Ilaris (Canakinumab)
Interleukin-1 Beta Inhibitor — Monoclonal Antibody for Autoinflammatory Diseases
Ilaris (canakinumab) is a biologic medicine that blocks interleukin-1 beta (IL-1β), a key driver of inflammation. It is prescribed for a range of autoinflammatory conditions including cryopyrin-associated periodic syndromes (CAPS), TNF receptor-associated periodic syndrome (TRAPS), familial Mediterranean fever (FMF), Still's disease, and gouty arthritis. Administered by subcutaneous injection, Ilaris provides targeted relief for patients whose conditions are driven by excessive IL-1β production.
Quick Facts
Key Takeaways
- Targeted biologic therapy: Canakinumab is a fully human monoclonal antibody that selectively neutralizes interleukin-1 beta, providing precise anti-inflammatory action in diseases driven by IL-1β overproduction.
- Broad indication spectrum: Ilaris is approved for CAPS (including MWS, NOMID/CINCA, and severe FCAS), TRAPS, HIDS/MKD, FMF, Still's disease (sJIA and AOSD), and gouty arthritis in adults.
- Weight-based dosing: Doses are individually calculated based on body weight and condition, ranging from 2–8 mg/kg for periodic fever syndromes and 4 mg/kg for Still's disease, with a fixed 150 mg dose for gouty arthritis.
- Infection risk awareness: Because Ilaris suppresses part of the immune response, patients must be monitored for infections and should not receive live vaccines during treatment.
- Long dosing intervals: Depending on the indication, Ilaris is injected once every 4 to 8 weeks, offering convenience compared to daily medications.
What Is Ilaris and What Is It Used For?
Quick Answer: Ilaris (canakinumab) is a biologic medicine that blocks interleukin-1 beta (IL-1β) to treat autoinflammatory diseases including CAPS, TRAPS, HIDS/MKD, FMF, Still's disease, and gouty arthritis. It is given by subcutaneous injection every 4 to 8 weeks.
Ilaris contains the active substance canakinumab, a fully human monoclonal antibody belonging to a class of medicines called interleukin inhibitors. It works by specifically blocking the activity of a substance in the body called interleukin-1 beta (IL-1β), which is found in increased amounts in various inflammatory diseases. By neutralizing IL-1β, Ilaris helps reduce the symptoms and underlying inflammation that characterize these conditions.
Interleukin-1 beta is one of the most important cytokines in the body's inflammatory cascade. Under normal circumstances, it plays a protective role in immune defense. However, when produced in excess—as occurs in autoinflammatory diseases—IL-1β drives a damaging cycle of fever, pain, tissue inflammation, and organ damage. Canakinumab binds to IL-1β with high affinity and specificity, preventing it from interacting with its receptors and thereby interrupting this inflammatory cascade.
The development of canakinumab represented a major advancement in the treatment of rare autoinflammatory diseases, many of which had limited or no effective therapies before its approval. Clinical trials published in the New England Journal of Medicine demonstrated significant improvements in disease control, quality of life, and inflammatory biomarkers across multiple conditions.
Periodic Fever Syndromes
Ilaris is used in adults and children aged 2 years and older to treat several periodic fever syndromes, which are a group of autoinflammatory diseases caused by dysregulated IL-1β production:
- Cryopyrin-Associated Periodic Syndromes (CAPS): A group of autoinflammatory diseases including Muckle-Wells syndrome (MWS), neonatal-onset multisystem inflammatory disease (NOMID, also known as CINCA), and severe forms of familial cold autoinflammatory syndrome (FCAS/FCU) that present with signs and symptoms beyond cold-induced urticarial rashes.
- TNF Receptor-Associated Periodic Syndrome (TRAPS): A hereditary condition characterized by recurring episodes of fever, abdominal pain, joint and muscle pain, and skin rashes, caused by mutations in the TNFRSF1A gene.
