Ilaris

Canakinumab

Treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents & childn ≥2 yr: Cryopyrin-associated periodic syndromes (CAPS) including Muckle-Wells syndrome; neonatal-onset multisystem inflammatory disease/chronic infantile neurological, cutaneous, articular syndrome; severe forms of familial cold autoinflammatory syndrome/familial cold urticaria presenting w/ signs & symptoms beyond cold-induced urticarial skin rash. Treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS). Treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD). Treatment of Familial Mediterranean Fever (FMF), in combination w/ colchicine, if appropriate. As monotherapy or in combination w/ methotrexate for the treatment of active Still's disease including adult-onset Still's disease (AOSD) & systemic juvenile idiopathic arthritis (SJIA) in patients ≥2 yr who have responded inadequately to previous therapy w/ NSAIDs & systemic corticosteroids. Symptomatic treatment of adult patients w/ frequent gouty arthritis attacks (at least 3 attacks in the previous 12 mth) in whom NSAIDs & colchicine are contraindicated, are not tolerated, or do not provide an adequate response, & in whom repeated courses of corticosteroids are not appropriate.

CAPS Adult, adolescent & childn ≥4 yr weighing >40 kg Initially 150 mg SC administered every 8 wk as a single dose, weighing 15-40 kg Initially 2 mg/kg SC administered every 8 wk as a single dose, weighing 7.5 kg to <15 kg Initially 4 mg/kg SC administered every 8 wk as a single dose. Childn 2 to <4 yr, weighing ≥7.5 kg Initially 4 mg/kg SC administered every 8 wk as a single dose. TRAPS, HIDS/MKD & FMF Adult, adolescent & childn ≥2 yr, weighing >40 kg Initially 150 mg SC administered every 4 wk as a single dose, weighing 7.5-40 kg Initially 2 mg/kg SC administered every 4 wk as a single dose. Still's disease Patients weighing ≥7.5 kg 4 mg/kg SC (up to a max 300 mg) administered every 4 wk. Gouty arthritis Adult 150 mg SC administered as a single dose during an attack.

Hypersensitivity. Active, severe infections.

Increased incidence of serious infection. Monitor patients for signs & symptoms of infections during & after treatment. Evaluate patients for both active & latent TB infection before treatment initiation. Closely monitor patients for signs & symptoms of TB during & after treatment. Neutropenia & leukopenia. Assess WBC counts including neutrophil counts prior to initiation of treatment & again after 1-2 mth. Reports of malignancies; hypersensitivity reactions; transient & asymptomatic cases of elevations of serum transaminases or bilirubin. CAPS patients w/o a confirmed NLRP3 gene mutation. Macrophage activation syndrome in patients w/ Still's disease. Concomitant use w/ tumor necrosis factor (TNF) inhibitors. Do not give concurrently w/ live vaccines. Minor influence on the ability to drive & use machines. Women should use effective contraceptives during treatment & for up to 3 mth after the last dose. Pregnancy & lactation. Childn <2 yr.

Resp tract infections (including pneumonia, bronchitis, influenza, viral infection, sinusitis, rhinitis, pharyngitis, tonsillitis, nasopharyngitis, upper resp tract infection), ear infection, cellulitis, gastroenteritis, UTI; inj site reaction. Vulvovaginal candidiasis; dizziness/vertigo; neutropenia. SJIA: Upper abdominal pain; arthralgia; CrCl decreased, proteinuria, leukopenia. Musculoskeletal pain. Gouty arthritis: Back pain.

Reversed expression of CYP450; perform therapeutic monitoring of CYP450 substrates w/ narrow therapeutic index. Increased risk of serious infections w/ TNF inhibitors.

Immunosuppressants

L04AC08 - canakinumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.

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