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inclisiran

Leqvio · ATC code C10AX

Key facts
Active substance
inclisiran
ATC code
C10AX
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Leqvio 284 mg solution for injection in pre-filled syringe
Marketing authorisation holder
Novartis Europharm Limited
Information as of
2026-10-27

Key facts

Inclisiran is an siRNA that inhibits hepatic PCSK9 production, lowering LDL cholesterol in primary hypercholesterolaemia or mixed dyslipidaemia.

What it is used for

  • Adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet
  • Paediatric patients aged 12 years and older with heterozygous familial hypercholesterolaemia
  • With a statin when LDL-C goals are not reached at the maximum tolerated statin dose
  • Alone or with other lipid-lowering therapies in statin intolerance or contraindication

Dosing

  • 284 mg as a single subcutaneous injection: initially, again at 3 months, then every 6 months
  • Missed by less than 3 months: give and continue the original schedule; by more than 3 months: restart the schedule
  • Switching from PCSK9 monoclonal antibodies: within 2 weeks after their last dose
  • No dose adjustment in the elderly, mild to moderate hepatic or any renal impairment
  • Administered by a healthcare professional into the abdomen, upper arm or thigh

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Haemodialysis should not be performed for at least 72 hours after dosing
  • Caution in severe hepatic impairment (no data) and severe renal impairment (limited experience)

Side effects

  • Common: injection site reactions (the only adverse reactions associated with inclisiran in trials)
  • Frequency not known: hypersensitivity including anaphylactic reaction, angioedema, rash, urticaria, pruritus

Interactions

  • No clinically significant interactions expected, including with atorvastatin, rosuvastatin or other statins

Pregnancy and breastfeeding

  • As a precaution, use during pregnancy is preferably avoided
  • Breast-feeding: a risk to infants cannot be excluded; decision weighing breast-feeding against therapy

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)

  • LeqvioNovartis Europharm Limited · EMEA/H/C/005333

Source: European Medicines Agency (EMA), product information

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

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. Leqvio – 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/leqvio-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.