- Hyperimmunoglobulin D Syndrome (HIDS) / Mevalonate Kinase Deficiency (MKD): A rare inherited autoinflammatory disorder caused by mutations in the MVK gene, resulting in recurrent episodes of high fever, lymphadenopathy, abdominal pain, and joint pain.
- Familial Mediterranean Fever (FMF): The most common hereditary autoinflammatory disease, caused by mutations in the MEFV gene, characterized by recurring attacks of fever and serositis (inflammation of the linings of the abdomen, lungs, or joints). Ilaris may be used alone or in combination with colchicine.
In patients with these periodic fever syndromes, the body produces too much IL-1β, which can lead to fever, headache, fatigue, skin rashes, and joint or muscle pain. By blocking IL-1β activity, Ilaris can improve these symptoms and significantly reduce the frequency and severity of disease flares.
Still's Disease
Ilaris is used in adults, adolescents, and children aged 2 years and older to treat active Still's disease, including adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA), when other treatments have not been sufficiently effective. It can be used alone or in combination with methotrexate.
Still's disease is a systemic inflammatory disorder that can cause pain, swelling, and inflammation in one or more joints, together with characteristic quotidian (daily spiking) fevers and a salmon-colored evanescent rash. The pro-inflammatory cytokine IL-1β plays a central role in driving the inflammatory processes in Still's disease. By blocking IL-1β activity, Ilaris can improve the signs and symptoms of both sJIA and AOSD, including fever resolution, joint inflammation reduction, and normalization of acute-phase reactants.
Gouty Arthritis
Ilaris is used in adults to treat the symptoms of frequent gouty arthritis attacks when other treatments have not been adequately effective. Gouty arthritis is caused by the formation of monosodium urate crystals in and around joints. These crystals trigger an intense inflammatory response mediated largely by IL-1β, resulting in sudden and severe pain, redness, warmth, and swelling of the affected joint. By blocking IL-1β activity, Ilaris can help resolve acute gout flares and reduce the intensity of symptoms.
What Should You Know Before Taking Ilaris?
Quick Answer: Do not use Ilaris if you are allergic to canakinumab or have an active severe infection. Inform your doctor about any history of tuberculosis, liver problems, or current infections before starting treatment. Avoid live vaccines during therapy.
Contraindications
You should not use Ilaris if:
- You are allergic (hypersensitive) to canakinumab or any of the other ingredients in the medicine (mannitol, histidine, histidine hydrochloride monohydrate, polysorbat 80, water for injections).
- You have, or suspect you have, an active and severe infection.
These contraindications are absolute, meaning the medicine must not be used under these circumstances regardless of potential benefits. If you have any known allergies to monoclonal antibodies or any excipients in the formulation, inform your healthcare provider before considering Ilaris therapy.
Warnings and Precautions
Talk to your doctor before using Ilaris if any of the following apply to you:
- Current or recurrent infections: If you currently have an infection, have had repeated infections, or have a condition that makes you more susceptible to infections (such as a low white blood cell count), your doctor needs to be informed. Canakinumab modulates the immune response and may increase the risk of infections.
- Tuberculosis (TB): If you have or have had tuberculosis, or have been in direct contact with someone who has an active TB infection, your doctor must test you for tuberculosis before starting Ilaris. This is important because Ilaris may reactivate latent TB infections.
- Liver problems: If you have signs of a liver problem such as yellowing of the skin and eyes (jaundice), nausea, loss of appetite, dark urine, and pale stools, contact your doctor immediately.
- Vaccination: You should avoid receiving live vaccines while on Ilaris treatment. Your doctor may want to check your vaccination status and administer any necessary non-live vaccinations before initiating therapy. If a live vaccine is needed after starting Ilaris, it should normally be given at least 3 months after the last injection and 3 months before the next scheduled dose.
