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Canakinumab: Pediatric drug information

Canakinumab: Pediatric drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Canakinumab: Drug information" and "Canakinumab: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Ilaris
Brand Names: Canada
  • Ilaris
Therapeutic Category
  • Interleukin-1 Receptor Antagonist;
  • Monoclonal Antibody
Dosing: Pediatric
Cryopyrin-associated periodic syndromes

Cryopyrin-associated periodic syndromes (CAPS): Patient syndromes included in trials were: Familial cold autoinflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS), chronic infantile neurological cutaneous articular syndrome/neonatal onset multisystemic inflammatory disease (CINCA/NOMID), and familial cold urticaria (FCU); data has shown that pediatric patients require higher doses than adults (Ref).

Manufacturer's labeling:

Children ≥4 years and Adolescents:

15 to 40 kg: SUBQ: Initial: 2 mg/kg/dose every 8 weeks; may increase to 3 mg/kg/dose if response inadequate.

>40 kg: SUBQ: 150 mg/dose every 8 weeks.

Alternate dosing: Limited data available:

Children 2 to <4 years and weighing ≥7.5 kg: SUBQ: 4 mg/kg/dose every 8 weeks; if no response after 7 days, may repeat 4 mg/kg dose; if response achieved then may continue patient on intensified maintenance of 8 mg/kg/dose every 8 weeks (Ref).

Children ≥4 years and Adolescents:

7.5 to <15 kg: SUBQ: 4 mg/kg/dose every 8 weeks. If no response after 7 days, may administered a second 4 mg/kg/dose; if full treatment response achieved then may continue patient on intensified maintenance of 8 mg/kg/dose every 8 weeks (Ref).

15 to 40 kg: SUBQ: 2 mg/kg/dose every 8 weeks. If response not satisfactory after 7 days, may repeat 2 mg/kg dose; if full treatment response achieved then may continue patient on intensified maintenance of 4 mg/kg/dose every 8 weeks. If after 7 days (ie, day 14) a satisfactory response still not achieved, may administer another 4 mg/kg dose; if full treatment response achieved then may continue patient on intensified maintenance of 8 mg/kg/dose every 8 weeks (Ref). Another dose-escalation regimen describes titration in 2 mg/kg/dose increments every 7 days up to a maximum dose of 8 mg/kg/dose (Ref).

>40 kg: SUBQ: 150 mg every 8 weeks. If response not satisfactory after 7 days, may repeat 150 mg/dose; if full treatment response achieved then may continue patient on intensified maintenance of 300 mg every 8 weeks. If after 7 days (ie, day 14) a satisfactory response still not achieved, may administer another 300 mg/dose; if full treatment response achieved then may continue patient on intensified maintenance of 600 mg every 8 weeks (Ref). Another dose-escalation regimen describes titration in 150 mg increments every 7 days up to a maximum dose of 600 mg (Ref).

Familial Mediterranean fever

Familial Mediterranean fever (FMF): Note: In trials, canakinumab was used as monotherapy and in combination with daily colchicine.

Children ≥2 years and Adolescents:

7.5 to 40 kg: SUBQ: Initial: 2 mg/kg/dose every 4 weeks; if inadequate response after 7 days may repeat dose (2 mg/kg) and increase maintenance dose to 4 mg/kg/dose every 4 weeks if full treatment response (Ref).

>40 kg: SUBQ: Initial: 150 mg every 4 weeks; if inadequate response after 7 days may repeat dose (150 mg) and increase maintenance dose to 300 mg every 4 weeks if full treatment response (Ref).

Hyperimmunoglobulin D syndrome/mevalonate kinase deficiency

Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD):

Children ≥2 years and Adolescents:

7.5 to 40 kg: SUBQ: Initial: 2 mg/kg/dose every 4 weeks; if inadequate response after 7 days may repeat dose (2 mg/kg) and increase maintenance dose to 4 mg/kg/dose every 4 weeks if full treatment response (Ref).

>40 kg: SUBQ: Initial: 150 mg every 4 weeks; if inadequate response after 7 days may repeat dose (150 mg) and increase maintenance dose to 300 mg every 4 weeks if full treatment response (Ref).

Juvenile idiopathic arthritis, systemic

Juvenile idiopathic arthritis, systemic: Children ≥2 years weighing at least 7.5 kg and Adolescents: SUBQ: 4 mg/kg/dose every 4 weeks; maximum dose: 300 mg/dose.

Tumor necrosis factor receptor–associated periodic syndrome

Tumor necrosis factor receptor–associated periodic syndrome (TRAPS):

Children ≥2 years and Adolescents:

7.5 to 40 kg: SUBQ: Initial: 2 mg/kg/dose every 4 weeks; if inadequate response after 7 days may repeat dose (2 mg/kg) and increase maintenance dose to 4 mg/kg/dose every 4 weeks if full treatment response (Ref).

>40 kg: SUBQ: Initial: 150 mg every 4 weeks; if inadequate response after 7 days may repeat dose (150 mg) and increase maintenance dose to 300 mg every 4 weeks if full treatment response (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Children ≥2 years and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.

Dosing: Liver Impairment: Pediatric

Children ≥2 years and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.

Dosing: Adult

(For additional information see "Canakinumab: Drug information")

Cryopyrin-associated periodic syndromes

Cryopyrin-associated periodic syndromes (CAPS): SUBQ: 150 mg (>40 kg) or 2 mg/kg (15 to 40 kg) every 8 weeks; in clinical trials, dosage adjustments up to 600 mg (>40 kg) or 8 mg/kg (≤40 kg) and/or increased dosing frequency were allowed for residual symptoms (Ref). For inadequate response, a dose titration schedule of 150 mg or 2 mg/kg every 7 days up to a maximum dose of 600 mg or 8 mg/kg (15 to 40 kg) has been recommended (Ref).

Familial Mediterranean fever, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency, tumor necrosis factor receptor–associated periodic syndrome

Familial Mediterranean fever (FMF), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), tumor necrosis factor receptor–associated periodic syndrome (TRAPS): SUBQ: Initial: 150 mg (>40 kg) or 2 mg/kg (≤40 kg) every 4 weeks; may increase to 300 mg (>40 kg) or 4 mg/kg (≤40 kg) every 4 weeks if response to the initial dose was not adequate or if an early supplemental dose was used (Ref).

Early inadequate response (off-label dosing): SUBQ: If inadequate response to initial dose occurs between days 8 and 28 (eg, baseline flare persists), an additional 150 mg (>40 kg) or 2 mg/kg (≤40 kg) may be given (Ref).

Gout, treatment

Gout, treatment (acute flares) (alternative agent):

Note: Reserve use for patients who have frequent flares and in whom first-line therapies are ineffective, contraindicated, or not tolerated (Ref).

SUBQ: 150 mg as a single dose; repeat doses may be administered at intervals of ≥12 weeks (Ref).

Still disease, adult onset

Still disease, adult onset: SUBQ: 4 mg/kg every 4 weeks (maximum: 300 mg/dose).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children, adolescents, and adults.

>10%:

Endocrine & metabolic: Increased uric acid (gout flares: 44%), weight gain (11%)

Gastrointestinal: Diarrhea (20%), gastroenteritis (3% to 11%), nausea (14%), upper abdominal pain (7% to 16%)

Hematologic & oncologic: Neutropenia (16%), thrombocytopenia (16%)

Infection: Infection (including upper respiratory tract infection, urinary tract infection, viral upper respiratory tract infection: ≤55%; serious infection: 2% to 5%), influenza (17%)

Local: Injection-site reaction (1% to 12%)

Nervous system: Headache (14%), vertigo (9% to 14%)

Neuromuscular & skeletal: Musculoskeletal pain (11%)

Respiratory: Bronchitis (11%), nasopharyngitis (11% to 34%), pharyngitis (3% to 11%), rhinitis (5% to 17%)

1% to 10%:

