Indications : התוויות

4.1 Therapeutic indications
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 (CAPS)
Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) in adults, adolescents and children aged 2 years and older with body weight of 7.5 kg or above, 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) in patients in whom colchicine 
ILA API MAR17 CL V6                                        EMA SmPC Approved 23.2.2017 is contraindicated, is not tolerated, or does not provide an adequate response despite the highest tolerable dose of colchicine.
Ilaris can be given as monotherapy or in combination with colchicine.

Ilaris is also indicated for the treatment of:

Systemic Juvenile Idiopathic Arthritis (SJIA)
Ilaris is indicated for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 4 years and older.

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 (see section 5.1).