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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
Generic Availability
NO
Nexlizet Indications
Indications
An adjunct to diet and maximally tolerated statin therapy, in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
Limitations of Use
The effect on cardiovascular morbidity and mortality has not been determined.
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, nursing mothers: not recommended.
Nexlizet Pharmacokinetics
See Literature
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; BPH, atrial fibrillation, hypersensitivity reactions (ezetimibe).
Nexlizet Clinical Trials
See Literature
Nexlizet Note
Not Applicable
Nexlizet Patient Counseling
See Literature
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