canakinumab
Ilaris · ATC code L04AC08
Also known as: Kanakinumab
- Key facts
- Active substance
- canakinumab
- Drug class
- Immunosuppressive drug
- ATC code
- L04AC08
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Ilaris 150 mg/ml solution for injection / Ilaris 150 mg solution for injection in pre-filled pen
- Marketing authorisation holder
- Novartis Europharm Limited
- Information as of
- 2026-10-28
Key facts
Canakinumab is a monoclonal antibody against interleukin-1 beta (IL-1 beta) used to treat autoinflammatory periodic fever syndromes, Still's disease and frequent gouty arthritis attacks (Ilaris).
What it is used for
- Periodic fever syndromes in adults, adolescents and children aged 2 years and older: cryopyrin-associated periodic syndromes (CAPS), TRAPS, HIDS/MKD and familial Mediterranean fever (FMF, with colchicine if appropriate).
- Active Still's disease (AOSD and SJIA) from 2 years after inadequate response to NSAIDs and systemic corticosteroids.
- Symptomatic treatment of frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in adults when NSAIDs and colchicine are unsuitable and repeated courses of corticosteroids are not appropriate.
Dosing
- CAPS: starting dose 150 mg (>40 kg), 2 mg/kg (15 to 40 kg) or 4 mg/kg (7.5 to <15 kg, and children 2 to <4 years), subcutaneously every eight weeks; if response is inadequate after 7 days, additional doses are possible. Details: see the full text.
- TRAPS, HIDS/MKD and FMF: 150 mg (>40 kg) or 2 mg/kg (7.5 to 40 kg) subcutaneously every four weeks; if response is inadequate after 7 days, a second dose can be considered (maintenance then 300 mg or 4 mg/kg every 4 weeks).
- Still's disease (≥ 7.5 kg): 4 mg/kg (maximum 300 mg) subcutaneously every four weeks.
- Gouty arthritis: 150 mg subcutaneously as a single dose during an attack, as early as possible; re-treatment no sooner than 12 weeks; urate-lowering therapy should be instituted or optimised.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Active, severe infections.
Important warnings
- Increased incidence of serious infections; do not start or continue during an active infection requiring medical intervention. Isolated opportunistic infections have been reported.
- Evaluate for active and latent tuberculosis before starting.
- Neutropenia and leukopenia: assess white blood cell counts before starting and after 1 to 2 months; do not start in patients with neutropenia or leukopenia.
- Live vaccines should not be given concurrently unless benefits clearly outweigh risks; give vaccinations before starting where possible.
- Be alert to macrophage activation syndrome in Still's disease; DRESS, malignancies and hypersensitivity reactions have also been reported.
Side effects
- Most frequent: infections, predominantly of the upper respiratory tract.
- Very common: respiratory tract infections, injection site reactions, upper abdominal pain, arthralgia, leukopenia.
- Common: dizziness/vertigo, vulvovaginal candidiasis, neutropenia, fatigue; opportunistic infections and hypersensitivity reactions have also been reported.
Interactions
- Use with TNF inhibitors is not recommended (increased risk of serious infections).
- No live vaccines during treatment unless benefits clearly outweigh risks.
Pregnancy and breastfeeding
- Women should use effective contraception during treatment and for up to 3 months after the last dose; treat in pregnancy only after thorough benefit-risk evaluation.
- Breast-feeding only after a thorough benefit-risk evaluation.
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.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
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)
- IlarisNovartis Europharm Limited · EMEA/H/C/001109
Source: European Medicines Agency (EMA), product information
Turkey
- IlarisNOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNLERİ SAN. VE TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Ilaris
- Liechtenstein
- Ilaris
- Norway
- Ilaris
EMA – Article 57 product data (EU/EEA), 2026-10-29
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
- European Medicines Agency. Ilaris – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/ilaris-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L04AC.
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.