This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Individuals who have a prior history of gout are at increased risk; monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. Refer to adult dosing. -Lipid levels should be checked within 8 to 12 weeks of treatment initiation. Avoid combination, Elagolix: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Elagolix. kidney disease (or if you are on dialysis); Bempedoic acid may harm an unborn baby. Consider therapy modification, Voxilaprevir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Voxilaprevir. Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by inhibition of cholesterol synthesis in the liver. ⦠Use the medicine exactly as directed. Nexlizet (bempedoic acid and ezetimibe) is not a statin medicine, but is used in conjunction with a statin, diet and exercise to lower your cholesterol levels. Other drugs may affect bempedoic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Brand Name: Nexletol Generic Name: bempedoic acid . In general, bempedoic acid should be discontinued if pregnancy occurs. Medically reviewed by Drugs.com on March 25, 2020. Consider therapy modification, Grazoprevir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Grazoprevir. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet. >10%: Endocrine & metabolic: Gout (2% [placebo: 0.4%]; with prior gout history: 11% [placebo: 2%]), hyperuricemia (4% to 26% [placebo: 1% to 10%]), Cardiovascular: Atrial fibrillation (2%), increased serum creatine kinase (1%), Gastrointestinal: Abdominal distress (â¤3%), abdominal pain (â¤3%), Genitourinary: Benign prostatic hyperplasia (1%), Hematologic & oncologic: Anemia (3%), leukopenia (9%), thrombocythemia (10%), Hepatic: Increased liver enzymes (2%), increased serum aspartate aminotransferase (1%), Neuromuscular & skeletal: Back pain (3%), limb pain (3%), muscle spasm (4%), Renal: Increased blood urea nitrogen (4%), increased serum creatinine (2%), Respiratory: Upper respiratory tract infection (5%), <1%: Neuromuscular & skeletal: Rupture of tendon (placebo: 0%). Other agents may be preferred if treatment is needed in a pregnant woman (AACE [Jellinger 2017]; NLA [Jacobson 2015]). Generic Name: bempedoic acid (BEM pe DOE ik AS id)Brand Name: NexletolDosage Forms: oral tablet (180 mg). What is bempedoic acid? 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; Lactation. The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Available for Android and iOS devices. atorvastatin, simvastatin, Lipitor, rosuvastatin, Crestor, ezetimibe. You may report side effects to FDA at 1-800-FDA-1088. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase in the cholesterol biosynthesis pathway. Tell your doctor right away if you become pregnant. Assess uric acid levels periodically as clinically indicated. Follow your doctor's instructions about any restrictions on food, beverages, or activity. Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. Tendon problems may be more likely in certain people (older adults, people with kidney disease, or people who take steroid medicine or certain antibiotics. Avoid combination, Pravastatin: Bempedoic Acid may increase the serum concentration of Pravastatin. Hepatic; primarily through metabolism of the acyl glucuronide; reversibly converted by aldo-keto reductase enzyme to an active metabolite (ESP15228), which is also converted to a glucuronide conjugate. Data sources include IBM Watson Micromedex (updated 2 Feb 2021), Cerner Multum™ (updated 3 Feb 2021), ASHP (updated 29 Jan 2021) and others. Bempedoic acid is also used to lower LDL cholesterol in adults with coronary artery disease (clogged arteries). Consider alternative therapy in patients with a history of tendon disorders or tendon rupture. Look up information on diseases, tests, and procedures; then consult the database with 5,000+ drugs ⦠This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. ⢠Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Avoid combination, Elagolix, Estradiol, and Norethindrone: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Elagolix, Estradiol, and Norethindrone. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. NEXLETOL TM (bempedoic acid) Tablet NEXLETOL is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by reducing cholesterol biosynthesis and up ⦠Avoid combination. Medically reviewed by Drugs.com. Avoid combination, Simvastatin: Bempedoic Acid may increase the serum concentration of Simvastatin. However, many people have no side effects or only have minor side effects. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by inhibiting cholesterol synthesis in the liver. Inhibition of ACL by ETC-1002-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of LDL receptors. Atherosclerotic cardiovascular disease, established: Treatment of established atherosclerotic cardiovascular disease, as an adjunct to diet and maximally tolerated statin therapy, in adult patients who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Our objective was to estimate its average effect on ⦠Find information on Bempedoic Acid/ezetimibe (Nexlizet) in Davisâs Drug Guide including dosage, side effects, interactions, nursing implications, mechanism of action, half life, administration, and more. Bempedoic acid is a small molecule drug intended to block cholesterol synthesis in the liver, similar to the approach of statins. Bempedoic Acid ⦠Written by Cerner Multum. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Asunaprevir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Asunaprevir. Nexlizet contains two medicines ⦠This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. Manufacturer1: Esperion Therapeutics . Compare formulary status to other drugs in the same class⦠Learn about bempedoic acid and the CLEAR program. But statins are also thought to affect cholesterol ⦠Store at room temperature away from moisture and heat. