2002 5. References: 1. Most Hyperuricemia may occur early in treatment and persist throughout treatment, and may lead to the development of gout, especially in patients with a history of gout. J Lipid Res. Please see full Prescribing Information for NEXLETOL and NEXLIZET. Discontinue NEXLETOL or NEXLIZET at the first sign of tendon rupture. Liver-specific ATP-citrate lyase inhibition by Linking to third-party sites is at your own risk. This drug is available at a middle level co-pay. 2 Inhibition of HMG-CoA is one the proposed mechanisms of action for statin-related myopathy. 2018;36(2):257-264. If cholelithiasis is suspected in a patient receiving NEXLIZET and fenofibrate, gallbladder studies are indicated and alternative lipid-lowering therapy should be considered. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway NEXLETOL and NEXLIZET are indicated as adjuncts 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. End-stage renal disease with dialysis: Not studied, Mild or moderate (Child-Pugh A or B): No dosage adjustment required, Inhibits renal tubular OAT2 and may increase blood uric acid levels, Elevated uric acid levels usually occurred within the first 4 weeks of treatment initiation and persisted throughout treatment; elevated blood uric acid may lead to gout, Associated with increased risk of tendon rupture or injury, Tendon rupture occurred within weeks to months of initiating, May occur more frequently in patients aged ≥60 yr, Discontinue immediately if tendon rupture occurs, Consider discontinuing with joint pain, swelling, or inflammation, Coadministration increases simvastatin or pravastatin serum concentrations and may increase simvastatin/pravastatin-related myopathy, Atorvastatin and rosuvastatin: Elevations of 1.7-fold in AUC of atorvastatin, rosuvastatin, and/or their major metabolites were observed with bempedoic acid coadministration, suggesting a weak interaction; these elevations were generally within the individual statin exposures and do not affect dosing recommendations, Treatment of hyperlipidemia is not generally necessary during pregnancy, Cholesterol and cholesterol derivatives are needed for normal fetal development, Bempedoic acid was not teratogenic in rats and rabbits when administered at doses resulting in exposures up to 11 and 12 times, respectively, the human exposures at the maximum clinical dose, based on AUC, Active metabolite, ESP15228: 51.2 mcgh/mL. All trademarks and trade names are the property of their respective acyl-coenzyme A synthetase-1; HMGR=3-hydroxy-3-methyl-glutaryl-coenzyme A reductase. Merck & Co., Inc.; 2013. ESPERION Therapeutics, Inc.; NEXLETOL REDUCES CHOLESTEROL BIOSYNTHESIS TO LOWER LDL-C, NEXLETOL is primarily activated in the liver1,3. Fibrates: Coadministration of NEXLIZET with fibrates other than fenofibrate is not recommended. trial data. bempedoic acid decreases LDL-C and attenuates atherosclerosis. The new mechanism drug Nexletol significantly reduces LDL-C levels in specific subgroups! Designs, Prescribing It may carry a low risk of statin-associated myopathy due to the absence of ACSVL1 in the skeletal muscle. Bempedoic acid provides a new mechanism of action to reduce LDL-C. Pinkosky SL, Newton RS, Medical Information Contact Center: 1-833-377-7633 (toll free, US Warnings and Precautions: Hyperuricemia: Bempedoic acid, a component of NEXLETOL and NEXLIZET, may increase blood uric acid levels. Access your plan list on any device – mobile or desktop. Your list will be saved and can be edited at any time. commonly, these are generic drugs. ESPERION Therapeutics, Inc. does not endorse and is not responsible for the content included on, or the way in which information is processed by, external websites. Cyclosporine: Caution should be exercised when using NEXLIZET and cyclosporine concomitantly due to increased exposure to both ezetimibe and cyclosporine. provider for the most current information. Share cases and questions with Physicians on Medscape consult. © 2020 ESPERION Therapeutics, Inc. All commonly, these are "non-preferred" brand drugs. We use cookies to offer you a better online experience, analyze site traffic, and serve targeted Monitor cyclosporine concentrations in patients receiving NEXLIZET and cyclosporine. 08/20 US-NXTL-2000453. and formulary information changes. Tendon Rupture: Bempedoic acid is associated with an increased risk of tendon rupture or injury. References: 1. 2500032-overview Adverse Reactions: In NEXLETOL clinical trials, the most commonly reported adverse reactions were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes. 3. Adverse reactions reported in clinical trials of ezetimibe, and occurring at an incidence greater than with placebo, included upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza. Indicated as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein cholesterol (LDL-C), 180 mg PO qDay in combination with maximally tolerated statin therapy, Limitations of use: Effect on cardiovascular morbidity and mortality not determined, Monitoring: After initiating, analyze lipid levels within 8-12 weeks, Discontinue bempedoic acid when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus, No available data regarding use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, Note: Statins are contraindicated in pregnant women, Data are not available regarding drug presence in human or animal milk, effects on breastfed infants, or effects on milk production, Since bempedoic acid decreases cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, these actions may cause harm to the breastfed infant, Based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment.