Active Ingredient: Canacinumab
Canakinumab is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including:
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
2 - 4 mg per kg of body weight
From 2 To 4 mg per kg of body weight once every 56 day(s)
The recommended starting dose of canakinumab for cryopyrin associated periodic syndromes (CAPS) patients is:
Adults, adolescents and children ≥4 years of age:
Children 2 to <4 years of age:
This is administered every eight weeks as a single dose via subcutaneous injection.
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 canakinumab at 150 mg or 2 mg/kg can be considered. If a full treatment response is subsequently achieved, the intensified dosing regimen of 300 mg or 4 mg/kg every 8 weeks should be maintained. If a satisfactory clinical response has not been achieved 7 days after this increased dose, a third dose of canakinumab at 300 mg or 4 mg/kg can be considered. If a full treatment response is subsequently achieved, maintaining the intensified dosing regimen of 600 mg or 8 mg/kg every 8 weeks should be considered, based on individual clinical judgement.
For patients with a starting dose of 4 mg/kg, if a satisfactory clinical response has not been achieved 7 days after treatment start, a second dose of canakinumab 4 mg/kg can be considered. If a full treatment response is subsequently achieved, maintaining the intensified dosing regimen of 8 mg/kg every 8 weeks should be considered, based on individual clinical judgement.
Clinical experience with dosing at intervals of less than 4 weeks or at doses above 600 mg or 8 mg/kg is limited.
The following are suitable injection sites: upper thigh, abdomen, upper arm or buttocks. It is recommended to select a different injection site each time the product is injected to avoid soreness. Broken skin and areas which are bruised or covered by a rash should be avoided. Injection into scar tissue should be avoided as this may result in insufficient exposure to canakinumab.
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