Canakinumab Injection
Canakinumab injection (Ilaris) is a targeted anti-inflammatory medicine used to treat rare periodic fever syndromes, Still's disease, and gout flares in adults and children.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Canakinumab Injection: Patient Information Guide
A plain-language walkthrough of Canakinumab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Ilaris (canakinumab) is a targeted injection approved for several rare inflammatory conditions in adults and children. Here is the full list of supported uses:
- Cryopyrin-Associated Periodic Syndromes (CAPS) — including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) — in adults and children 4 years and older
- TNF Receptor Associated Periodic Syndrome (TRAPS) — in adults and children of any age
- Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency (HIDS/MKD) — in adults and children of any age
- Familial Mediterranean Fever (FMF) — in adults and children of any age
- Active Still's disease, including Adult-Onset Still's Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) — in patients 2 years and older
- Gout flares in adults — specifically when NSAIDs and colchicine cannot be used or haven't worked, and repeated steroid courses are not appropriate
⚙️How it works▾
Canakinumab is a human monoclonal antibody — a highly targeted protein designed to seek out and bind to IL-1β (interleukin-1 beta), a key messenger that drives inflammation. When IL-1β is blocked, it cannot attach to its receptors and set off the cascade of inflammation that causes fever, pain, and joint damage. In conditions like CAPS, genetic mutations cause the body's inflammasome (an internal alarm system) to overproduce IL-1β. In gout flares, uric acid crystals in joints trigger the same IL-1β overproduction. Blocking IL-1β at the source calms this abnormal inflammatory response.
💊How it's taken▾
Ilaris is given as a subcutaneous injection (under the skin) by a healthcare provider. The dosing schedule varies by condition and body weight:
- For CAPS: typically every 8 weeks
- For TRAPS, HIDS/MKD, and FMF: typically every 4 weeks
- For Still's disease (AOSD/SJIA): every 4 weeks
- For gout flares: a single dose, with at least 12 weeks between doses if re-treatment is needed
There are no food restrictions. Your prescriber will set the exact dose based on your weight and condition. Do not adjust your schedule without talking to your doctor first.
🤒Side effects — in detail▾
The most commonly reported side effects with Ilaris include:
- Nasopharyngitis (cold-like symptoms) and other upper respiratory infections
- Injection-site reactions — usually mild redness or discomfort at the shot site
- Diarrhea, nausea, or abdominal pain
- Headache
- Vertigo (a spinning or dizziness sensation), mostly reported in Muckle-Wells Syndrome patients
- Weight gain
- Urinary tract infections (reported in gout-flare studies)
Serious reactions to watch for and act on immediately include signs of infection (persistent fever, cough, or wounds that won't heal), severe allergic reactions (difficulty breathing, widespread rash, facial swelling), or a serious skin/organ reaction called DRESS — stop Ilaris and seek care right away if any of these occur.
⚠️Warnings & precautions▾
- Serious infections: Ilaris suppresses the immune system and raises the risk of bacterial, fungal, and viral infections — including unusual ones. It must be stopped if a serious infection develops and should not be started during an active infection. Combining Ilaris with TNF inhibitors is not recommended due to dramatically increased infection risk.
- Tuberculosis (TB): All patients must be screened for active and latent TB before starting Ilaris. Report any persistent cough, unexplained weight loss, or night sweats to your doctor.
- Live vaccines: Live vaccines must not be given while on Ilaris. Complete all recommended vaccinations before starting treatment.
- Macrophage Activation Syndrome (MAS): Patients with Still's disease face a risk of MAS — a rare, life-threatening immune overreaction. Report sudden worsening of symptoms immediately.
- Hypersensitivity/DRESS: Severe allergic reactions and a serious skin reaction called DRESS have been reported. Stop Ilaris and seek immediate care if these occur.
- Cancer risk: The long-term impact of immune suppression on cancer risk is not fully known.
