Canakinumab

Canakinumab is a human monoclonal anti-human IL-1β antibody of the IgG1/κ isotype. Canakinumab binds to human IL-1β and neutralizes its activity by blocking its interaction with IL-1 receptors, but it does not bind IL-1α or IL-1 receptor antagonist (IL-1ra).

• ILARIS is an interleukin-1β blocker indicated for the treatment of: • Periodic Fever Syndromes ( 1.1 ): - Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older, including: ◾ Familial Cold Auto-inflammatory Syndrome (FCAS) ◾ Muckle-Wells Syndrome (MWS) - Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients - Hyperimmunoglobulin D Syndrome (HIDS)/ Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients - Familial Mediterranean Fever (FMF) in adult and pediatric patients • Active Still’s Disease, including Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients 2 years of age and older ( 1.2 ) • Gout flares in adults in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate ( 1.3 ) 1.1 Periodic Fever Syndromes ILARIS ® (canakinumab) is an interleukin-1β (IL-1β) blocker indicated for the treatment of the following autoinflammatory Periodic Fever Syndromes: Cryopyrin-Associated Periodic Synd…ICD-10: M10.9

• Confirmed hypersensitivity to canakinumab or to any of the excipients [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)] . Confirmed hypersensitivity to canakinumab or to any of the excipients.contraindicated

• CAPS: Recommended weight-based dosage is: - For patients > 40 kg: 150 mg subcutaneously, every 8 weeks - For patients ≥ 15 kg and < 40 kg: 2 mg/kg subcutaneously, every 8 weeks. For pediatric patients 15 kg to 40 kg with an inadequate response, the dose can be increased to 3 mg/kg. ( 2.2 ) • TRAPS, HIDS/MKD, and FMF: Recommended weight-based dosage is: - For patients > 40 kg: Starting dosage is 150 mg subcutaneously every 4 weeks. The dosage can be increased to 300 mg every 4 weeks if the clinical response is not adequate. ( 2.3 ) - For patients ≤ 40 kg: Starting dosage is 2 mg/kg subcutaneously every 4 weeks. The dosage can be increased to 4 mg/kg every 4 weeks if the clinical response is not adequate. ( 2.3 ) Still’s disease (AOSD and SJIA): Recommended weight-based dosage for patients ≥ 7.5 kg is 4 mg/kg (maximum dose of 300 mg), subcutaneously, every 4 weeks. ( 2.4 ) Gout Flares: Recommended dosage is 150 mg subcutaneously. In patients who require re-treatment, there should be an interval of at least 12 weeks before a new dose of ILARIS may be administered. ( 2.5 ) 2.1 General Dosing Information ILARIS IS FOR SUBCUTANEOUS USE ONLY. 2.2 Recommended Dosage for Cryopyrin-Associated Periodic Syndromes (CAPS) The recommended weight-based dosage of ILARIS is: For patients with CAPS > 40 kg: 150 mg subcutaneously, every 8 weeks For patients with CAPS ≥ 15 kg and ≤ 40 kg: 2 mg/kg subcutaneously, every 8 weeks. For pediatric patients with CAPS 15 kg to 40 kg with an inadequate response, the dosage can be increased to 3 mg/kg subcutaneously, every 8 weeks.

Serious Infections: ILARIS has been associated with an increased incidence of serious infections. Exercise caution when administering ILARIS to patients with infections, a history of recurring infections or underlying conditions which may predispose them to infections. Discontinue ILARIS if a patient develops a serious infection. Avoid administering ILARIS to patients during an active infection requiring medical intervention. ( 5.1 ) Hypersensitivity Reactions and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) can occur; discontinue ILARIS, treat promptly, and monitor until reaction resolves. ( 5.3 ) Immunizations: Avoid administration of live vaccines concurrently with ILARIS. Update all recommended vaccinations prior to initiation of therapy with ILARIS. ( 5.4 ) 5.1 Serious Infections ILARIS has been associated with an increased risk of serious infections. Exercise caution when administering ILARIS to patients with infections, a history of recurring infections or underlying conditions which may predispose them to infections. Avoid administering ILARIS to patients during an active infection requiring medical intervention. Discontinue ILARIS if a patient develops a serious infection. Infections, predominantly of the upper respiratory tract, in some instances serious, have been reported with ILARIS. Generally, the observed infections responded to standard therapy. Isolated cases of unusual or opportunistic infections (e.g., aspergillosis, atypical mycobacterial infections, cytomegalovirus, herpes zoster) were reported during ILARIS treatment.

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions (5.1)] Immunosuppression [see Warnings and Precautions (5.2)] Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Macrophage Activation Syndrome [see Warnings and Precautions (5.5)] CAPS: The most common adverse reactions (>10%) are nasopharyngitis, diarrhea, influenza, rhinitis, nausea, headache, bronchitis, gastroenteritis, pharyngitis, weight increased, musculoskeletal pain, and vertigo. ( 6 ) TRAPS, HIDS/MKD, and FMF: The most common adverse reactions (≥10%) are injection-site reactions and nasopharyngitis. ( 6 ) Still’s Disease: The most common adverse drug reactions (>10%) are infections (nasopharyngitis and upper respiratory tract infections), abdominal pain, and injection-site reactions. ( 6 ) Gout Flares: The most common adverse reactions (>2%) reported by are nasopharyngitis, upper respiratory tract infections, urinary tract infections, hypertriglyceridemia, and back pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

8.1 Pregnancy Risk Summary Available human data from postmarketing experience and published case reports on ILARIS use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes. Canakinumab, like other monoclonal antibodies, is actively transported across the placenta mainly during the third trimester of pregnancy and may cause immunosuppression in the in utero exposed infant ( see Clinical Considerations ). In an animal embryo-fetal development study with marmoset monkeys, there was no evidence of embryotoxicity or fetal malformations with subcutaneous administration of canakinumab during the period of organogenesis and later in gestation at doses that produced exposures approximately 11 times the exposure at the maximum recommended human dose (MRHD) and greater. Delays in fetal skeletal development were observed in marmoset monkeys following prenatal exposure to ILARIS at concentrations approximately 11 times the MRHD and greater. Similar delays in fetal skeletal development were observed in mice administered a murine analog of ILARIS during the period of organogenesis.

