Nexlizet

— THERAPEUTIC CATEGORIES —
  • Hyperlipoproteinemias
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Nexlizet Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Bempedoic acid 180mg, ezetimibe 10mg; tabs.

    Pharmacological Class

    Adenosine triphosphate-citrate lyase (ACL) inhibitor + cholesterol absorption inhibitor.

    How Supplied

    Tabs—30, 90

    Manufacturer

    Esperion Therapeutics, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Bempedoic acid is an ACL inhibitor that lowers LDL-C by inhibition of cholesterol synthesis in the liver. Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine.

    Nexlizet Indications

    Indications

    An adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). Bempedoic acid when used as a component of Nexlizet: to reduce the risk of myocardial infarction (MI) and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with: established cardiovascular disease (CVD), or a high risk for a CVD event but without established CVD.

    Nexlizet Dosage and Administration

    Adult

    Swallow whole. 180mg/10mg once daily. After initiation, assess lipid levels within 8–12 weeks. Concomitant bile acid sequestrants: give Nexlizet either ≥2hrs before or ≥4hrs after.

    Children

    Not established.

    Nexlizet Contraindications

    Not Applicable

    Nexlizet Boxed Warnings

    Not Applicable

    Nexlizet Warnings/Precautions

    Warnings/Precautions

    Hyperuricemia. Assess serum uric acid as clinically indicated. History of gout. Increased risk for tendon rupture/injury (esp. >60yrs, in those taking corticosteroid or fluoroquinolone drugs, renal failure, previous tendon disorders). Consider discontinuing if joint pain, swelling, or inflammation develop. History of tendon disorders/rupture: consider alternative therapy. Elderly. Moderate or severe hepatic (Child-Pugh B or C): not recommended. Severe renal impairment (eGFR <30mL/min/1.73 m2). ESRD on dialysis. Pregnancy: discontinue if occurs. Nursing mothers: not recommended.

    Nexlizet Pharmacokinetics

    Distribution

    Bempedoic acid

    • Apparent volume of distribution (V/F): 18 L.
    • Plasma protein bound: 99.3%.

    Ezetimibe

    • Plasma protein bound: >90%.

     

    Metabolism

    Hepatic.

    Elimination

    Bempedoic acid

    • Renal (70%), fecal (~30%). Half-life: 21 ± 11 hours.

    Ezetimibe

    • Renal (11%), fecal (78%). Half-life: ~22 hours.

     

    Nexlizet Interactions

    Interactions

    Avoid concomitant simvastatin >20mg or pravastatin >40mg. Concomitant cyclosporine increases ezetimibe and cyclosporine levels; monitor. Concomitant use with fibrates (except fenofibrate): not recommended. Concomitant use with fenofibrate: consider alternative therapy if cholelithiasis is suspected. Antagonized by cholestyramine (see Adult dose).

    Nexlizet Adverse Reactions

    Adverse Reactions

    Upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, elevated liver enzymes, diarrhea, arthralgia, sinusitis, fatigue, influenza, renal impairment, anemia, gout, cholelithiasis; BPH, atrial fibrillation, hypersensitivity reactions (ezetimibe).

    Nexlizet Clinical Trials

    See Literature

    Nexlizet Note

    Not Applicable

    Nexlizet Patient Counseling

    See Literature

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