This is a summary of the European public assessment report (EPAR) for Ilaris. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ilaris. For practical information about using Ilaris, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic indication **Periodic fever syndromes** Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older: **Cryopyrin-associated periodic syndromes** Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including: - Muckle-Wells syndrome (MWS), - Neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA), - Severe forms of familial cold autoinflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash. **Tumour necrosis factor receptor associated periodic syndrome (TRAPS)** Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS). **Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD)** Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD). **Familial Mediterranean fever (FMF)** Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF). Ilaris should be given in combination with colchicine, if appropriate. Ilaris is also indicated for the treatment of: **Still’s disease** Ilaris is indicated for the treatment of active Still’s disease including adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate. **Gouty arthritis** Ilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate.
Therapeutic Area (MeSH)
ATC Code
L04AC08
ATC Item
canakinumab
Pharmacotherapeutic Group
Interleukin inhibitors
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Canakinumab | N/A | 卡那奴单抗 |
EMA Name
Ilaris
Medicine Name
Ilaris
Aliases
N/ANo risk management plan link.