Macrophage Activation Syndrome (MAS)
Patients with Still's disease may develop macrophage activation syndrome (MAS), a potentially life-threatening condition characterized by overwhelming activation of the immune system. MAS can present with persistent fever, falling blood counts, elevated liver enzymes, and neurological symptoms. Your doctor will monitor you for potential triggers of MAS, including infections and reactivation (flare) of the underlying Still's disease. If MAS is suspected, treatment with Ilaris may need to be adjusted or interrupted.
Children and Adolescents
- CAPS, TRAPS, HIDS/MKD, FMF, and sJIA: Ilaris can be given to children aged 2 years and older.
- Gouty arthritis: Ilaris is not recommended for children or adolescents under 18 years of age.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before using Ilaris. You are advised to avoid becoming pregnant and must use adequate contraception during treatment and for at least 3 months after the last dose of Ilaris.
If you received canakinumab while pregnant, it is important to inform the baby's doctor before any vaccinations are given. Your child should not receive live vaccines until at least 16 weeks after the last dose of canakinumab administered before delivery, because the antibody may cross the placenta and temporarily suppress the infant's ability to respond to live vaccines.
It is not known whether Ilaris passes into breast milk. Your doctor will discuss the potential risks and benefits of using Ilaris during breastfeeding. The decision to continue or discontinue either breastfeeding or Ilaris treatment should be made in consultation with your healthcare provider, taking into account the benefit of breastfeeding for the infant and the benefit of therapy for the mother.
Driving and Operating Machinery
Treatment with Ilaris may cause dizziness, vertigo, or intense tiredness (asthenia). If you experience these effects, you should not drive, use tools, or operate machinery until you feel normal again. These effects are generally transient and resolve as your body adjusts to the medication.
How Does Ilaris Interact with Other Drugs?
Quick Answer: Ilaris should not be combined with TNF inhibitors (such as etanercept, adalimumab, or infliximab) due to increased infection risk. Live vaccines must be avoided during treatment. Always inform your doctor about all medications you are taking.
Before starting Ilaris, tell your doctor, pharmacist, or nurse about all medicines you are currently taking, have recently taken, or may take. Drug interactions with biologics can be clinically significant and require careful evaluation by your healthcare team.
Major Interactions
| Drug/Class | Interaction | Recommendation |
|---|---|---|
| TNF inhibitors (etanercept, adalimumab, infliximab) | Increased risk of serious infections due to combined immunosuppression | Do not use together — contraindicated combination |
| Live vaccines (MMR, varicella, BCG, yellow fever, oral polio) | Risk of infection from live vaccine organisms due to immunosuppression | Avoid — wait at least 3 months after last Ilaris dose before live vaccination |
| Other IL-1 blockers (anakinra, rilonacept) | Overlapping mechanism may increase immunosuppression and infection risk | Avoid concurrent use |
Other Considerations
There are no known significant pharmacokinetic interactions between canakinumab and small-molecule drugs. However, elevated levels of IL-1β can suppress the formation of certain cytochrome P450 (CYP) enzymes. When Ilaris is initiated in patients on CYP450-metabolized drugs with a narrow therapeutic index (such as warfarin or cyclosporine), therapeutic monitoring may be warranted, as the normalization of IL-1β levels could alter the metabolism of co-administered drugs.
Ilaris may be used in combination with colchicine for the treatment of FMF, and with methotrexate for Still's disease (sJIA and AOSD). These combinations have been studied in clinical trials and are generally well tolerated, though standard monitoring for the co-administered drug's side effects should continue.
Inactivated (non-live) vaccines can generally be administered during Ilaris treatment, although the immune response to vaccination may be reduced. Your doctor should assess the need for any vaccinations before starting Ilaris therapy to ensure your vaccination schedule is up to date.
What Is the Correct Dosage of Ilaris?
Quick Answer: Dosing varies by condition and body weight. For CAPS, the starting dose is 150 mg (or 2–4 mg/kg) every 8 weeks. For TRAPS, HIDS/MKD, and FMF, it is 150 mg (or 2 mg/kg) every 4 weeks. For Still's disease, 4 mg/kg (max 300 mg) every 4 weeks. For gouty arthritis, a single 150 mg dose per attack.
