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CAPS and SJIA
Treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of the relevant indication.
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).
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.
Clinical experience with dosing at intervals of less than 4 weeks or at doses above 600 mg or 8 mg/kg is limited.
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
Treatment should be initiated and supervised by physicians experienced in the diagnosis and treatment of gouty arthritis and in the use of biologics. Ilaris should be administered by a healthcare professional.
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
The safety and efficacy of Ilaris in CAPS and SJIA patients under 2 years of age have not been established.
There is no relevant use of Ilaris in the paediatric population in the indication gouty arthritis.
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.
For instructions on use and handling of the reconstituted solution, see section 6.6.
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