a 1.2-fold increase in bempedoic acid AUC and Cmax, respectively. High-density lipoprotein (HDL) and triglycerides (TG) were examined as exploratory endpoints and were not included in the statistical hierarchy. The mean baseline LDL-C was 120.4 mg/dL. Esperion Therapeutics, Inc. If you miss a dose, take it as soon as you remember. In Canada - Call your doctor for medical advice about side effects. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Each film-coated tablet of Nexletol contains 180 mg of bempedoic acid and the following inactive ingredients: colloidal silicon dioxide, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Tablets: 180 mg, white to off-white, oval shaped, debossed with "180" on one side and "ESP" on the other side. Ninety-five percent (95%) of patients had established atherosclerotic cardiovascular disease, and 5% of patients had HeFH. The mean ± SD half-life for bempedoic acid in humans was 21 ± 11 hours at steady-state. Tendon damage may occur during treatment with this medication. © 2020 Esperion Therapeutics, Inc. Crestor, Lipitor, ezetimibe, Zetia, Nexlizet, atorvastatin, simvastatin, rosuvastatin. Decrease in Hemoglobin and Leukocytes: Approximately 5.1% of patients (versus 2.3% placebo) had decreases in hemoglobin levels of 2 or more g/dL and below the lower limit of normal on one or more occasion. Take Nexletol exactly as your healthcare provider tells you to take it. Available for Android and iOS devices. Piramal Healthcare UK Limited Check with your healthcare provider or pharmacist if you are not sure. Compared to patients with normal hepatic function, the bempedoic acid mean Cmax and AUC were decreased by 11% and 22%, respectively, in patients with mild hepatic impairment and by 14% and 16%, respectively, in patients with moderate hepatic impairment. United Kingdom, Manufactured for: Consult your doctor for more details. Gout may happen more in people who have had gout before but also can happen in people who have never had it before. Nexletol and Nexlizet can be used with statins that have moderate or minimal side effects. Abdominal pain may occur. Increase in Liver Enzymes: Increases in hepatic transaminases (AST and/or ALT) were observed with Nexletol. Patients on simvastatin 40 mg/day or higher were excluded from the trial. Adverse reactions led to discontinuation of treatment in 11% of Nexletol-treated patients and 8% of placebo-treated patients. Elevations in transaminases were generally asymptomatic and not associated with elevations ≥2× ULN in bilirubin or with cholestasis. Bempedoic acid and its active metabolite, ESP15228, require coenzyme A (CoA) activation by very long-chain acyl-CoA synthetase 1 (ACSVL1) to ETC-1002-CoA and ESP15228-CoA, respectively. Store in original container at room temperature away from light and moisture. Before you start taking Nexletol, tell your healthcare provider about all your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Take 1 Nexletol tablet by mouth each day. Nexletol may cause serious side effects, including: increased levels of uric acid in your blood (hyperuricemia). Ninety-five percent (95%) of patients had established atherosclerotic cardiovascular disease, and 5% of patients had HeFH. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Bempedoic acid, ESP15228 and their respective conjugated forms were detected in plasma with bempedoic acid accounting for the majority (46%) of the AUC0-48h and its glucuronide being the next most prevalent (30%). This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. It is not known if Nexletol passes into your breast milk. Discontinue Nexletol immediately if the patient experiences rupture of a tendon. Select one or more newsletters to continue.