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Nexletol Generic Name & Formulations
Legal Class
Rx
General Description
Bempedoic acid 180mg; tabs.
Pharmacological Class
Adenosine triphosphate-citrate lyase (ACL) inhibitor.
How Supplied
Tabs—30, 90
Manufacturer
Generic Availability
NO
Nexletol Indications
Indications
An adjunct to diet and maximally tolerated statin therapy, in patients with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
Limitations of Use
The effect of Nexletol on cardiovascular morbidity and mortality has not been determined.
Nexletol Dosage and Administration
Adult
180mg once daily.
Children
Not established.
Nexletol Contraindications
Not Applicable
Nexletol Boxed Warnings
Not Applicable
Nexletol Warnings/Precautions
Warnings/Precautions
Hyperuricemia. Assess serum uric acid as clinically indicated. History of gout. Increased risk for tendon rupture/injury (esp. >60yrs, renal failure); discontinue immediately if occurs; consider discontinuing if joint pain, swelling, or inflammation develop. History of tendon disorders/rupture: consider alternative therapy. Assess lipid levels within 8–12 weeks after initiation. Elderly. Severe hepatic (Child-Pugh C) or renal impairment (eGFR <30mL/min/1.73 m2). ESRD on dialysis. Pregnancy: discontinue if occurs. Nursing mothers: not recommended.
Nexletol Pharmacokinetics
See Literature
Nexletol Interactions
Interactions
Avoid concomitant simvastatin >20mg or pravastatin >40mg. Increased risk for tendon rupture with corticosteroid or fluoroquinolone drugs.
Nexletol 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; gout, BPH.
Nexletol Clinical Trials
See Literature
Nexletol Note
Not Applicable
Nexletol Patient Counseling
See Literature
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