evolocumab
Repatha · ATC code C10AX13
- Key facts
- Active substance
- evolocumab
- ATC code
- C10AX13
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Repatha 140 mg solution for injection in pre-filled syringe / Repatha 140 mg solution for injection in pre-filled pen / Repatha 420 mg solution for injection in cartridge
- Marketing authorisation holder
- Amgen Europe B.V.
- Information as of
- 2026-10-27
Key facts
Evolocumab is a monoclonal antibody against PCSK9 that lowers LDL cholesterol. It is used for hypercholesterolaemia, mixed dyslipidaemia and to reduce cardiovascular risk in atherosclerotic cardiovascular disease.
What it is used for
- Primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in adults, as an adjunct to diet
- Heterozygous familial hypercholesterolaemia in paediatric patients aged 10 years and over
- In combination with a statin when LDL-C goals are not reached on the maximum tolerated statin dose, or alone/with other lipid-lowering therapies in statin intolerance or contraindication
- Homozygous familial hypercholesterolaemia in adults and children aged 10 years and over, with other lipid-lowering therapies
- Adults with established or high risk of atherosclerotic cardiovascular disease, to reduce cardiovascular risk
Dosing
- Primary hypercholesterolaemia, mixed dyslipidaemia and atherosclerotic disease: 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent
- Homozygous familial hypercholesterolaemia: initially 420 mg once monthly; after 12 weeks without a clinically meaningful response, may be up-titrated to 420 mg every 2 weeks
- Patients on apheresis may start with 420 mg every two weeks to match their apheresis schedule
- No dose adjustment in the elderly, in renal impairment or in mild hepatic impairment
- Subcutaneous injection into abdomen, thigh or upper arm; not intravenous or intramuscular
- 420 mg via pre-filled syringe or pen: three injections consecutively within 30 minutes; via cartridge: one cartridge with the automated mini-doser
Contraindications
- Hypersensitivity to the active substance or any of the excipients
Important warnings
- Moderate hepatic impairment: reduced exposure that may reduce the LDL-C-lowering effect; close monitoring may be warranted
- Severe hepatic impairment (Child-Pugh class C) not studied; use with caution
- The pre-filled syringe needle cover contains dry natural rubber (a latex derivative), which may cause severe allergic reactions
- Record the name and batch number of the biological product for traceability
Side effects
- Most common: nasopharyngitis (7.4%), upper respiratory tract infection (4.6%), back pain (4.4%), arthralgia (3.9%), influenza (3.2%) and injection site reactions (2.2%)
- Common: hypersensitivity, rash, headache, nausea, myalgia
- Uncommon: urticaria, influenza-like illness
- Rare: angioedema
Interactions
- Statins increase evolocumab clearance by approximately 20% without adversely affecting its lipid effect; no statin dose adjustment is needed
- No interaction studies with lipid-lowering medicines other than statins and ezetimibe
Pregnancy and breastfeeding
- Pregnancy: no or limited data; should not be used unless the woman's clinical condition requires treatment with evolocumab
- Breast-feeding: unknown whether excreted in human milk; a risk to the infant cannot be excluded, so a benefit-risk decision is required
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.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
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)
- RepathaAmgen Europe B.V. · EMEA/H/C/003766
Source: European Medicines Agency (EMA), product information
Turkey
- RepathaAMGEN İLAÇ TİC. LTD. ŞTİ. · 4 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 2 more European countries
- Iceland
- Repatha
- Norway
- Repatha
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.
Other substances in the same group
Related calculators
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Repatha – 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/repatha-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
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.