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Anakinra

Kineret · ATC code L04AC03

Key facts
Active substance
Anakinra
Drug class
Immunosuppressive drug
ATC code
L04AC03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.
Marketing authorisation holder
Swedish Orphan Biovitrum AB (publ)
Information as of
2026-10-27

Key facts

Anakinra is an interleukin-1 receptor antagonist (Kineret). It is used for rheumatoid arthritis, COVID-19 pneumonia, periodic fever syndromes and Still's disease.

What it is used for

  • Rheumatoid arthritis in adults, with methotrexate after inadequate response to methotrexate alone
  • COVID-19 in adults with pneumonia requiring oxygen and suPAR ≥ 6 ng/ml
  • Cryopyrin-associated periodic syndromes (CAPS: NOMID/CINCA, MWS, FCAS) from 8 months of age and 10 kg body weight
  • Familial Mediterranean fever (FMF), with colchicine if appropriate
  • Still's disease

Dosing

  • RA: 100 mg once daily by subcutaneous injection, at about the same time each day
  • COVID-19: 100 mg once daily subcutaneously for 10 days
  • CAPS: starting dose 1-2 mg/kg/day; usual maintenance in severe CAPS 3-4 mg/kg/day, up to a maximum of 8 mg/kg/day
  • FMF and Still's disease: 50 kg or more 100 mg/day; under 50 kg 1-2 mg/kg/day
  • Elderly: no dose adjustment in RA and COVID-19
  • Treatment is initiated and supervised by experienced specialists

Contraindications

  • Hypersensitivity to the active substance, excipients or E. coli derived proteins
  • Must not be initiated in neutropenia (ANC < 1.5 x 10⁹/l)

Important warnings

  • Allergic reactions including anaphylaxis and angioedema; discontinue if severe
  • Hepatic events; in Still's disease also non-infectious hepatitis including acute liver failure, mainly in the first month
  • Serious infections occurred more often than with placebo
  • Neutropenia may occur

Side effects

  • Most frequent: injection site reactions, mostly mild to moderate
  • Serious infections (1.8% vs. 0.7% with placebo in RA)
  • Decreased neutrophils, raised liver function tests, rash

Interactions

  • Use with etanercept or any other TNF-α antagonist is not recommended (more serious infections and neutropenia)
  • No formal interaction studies; possible effects on CYP450 substrates are in the full text

Pregnancy and breastfeeding

  • Pregnancy: limited data; as a precaution, use is preferably avoided
  • Breast-feeding should be discontinued 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 →

Common questions – ask Medelix

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)

  • KineretSwedish Orphan Biovitrum AB (publ) · EMEA/H/C/000363

Source: European Medicines Agency (EMA), product information

Turkey

  • KıneretPROCEUTİCA İLAÇ PAZARLAMA VE DANIŞMANLIK A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

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

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

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Kineret – 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/kineret-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC L04AC.

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.