Canakinumab

CAPS up-titration: for patients with a starting dose of 150 mg or 2 mg/kg, if a satisfactory clinical response (resolution of rash and other generalised inflammatory symptoms) has not been achieved 7 days after treatment start, a second dose of 150 mg or 2 mg/kg can be considered; if a full treatment response is subsequently achieved, the intensified regimen of 300 mg or 4 mg/kg every 8 weeks needs to be maintained; if a satisfactory response has still not been achieved 7 days after this increased dose, a third dose of 300 mg or 4 mg/kg can be considered and, if a full response follows, maintaining 600 mg or 8 mg/kg every 8 weeks is to be considered on individual clinical judgement. For patients starting on 4 mg/kg, a second 4 mg/kg dose can be considered at 7 days and maintaining 8 mg/kg every 8 weeks considered thereafter. TRAPS, HIDS/MKD and FMF up-titration: if a satisfactory clinical response has not been achieved 7 days after treatment start, a second dose of 150 mg or 2 mg/kg can be considered; if a full response follows, maintain the intensified regimen of 300 mg (or 4 mg/kg for patients weighing 40 kg or less) every 4 weeks. In patients without clinical improvement the treating physician should reconsider continued treatment. Gouty arthritis: management of hyperuricaemia with appropriate urate-lowering therapy needs to be instituted or optimised; canakinumab is used as on-demand therapy and should be given as soon as possible after attack onset; patients who do not respond to initial treatment should not be re-treated; those who respond and require re-treatment need an interval of at least 12 weeks. Missed doses (CAPS, TRAPS, HIDS/MKD, FMF, Still's disease): administer as soon as possible without waiting for the next scheduled dose, then resume the recommended intervals. Elderly: no dose adjustment required. Hepatic impairment: not studied, no posology recommendation can be made. Administration: subcutaneous use into the upper thigh, abdomen, upper arm or buttocks, rotating sites; avoid broken, bruised or rashy skin and scar tissue; the pen must not be shaken; each pre-filled pen is for a single dose in a single patient. After proper training, adult and adolescent patients aged 12 years or older weighing above 40 kg, or their caregivers, may self-inject if the physician determines it appropriate. All prescribers must be familiar with the SmPC and provide the Patient Card. SPC section 4.5 was not retrieved in this bundle - verify interactions against the full SPC.

The source states weight-banded per-kg doses rather than a single per-kg figure, so no single dosePerKg value can be given. CAPS, children aged 4 years and over: 2 mg/kg for body weight 15 kg or above and 40 kg or below; 4 mg/kg for body weight 7.5 kg or above and below 15 kg; 150 mg for body weight over 40 kg. CAPS, children 2 to under 4 years: 4 mg/kg for body weight 7.5 kg or above. TRAPS, HIDS/MKD and FMF, children aged 2 years and over: 2 mg/kg for body weight 7.5 kg or above and 40 kg or below; 150 mg for body weight over 40 kg. Still's disease (SJIA), body weight 7.5 kg or above: 4 mg/kg up to a maximum of 300 mg. Safety and efficacy in patients under 2 years of age have not been established for CAPS, TRAPS, HIDS/MKD, FMF or SJIA. There is no relevant paediatric use in gouty arthritis. Verify against a children's formulary.