Product image of Ilaris (Canakinumab) supplied by GNH India

Ilaris

Active Ingredient:
Canakinumab
Origin:
EU

Ilaris (Canakinumab)

Canakinumab, the active ingredient in Ilaris, is a monoclonal antibody presented as a 150 mg/1 mL solution for injection for subcutaneous use. It selectively neutralizes interleukin‑1β and is approved for cryopyrin‑associated periodic syndromes—including familial cold autoinflammatory syndrome, Muckle‑Wells syndrome and neonatal‑onset multisystem inflammatory disease—along with systemic juvenile idiopathic arthritis, adult‑onset Still’s disease, and acute gout flares.

GNH India supplies Ilaris as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies, clinics, including specialty centers and research institutions worldwide and ensures compliance with local regulatory requirements.

Manufacturer / TM Owner

Novartis Europharm Limited

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Indications & Clinical Uses

Canakinumab (Ilaris) is an interleukin‑1β inhibitor used to manage autoinflammatory and inflammatory disorders.

  • Cryopyrin‑associated periodic syndromes (CAPS): reduces frequency and severity of inflammatory episodes.
  • Systemic juvenile idiopathic arthritis (SJIA): controls systemic inflammation and joint symptoms.
  • Adult‑onset Still’s disease: alleviates fever, rash and arthritis.
  • Gout flares: provides rapid relief of acute gouty arthritis.
  • Atherosclerotic disease (investigational): studied for reducing cardiovascular events.

How It Works

  • Canakinumab is a fully human IgG1 monoclonal antibody that binds with high affinity to interleukin‑1β, preventing it from interacting with the interleukin‑1 receptor type I on target cells. By neutralizing IL‑1β, the drug blocks downstream signaling cascades that drive the production of pro‑inflammatory mediators such as IL‑6, CRP and other acute‑phase proteins, thereby reducing systemic and tissue inflammation.

Side Effects

Canakinumab may be associated with a range of adverse reactions, most of which are mild to moderate in severity.

Common Side Effects

  • Injection site reactions: redness, swelling or pain at the injection site.
  • Upper respiratory tract infection: mild cold‑like symptoms.
  • Headache: transient headache episodes.
  • Diarrhea: loose stools, usually self‑limiting.
  • Nausea: occasional feeling of nausea.
  • Fatigue: general tiredness.

Serious or Rare Side Effects

  • Serious infections: increased risk of bacterial, viral or fungal infections.
  • Neutropenia: low neutrophil count requiring monitoring.
  • Hypersensitivity reactions: rash, urticaria or anaphylaxis.
  • Gastrointestinal perforation: rare but severe abdominal events.
  • Elevated liver enzymes: potential hepatic involvement.
  • Malignancy (rare): isolated reports of cancer development.

Precautions & Warnings

When prescribing canakinumab, clinicians should consider several precautionary measures to minimize risk.

  • Screening for active infections: assess before initiating therapy.
  • Monitoring blood counts: perform regular CBC to detect neutropenia.
  • Evaluating liver function: check transaminases periodically.
  • Vaccination status: avoid live vaccines during treatment.
  • Pregnancy and lactation: use only if benefit outweighs risk (category unknown).
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Canakinumab can interact with other agents, primarily affecting immune function or drug clearance.

Major Interactions (Avoid)

  • Live vaccines: contraindicated during therapy.
  • Immunosuppressive chemotherapy: may increase infection risk.
  • Antiviral biologics (e.g., interferon): potential additive immunosuppression.

Moderate Interactions (Monitor Closely)

  • CYP450 substrates: cytokine modulation may alter metabolism.
  • Anticoagulants: monitor INR or clotting parameters.
  • Other IL‑1 inhibitors: avoid concurrent use to prevent overlapping immunosuppression.

Frequently Asked Questions

Ilaris (canakinumab) is indicated for cryopyrin‑associated periodic syndromes such as familial cold autoinflammatory syndrome, Muckle‑Wells syndrome and neonatal‑onset multisystem inflammatory disease. It is also approved for systemic juvenile idiopathic arthritis, adult‑onset Still’s disease, and for acute gout flares. In addition, it has been studied in cardiovascular disease trials for its anti‑inflammatory effects.

Canakinumab is a fully human monoclonal antibody that binds specifically to interleukin‑1β, a key cytokine in the inflammatory cascade. By neutralizing IL‑1β, the drug prevents activation of the interleukin‑1 receptor, thereby blocking downstream signaling that leads to production of other pro‑inflammatory mediators such as IL‑6 and C‑reactive protein, reducing systemic inflammation.

The dose of Ilaris is individualized by the prescribing clinician based on the specific indication, patient weight, disease severity and response to therapy. Dosing regimens may vary between conditions such as CAPS, SJIA or gout, and are typically administered as a subcutaneous injection at intervals determined by the treating physician.

Canakinumab’s pregnancy category is unknown, and limited data are available on its use in pregnant or nursing women. It should only be used when the potential benefit justifies any potential risk to the fetus or infant. Women of child‑bearing potential should discuss contraception and risk considerations with their healthcare provider.

To request Ilaris, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will ask for trade or institutional credentials. After verification, the sales team provides pricing, availability, cold‑chain shipping details (if required) and assists with import documentation.

The main alternative IL‑1 targeting agents are anakinra, an IL‑1 receptor antagonist, and rilonacept, a soluble decoy receptor. Canakinumab differs by being a monoclonal antibody with a longer half‑life, allowing less frequent dosing (typically every 4–8 weeks) compared with daily anakinra injections. Efficacy and safety profiles vary by indication, and choice depends on disease, patient preference and clinical response.

Ilaris should be stored in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F). Keep the vial in its original packaging, protect it from light, and do not freeze or shake the solution. If temporary storage at room temperature is unavoidable, limit exposure to no more than 30 minutes before administration.

Ilaris is supplied as a sterile solution for subcutaneous injection. The injection is performed by a qualified healthcare professional, typically into the abdomen, thigh or upper arm. The volume administered corresponds to the prescribed dose, and the injection site should be rotated to reduce local reactions.

The most serious risks include severe or opportunistic infections, neutropenia (low neutrophil count), hypersensitivity reactions that can be life‑threatening, gastrointestinal perforation, and rare reports of malignancy. Patients should be monitored regularly for signs of infection, blood count changes and any unexpected symptoms.

Ilaris is contraindicated in patients with known hypersensitivity to canakinumab or any component of the formulation. It should be avoided in individuals with active, uncontrolled infections, and caution is advised in those with a history of recurrent infections, severe neutropenia, or who are receiving other potent immunosuppressants.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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