Bempedoic acid
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami-Ardakani
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Overview
Bempedoic acid is an Adenosine Triphosphate-Citrate Lyase (ACL) Inhibitor. that is FDA approved for the treatment of Heterozygous familial hypercholesterolemia (HeFH) and Established atherosclerotic cardiovascular disease (ASCVD). Common adverse reactions include Muscle spasms, back pain, pain in extremities, Diarrhea, Hyperuricemia, and fatigue..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
The recommended dosage is 180 mg orally once daily.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Bempedoic acid in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Bempedoic acid in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Bempedoic acid is not approved for use in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Bempedoic acid in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Bempedoic acid in pediatric patients.
Contraindications
Hypersensitivity to bempedoic acid or any of its components.
Warnings
Hyperuricemia: Bempedoic acid may increase blood uric acid levels, leading to gout. Monitor patients for signs and symptoms of hyperuricemia.
Tendon Rupture: Tendon rupture has occurred in patients taking bempedoic acid. Discontinue use if tendon rupture is suspected.
Risk of Myopathy with Simvastatin or Pravastatin: Concomitant use with simvastatin or pravastatin may increase the risk of myopathy.
Adverse Reactions
Clinical Trials Experience
Musculoskeletal: Muscle spasms, back pain, pain in extremities.
Gastrointestinal: Diarrhea.
Metabolic: Hyperuricemia.
General: Fatigue.
Postmarketing Experience
There is limited information regarding Bempedoic acid Postmarketing Experience in the drug label.
Drug Interactions
Simvastatin: Concomitant use increases simvastatin concentration, potentially increasing the risk of myopathy.
Pravastatin: Similar interaction as with simvastatin.
Atorvastatin and Rosuvastatin: Bempedoic acid may increase their plasma concentrations; monitor for adverse effects.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Bempedoic acid in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bempedoic acid in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Bempedoic acid during labor and delivery.
Nursing Mothers
It is unknown whether bempedoic acid is excreted in human milk; breastfeeding is not recommended during treatment.
Pediatric Use
There is no FDA guidance on the use of Bempedoic acid in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Bempedoic acid in geriatric settings.
Gender
There is no FDA guidance on the use of Bempedoic acid with respect to specific gender populations.
Race
There is no FDA guidance on the use of Bempedoic acid with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Bempedoic acid in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Bempedoic acid in patients with hepatic impairment.
Females of Reproductive Potential and Males
Advise females of reproductive potential to use effective contraception during treatment.
Immunocompromised Patients
There is no FDA guidance one the use of Bempedoic acid in patients who are immunocompromised.
Administration and Monitoring
Administration
Administer orally once daily with or without food.
Monitoring
Monitor serum uric acid levels periodically.
Monitor for signs and symptoms of tendon rupture.
Monitor lipid levels to assess efficacy.
IV Compatibility
Not applicable
Overdosage
There is limited information regarding Bempedoic acid overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Bempedoic acid Pharmacology in the drug label.
Mechanism of Action
Bempedoic acid inhibits ATP-citrate lyase (ACL), an enzyme involved in cholesterol synthesis in the liver, leading to decreased LDL-C levels.
Structure
There is limited information regarding Bempedoic acid Structure in the drug label.
Pharmacodynamics
Reduces LDL-C, non-HDL-C, and apolipoprotein B levels.
Pharmacokinetics
Absorption: Median time to peak concentration is 3.5 hours.
Distribution: Volume of distribution is 18 L; 99.3% protein-bound.
Metabolism: Converted to active metabolite ESP15228; metabolized via glucuronidation.
Elimination: Half-life of 21 ± 11 hours; excreted primarily in urine (70%) and feces (30%).
Nonclinical Toxicology
There is limited information regarding Bempedoic acid Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Bempedoic acid Clinical Studies in the drug label.
How Supplied
Form: Oral tablets.
Strength: 180 mg per tablet.
Packaging: Bottles containing 30, 90, or 100 tablets; also available in unit-dose blister packs.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
Protect from moisture and excessive heat.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Inform patients:
To take the medication once daily, with or without food.
To report any unexplained muscle pain, tenderness, or weakness.
About possible symptoms of tendon rupture (pain, swelling, bruising).
To inform their healthcare provider if they experience symptoms of hyperuricemia or gout.
That effective contraception is recommended during treatment if applicable.
Precautions with Alcohol
Alcohol-Bempedoic acid interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Nexletol®
Manufactured by Esperion Therapeutics, Inc.
Look-Alike Drug Names
There is limited information regarding Bempedoic acid Look-Alike Drug Names in the drug label.
Price
References
The contents of this FDA label are provided by the National Library of Medicine.