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bempedoic acid

Nilemdo · ATC code C10AX

Also known as: Bempedoinsäure

Key facts
Active substance
bempedoic acid
ATC code
C10AX
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Nilemdo 180 mg film-coated tablets
Marketing authorisation holder
Daiichi Sankyo Europe GmbH
Information as of
2026-10-27

Key facts

Bempedoic acid (Nilemdo) is an oral lipid-lowering medicine. It is used in adults with primary hypercholesterolaemia or mixed dyslipidaemia and to reduce cardiovascular risk by lowering LDL-C.

What it is used for

  • Primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in adults, as an adjunct to diet
  • With a statin when LDL-C goals are not reached on the maximum tolerated statin dose
  • Alone or with other lipid-lowering therapies in patients who are statin-intolerant or for whom a statin is contraindicated
  • Adults with established or high risk of atherosclerotic cardiovascular disease, to reduce cardiovascular risk

Dosing

  • One 180 mg film-coated tablet once daily, with or without food, swallowed whole
  • With simvastatin: limit simvastatin to 20 mg daily (40 mg daily in selected cases)
  • No dose adjustment in elderly patients or in mild to moderate renal or hepatic impairment
  • Severe renal impairment and dialysis: limited data; additional monitoring may be warranted
  • Children under 18 years: safety and efficacy not established

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Pregnancy
  • Concomitant use with simvastatin > 40 mg daily

Important warnings

  • Bempedoic acid increases statin plasma concentrations: increased risk of myopathy, rarely rhabdomyolysis
  • Unexplained muscle pain, tenderness or weakness should be reported promptly
  • If myopathy is confirmed (CPK > 10× ULN), stop bempedoic acid and any statin immediately
  • Caution with concomitant fibrates

Side effects

  • Most common: hyperuricaemia (3.8%), pain in extremity (3.1%), anaemia (2.5%), gout (1.4%)
  • Common: aspartate aminotransferase increased
  • Uncommon: haemoglobin decreased, weight decreased, alanine aminotransferase and liver function tests increased

Interactions

  • Statins (especially simvastatin): increased statin levels; observe dose limits
  • Probenecid increases exposure, without clinically meaningful impact on dosing

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; discontinue before conception or as soon as pregnancy is planned or recognised
  • Women of childbearing potential should use effective contraception during treatment

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • NilemdoDaiichi Sankyo Europe GmbH · EMEA/H/C/004958

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Nilemdo
Liechtenstein
Nilemdo
Norway
Nilemdo

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Nilemdo – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/nilemdo-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.