Drug Class Description
This medicine is monitored intensively by the CHM and MHRA
Drug Description
One vial contains 150 mg of canakinumab*.After reconstitution, each ml of solution contains 150 mg canakinumab.* fully human monoclonal antibody produced in mouse hybridoma Sp2/0 cells by recombinant DNA technology
Presentation
Powder for solution for injection.The powder is white.
Indications
Ilaris is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents and children aged 4 years and older with body weight above 15 kg, 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.
Adult Dosage
Treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of CAPS.
After proper training in the correct injection technique, patients may self-inject Ilaris if their physician determines that it is appropriate and with medical follow-up as necessary.
Adults, adolescents and children aged 4 years and older
The recommended dose of Ilaris is 150 mg for CAPS patients with body weight > 40 kg and 2 mg/kg for CAPS patients with body weight 15 kg and 40 kg. This is administered every eight weeks as a single dose via subcutaneous injection.
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 and 4 mg/kg should be maintained. No experience exists for doses > 600 mg every 8 weeks. Clinical experience with dosing at intervals of less than 4 weeks is limited.
Special populations
Paediatric population
Ilaris is not recommended for use in children below 4 years of age or with body weight below 15 kg due to a lack of clinical data.
Elderly
Clinical experience in patients above 65 years is limited, therefore caution is recommended.
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.
Contra Indications
Hypersensitivity to the active substance or to any of the excipients.
Active, severe infections
Special Precautions
Serious infections