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. More about bempedoic acid. The evaluation of ICER will be ongoing over the next ⦠Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Based on the mechanism of action, in utero exposure to bempedoic acid may cause fetal harm. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Bempedoic acid is first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor used once a day for reducing LDL cholesterol levels in statin-refractory patients. Heterozygous familial hypercholesterolemia: Treatment of heterozygous familial hypercholesterolemia, as an adjunct to diet and maximally tolerated statin therapy, in adult patients who require additional lowering of LDL-C. This is not a complete list of side effects and others may occur. Note: This is not a comprehensive list of all side effects. Nexletol (bempedoic acid) is a first-in-class, adenosine triphosphate-citrate lyase (ACL) inhibitor for the treatment of adults with heterozygous familial hypercholesterolemia or established ⦠Bempedoic acid belongs to a group of drugs called adenosine triphosphate-citrate lyase inhibitors. 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. Bempedoic acid, sold under the brand name Nexletol among others, is a medication for the treatment of hypercholesterolemia (high blood cholesterol levels). ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase in the cholesterol biosynthesis pathway. Atherosclerotic cardiovascular disease, established: Oral: 180 mg once daily. All drugs may cause side effects. Bempedoic acid and ezetimibe is a combination medicine that is used to lower blood levels of "bad" cholesterol (low-density ⦠A new type of drug - called bempedoic acid - could offer another weapon in the fight against bad cholesterol. Oral: May be administered without regard to food. Follow all directions on your medicine label and package. Call your doctor for medical advice about side effects. Tendon Rupture: Bempedoic acid ⦠Bempedoic acid is a novel class of nonstatin therapy that targets hepatic cholesterol synthesis and has demonstrated significant LDL-C lowering ability as monotherapy ⦠Drug Class1,2,3,4,5: adenosine triphosphate-citrate lyase (ACL) inhibitor, antilipemic agent . Bempedoic acid is in a class of medications called adenosine triphosphate-citrate lyase (ACL) inhibitors. Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS; NEXLETOL: BEMPEDOIC ACID: 180MG: TABLET;ORAL: Prescription: None Yes: Yes: ⦠Last updated on July 17, 2020. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative. Pharmacokinetics were not affected by weight. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Management: Avoid coadministration of bempedoic acid with simvastatin doses greater than 20 mg due to the potential for increased simvastatin concentrations and simvastatin-related myopathy. Bempedoic acid and its fixed combination drug product with ezetimibe were approved in the European Union and the United States earlier this year with different labels ⦠Assess uric acid levels periodically as clinically indicated. A new class of oral cholesterol-lowering drug could help patients unable to take statins due to side effects. Uses: As an adjunct to diet and maximally tolerated statin therapy for the treatment of heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease in those requiring additional LDL-C lowering. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. Heterozygous familial hypercholesterolemia: Oral: 180 mg once daily. ⢠Hyperuricemia: Increases in serum uric acid have occurred, usually within the first 4 weeks of treatment initiation, and persisted throughout treatment. Follow all directions on your prescription label and read all medication guides or instruction sheets. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Nexletol (bempedoic acid) is a member of the miscellaneous antihyperlipidemic agents drug class and is commonly used for High Cholesterol - Familial Heterozygous. ⦠You should not breastfeed while using bempedoic acid. Bempedoic acid; Other brands: Nexletol. Feces (30%; <5% as unchanged drug); urine (<5% as unchanged drug; ~70% of total dose as bempedoic acid and metabolites). Do not take two doses at one time. Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. It was developed by ⦠Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use. Data are not available regarding drug ⦠Bempedoic acid is a first-in-class oral adenosine triphosphate (ATP) citrate lyase inhibitor being evaluated as an additional treatment option for high-risk patients requiring further reduction in LDL-C. Bempedoic acid ⦠⢠Tendon rupture: Tendon rupture or injury has occurred within weeks to months of treatment initiation; increased risk in patients >60 years of age, those taking corticosteroid or fluoroquinolone drugs, and patients with renal failure. Bempedoic acid is used together with diet and other medicines to lower blood levels of "bad" cholesterol (low-density lipoprotein, or LDL). bempedoic acid is a topic covered in the Davis's Drug Guide.. To view the entire topic, please sign in or purchase a subscription.. Talk to your doctor if you have questions. Store in original package (with desiccant) at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Usual Adult Dose for Cardiovascular Risk Reduction: Tell your doctor about all other cholesterol medicines you use, especially: This list is not complete. ... "What we have is a new class of drug that could be given to ⦠Note: Use is recommended in combination with maximally tolerated statin therapy. Usual Adult Dose for Heterozygous Familial Hypercholesterolemia: 180 mg orally once a day Comments:-This drug should be