Bempedoic acid

Class
Hypolipidemic agents
Subclass
ATP citrate lyase inhibitors
Substance name
Bempedoic acid
Brand names
Nexletol®
Common formulations
Film-coated tablet
Contained in
Bempedoic acid / ezetimibe (Nexlizet®)
Dosage and administration
Adults patients
Treatment
Heterozygous familial hypercholesterolemia
•
180 mg PO daily
Assess lipid levels 8-12 weeks after initiation.
Primary hyperlipidemia
•
180 mg PO daily
Assess lipid levels 8-12 weeks after initiation.
Prevention
Prevention of cardiovascular events in patients with established CVD or at high risk for CVD events
•
180 mg PO daily
Indications for use
Labeled indications
Adults
•
Treatment of heterozygous familial hypercholesterolemia
•
Treatment of primary hyperlipidemia
•
Prevention of cardiovascular events in patients with established CVD or at high risk for CVD events
Safety risks
Contraindications
Hypersensitivity to bempedoic acid or its components
Warnings and precautions
Increased urine uric acid
•
Maintain a high level of suspicion, as bempedoic acid may increase blood uric acid levels and lead to the development of gout.
Tendon rupture
•
Maintain a high level of suspicion, as bempedoic acid has been associated with an increasing risk of tendon rupture or injury.
Specific populations
Renal impairment
eGFR ≥ 30 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR < 30 mL/min/1.73 m²
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Consider safer alternatives. Bempedoic acid may cause fetal harm based on the mechanism of action. Discontinue bempedoic acid when pregnancy is detected unless the benefits outweigh the potential risks.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
May potentially cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
↑ platelet count, ↑ serum uric acid, renal dysfunction
Common 1-10%
•
Anemia, bronchitis, cholelithiasis, ↓ WBC count, gout, ↑ BUN, ↑ liver enzymes, ↑ serum CK, ↑ serum creatinine, ↑ serum transaminases, abdominal pain, abdominal discomfort, back pain, muscle spasms, pain in extremity, upper respiratory tract infections
Uncommon < 1%
•
Tendon rupture
Unknown frequency
•
Angioedema, wheezing, skin rash, urticaria
Interactions
Drug(s)
Check Interactions
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