Quick answers
- What is Canakinumab used for?
- The FDA-approved label (Ilaris, Novartis Pharmaceuticals Corporation, June 8, 2026) says: “ILARIS is an interleukin-1β blocker indicated for the treatment of: • Periodic Fever Syndromes: - Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older, including …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Canakinumab have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Canakinumab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Canakinumab been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Canakinumab?
- 1 company lists prescription products of Canakinumab in the FDA NDC Directory, including Novartis Pharmaceuticals Corporation.
What Canakinumab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ILARIS is an interleukin-1β blocker indicated for the treatment of: • Periodic Fever Syndromes: - Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older, including …
— FDA label: Ilaris, Novartis Pharmaceuticals Corporation, effective June 8, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Ilaris |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Novartis Pharmaceuticals Corporation1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125319 ILARIS | Novartis Pharms | June 17, 2009 | 14, latest November 1, 2024 2024: Labeling · 2023: Efficacy · 2020: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1864324, 1864326 |
|---|---|
| SPL set ID of the quoted label | 7d271f3b-e4f9-4d80-8dcf-28d49123f80e |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125319 |
| Active ingredients (FDA) | CANAKINUMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ilaris, Novartis Pharmaceuticals Corporation, effective June 8, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →