Nexletol

Nexletol is an FDA-registered drug product whose active ingredient is BEMPEDOIC ACID. It is labelled by Esperion Therapeutics, Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 72426-118, application NDA211616, label effective 20260625. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BEMPEDOIC ACID are most often described in connection with: ldl-c lowering, indicated reduce, risk major, adverse cardiovascular, death myocardial, infarction stroke, coronary revascularization, adults increased. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE NEXLETOL is indicated: to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin). as an adjunct to diet and exercise, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). NEXLETOL, an adenosine triphosphate-citrate lyase (ACL) inhibitor, is indicated: to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin). ( 1 ) as an adjunct to diet and exercise, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). ( 1 )

2 DOSAGE AND ADMINISTRATION Administer 180 mg orally once daily with or without food. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of NEXLETOL is 180 mg administered orally once daily. NEXLETOL can be taken with or without food. After initiation of NEXLETOL, analyze lipid levels within 8 to 12 weeks.

4 CONTRAINDICATIONS NEXLETOL is contraindicated in patients with a prior serious hypersensitivity reaction to bempedoic acid or any of the excipients in NEXLETOL. Serious hypersensitivity reactions, such as angioedema, have occurred [see Adverse Reactions (6.2) ]. History of a serious hypersensitivity reaction to bempedoic acid or any of the excipients in NEXLETOL. ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hyperuricemia [see Warnings and Precautions (5.1) ] Tendon Rupture [see Warnings and Precautions (5.2) ] Common adverse reactions in the ( 6.1 ): Primary hypercholesterolemia trials (incidence ≥ 2% and more frequent than placebo) were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes. Cardiovascular outcomes trial (incidence ≥ 2% and 0.5% greater than placebo) were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis. To report SUSPECTED ADVERSE REACTIONS, contact Esperion at 833-377-7633 (833 ESPRMED) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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 clinical practice. The data in Table 1 reflect exposure to NEXLETOL in two placebo-controlled primary hypercholesterolemia trials that included 2,009 patients treated with NEXLETOL for 52 weeks (median treatment duration of 52 weeks) [see Clinical Studies (14.2) ] . The mean age for NEXLETOL-treated patients was 65 years, 29% were female, 95% were White, 3% were Black or African American, 1% were Asian, and 1% were other races; 3% identified as Hispanic or Latino ethnicity. All patients received NEXLETOL 180 mg orally once daily plus maximally tolerated statin therapy alone or in combination with other lipid-lowering therapies. At baseline, 97% of patients had CVD and about 4% had a diagnosis of HeFH. Patients on simvastatin 40 mg/day or higher were excluded from the trials. In the primary hypercholesterolemia trials, adverse reactions led to discontinuation of treatment in 11% of NEXLETOL-treated patients and 8% of placebo-treated patients. The most common reasons for NEXLETOL treatment discontinuation were muscle spasms (0.5% versus 0.3% placebo), diarrhea (0.4% versus 0.1% placebo), and pain in extremity (0.3% versus 0.0% placebo). Adverse reactions reported in at least 2% of NEXLETOL-treated patients and more frequently than in placebo-treated patients are shown in Table 1. Table 1. Adverse Reactions (≥ 2% and greater than placebo) in NEXLETOL-Treated Patients with Primary Hypercholesterolemia and CVD or HeFH (Trials 2 and 3) Adverse Reaction Placebo Background therapy included statin and ± other lipid-lowering therapies (N = 999) % NEXLETOL (N = 2,009) % Upper respiratory tract infection 4.0 4.5 Muscle spasms 2.3 3.6 Hyperuricemia Grouped term that includes other related terms 1.1 3.5 Back pain 2.2 3.3 Abdominal pain or discomfort 2.2 3.1 Bronchitis 2.5 3.0 Pain in extremity 1.7 3.0 Anemia 1.9 2.8 Elevated liver enzymes 0.8 2.1 In the cardiovascular outcomes trial, in which 7,001 patients were exposed to NEXLETOL and 6,964 patients were exposed to placebo for a median of 3.1 years [see Clinical Studies, (14.1) ] , adverse reactions led to discontinuation of treatment in 11% of NEXLETOL-treated patients and 10% of placebo-treated patients. Adverse reactions reported in at least 2% of NEXLETOL-treated patients and 0.5% greater than placebo are shown in Table 2. Table 2. Adverse Reactions (≥ 2% and 0.5% greater than placebo) in NEXLETOL-Treated Patients with CVD or at High Risk for CVD (Trial 1) Adverse Reaction Placebo (N=6,964) % NEXLETOL (N=7,001) % Hyperuricemia Grouped term that includes other related terms 8 16 Renal impairment Renal impairment includes laboratory related terms including glomerular filtration rate decreased, blood creatinine increased and hematuria 9 11 Anemia 4 5 Elevated liver enzymes 3 4 Muscle spasms 3 4 Gout 2 3 Cholelithiasis 1 2 Other