Nexletol Special Precautions

Potential risk of myopathy with concomitant use of statins: Bempedoic acid increases plasma concentrations of statins (see Interactions). Patients receiving Nexletol as adjunctive therapy to a statin should be monitored for adverse reactions that are associated with the use of high doses of statins. Statins occasionally cause myopathy. In rare cases, myopathy may take the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and can lead to fatality. All patients receiving Nexletol in addition to a statin should be advised of the potential increased risk of myopathy and told to report promptly any unexplained muscle pain, tenderness, or weakness. If such symptoms occur while a patient is receiving treatment with Nexletol and a statin, a lower maximum dose of the same statin or an alternative statin, or discontinuation of Nexletol and initiation of an alternative lipid-lowering therapy should be considered under close monitoring of lipid levels and adverse reactions. If myopathy is confirmed by a creatine phosphokinase (CPK) level >10x upper limit of normal (ULN), Nexletol and any statin that the patient is taking concomitantly should be immediately discontinued.
Myositis with a CPK level >10x ULN was rarely reported with bempedoic acid and background simvastatin 40 mg therapy. Doses of simvastatin >40 mg should not be used with Nexletol (see Dosage & Administration and Contraindications).
Increased serum uric acid: Bempedoic acid may raise the serum uric acid level due to inhibition of renal tubular OAT2 and may cause or exacerbate hyperuricaemia and precipitate gout in patients with a medical history of gout or predisposed to gout (see Adverse Reactions). Treatment with Nexletol should be discontinued if hyperuricaemia accompanied with symptoms of gout appear.
Elevated liver enzymes: In clinical trials, elevations of >3x ULN in the liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been reported with bempedoic acid. These elevations have been asymptomatic and not associated with elevations ≥2x ULN in bilirubin or with cholestasis and have returned to baseline with continued treatment or after discontinuation of therapy. Liver function tests should be performed at initiation of therapy. Treatment with Nexletol should be discontinued if an increase in transaminases of >3x ULN persists (see Adverse Reactions).
Renal impairment: There is limited experience with bempedoic acid in patients with severe renal impairment (defined as eGFR <30 mL/min/1.73 m²), and patients with ESRD on dialysis have not been studied (see Pharmacology: Pharmacokinetics under Actions). Additional monitoring for adverse reactions may be warranted in these patients when Nexletol is administered.
Hepatic impairment: Patients with severe hepatic impairment (Child-Pugh C) have not been studied (see Pharmacology: Pharmacokinetics under Actions). Periodic liver function tests should be considered for patients with severe hepatic impairment.
Excipients: Nexletol contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per 180 mg film-coated tablet (daily dose), that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: Nexletol has no or negligible influence on the ability to drive and use machines.
Use in Pregnancy: Contraception: Women of childbearing potential must use effective contraception during treatment. Patients should be advised to stop taking Nexletol before stopping contraceptive measures if they plan to become pregnant.