Endocrine & metabolic: Decreased serum calcium (8%) (Lachmann 2009), hypertriglyceridemia (3% to 6%)

Genitourinary: Proteinuria (8%) (Lachmann 2009)

Hematologic & oncologic: Eosinophilia (7%) (Lachmann 2009), leukopenia (6%)

Hepatic: Increased serum alanine aminotransferase (≤4%), increased serum aspartate aminotransferase (≤4%), increased serum bilirubin (7%) (Lachmann 2009)

Immunologic: Antibody development (non-neutralizing: 1% to 4%; neutralizing: <1%)

Nervous system: Dizziness (2%)

Neuromuscular & skeletal: Back pain (3%)

Renal: Decreased creatinine clearance (8%) (Lachmann 2009)

Postmarketing:

Hypersensitivity: Drug reaction with eosinophilia and systemic symptoms, hypersensitivity reaction

Infection: Opportunistic infection

Contraindications

Hypersensitivity to canakinumab or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Active, severe infections

Warnings/Precautions

Concerns related to adverse effects:

• Hematologic effects: A decrease in WBC, neutrophils, and platelets was observed in clinical trials; some changes were transient and/or mild (eg, thrombocytopenia). One case of neutropenia (ANC <1,500/mm3) was reported; monitor blood counts as indicated.

• Hypersensitivity: Hypersensitivity reactions (excluding anaphylactic reactions) have been reported with use; symptoms may be similar to those that are disease related. Drug reaction with eosinophilia and systemic symptoms, including severe skin eruptions, has been reported in patients with autoinflammatory conditions. Discontinue therapy immediately and initiate appropriate therapy if severe hypersensitivity occurs.

• Infections: Caution should be exercised when considering use in patients with a history of new/recurrent infections, with conditions that predispose them to infections, or with latent or localized infections. Patients who develop a new infection while undergoing treatment should be monitored closely. If a patient develops a serious infection, therapy should be discontinued. Therapy should not be initiated in patients with active or chronic infections.

• Macrophage activation syndrome: Macrophage activation syndrome (MAS) may develop in patients with Still disease and should be treated aggressively. Infection or worsening Still disease may be triggers for MAS.

• Malignancy: Use may impair defenses against malignancies; impact on the development and course of malignancies is not fully defined.

• Tuberculosis: Avoid use in patients with tuberculosis (TB) disease (active TB). Patients should be evaluated for TB infection (latent TB) with a tuberculin skin test prior to starting therapy. Treat TB infection prior to initiating canakinumab therapy. During and following treatment, monitor for signs/symptoms of TB disease.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Other warnings/precautions:

• Immunizations: All patients should be brought up to date with all immunizations including pneumococcal and influenza vaccines before initiating therapy. Live vaccines should not be given concurrently; no data available on either the efficacy or on the risks concerning secondary transmission of infection by live vaccines in patients receiving therapy. Administration of inactivated (killed) vaccines while on therapy may not be effective.

Warnings: Additional Pediatric Considerations

Reactivation of TB has been reported in pediatric patients receiving biologic response modifiers (infliximab and etanercept); prior to therapy, patients with no TB risk factors should be screened for latent TB infection (LTBI) with an age appropriate test (ie, <5 years of age: tuberculin skin test, and ≥5 years of age: IGRA [interferon gamma release assay]); if any TB risk factors are present or symptoms, both LTBI screening tests should be performed (AAP [Davies 2016])

Influenza reported in 17% of patients during clinical trials. Vertigo has been reported exclusively in patients with MWS (9% to 14%); events appear self-resolving with continued therapy. Infection reported more frequently in children than adults (Kuemmerle-Deschner 2011) for both CAPS and JIA. Treatment for CAPS has been associated with higher incidence of reported adverse reactions including diarrhea (20%), nasopharyngitis (34%), and rhinitis (17%).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous [preservative free]:

Ilaris: 150 mg/mL (1 mL) [contains polysorbate 80]

Generic Equivalent Available: US

No

Pricing: US

Solution (Ilaris Subcutaneous)

150 mg/mL (per mL): $24,265.93

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous:

Ilaris: 150 mg/mL (1 mL) [contains polysorbate 80]

Administration: Pediatric

SubQ: Do not shake; administer subcutaneously at a concentration of 150 mg/mL by a health care provider; avoid sites with scar tissue

Administration: Adult

SUBQ: For subcutaneous injection only by a health care provider. Do not shake solution. Do not inject into scar tissue.

