ILARIS

What it is

Ilaris contains canakinumab, a high-affinity human anti-human-IL-1β monoclonal antibody that belongs to the IgG1/κ isotype subclass. The powder formulation is a sterile, white, lyophilised powder that is reconstituted with water for injections and administered as a subcutaneous injection. The solution formulation is a colourless to slightly brownish yellow solution, in a 2 mL colourless glass vial with grey rubber stopper and green flip off cap and administered as a subcutaneous injection.

Approved indications —

Familial Cold Autoinflammatory Syndrome (FCAS) / Familial Cold Urticaria (FCU) in adults, adolescents and children aged 2 years or older — Muckle-Wells Syndrome (MWS) in adults, adolescents and children aged 2 years or older — Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA) in adults, adolescents and children aged 2 years or older — Tumour necrosis factor receptor associated periodic syndrome (TRAPS) — Hyperimmunoglobulin D syndrome (HIDS) / mevalonate kinase deficiency (MKD) — Familial Mediterranean Fever (FMF) — Active Systemic Juvenile Idiopathic Arthritis (sJIA) in patients aged 2 years or older

Dosing overview

For Cryopyrin-Associated Periodic Syndromes (CAPS), the recommended starting dose for adults and children ≥4 years of age is 150 mg with body weight >40 kg, 2 mg/kg with body weight ≥15 kg and ≤40 kg, or 4 mg/kg with body weight ≥7.5 kg and <15 kg, administered every eight weeks as a single subcutaneous dose. For TRAPS, HIDS/MKD and FMF, the recommended starting dose in adults, adolescents and children aged 2 years and older is 150 mg for patients with body weight >40 kg or 2 mg/kg for patients with body weight ≥7.5 kg and ≤40 kg, administered every four weeks as a single subcutaneous dose. For sJIA, the recommended dose for patients with body weight ≥7.5 kg is 4 mg/kg (up to maximum of 300 mg) administered every four weeks via subcutaneous injection.

Key safety warnings

Ilaris is associated with an increased incidence of serious infections, and physicians should exercise caution when administering it to patients with infections, a history of recurring infections or underlying conditions which may predispose them to infections. Treatment should not be initiated or continued in patients with active infection requiring medical intervention. Isolated cases of unusual or opportunistic infections (including aspergillosis, atypical mycobacterial infections, herpes zoster) have been reported during Ilaris treatment. Drug reaction with eosinophilia and systemic symptoms (DRESS) has rarely been reported in patients treated with Ilaris, predominantly in patients with systemic juvenile idiopathic arthritis. Patients with DRESS may require hospitalisation, as this condition may be fatal. If signs and symptoms of DRESS are present and an alternative aetiology cannot be established, Ilaris should not be re-administered, and the patient should be treated promptly and monitored until signs and symptoms resolve. Before initiation of therapy, all patients must be evaluated for both active and latent tuberculosis infection, with a detailed medical history and appropriate screening tests in adult patients. Patients must be monitored closely for signs and symptoms of tuberculosis during and after treatment with Ilaris. Neutropenia and leukopenia have been observed with Ilaris. Treatment should not be initiated in patients with neutropenia or leukopenia. It is recommended that white blood cell counts including neutrophil counts be assessed prior to initiating treatment and again after 1 to 2 months, and periodically during chronic or repeated therapies.

Contraindications

Ilaris is contraindicated in patients with confirmed hypersensitivity to canakinumab or to any of the excipients.

PBS listing

This medicine does not have a current PBS listing. A previous PBAC recommendation for Cryopyrin associated periodic syndromes in November 2021 was withdrawn.

Regulatory history

Ilaris canakinumab 150 mg/1 mL solution for injection was first listed on the ARTG on 26 May 2017. In November 2017, the PBAC recommended listing for moderate to severe Cryopyrin associated periodic syndromes under the Highly Specialised Drugs Program with authority required streamlined restriction on a cost-minimisation basis compared to anakinra. In November 2021, this recommendation was rescinded by the PBAC.