Home Drug Guide Bempedoic Acid; Ezetimibe

Drug Guide

Generic Name

Bempedoic Acid; Ezetimibe

Brand Names Nexlizet

Classification

Therapeutic: Lipid-lowering agent

Pharmacological: S, Ezetimibe: Cholesterol absorption inhibitor; Bempedoic Acid: ATP Citrate Lyase Inhibitor

FDA Approved Indications

Major dyslipidemia (primary hyperlipidemia or mixed dyslipidemia) in adults as an adjunct to diet and maximally tolerated statin therapy.

Mechanism of Action

Bempedoic acid inhibits ATP citrate lyase, an enzyme in the cholesterol biosynthesis pathway, reducing LDL cholesterol. Ezetimibe inhibits intestinal absorption of cholesterol by blocking the NPC1L1 transporter.

Dosage and Administration

Adult: Usually, 180 mg of bempedoic acid combined with 10 mg of ezetimibe once daily; administer orally with or without food.

Pediatric: Not approved for pediatric use.

Geriatric: No specific dosage adjustment required; monitor renal and hepatic function as appropriate.

Renal Impairment: Use with caution; dosage adjustments may be necessary for severe impairment.

Hepatic Impairment: Use with caution; avoid in severe hepatic impairment.

Pharmacokinetics

Absorption: Rapidly absorbed with food; peak plasma concentrations in 3-4 hours.

Distribution: Extensively bound to plasma proteins.

Metabolism: Bempedoic acid is activated in the liver; ezetimibe is extensively metabolized via glucuronidation.

Excretion: Primarily excreted in feces; ezetimibe metabolites are excreted in feces and urine.

Half Life: Bempedoic acid: approximately 21 hours; ezetimibe: about 22 hours.

Contraindications

Hypersensitivity to components

Precautions

Monitor liver function tests; use with caution in patients with hepatic impairment.
May increase risk of tendinopathies or tendon rupture.
Use with caution in patients on other lipid-lowering therapies.

Adverse Reactions - Common

Hyperuricemia (Common)
Elevated hepatic enzymes (Common)
Muscle pain (Uncommon)

Adverse Reactions - Serious

Rhabdomyolysis (Rare)
Hepatotoxicity (Rare)

Drug-Drug Interactions

Statins: Increased risk of adverse effects; monitor closely.
Gout medications: Elevated uric acid may exacerbate gout.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor lipid profile, liver function tests, uric acid levels, and muscle symptoms.

Diagnoses:

Risk for muscle injury related to lipid-lowering therapy
Potential for hepatic dysfunction

Implementation: Administer as prescribed, educate patient about symptoms of side effects, monitor labs regularly.

Evaluation: Assess reduction in LDL cholesterol, monitor for adverse effects.

Patient/Family Teaching

Take medication exactly as prescribed, with or without food.
Report muscle pain, weakness, or tenderness immediately.
Avoid excessive alcohol intake to reduce hepatic risk.
Maintain regular follow-up appointments for lab tests.

Special Considerations

Black Box Warnings:

Myopathy and rhabdomyolysis, especially when combined with statins.

Genetic Factors: Not specifically affected by genetic testing.

Lab Test Interference: Elevations in hepatic enzymes and uric acid levels.

Overdose Management

Signs/Symptoms: Muscle pain, weakness, elevated liver enzymes, symptoms of hepatic failure.

Treatment: Supportive care; activated charcoal if ingestion is recent; hemodialysis is not effective.

Storage and Handling

Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F).

Stability: Stable under recommended storage conditions; discard expired medication.