Adverse Reactions Tendon Rupture In the hypercholesterolemia trials, tendon rupture occurred in 0.5% of NEXLETOL-treated patients versus 0% of placebo-treated patients. In the cardiovascular outcomes trial, tendon rupture events occurred in 1.2% of NEXLETOL-treated patients versus 0.9% of placebo-treated patients. Gout In the hypercholesterolemia trials, gout occurred in 1.5% of NEXLETOL-treated patients versus 0.4% of placebo-treated patients. In the cardiovascular outcomes trial, gout occurred in 3.2% of NEXLETOL-treated patients versus 2.2% of placebo-treated patients. Laboratory Tests NEXLETOL was associated with persistent changes in multiple laboratory tests that occurred within the first 4 weeks of treatment and returned to baseline following discontinuation of treatment. Increase in Creatinine and Blood Urea Nitrogen In the hypercholesterolemia trials, there was a mean increase in serum creatinine of 0.05 mg/dL compared to baseline with NEXLETOL at Week 12. Approximately 3.8% of patients treated with NEXLETOL had blood urea nitrogen values that doubled (versus 1.5% placebo), and about 2.2% of patients had creatinine values that increased by 0.5 mg/dL (versus 1.1% placebo). In the cardiovascular outcomes trial, 7.1% of patients had creatinine values that increased by 0.5 mg/dL (versus 5.5% placebo) and 9.5% of patients in the NEXLETOL group had BUN values that increased ≥ 2× baseline (versus 6.2% placebo). Decrease in Hemoglobin and Leukocytes In the hypercholesterolemia trials, approximately 5.1% of patients treated with NEXLETOL (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. Anemia was reported in 2.8% of patients treated with NEXLETOL and 1.9% of patients treated with placebo. Approximately 9.0% of NEXLETOL-treated patients with normal baseline leukocyte count had a decrease to less than the lower limit of normal on one or more occasion (versus 6.7% placebo). Leukocyte decrease was generally asymptomatic and did not require medical intervention. In the hypercholesterolemia trials, there was a small imbalance in skin or soft tissue infections, including cellulitis (0.8% versus 0.4%), but there was no imbalance in other infections. In the cardiovascular outcomes trial, 10.8% of patients (versus 7.4% placebo) had a decrease in hemoglobin of 2 or more g/dL and below the lower limit of normal. Anemia was reported in 4.7% of patients treated with NEXLETOL and 3.9% of patients treated with placebo. There were 9.3% of NEXLETOL-treated patients with a leukocyte count below the lower limit of normal (and normal at baseline) at any point (versus 6.8% placebo). Increase in Platelet Count In the hypercholesterolemia trials, approximately 10.1% of patients (versus 4.7% placebo) had increases in platelet counts of 100× 10 9 /L or more on one or more occasion. In the cardiovascular outcomes trial, 18.6% of patients in the NEXLETOL-treated group (versus 10.2% placebo) had an increase in platelet count of 100 × 10 9 /L or more. Platelet count increase was asymptomatic and did not result in increased risk for thromboembolic events. Increase in Liver Enzymes In the hypercholesterolemia trials, increases in hepatic transaminases (AST and/or ALT) were observed with NEXLETOL. In most cases, the elevations were transient and resolved or improved with continued therapy or after discontinuation of therapy. Increases to more than 3× the upper limit of normal (ULN) in AST occurred in 1.4% of patients treated with NEXLETOL versus 0.4% of placebo patients, and increases to more than 5× ULN occurred in 0.4% of NEXLETOL-treated versus 0.2% of placebo-treated patients. Increases in ALT occurred with similar incidence between NEXLETOL- and placebo-treated patients. Elevations in transaminases were generally asymptomatic and not associated with elevations ≥ 2× ULN in bilirubin or with cholestasis. In the cardiovascular outcomes trial, the incidence of repeated and confirmed ALT and/or AST >3× ULN was 1.6% in the NEXLETOL-treated group (versus 1.0% placebo). A higher percentage of patients in the NEXLETOL-treated group had hepatic enzyme elevations versus placebo (4.5% versus 3.0%, respectively). Increase in Creatine Kinase In the hypercholesterolemia trials, approximately 1.0% of patients (versus 0.6% placebo) had elevations of CK levels of 5 or more times the normal value on one or more occasions, and 0.4% of patients (versus 0.2% placebo) had elevations of CK levels of 10 or more times. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of NEXLETOL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Hypersensitivity reactions including: angioedema, wheezing, rash, and urticaria.

What is Nexletol used for?
1 INDICATIONS AND USAGE NEXLETOL is indicated: to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin). as an adjunct to diet and exercise, in combination with other low-density …

Who makes Nexletol?
Esperion Therapeutics, Inc. is the labeler of record for Nexletol.

What form does Nexletol come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Nexletol prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Nexletol been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.