Posology : מינונים

4.2      Posology and method of administration

For CAPS, TRAPS, HIDS/MKD, FMF and SJIA, 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.

After proper training in the correct injection technique, patients or their caregivers may inject Ilaris if the physician determines that it is appropriate and with medical follow-up as necessary (see section 6.6).

Posology
CAPS: Adults, adolescents and children aged 2 years and older
The recommended starting dose of Ilaris 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 Ilaris 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 Ilaris 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 Ilaris 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.

ILA API MAR17 CL V6                                         REF EMA SmPC APP 2.3.17 Clinical experience with dosing at intervals of less than 4 weeks or at doses above 600 mg or 8 mg/kg is limited.

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 Ilaris 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 Ilaris 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 Ilaris in patients without clinical improvement should be reconsidered by the treating physician.


ILA API MAR17 CL V6                                          REF EMA SmPC APP 2.3.17 

SJIA
The recommended dose of Ilaris for SJIA patients 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 Ilaris 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. Ilaris should be used as an on-demand therapy to treat gouty arthritis attacks.
The recommended dose of Ilaris for adult patients with gouty arthritis is 150 mg administered subcutaneously as a single dose during an attack. For maximum effect, Ilaris 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 Ilaris. In patients who respond and require re-treatment, there should be an interval of at least 12 weeks before a new dose of Ilaris may be administered (see section 5.2).

Special populations:

Paediatric population
CAPS, TRAPS, HIDS/MKD and FMF
The safety and efficacy of Ilaris 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 Ilaris in SJIA patients under 2 years of age have not been established (see section 4.1 Therapeutic indications). No recommendation on a posology can be made.

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

ILA API MAR17 CL V6                                         REF EMA SmPC APP 2.3.17 Elderly
No dose adjustment is required.

Hepatic impairment
Ilaris has not been studied in patients with hepatic impairment.

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 Ilaris.
Each vial of Ilaris is for a single use in a single patient, for a single dose.
For instructions on use and handling of the reconstituted solution, see section 6.6.