given with maximally tolerated statin therapy. low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet. We comply with the HONcode standard for trustworthy health information -, heterozygous familial hypercholesterolemia, Drug class: miscellaneous antihyperlipidemic agents. ⦠Avoid combination, Eluxadoline: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase the serum concentration of Eluxadoline. Bempedoic acid is first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor used once a day for reducing LDL cholesterol levels in statin-refractory patients. Bempedoic acid may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the arm, shoulder, or Achilles' tendon of the heel. Not all possible drug interactions are listed here. Consider therapy modification, Revefenacin: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentrations of the active metabolite(s) of Revefenacin. The findings come from the largest study to date to test the effectiveness and safety of bempedoic acid⦠Bempedoic acid is a first-in-class lipid-lowering drug recommended by guidelines for the treatment of hypercholesterolemia. Nursing Central is an award-winning, complete mobile solution for nurses and students. How ⦠The drug, bempedoic acid, is the first in a new class of drugs to treat low-density-lipoprotein cholesterol, also called âbadâ cholesterol, which causes the buildup of fatty deposits ⦠We comply with the HONcode standard for trustworthy health information -, Drug class: miscellaneous antihyperlipidemic agents, Antilipemic Agent, Adenosine Triphosphate-Citrate Lyase (ACL) Inhibitor. Management: Decrease the eluxadoline dose to 75 mg twice daily if combined with OATP1B1/1B3 inhibitors and monitor patients for increased eluxadoline effects/toxicities. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Bempedoic acid is used together with diet and other medicines to lower blood levels of "bad" cholesterol (low-density lipoprotein, or LDL). Professional resources. Monitor lipid levels within 8 to 12 weeks of therapy initiation; signs/symptoms of hyperuricemia, assess uric acid levels as clinically indicated; signs/symptoms of tendon rupture (eg, joint pain, swelling, inflammation). ... On Feb. 21, 2020, the Food and Drug Administration (FDA) provided approval for the use of bempedoic acid⦠This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. What is bempedoic acid and ezetimibe? Bempedoic acid is for use in adults with an inherited form of high cholesterol. There are no contraindications listed in the manufacturer's labeling. 6, 7 It was developed by ⦠Ezetimibe belongs to a group of drugs called cholesterol absorption inhibitors. Limitations of use: The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined. This can happen within days or months after you start taking bempedoic acid. Version: 1.01. atorvastatin, simvastatin, Lipitor, rosuvastatin, Crestor, ezetimibe. ICER had previously announced in July of last year that evaluating bempedoic acid was in their potential plans for 2020. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. It is not known if bempedoic acid can lower the risk of complications related to high cholesterol (such as heart problems, heart attack, stroke, or death). Specifically, concentrations of elagolix may be increased. You may take bempedoic acid with or without food. âBempedoic acid is a first-in-class adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers LDL-C by inhibiting cholesterol synthesis in the liver. Side Effects; During Pregnancy; Drug Interactions; En Español; Drug class: miscellaneous antihyperlipidemic agents; Consumer resources. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. Bempedoic acid is a non-statin, targeted therapy designed to primarily work in the liver to inhibit cholesterol biosynthesis. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: ⢠Unable to move or put weight on a joint, ⢠Hear or feel a snap or pop in a joint, ⢠Tendon inflammation or rupture like pain, bruising, or swelling in the back of the ankle, shoulder, hand, or other joints. ACSVL1 is expressed primarily in the liver. âBempedoic acid (Esperion Therapeutics) is a first-in-class small molecule inhibitor of ATP citrate lyase, an enzyme upstream of HMG-CoA reductase in cholesterol ⦠Bempedoic acid may also be used for purposes not listed in this medication guide. Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by inhibiting cholesterol synthesis in the liver. pain in your back, shoulder, legs, or arms; cold symptoms such as stuffy nose, sneezing, sore throat. Davis Drug ⦠Consider discontinuing therapy if joint pain, swelling, or inflammation occurs; discontinue immediately if tendon rupture occurs. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol bi⦠Data sources include IBM Watson Micromedex (updated 2 Feb 2021), Cerner Multum™ (updated 3 Feb 2021), ASHP (updated 29 Jan 2021) and others. 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 ESP1522⦠Stop taking bempedoic acid and seek medical attention right away if you have signs of tendon rupture: sudden pain, swelling, bruising, or tenderness; or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions). It works by blocking the production of cholesterol in the liver. Available for Android and iOS devices. Copyright 1996-2021 Cerner Multum, Inc. Management: Avoid coadministration of bempedoic acid with pravastatin doses greater than 40 mg due to the potential for increased pravastatin concentrations and pravastatin-related myopathy. âBempedoic acid does not have any baggage we know of, like anacetrapib with its lingering drug levels four years later.â U.S. Cardiologist After conducting interviews with experts in the field, survey of practicing physicians, and our own literature reviews, we here at DRG think bempedoic acid â¦