alirocumab
Praluent · ATC code C10AX14
Also known as: Alirokumab
- Key facts
- Active substance
- alirocumab
- ATC code
- C10AX14
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Praluent 75 mg solution for injection in pre-filled pen / Praluent 150 mg solution for injection in pre-filled pen / Praluent 75 mg solution for injection in pre-filled syringe
- Marketing authorisation holder
- Sanofi Winthrop Industrie
- Information as of
- 2026-10-28
Key facts
Alirocumab (Praluent) is a monoclonal antibody against PCSK9 that lowers LDL cholesterol; it is used for hypercholesterolaemia, mixed dyslipidaemia and established atherosclerotic cardiovascular disease.
What it is used for
- Adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia, as an adjunct to diet: with a statin (± other lipid-lowering therapies) when LDL-C goals are not reached on the maximum tolerated statin dose, or alone/with other therapies when statins are not tolerated or contraindicated.
- Adults with established atherosclerotic cardiovascular disease, to reduce cardiovascular risk by lowering LDL-C, as an adjunct to correction of other risk factors.
Dosing
- Adults: 75 mg or 150 mg once every 2 weeks, or 300 mg once every 4 weeks, by subcutaneous injection; 150 mg once every 2 weeks is the maximum dose. Lipid levels can be assessed 4 to 8 weeks after starting or titration.
- Children 8 years and older with HeFH, less than 50 kg: 150 mg once every 4 weeks (75 mg once every 2 weeks if more LDL-C reduction is needed).
- Children 8 years and older with HeFH, 50 kg or more: 300 mg once every 4 weeks (150 mg once every 2 weeks if more reduction is needed).
- The 300 mg dose is given as one 300 mg injection or two 150 mg injections at two different sites.
- No dose adjustment in the elderly or in mild or moderate hepatic or renal impairment; limited or no data in severe impairment.
- Missed dose: inject as soon as possible, then resume the original schedule.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
Important warnings
- Allergic reactions including pruritus, and rarely serious reactions such as hypersensitivity, nummular eczema, urticaria and hypersensitivity vasculitis, have been reported; angioedema has been reported after marketing. Treatment must be stopped if serious allergic reactions occur.
- Use with caution in severe renal impairment (eGFR < 30 mL/min/1.73 m2).
- Use with caution in severe hepatic impairment (Child-Pugh C), which has not been studied.
- Secondary causes of hyperlipidaemia (e.g. nephrotic syndrome, hypothyroidism) should be excluded before starting.
Side effects
- Most common: local injection site reactions (6.1%), upper respiratory tract signs and symptoms (2.0%) and pruritus (1.1%).
- Rare: hypersensitivity, hypersensitivity vasculitis, urticaria, nummular eczema.
- Not known: angioedema, flu-like illness.
Interactions
- No pharmacokinetic effects on other medicines or on cytochrome P450 enzymes are expected.
- Statins, ezetimibe and fenofibrate lower alirocumab exposure by about 40%, 15% and 35% respectively; LDL-C reduction is maintained with every-two-week dosing.
Pregnancy and breastfeeding
- No data in pregnant women; alirocumab is expected to cross the placenta. Use in pregnancy is not recommended unless the woman's clinical condition requires treatment with alirocumab.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Package leaflet, verbatim
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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)
- PraluentSanofi Winthrop Industrie · EMEA/H/C/003882
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Praluent
- Liechtenstein
- Praluent
- Norway
- Praluent
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Sources
- European Medicines Agency. Praluent – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/praluent-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-28 · 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.