Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:
Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including:
Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS).
Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD).
Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF). Ilaris should be given in combination with colchicine, if appropriate.
Ilaris is also indicated for the treatment of:
Ilaris is indicated for the treatment of active Still’s disease including adult-onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate.
Ilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate (see section 5.1).
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.
The recommended starting dose of canakinumab for 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.
h3 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:
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.
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.
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).
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.
The safety and efficacy of canakinumab in SJIA patients under 2 years of age have not been established. No data are available.
There is no relevant use of canakinumab in the paediatric population in the indication gouty arthritis.
No dose adjustment is required.
Canakinumab has not been studied in patients with hepatic impairment. No recommendation on a posology can be made.
No dose adjustment is needed in patients with renal impairment. However, clinical experience in such patients is limited.
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 single use in a single patient, for a single dose.
After proper training in the correct injection technique, patients or their caregivers may inject canakinumab if the physician determines that it is appropriate and with medical follow-up as necessary (see section 6.6).
Reported experience with overdose is limited. In early clinical trials, patients and healthy volunteers received doses as high as 10 mg/kg, administered intravenously or subcutaneously, without evidence of acute toxicity.
In case of overdose, it is recommended for the patient to be monitored for any signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately.
Shelf life: 3 years.
From a microbiological point of view, the product should be used immediately after first opening.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Store in the original package in order to protect from light.
Solution for injection in a vial (type I glass) with a stopper (laminated chlorobutyl rubber) and flip-off cap (aluminium).
Packs containing 1 vial.
Not all pack sizes may be marketed.
Ilaris 150 mg/ml solution for injection is supplied in a single-use vial for individual use.
Allow the vial to warm to room temperature before injection. The solution should be practically free of visible particles and clear to opalescent. The solution should be colourless or may have a slight brownish-yellow tint. Using an 18 G or 21 G x 2 inch needle (or similar as available on the market) and a 1 ml syringe, carefully withdraw the required volume depending on the dose to be administered. Once the required volume is withdrawn, recap and remove the withdrawal needle from the syringe and attach a 27 G x 0.5 inch needle (or similar as available on the market) to immediately inject the solution subcutaneously.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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