Usual Adult Dose for Heterozygous Familial Hypercholesterolemia

180 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 in those requiring additional LDL-C lowering.

Usual Adult Dose for Cardiovascular Risk Reduction

180 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 in those requiring 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

Liver Dose Adjustments

Mild to moderate hepatic impairment (Child Pugh A or B): No adjustment recommended
Severe hepatic impairment: Data not available

Precautions

CONTRAINDICATIONS: None

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

General:

• This drug, in combination with maximally tolerated statins (with or without other lipid modifying agents) decreases LDL-C, non-high-density lipoprotein cholesterol, apolipoprotein B, and total cholesterol.
• 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.