Nilemdo

Posology The recommended dose of Nilemdo is one film-coated tablet of 180 mg taken once daily. 5). 2). Patients with renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment. 2). 4). Patients with hepatic impairment No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh A or B).

No data are available in patients with severe hepatic impairment (Child-Pugh C). 4). Paediatric population The safety and efficacy of Nilemdo in children aged less than 18 years have not yet been established. No data are available. Method of administration Each film-coated tablet should be taken orally with or without food.

Tablet should be swallowed whole.

4%). 2%), although differences between bempedoic acid and placebo were not significant. 7 Tabulated list of adverse reactions Adverse reactions reported with bempedoic acid, based on incidence rates from phase 3 primary hyperlipidaemia studies and exposure adjusted incidence rates from CLEAR Outcomes study, are displayed by system organ class and frequency in table 1.

Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); and not known (cannot be estimated from the available data).

Table 1:

Adverse reactions System organ class (SOC) Adverse reactions Frequency categories Blood and lymphatic system disorders Anaemiaa Common Haemoglobin decreased Uncommon Metabolism and nutrition disorders Gout Common Hyperuricaemiaa,b Common Weight decreasedc Uncommon Hepatobiliary disorders Aspartate aminotransferase increased Common Alanine aminotransferase increased Uncommon Liver function test increased Uncommon Musculoskeletal and connective tissue disorders Pain in extremity Common Renal and urinary disorders Glomerular filtration rate decreased Common Blood creatinine increased Uncommon Blood urea increased Uncommon a.

5 b. Hyperuricaemia includes hyperuricaemia and blood uric acid increased c. 28 kg at month 36. 5 kg in patients with a baseline BMI of 25 to <30 kg/m2. Bempedoic acid was not associated with a mean change in body weight in patients with a baseline BMI of < 25 kg/m2 Description of selected adverse reactions Hepatic enzyme elevations Increases in serum transaminases (AST and/or ALT) have been reported with bempedoic acid.

3% for placebo. 0%). 4). 5). 8 mg/dL) in uric acid compared to baseline was observed with bempedoic acid at week 12. The elevations in serum uric acid usually occurred within the first 4 weeks of treatment and returned to baseline following discontinuation of treatment.

5). 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. 4 Myositis with a CPK level > 10× ULN was rarely reported with bempedoic acid and background simvastatin 40 mg therapy.

3). Concomitant use of fibrates Concomitant administration of fibrates with bempedoic acid resulted in increased triglycerides and decreased high-density lipoprotein cholesterol (HDL-C) in some patients in clinical studies and post- marketing reports.

5). 8). 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.

1. 6). 5).