Ilaris (Canakinumab)

Description

Ilaris (canakinumab) is a fully human monoclonal antibody that selectively targets interleukin-1 beta (IL-1ß), a key cytokine in the inflammatory pathway. By binding to IL-1ß and preventing its interaction with the IL-1 receptor, Ilaris inhibits downstream inflammation. It is indicated for the treatment of periodic fever syndromes including Cryopyrin-Associated Periodic Syndromes (CAPS) (such as familial cold autoinflammatory syndrome and Muckle-Wells syndrome), Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), Familial Mediterranean Fever (FMF), Systemic Juvenile Idiopathic Arthritis (SJIA), Still’s disease, and gout flares.

Directions

Ilaris is administered by subcutaneous injection, with dosing dependent on the specific indication and patient weight:

• CAPS: 150 mg every 8 weeks (adults and children =15 kg); may be increased to 300 mg if needed

• SJIA/Still’s disease: 4 mg/kg (max 300 mg) every 4 weeks

• Gout flares (offered in certain countries): 150 mg single dose; repeat in 12 weeks if needed

• FMF, TRAPS, HIDS/MKD: 150 mg every 4 weeks

The injection should be administered by a healthcare provider or by a trained patient/caregiver. The prefilled syringe or vial should be brought to room temperature before use and injected into the thigh, abdomen, or upper arm, with site rotation.

Ingredients

Each vial or prefilled syringe of Ilaris contains:

• Canakinumab 150 mg

• Sucrose

• Histidine

• Polysorbate 80

• Water for injection

The lyophilized powder requires reconstitution before administration when not using a prefilled syringe.

Contraindications

Ilaris is contraindicated in patients with:

• Known hypersensitivity to canakinumab or any of its excipients

• Active or severe infections, particularly tuberculosis or other opportunistic infections

Cautions

Ilaris increases the risk of serious infections, including opportunistic infections and reactivation of latent tuberculosis. Patients should be screened for TB before initiating therapy and monitored regularly throughout treatment. Avoid use in combination with other biologic immunosuppressive agents, especially other IL-1 inhibitors or TNF blockers. Monitor for neutropenia and changes in liver function. Live vaccines should not be administered during or shortly after treatment. Use in pregnancy should be based on benefit-risk assessment due to limited data on fetal safety.

Side Effects

Common side effects of Ilaris include:

• Upper respiratory tract infections

• Headache

• Injection site reactions

• Diarrhea

• Nasopharyngitis

• Nausea

• Abdominal pain

Serious adverse effects may include:

• Serious infections (bacterial, viral, fungal)

• Neutropenia

• Hypersensitivity reactions

• Elevated liver enzymes

• Macrophage activation syndrome (in SJIA/Still’s disease patients)

Product Code : 15199