Canakinumab

Recombinant, human monoclonal anti-human interleukin-1beta antibody of the IgG1κ isotype.

Adults and children aged 2 years and older for the treatment of cryopyrin-associated periodic syndromes (CAPS) [Muckle-Wells syndrome (MWS), Familial cold autoinflammatory syndrome (FCAS)/Familial cold urticaria (FCU), Neonatal-onset multisystem inflammatory disorder (NOMID)/Chronic infantile neurodermoarticular syndrome (CINCA)]. Further approvals: Tumour necrosis factor receptor-associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS), familial Mediterranean fever (FMF), Still’s syndrome, mevalonate kinase deficiency (MKD), active systemic juvenile idiopathic arthritis (sJIA).

No

Partial, time-limited limits on CAPS, sJIA, MKD, TRAPS, HIDS and FMF.

Solution for injection.

Differential blood count, CRP, transaminases, creatinine, urinalysis, screening for HBV, HCV, HIV and TB (optional: including chest X-ray).

Differential blood count, transaminases, creatinine, CRP.

After 1 month, then every 3 months.

Depending on the indication.

For CAPS: 150 mg for a body weight (kg) of >40 kg and 2 mg/kg body weight for a body weight of ≥15 kg and ≤40 kg every 8 weeks; if necessary, a second administration of the same dose if no improvement has occurred within 7 days of the first administration, and, if necessary, a third dose of 300 mg or 4 mg/kg body weight after 7 days (then increase the dose to 600 mg or 8 mg/kg body weight, administered every 8 weeks).

Data varies depending on the clinical presentation; a first clinical review is recommended after seven days.

Predisposition to infections (particularly TB), intolerances

72,502 (for body weight (kg) > 40 kg, administered every 8 weeks)

Elective surgery is recommended 4 weeks after the last injection, and treatment should only be resumed once wound healing is complete. In the event of an acute infection, it is recommended to suspend treatment until the infection has cleared.

Max. 7 days after the first dose (as a repeat dose and/or an increase in dose may be necessary).

No antibody formation in TRAPS, HIDS/MKD and FMF; 1.5–3% of patients develop antibodies against canakinumab in CAPS and systemic juvenile idiopathic arthritis.

Hypersensitivity to the active substance or to any of the other ingredients. Active severe infections (particularly TB). Chronic viral infections (HIV, HBV, HCV).

No data available on use during pregnancy and breastfeeding (no toxicity observed in pre-clinical trials in mice).

Upper respiratory tract infections, nasopharyngitis, sinusitis, urinary tract infections, vertigo, neutropenia, thrombocytopenia, elevated transaminases, hypersensitivity reaction, macrophage activation syndrome, DRESS syndrome

An increase in serious infections is anticipated when administered concomitantly with a TNF-α inhibitor (combination with other biologics or JAK inhibitors is generally not recommended).

No live vaccines.

Start TB prophylaxis at least 1 month before the start of treatment.

Testing before the start of treatment, including a detailed medical history.