🔀What it interacts with▾
Ilaris can interact with several types of medications — let your prescriber and pharmacist know everything you take:
- TNF inhibitors (e.g., etanercept, adalimumab) — combining these with Ilaris greatly increases the risk of serious infections; this combination is not recommended
- Other IL-1 blocking agents — combining with Ilaris is not recommended due to overlapping immune suppression effects
- Live vaccines — must be avoided while on Ilaris; they could cause infection because the immune system is suppressed
- Warfarin and other narrow-margin drugs processed by CYP450 liver enzymes — Ilaris may change how these drugs are metabolized, requiring closer monitoring and possible dose adjustments
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not take Ilaris if you have a confirmed allergy to canakinumab or any of its ingredients
- Tell your doctor about any current or recent infections — Ilaris should not be started during an active infection requiring treatment
- Tell your doctor if you have a history of recurring infections, tuberculosis, or known TB exposure — TB screening is required before starting
- Make sure all recommended vaccines are up to date before starting Ilaris; live vaccines cannot be given during treatment
- If you are pregnant or planning to become pregnant, discuss the risks — Ilaris crosses the placenta, especially in the third trimester, and may temporarily suppress the baby's immune system
- Live vaccines should be delayed in infants exposed to Ilaris in the womb for at least 4 to 12 months after the mother's last dose
- It is unknown whether Ilaris passes into breast milk; discuss risks and benefits with your doctor if breastfeeding
- Ilaris is not approved for gout flares in children; safety and effectiveness in CAPS patients under 4 years and SJIA patients under 2 years have not been established
- No formal studies have been done in patients with kidney or liver impairment
🚑If you take too much▾
No confirmed cases of canakinumab overdose have been reported. If an overdose is suspected, the person should be monitored closely for any signs of side effects or adverse reactions, and medical treatment should be started right away based on symptoms. Contact a healthcare provider or poison control center immediately.
📡Pharmacodynamics — effects in the body▾
Ilaris works by rapidly reducing two key markers of inflammation in the body — C-reactive protein (CRP) and Serum Amyloid A (SAA). In CAPS and gout-flare patients, these levels return to normal within about 8 days of treatment. In SJIA patients, CRP dropped by a median of 91% by Day 15. Keeping SAA levels low is especially important in CAPS patients, as persistently high SAA can lead to a serious complication called systemic amyloidosis (buildup of abnormal protein in organs).
🔬Pharmacokinetics — how your body processes it▾
After a subcutaneous injection, canakinumab is slowly absorbed, reaching peak blood levels in roughly 7 days in adults. Its half-life — the time for the body to clear half of the drug — is approximately 26 days, which is why doses are given weeks apart. About 66% of the injected dose reaches the bloodstream. The drug's behavior in the body is influenced by body weight, so dosing is often weight-based; no significant differences were seen based on gender or age alone after accounting for weight.
📦How to store it▾
The unopened vial must be stored refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Store in the original carton to protect from light.
📄 Written from Canakinumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Canakinumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What conditions does Ilaris actually treat — and is it right for me? ▾
How is Ilaris given, and will I do the injections myself at home? ▾
What side effects are most likely, and which ones should make me call my doctor? ▾
Can I get my vaccines while on Ilaris? ▾
Is Ilaris safe during pregnancy or if I'm breastfeeding? ▾
Are there any medications I need to avoid while taking Ilaris? ▾
Is Canakinumab Injection available over the counter? ▾
When was Canakinumab Injection first available? ▾
Who makes Canakinumab Injection? ▾
💬 Answers drafted from Canakinumab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Canakinumab Injection comes
Canakinumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Ilaris subcutaneous injection treats Cryopyrin-Associated Periodic Syndromes (CAPS) in adults and children 4 years and older
- Ilaris subcutaneous injection treats TRAPS, HIDS/MKD, and Familial Mediterranean Fever (FMF) in adults and children
- Ilaris subcutaneous injection treats active Still's disease (AOSD and SJIA) in patients 2 years and older
- Ilaris subcutaneous injection treats gout flares in adults when standard treatments cannot be used or have failed
- Ilaris is for subcutaneous (under-the-skin) use only — never given into a vein on its own by patients
- Ilaris solution should be clear to slightly opalescent and colorless to slightly brownish-yellow — do not use if it appears brown, cloudy, or contains visible particles
- Ilaris injections should be given using the syringe and needle sizes specified by your healthcare provider; avoid injecting into scar tissue
- For gout flares, Ilaris allows re-treatment no sooner than 12 weeks after the previous dose
📊 Canakinumab Injection across the U.S. market
How Canakinumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Canakinumab Injection is used
A general measure of how commonly Canakinumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Canakinumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Canakinumab Injection prescribed? Of the 1,596 medications we measure, Canakinumab Injection ranks #991 by Medicaid prescriptions — more than 38% of them.
Utilization by Canakinumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
1 ML canakinumab 150 MG/ML Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1864324
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Canakinumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Canakinumab Injection NDCs with Medicaid activity.
🔍 Compare Canakinumab Injection products
A representative set of FDA-listed product records for Canakinumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 150 mg/mL | Subcutaneous | Novartis Pharmaceuticals Corporation × 3 listings | BLA | View NDC → |
| 150 mg/mL | — | Novartis Pharma Stein AG | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Canakinumab Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Canakinumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Canakinumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Canakinumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 853491 1 dose form · 1 strength
-
Dose form (SCDF) Injection RxCUI 1655972In current FDA listingsClinical drug / strength (SCD) 1 ML canakinumab 150 MG/MLRxCUI 1864324
Look up RxCUI 853491 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Canakinumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Canakinumab Injection belongs to the Interleukin inhibitors class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.