Usual Adult Dose for Heterozygous Familial Hypercholesterolemia

Bempedoic acid 180 mg/ ezetimibe 10 mg orally once a day

Comments:

• This drug should be given with maximally tolerated statin therapy.
• Lipid levels should be checked within 8 to 12 weeks of treatment initiation.

Uses: As an adjunct to diet and maximally tolerated statin therapy for the treatment of heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional LDL-C lowering.

Usual Adult Dose for Cardiovascular Risk Reduction

Bempedoic acid 180 mg/ ezetimibe 10 mg orally once a day

Comments:

• This drug should be given with maximally tolerated statin therapy.
• Lipid levels should be checked within 8 to 12 weeks of treatment initiation.

Uses: As an adjunct to diet and maximally tolerated statin therapy for the treatment of heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional LDL-C lowering.

Renal Dose Adjustments

Mild to moderate renal impairment (eGFR 30 mL/min/1.73 m2 or greater): No adjustment recommended
Severe renal impairment (eGFR less than 30 mL/min/1.73 m2): Use caution as there is limited experience with bempedoic acid

Liver Dose Adjustments

Mild hepatic impairment (Child Pugh A): No adjustment recommended
Moderate to Severe hepatic impairment: Not recommended due to unknown effects of increased exposure to ezetimibe

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to ezetimibe; hypersensitivity reactions have included anaphylaxis, angioedema, rash, and urticaria

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally once a day with or without food
• Swallow whole
• Administer either 2 hours before or at least 4 hours after bile acid sequestrants

General:

• Administration of bempedoic acid and ezetimibe in combination with maximally tolerated statins, with or without other lipid modifying agents, decreases LDL-C, non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (apo B), and total cholesterol (TC) in patients with hyperlipidemia.
• Concomitant use with simvastatin or pravastatin my increase the risk of simvastatin or pravastatin associated myopathy as it may increase the serum concentrations of these drugs.

Monitoring:

• Lipid levels should be checked within 8 to 12 weeks of therapy initiation
• Serum uric acid levels should be obtained as clinically indicated

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Patient Information).
• Patients should be instructed to report tendinitis or tendon rupture symptoms.
• Patients should be instructed to report signs or symptoms of hyperuricemia.
• Patients should be instructed to speak with their healthcare provider if they are or are planning to become pregnant or breastfeeding.