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Potential risk of myopathy with concomitant use of statins: Bempedoic acid increases plasma concentrations of statins (see Interactions). Patients receiving Nilemdo 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 Nilemdo 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 Nilemdo and a statin, a lower maximum dose of the same statin or an alternative statin, or discontinuation of Nilemdo 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 >10× upper limit of normal (ULN), Nilemdo and any statin that the patient is taking concomitantly should be immediately discontinued.
Myositis with a CPK level >10× ULN was rarely reported with bempedoic acid and background simvastatin 40 mg therapy. Doses of simvastatin >40 mg should not be used with Nilemdo (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 Nilemdo should be discontinued if hyperuricaemia accompanied with symptoms of gout appear.
Elevated liver enzymes: In clinical trials, elevations of >3× 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 ≥2× 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 Nilemdo should be discontinued if an increase in transaminases of >3× 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 Nilemdo 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.
Contraception measures in women of child-bearing potential: Before initiating treatment in women of child-bearing potential, appropriate advice on effective methods of contraception should be provided, and effective contraception initiated.
Patients taking oestrogen-based oral contraceptives should be advised about possible loss of effectiveness due to diarrhoea and/or vomiting. Patients should be advised to immediately contact their physician and stop treatment if they are planning to become pregnant or if they become pregnant (see Use in Pregnancy & Lactation).
Excipients: Nilemdo 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: Nilemdo has no or negligible influence on the ability to drive and use machines.
