Canakinumab (Ilaris) is a recombinant humanized monoclonal antibody indicated for the treatment of various autoinflammatory diseases. It exerts its therapeutic effect by specifically neutralizing the activity of interleukin-1β (IL-1β), thereby controlling inflammation associated with the excessive production of IL-1β.

What are the Indications for Canakinumab (Ilaris)?

Periodic Fever Syndromes

Cryopyrin-Associated Periodic Syndromes (CAPS): Indicated for the treatment of adult and pediatric patients aged 4 years and older, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS): Indicated for adult and pediatric patients.

Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency (HIDS/MKD): Indicated for adult and pediatric patients.

Familial Mediterranean Fever (FMF): Indicated for adult and pediatric patients.

Still's Disease

Canakinumab is indicated for the treatment of active Still’s disease in patients aged 2 years and older, including Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA).

Acute Gout Flares

Canakinumab is indicated for the symptomatic treatment of acute gout flares in adults.

Specific Conditions for Use: Reserved for patients with contraindications to, intolerance of, or inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) and colchicine, and who are not suitable for repeated courses of corticosteroids.

Dosage Form, Strength and Physical Characteristics of Canakinumab (Ilaris)

Dosage Form and Strength

Canakinumab is supplied as an injection in single-dose glass vials.

Each vial contains 1 mL of solution with a canakinumab concentration of 150 mg/mL, corresponding to a total content of 150 mg per vial.

Physical Characteristics

The medicinal solution should be a sterile, preservative-free liquid. Under normal conditions, it appears as a clear to slightly opalescent solution, colorless to light tan-yellow.

A visual inspection of the solution must be performed prior to use. Do not use the product if the solution shows significant browning, marked opalescence, or contains visible particles.

The vial should not be shaken before administration.

Composition

Active Ingredient: Canakinumab.

Excipients: L-histidine, L-histidine hydrochloride monohydrate, mannitol, polysorbate 80, and water for injection.

Storage and Handling of Canakinumab (Ilaris)

Storage Conditions

Temperature: Unopened vials must be stored under refrigeration at 2°C to 8°C (36°F to 46°F).

Light Protection: The vials should always be kept in the original carton to protect from light.

Prohibition of Freezing: Do not freeze.

Shelf Life and Usage

The product must be used before the expiration date indicated on the vial label.

As this product contains no preservatives, any unused solution remaining after aspiration of the required dose should be discarded in accordance with local regulations and must not be retained for subsequent use.

Precautions

Keep the medicine out of the reach of children.

After removal from the refrigerator, the injection should be administered as soon as possible under the guidance of a healthcare professional.