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Bempedoic acid / ezetimibe

Class
Hypolipidemic agents
Subclass
ATP citrate lyase inhibitor / cholesterol absorption inhibitor combination
Generic name
Bempedoic acid / ezetimibe
Brand names
Nexlizet®
Contains
Bempedoic acid
Ezetimibe
Common formulations
Film-coated tablet
Dosage and administration
Adults patients
Heterozygous familial hypercholesterolemia
•
180/10 mg PO daily
Assess lipid levels 8-12 weeks after initiation.
Primary hyperlipidemia
•
180/10 mg PO daily
Assess lipid levels 8-12 weeks after initiation.
Indications for use
Labeled indications
Adults
•
Treatment of heterozygous familial hypercholesterolemia
•
Treatment of primary hyperlipidemia
Safety risks
Contraindications
Hypersensitivity to bempedoic acid/ezetimibe or its components
Warnings and precautions
Decreased serum ezetimibe levels
•
Use caution in patients taking bile acid sequestrants. Administer bempedoic acid/ezetimibe either at least 2 hours before or 4 hours after taking bile acid sequestrants.
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)
•
Do not use.
Child-Pugh C (severe)
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Consider safer alternatives. Bempedoic acid/ezetimibe may cause fetal harm based on the mechanism of action. Discontinue bempedoic acid/ezetimibe 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, influenza virus infection, abdominal pain, abdominal discomfort, arthralgia, back pain, diarrhea, fatigue, muscle spasms, pain in extremity, sinusitis, upper respiratory tract infections
Uncommon < 1%
•
Tendon rupture
Unknown frequency
•
Acute pancreatitis, hepatitis, acute cholecystitis, anaphylaxis, myopathy, rhabdomyolysis, angioedema, wheezing, skin rash, urticaria, ↓ platelet count, nausea, dizziness, paresthesia, headache, depression, erythema multiforme
Interactions
Drug(s)
Check Interactions
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