Metabolism

The pharmacokinetic properties of canakinumab are typical for an IgG-type antibody and are comparable in different diseases but influenced by body weight. Absorption The peak serum canakinumab concentration (C max ) of 16 ± 3.5 mcg/mL occurred approximately 7 days after subcutaneous administration of a single, 150 mg dose subcutaneously to adult CAPS patients.

No confirmed case of overdose has been reported. In the case of overdose, it is recommended that the subject be monitored for any signs and symptoms of adverse reactions or effects, and appropriate symptomatic treatment be instituted immediately.

• Jun 17, 2009BLABLA125319Novartis Pharms

1. 1Pyrexia1,41513%
2. 2Inappropriate Schedule Of Drug Administration1,24212%
3. 3Drug Ineffective1,19511%
4. 4Inappropriate Schedule Of Product Administration9549.0%
5. 5Pain9378.8%
6. 6Condition Aggravated8538.0%
7. 7Malaise7216.8%
8. 8Off Label Use6936.5%
9. 9Arthralgia6065.7%
10. 10Rash5615.3%
11. 11Incorrect Dose Administered5024.7%
12. 12Joint Swelling4874.6%
13. 13Headache4384.1%
14. 14Fatigue3893.7%
15. 15Pulmonary Embolism3873.6%

The 10 most recently updated of 117 ClinicalTrials.gov registrations naming Canakinumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Canakinumab for the Prevention of Lung Cancer, the Can-Prevent-Lung Trial
  Recruiting · Phase 2 · Interventional · 50 enrolled · M.D. Anderson Cancer Center
  NCT04789681updated 2026-06-12
• A Study on the Use of Canakinumab Among Familial Mediterranean Fever and Still's Disease Patients
  Recruiting · Observational · 160 enrolled · Novartis Pharmaceuticals
  NCT07517250updated 2026-06-09
• Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 45 enrolled · Wei-Che Ko
  NCT05535738updated 2026-06-09
• Evaluation of Canakinumab in High-Risk Former-Smokers
  Active not recruiting · Phase 2 · Interventional · 41 enrolled · Peter Shields
  NCT06038526updated 2026-05-20
• A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS/IPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia
  Recruiting · Phase 2 · Interventional · 76 enrolled · M.D. Anderson Cancer Center
  NCT04239157updated 2026-05-20
• A Study to Assess the Effectiveness and Safety of Canakinumab in Clinical Use in Patients With Schnitzler's Syndrome
  Not yet recruiting · Observational · 5 enrolled · Novartis Pharmaceuticals
  NCT07598422updated 2026-05-20
• Ilaris NIS in Korea
  Recruiting · Observational · 25 enrolled · Novartis Pharmaceuticals
  NCT06838143updated 2026-05-19
• Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis
  Recruiting · Phase 2 · Interventional · 120 enrolled · Massachusetts General Hospital
  NCT06691217updated 2026-05-13
• Study of Canakinumab in Patients With Myelofibrosis
  Active not recruiting · Phase 2 · Interventional · 14 enrolled · John Mascarenhas
  NCT05467800updated 2026-05-07
• A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma
  Completed · Early phase 1 · Interventional · 17 enrolled · Columbia University
  NCT04028245updated 2026-04-15

Frequently asked questions

How does Canakinumab work?

Canakinumab is a human monoclonal anti-human IL-1β antibody of the IgG1/κ isotype. Canakinumab binds to human IL-1β and neutralizes its activity by blocking its interaction with IL-1 receptors, but it does not bind IL-1α or IL-1 receptor antagonist (IL-1ra).

What is Canakinumab used for?

According to FDA labeling, Canakinumab carries indications including: ILARIS is an interleukin-1β blocker indicated for the treatment of: • Periodic Fever Syndromes ( 1.1 ): - Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older, including: ◾ Familial Cold Auto-inflammatory Syndrome (FCAS) ◾ Muckle-Wells Syndrome (MWS) - Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients - Hyperimmunoglobulin D Syndrome (HIDS)/ Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients - Familial Mediterranean Fever (FMF) in adult and pediatric patients • Active Still’s Disease, including Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients 2 years of age and older ( 1.2 ) • Gout flares in adults in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate ( 1.3 ) 1.1 Periodic Fever Syndromes ILARIS ® (canakinumab) is an interleukin-1β (IL-1β) blocker indicated for the treatment of the following autoinflammatory Periodic Fever Syndromes: Cryopyrin-Associated Periodic Synd…. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Canakinumab?

Canakinumab is classified as Interleukin inhibitors, Interleukin 1 Receptor Antagonists, Decreased Immunologic Activity.

What are the brand names for Canakinumab?

Canakinumab is marketed under brand names including Ilaris.

What are the contraindications for Canakinumab?

Canakinumab labeling lists contraindications including: Confirmed hypersensitivity to canakinumab or to any of the excipients [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)] . Confirmed hypersensitivity to canakinumab or to any of the excipients.. Always consult the full prescribing information and a clinician.