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Canakinumab(ILARIS)

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INJECTION

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Reminder: The outer packaging is for reference only, please purchase and use under the guidance of a pharmacist. For read by medical and pharmaceutical professionals only.

ILARIS® is a recombinant human monoclonal IgG1/κ antibody that selectively neutralizes interleukin-1β (IL-1β), a proinflammatory cytokine central to innate immune dysregulation. By binding IL-1β, it inhibits interaction with IL-1 receptors, thereby attenuating inflammation. ILARIS does not cross-react with IL-1α or IL-1 receptor antagonist (IL-1ra). It is approved for autoinflammatory syndromes driven by excessive IL-1β activity, including CAPS, TRAPS, HIDS/MKD, FMF, Still’s disease, and acute gout flares refractory to conventional therapies.

ILARIS is supplied as a 150 mg/mL sterile solution for subcutaneous injection in single-dose vials. Dosing frequency varies by indication: every 8 weeks for CAPS, every 4 weeks for TRAPS/HIDS/MKD/FMF/Still’s disease, and as a single dose for gout flares (minimum 12-week interval between doses). Contraindications include hypersensitivity to canakinumab or excipients. Warnings emphasize serious infections (e.g., tuberculosis reactivation, opportunistic pathogens), hypersensitivity reactions (including DRESS), and avoidance of live vaccines. Pre-treatment screening for latent infections and close monitoring during therapy are critical.

Generic name

Canakinumab(ILARIS)

English name

Canakinumab

Alternative Names

ILARIS

Drug prices

Indications

ILARIS® is indicated for:

1.Periodic Fever Syndromes:

Cryopyrin-Associated Periodic Syndromes (CAPS): Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS) in adults and pediatric patients ≥4 years.Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS).

Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency (HIDS/MKD).

Familial Mediterranean Fever (FMF).

2.Still's Disease:

Adult-Onset Still's Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients ≥2 years.

3.Gout Flares:

Symptomatic treatment in adults with contraindications/intolerance to NSAIDs, colchicine, or repeated corticosteroids.

Therapeutic Target

Interleukin-1β (IL-1β), a proinflammatory cytokine.

Active Ingredients

Canakinumab (recombinant human anti-IL-1β monoclonal antibody).

Dosage form

INJECTION

specifications

Single-Dose Vial: 150 mg/mL (NDC 0078-0734-61).

Description

Molecular Structure: Recombinant human IgG1/κ monoclonal antibody targeting IL-1β.

Molecular Weight: 145,157 Daltons (deglycosylated).

Formulation: Sterile, preservative-free, clear to opalescent solution with L-histidine, mannitol, and polysorbate 80.

Dosage and Administration

General Instructions:

Administer subcutaneously. Avoid injection into scar tissue.

Preparation: Use 18-gauge needle to withdraw; inject with 27-gauge needle.

Dosing by Indication:

CAPS:

>40 kg: 150 mg every 8 weeks.

15–40 kg: 2 mg/kg every 8 weeks (may increase to 3 mg/kg if inadequate response).

TRAPS, HIDS/MKD, FMF:

>40 kg: 150 mg every 4 weeks (may increase to 300 mg).

≤40 kg: 2 mg/kg every 4 weeks (may increase to 4 mg/kg).

Still’s Disease (AOSD/SJIA):

≥7.5 kg: 4 mg/kg (max 300 mg) every 4 weeks.

Gout Flares:

150 mg as a single dose. Re-treatment only after ≥12 weeks.

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