Posology : מינונים

4.2     Posology and method of administration

For CAPS, TRAPS, HIDS/MKD, FMF and Still’s disease, the treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of the relevant indication.

For gouty arthritis, the physician should be experienced in the use of biologics and Ilaris should be administered by a healthcare professional.

Posology
CAPS: Adults, adolescents and children aged 2 years and older
The recommended starting dose of canakinumab for CAPS patients is:
Adults, adolescents and children ≥ 4 years of age:
• 150 mg for patients with body weight >40 kg
• 2 mg/kg for patients with body weight ≥15 kg and ≤40 kg
• 4 mg/kg for patients with body weight ≥7.5 kg and <15 kg Children 2 to <4 years of age:
• 4 mg/kg for patients with body weight ≥7.5 kg 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.


ILR API Dec21 V4                         Based on EU SmPC 28.09.2021
CAPS in adults and children ≥ 4 years of age                    CAPS in children 2-< 4 years of age or ≥ 15 kg                                      children ≥ 4 years of age ≥ 7.5 kg and < 15 kg 


TRAPS, HIDS/MKD and FMF: Adults, adolescents and children aged 2 years and older The recommended starting dose of canakinumab in TRAPS, HIDS/MKD and FMF patients is:
•     150 mg for patients with body weight > 40 kg
•     2 mg/kg for patients with body weight ≥ 7.5 kg and ≤ 40 kg 
This is administered every four weeks as a single dose via subcutaneous injection.

If a satisfactory clinical response 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 for patients weighing ≤ 40 kg) every 4 weeks should be maintained.

Continued treatment with canakinumab in patients without clinical improvement should be reconsidered by the treating physician.


ILR API Dec21 V4                          Based on EU SmPC 28.09.2021 

Still’s disease (SJIA and AOSD)
The recommended dose of canakinumab for patients with Still’s disease with body weight ≥ 7.5 kg is 4 mg/kg (up to a maximum of 300 mg) administered every four weeks via subcutaneous injection.
Continued treatment with canakinumab in patients without clinical improvement should be reconsidered by the treating physician.

Gouty arthritis
Management of hyperuricaemia with appropriate urate lowering therapy (ULT) should be instituted or optimised. Canakinumab should be used as an on-demand therapy to treat gouty arthritis attacks.
The recommended dose of canakinumab for adult patients with gouty arthritis is 150 mg administered subcutaneously as a single dose during an attack. For maximum effect, canakinumab should be administered as soon as possible after the onset of a gouty arthritis attack.
Patients who do not respond to initial treatment should not be re-treated with canakinumab . In patients who respond and require re-treatment, there should be an interval of at least 12 weeks before a new dose of canakinumab may be administered (see section 5.2).

Special populations
Paediatric population
CAPS, TRAPS, HIDS/MKD and FMF
The safety and efficacy of canakinumab in CAPS, TRAPS, HIDS/MKD and FMF patients under 2 years of age have not been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.

SJIA
The safety and efficacy of canakinumab in SJIA patients under 2 years of age have not been established.
No data are available.

Gouty arthritis
There is no relevant use of canakinumab in the paediatric population in the indication gouty arthritis.


ILR API Dec21 V4                         Based on EU SmPC 28.09.2021
Elderly
No dose adjustment is required.
Hepatic impairment
Canakinumab has not been studied in patients with hepatic impairment. No recommendation on a posology can be made.

Renal impairment
No dose adjustment is needed in patients with renal impairment. However, clinical experience in such patients is limited.

Method of administration
For subcutaneous use.
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 .

Each vial is for a single use in a single patient, for a single dose.

Administration should be by healthcare providers.