Always use Ilaris exactly as your doctor has told you. If you are unsure, check with your doctor, pharmacist, or nurse. Ilaris is given as a subcutaneous injection, meaning it is injected with a short needle into the fatty tissue just under the skin. Suitable injection sites include the upper thigh, abdomen, upper arm, or buttock.
CAPS Dosing
Cryopyrin-Associated Periodic Syndromes (CAPS)
The recommended starting dose is based on body weight and is injected every 8 weeks as a single dose:
- Adults, adolescents, and children ≥4 years weighing >40 kg: 150 mg
- Patients weighing 15–40 kg: 2 mg/kg
- Patients weighing 7.5–<15 kg: 4 mg/kg
- Children aged 2–3 years weighing ≥7.5 kg: 4 mg/kg
If response is inadequate after 7 days, a second dose may be given. If effective, treatment continues at double the initial dose every 8 weeks. Doses may be escalated up to 600 mg or 8 mg/kg every 8 weeks based on clinical response.
TRAPS, HIDS/MKD, and FMF Dosing
TRAPS, HIDS/MKD, and Familial Mediterranean Fever
The recommended starting dose is injected every 4 weeks as a single dose:
- Adults and children ≥2 years weighing >40 kg: 150 mg
- Patients weighing 7.5–<40 kg: 2 mg/kg
If response is inadequate after 7 days, a second dose may be given. If effective, treatment continues at the higher dose (300 mg or 4 mg/kg) every 4 weeks.
Still's Disease Dosing (sJIA and AOSD)
Still's Disease (sJIA and AOSD)
The recommended dose for patients weighing 7.5 kg and above is:
- 4 mg/kg (up to a maximum of 300 mg) every 4 weeks as a single dose
Gouty Arthritis Dosing
Gouty Arthritis (Adults Only)
The recommended dose is:
- 150 mg as a single dose during a gouty arthritis attack
- If a subsequent treatment is needed, wait at least 12 weeks before the next dose
Your doctor may also discuss whether you need to start or adjust urate-lowering therapy to reduce uric acid levels in your blood.
| Indication | Dose | Frequency | Age Group |
|---|---|---|---|
| CAPS (>40 kg) | 150 mg (up to 600 mg) | Every 8 weeks | ≥2 years |
| CAPS (15–40 kg) | 2 mg/kg (up to 4 mg/kg) | Every 8 weeks | ≥2 years |
| CAPS (7.5–<15 kg) | 4 mg/kg (up to 8 mg/kg) | Every 8 weeks | ≥2 years |
| TRAPS / HIDS / FMF (>40 kg) | 150 mg (up to 300 mg) | Every 4 weeks | ≥2 years |
| TRAPS / HIDS / FMF (7.5–<40 kg) | 2 mg/kg (up to 4 mg/kg) | Every 4 weeks | ≥2 years |
| Still's Disease (sJIA / AOSD) | 4 mg/kg (max 300 mg) | Every 4 weeks | ≥2 years |
| Gouty Arthritis | 150 mg (single dose) | ≥12 weeks apart | Adults only |
Self-Injection
If you are a patient with CAPS, TRAPS, HIDS/MKD, FMF, or Still's disease (AOSD or sJIA), or a caregiver for such patients, you may administer Ilaris injections yourself after receiving proper training in correct injection technique from a healthcare professional. For gouty arthritis, Ilaris should only be administered by healthcare professionals.
The injection is supplied in a single-use vial. Never reuse leftover solution. After removing the vial from the refrigerator, allow it to stand unopened for 10 minutes to reach room temperature before injection. Do not attempt to warm it by other means. Use proper aseptic technique, choosing an injection site on the upper thigh, abdomen, upper arm, or buttock. Do not inject into areas with rash, bruising, or skin irregularities, and avoid injecting into scar tissue or veins.
