Leaflet ILARIS 150mg powder for solution for injection

Indicated for: autoimmune inflammatory diseases

Route of administration: injectable

Substance: canakinumab (monoclonal antibody)

ATC: L04AC08 (Antineoplastic and immunomodulating agents | Immunosuppressants | Interleukin inhibitors)

Precautions:
Anaphylaxis
Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Canakinumab is a monoclonal antibody used for the treatment of rare inflammatory diseases such as cryopyrin-associated periodic syndromes (CAPS) and systemic juvenile idiopathic arthritis (sJIA). It works by inhibiting interleukin-1 beta (IL-1β), a protein involved in inflammation.

The medication helps reduce inflammation, fever, and other symptoms associated with these conditions. It is administered as a subcutaneous injection, usually once every few weeks, as directed by a doctor.

Canakinumab is used under strict medical supervision, and patients should be monitored for signs of infections or other adverse reactions. It is important to inform the doctor about any other medications being taken or pre-existing conditions.

Side effects may include injection site reactions, respiratory infections, headaches, or, in rare cases, severe allergic reactions. Patients should report any unusual symptoms to their doctor.

General data about ILARIS 150mg

  • Substance: canakinumab
  • Date of latest medicines list: 01-03-2021
  • Product code: W67327001
  • Concentration: 150mg
  • Pharmaceutical form: powder for solution for injection
  • Quantity: 1
  • Product type: Original
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: NOVARTIS PHARMA GMBH - GERMANIA
  • Holder: NOVARTIS EUROPHARM LIMITED - IRLANDA
  • Number: 564/2009/04
  • Shelf life: 3 years

Pharmaceutical forms available for canakinumab

Concentrations available for canakinumab

  • 150mg
  • 150mg/ml
PDF icon EMA leaflet
Published: 12/11/2009
Updated: 05/05/2026