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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ilaris 150 mg powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 150 mg of canakinumab*. After reconstitution, each ml of solution contains 150 mg canakinumab. * human monoclonal antibody produced in mouse myeloma Sp2/0 cells by recombinant DNA technology For the full list of excipients, see section 3. PHARMACEUTICAL FORM Powder for solution for injection. The powder is white. 4. CLINICAL PARTICULARS Therapeutic indications Periodic fever syndromes Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older: Cryopyrin-associated periodic syndromes Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including: Muckle-Wells syndrome (MWS), Neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA), Severe forms of familial cold autoinflamma

2 1. NAME OF THE MEDICINAL PRODUCT Ilaris 150 mg powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial …

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Transcription of ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

1 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ilaris 150 mg powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 150 mg of canakinumab*. After reconstitution, each ml of solution contains 150 mg canakinumab. * human monoclonal antibody produced in mouse myeloma Sp2/0 cells by recombinant DNA technology For the full list of excipients, see section 3. PHARMACEUTICAL FORM Powder for solution for injection. The powder is white. 4. CLINICAL PARTICULARS Therapeutic indications Periodic fever syndromes Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older: Cryopyrin-associated periodic syndromes Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including: Muckle-Wells syndrome (MWS), Neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological, cutaneous, articular syndrome (CINCA), Severe forms of familial cold autoinflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash.

2 Tumour necrosis factor receptor associated periodic syndrome (TRAPS) Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS). Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD). Familial Mediterranean fever (FMF) Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF). Ilaris should be given in combination with colchicine, if appropriate. 3 Ilaris is also indicated for the treatment of: Still s disease 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.

3 Ilaris can be given as monotherapy or in combination with methotrexate. Gouty arthritis 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 ). 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.

4 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 kg and < 15 kg Children 2 to < 4 years of age: 4 mg/kg for patients with body weight 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.

5 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. 4 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.

6 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 15 kg Maintenance dose: 150 mg or 2 mg/kg every 8 weeks Additional dose of 150 mg or 2 mg/kg can be considered 150 mg or 2 mg/kg Additional dose of 300 mg or 4 mg/kg can be considered Maintenance dose 4 mg/kg every 8 weeks Additional dose of 4 mg/kg can be considered Satisfactory clinical response after 7 days? Satisfactory clinical response after 7 days? Maintenance dose: 300 mg or 4 mg/kg every 8 weeks If full treatment response after 7 days, maintenance dose: 600 mg or 8 mg/kg every 8 weeks Satisfactory clinical response after 7 days? 4 mg/kg CAPS in children 2-< 4 years of age or children 4 years of age kg and < 15 kg If full treatment response after 7 days, maintenance dose: 8 mg/kg every 8 weeks Yes No No No Yes Yes 5 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 kg and 40 kg This is administered every four weeks as a single dose via subcutaneous injection.

7 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. Still s disease (SJIA and AOSD) The recommended dose of canakinumab for patients with Still s disease with body weight 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.

8 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. TRAPS, HIDS/MKD and FMF patients with body weight > 40 kg Maintenance dose: 150 mg every 4 weeks Additional dose of 150 mg can be considered 150 mg Maintenance dose 2 mg/kg every 4 weeks Additional dose of 2 mg/kg can be considered Satisfactory clinical response after 7 days?

9 Satisfactory clinical response after 7 days? 2 mg/kg TRAPS, HIDS/MKD and FMF patients with body weight kg and 40 kg If full treatment response is achieved, maintenance dose: 4 mg/kg every 4 weeks No No Yes Yes If full treatment response is achieved, maintenance dose: 300 mg every 4 weeks 6 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 ). 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.

10 Currently available data are described in sections , and 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. 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.


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