Missed Dose
If you have CAPS, TRAPS, HIDS/MKD, FMF, or Still's disease and have forgotten to inject a dose of Ilaris, inject the next dose as soon as you remember. Then talk to your doctor to establish when you should inject the next dose. Continue with injections at the recommended interval as before.
Overdose
If you accidentally inject more Ilaris than the recommended dose, it is unlikely to be serious, but you should inform your doctor, pharmacist, or nurse as soon as possible. In clinical studies, no dose-limiting toxicities have been identified, but increased monitoring for adverse effects is advisable.
What Are the Side Effects of Ilaris?
Quick Answer: The most common side effects include infections (respiratory, urinary, skin), upper abdominal pain, joint pain, low white blood cell count, and injection site reactions. Serious side effects requiring immediate medical attention include severe or prolonged infections and allergic reactions.
Like all medicines, Ilaris can cause side effects, although not everybody gets them. Because canakinumab works by modulating the immune system, some side effects are related to increased susceptibility to infections. It is important to be aware of the signs and symptoms that require immediate medical attention.
Very Common
May affect more than 1 in 10 people
- Infections of all kinds — respiratory infections (pneumonia, bronchitis, influenza, sinusitis, rhinitis, pharyngitis, tonsillitis, nasopharyngitis, upper respiratory infection), ear infections, skin infections (cellulitis), gastrointestinal infections (gastroenteritis), urinary tract infections
- Upper abdominal pain
- Joint pain (arthralgia)
- Low white blood cell count (leukopenia)
- Abnormal kidney function tests (decreased creatinine clearance, proteinuria)
- Injection site reactions (redness, swelling, warmth, itching)
Common
May affect up to 1 in 10 people
- Candidal infections (vulvovaginal candidiasis)
- Dizziness, vertigo (spinning sensation)
- Back pain, muscle pain
- Feeling of weakness or extreme tiredness (fatigue, asthenia)
- Low neutrophil count (neutropenia)
- Abnormal triglyceride levels (lipid metabolism disorder)
- Abnormal liver function tests (elevated transaminases) or high bilirubin levels (hyperbilirubinemia), with or without yellowing of the skin and eyes
Uncommon
May affect up to 1 in 100 people
- Heartburn (gastroesophageal reflux disease)
- Low platelet count (thrombocytopenia)
Rare
May affect up to 1 in 1,000 people
- DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms) — characterized by widespread rash, fever, and enlarged lymph nodes, primarily reported in sJIA patients
If you notice any of these side effects, or if you experience any symptoms not listed above that concern you, contact your doctor or pharmacist. Regular blood tests may be performed to monitor your white blood cell count, liver function, and other parameters during treatment.
Reporting Side Effects
Reporting suspected adverse reactions after the medicine has been authorized is important. It allows continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals and patients are encouraged to report suspected adverse reactions through their national reporting system (e.g., the FDA MedWatch program in the United States, the Yellow Card Scheme in the United Kingdom, or the EMA EudraVigilance system in the European Union).
How Should You Store Ilaris?
Quick Answer: Store Ilaris in the refrigerator at 2–8°C. Do not freeze. Keep the vial in the outer carton to protect from light. Use immediately after first opening. Do not use if the solution is not clear to opalescent or contains particles.
- Keep this medicine out of the sight and reach of children.
- Do not use after the expiry date stated on the label and carton after “EXP.” The expiry date refers to the last day of that month.
- Store in a refrigerator (2°C–8°C / 36°F–46°F). Do not freeze.
- Keep the vial in the outer carton to protect from light.
- The solution should be used immediately after first opening (puncture of the rubber stopper) to prepare the injection.
- Do not use if the solution is not clear to opalescent, or if it contains visible particles.
- The solution should be colorless or may have a slight brownish-yellow tint.
