Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, 81379 Munich, Germany
Nilemdo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet:
Nilemdo is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
The recommended dose of Nilemdo is one film-coated tablet of 180 mg taken once daily.
When Nilemdo is coadministered with simvastatin, simvastatin dose should be limited to 20 mg daily (or 40 mg daily for patients with severe hypercholesterolaemia and high risk for cardiovascular complications, who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks) (see sections 4.4 and 4.5).
No dose adjustment is necessary in elderly patients (see section 5.2).
No dose adjustment is necessary in patients with mild or moderate renal impairment. There are limited data available in patients with severe renal impairment (defined as estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m²), and patients with end-stage renal disease (ESRD) on dialysis have not been studied. Additional monitoring for adverse reactions may be warranted in these patients when Nilemdo is administered (see section 4.4).
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). Periodic liver function tests should be considered for patients with severe hepatic impairment (see section 4.4).
The safety and efficacy of Nilemdo in children aged less than 18 years have not yet been established. No data are available.
Each film-coated tablet should be taken orally with or without food. Tablet should be swallowed whole.
Doses up to 240 mg/day (1.3 times the approved recommended dose) have been administered in clinical trials with no evidence of dose limiting toxicity.
No adverse events were observed in animal studies at exposures up to 14-fold higher than those in patients treated with bempedoic acid at 180 mg once daily.
There is no specific treatment for a Nilemdo overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
36 months.
This medicinal product does not require any special storage conditions.
Polyvinyl chloride (PVC)/aluminum blisters.
Pack sizes of 10, 14, 28, 30, 84, 90, 98 or 100 film-coated tablets.
Polyvinyl chloride (PVC)/aluminum perforated unit dose blisters.
Pack sizes of 10 × 1, 50 × 1 or 100 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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