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Maintenance dosing information for ILARIS in the treatment of familial Mediterranean fever (FMF), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), tumour necrosis factor receptor-associated periodic syndrome (TRAPS) and cryopyrin-associated periodic syndromes (CAPS) and adult-onset Still’s disease (AOSD)/systemic juvenile idiopathic arthritis (SJIA).
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.
ILARIS® (canakinumab) has a convenient 4-weekly maintenance dosing schedule1
Adapted from ILARIS (canakinumab) Summary of Product Characteristics.
In FMF, HIDS/MKD and TRAPS, ILARIS is administered as a subcutaneous injection once every 4 weeks.1
Continued treatment with canakinumab in patients without clinical improvement should be reconsidered by the treating physician.1
ILARIS has a convenient 8-weekly maintenance dosing schedule, and patients are able to receive treatment at home1
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
Adapted from ILARIS (canakinumab) Summary of Product Characteristics.
In cryopyrin-associated periodic syndromes (CAPS), ILARIS is administered as a subcutaneous injection once every 8 weeks.1
Clinical experience with dosing at intervals of less than 4 weeks or at doses above 600 mg or 8 mg/kg is limited.1
ILARIS® has a convenient 4-weekly maintenance dosing schedule1
The recommended dose of Ilaris for patients with Still’s disease:1
Patient with body weight ≥ 7.5 kg
=
4 mg/kg (up to 300 mg max.)
Every 4 weeks via subcutaneous injection
Continued treatment with Ilaris in patients without clinical improvement should be reconsidered by the treating physician.
Monitoring1
Prior to initiation
- Tuberculosis (TB): TB screening (e.g. tuberculin skin test, interferon gamma release assay or chest X-ray)
- Neutropenia and leukopenia: white blood cell (WBC) counts including neutrophil counts
- Vaccinations: Patients are recommended to receive all vaccinations, as appropriate, including pneumococcal vaccine and inactivated influenza vaccine
Ongoing
- Signs and symptoms of infections
- Signs and symptoms of TB
- Neutropenia and leukopenia: WBC counts including neutrophil counts, 1 to 2 months after the first neutropenia assessment and periodically during treatment
- Macrophage activation syndrome (MAS) in patients with Still’s disease (SJIA and AOSD): Symptoms of injection or worsening of Still’s disease (known triggers for MAS)
- Signs and symptoms of drug reaction with eosinophilia and systemic symptoms (DRESS)
- Interactions with other medicinal products: The effect or the active substance concentration of ILARIS in patients being treated with CYP450 substrates
Indications1
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:
- 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
- TRAPS
- HIDS/MKD
- FMF
- ILARIS should be given in combination with colchicine, if appropriate.
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. ILARIS can be given as monotherapy or in combination with methotrexate.
AOSD, adult-onset Still’s disease; CAPS, cryopyrin-associated periodic syndromes; CINCA, chronic infantile neurological, cutaneous, articular syndrome; CYP450, cytochrome P450; FCAS, familial cold autoinflammatory syndrome; FCU, familial cold urticaria; FMF, familial Mediterranean fever; HIDS, hyperimmunoglobulin D syndrome; MAS, macrophage activation syndrome; MKD, mevalonate kinase deficiency; MWS, Muckle-Wells syndrome; NOMID, neonatal-onset multisystem inflammatory disease; NSAID, non-steroidal anti-inflammatory drug; SJIA, systemic juvenile idiopathic arthritis; TB, tuberculosis; TRAPS, tumour necrosis factor receptor-associated periodic syndrome; WBC, white blood cell.
Reference
- ILARIS® (canakinumab) Summary of Product Characteristics.