- Any unused medicine must be discarded after the dose has been injected.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.
What Does Ilaris Contain?
Quick Answer: Each vial contains 150 mg canakinumab in 1 mL solution. Inactive ingredients include mannitol, histidine, histidine hydrochloride monohydrate, polysorbat 80, and water for injections.
Active Ingredient
Each single-use vial contains 150 mg canakinumab in 1 mL of solution. Canakinumab is a fully human monoclonal antibody produced in murine Sp2/0 cells by recombinant DNA technology.
Inactive Ingredients (Excipients)
- Mannitol — a sugar alcohol used as a stabilizer and tonicity agent
- Histidine — an amino acid used as a buffering agent to maintain pH
- Histidine hydrochloride monohydrate — buffer component
- Polysorbat 80 — a surfactant used to prevent protein aggregation (contains 0.4 mg per mL; may cause allergic reactions in sensitive individuals)
- Water for injections — solvent
Appearance and Packaging
Ilaris is supplied as a solution for injection in a 2 mL glass vial. The solution is a clear to opalescent liquid that is colorless or may have a slight brownish-yellow tint. Do not use the solution if it contains clearly visible particles, is cloudy, or is distinctly brown. Ilaris is available in packs containing 1 vial.
The marketing authorization holder is Novartis Europharm Limited (Dublin, Ireland). Manufacturing is performed at multiple sites including Novartis facilities in Barcelona (Spain), Nuremberg (Germany), and Ljubljana (Slovenia).
Frequently Asked Questions About Ilaris
Medical References
- European Medicines Agency (EMA). (2025). Ilaris (canakinumab) — Summary of Product Characteristics. EMA EPAR. [Evidence Level: Regulatory]
- Lachmann, H. J., et al. (2009). Use of Canakinumab in the Cryopyrin-Associated Periodic Syndrome. New England Journal of Medicine, 360(23), 2416–2425. doi:10.1056/NEJMoa0810787. [Evidence Level: 1B — RCT]
- De Benedetti, F., et al. (2012). Canakinumab for the Treatment of Autoinflammatory Recurrent Fever Syndromes. New England Journal of Medicine, 378(20), 1908–1919. doi:10.1056/NEJMoa1706314. [Evidence Level: 1B — RCT]
- Ruperto, N., et al. (2012). Two Randomized Trials of Canakinumab in Systemic Juvenile Idiopathic Arthritis. New England Journal of Medicine, 367(25), 2396–2406. doi:10.1056/NEJMoa1205099. [Evidence Level: 1B — RCT]
- Schlesinger, N., et al. (2012). Canakinumab for acute gouty arthritis in patients who are unresponsive to or intolerant of conventional treatments. Annals of the Rheumatic Diseases, 71(11), 1839–1848. doi:10.1136/annrheumdis-2011-200270. [Evidence Level: 1B — RCT]
- U.S. Food and Drug Administration (FDA). (2024). Ilaris (canakinumab) — Prescribing Information. FDA Label. [Evidence Level: Regulatory]
- World Health Organization (WHO). (2023). WHO Model List of Essential Medicines – 23rd List. WHO EML. [Evidence Level: Expert Consensus]
- Ozen, S., et al. (2016). EULAR/PRINTO/PRES criteria for the classification and diagnosis of autoinflammatory diseases. Annals of the Rheumatic Diseases, 75(8), 1570–1577. [Evidence Level: Expert Consensus]
Evidence Grading: References are graded according to the GRADE framework. Level 1A = systematic reviews; Level 1B = randomized controlled trials; Regulatory = official regulatory agency documentation; Expert Consensus = international expert panel guidelines.
iMedic Medical Editorial Team
Specialists in Clinical Pharmacology, Rheumatology & Immunology
Clinical Pharmacologists
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Rheumatology Specialists
Experts in autoinflammatory diseases and biologic therapies
Immunology Researchers
Specialists in innate immunity and IL-1 mediated diseases
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