Storage/Stability

Store intact vial at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. Discard any unused portion.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125319s107lbl.pdf#page=24, must be dispensed with this medication.

Use

Treatment of cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS) (FDA approved in ages ≥4 years and adults); treatment of active systemic juvenile idiopathic arthritis (SJIA) (FDA approved in ages ≥2 years weighing at least 7.5 kg); treatment of tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) and familial Mediterranean fever (FMF) (FDA approved in ages ≥2 years and adults); treatment of active adult-onset Still's disease (AOSD) (FDA approved in adults); treatment of gout flares in patients in whom non-steroidal anti-inflammatory drugs and colchicine are contraindicated, not tolerated, or do not provide an adequate response and in whom repeated corticosteroid use is not appropriate (FDA approved in adults).

Medication Safety Issues
Sound-alike/look-alike issues:

Ilaris may be confused with Ilumya

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Anti-TNF Agents: May increase adverse/toxic effects of Canakinumab. Specifically, the risk for serious infections and/or neutropenia may be increased. Risk X: Avoid

Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid

Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate 2 to 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Interleukin-1 Inhibitors: May increase adverse/toxic effects of Canakinumab. Risk X: Avoid

Interleukin-1 Receptor Antagonist: May increase adverse/toxic effects of Canakinumab. Risk X: Avoid

Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Rabies Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

Fertility may be decreased in males and females with inflammatory diseases such as familial Mediterranean fever. Based on case reports, treatment with canakinumab may improve fertility (Babaoglu 2020; Youngstein 2017).

Pregnancy Considerations

Canakinumab crosses the placenta; newborn concentrations may be greater than maternal serum concentrations at delivery (Bosshard 2021; Egawa 2017; Weber 2022).

Canakinumab is a recombinant IgG monoclonal antibody; IgG is known to cross the placenta in a linear fashion as pregnancy progresses; potential fetal exposure is likely to be greater during the second and third trimesters.

Outcome data related to the use of canakinumab in pregnancy are limited (Babaoglu 2020; Brien 2021; Dernoncourt 2023; Egawa 2017; İlgen 2022; Youngstein 2017). Other agents are currently preferred for the treatment of adult-onset Still disease (Jamilloux 2014) or familial Mediterranean fever (EULAR [Ozen 2016]) in pregnant patients.

Monitoring Parameters

Hypersensitivity, CBC with differential, C-reactive protein (CRP), serum amyloid A; LFTs at baseline; signs or symptoms of infection; latent TB screening (prior to initiating therapy), body weight. Eye examinations for patients with CAPS (Caorsi 2013) and symptoms of disease for patients with CAPS, SJIA, TRAPS, FMF, or HIDS/MKD were also monitored in clinical trials (Arostegui 2015; Brik 2014; Caorsi 2013; Lachmann 2009; Ruperto 2012; Torene 2017).

Mechanism of Action

Canakinumab reduces inflammation by binding to interleukin-1 beta (IL-1beta) (no binding to IL-1 alpha or IL-1 receptor antagonist [IL-1ra]) and preventing interaction with cell surface receptors. Cryopyrin-associated periodic syndromes (CAPS) refers to rare genetic syndromes caused by mutations in the nucleotide-binding domain, leucine rich family (NLR), pyrin domain containing 3 (NLRP-3) gene or the cold-induced autoinflammatory syndrome-1 (CIAS1) gene. Cryopyrin, a protein encoded by this gene, regulates IL-1beta activation. Deficiency of cryopyrin results in excessive inflammation.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Maximum effect: Within 8 days CRP and serum amyloid normalization.

Distribution: Vdss: Children: 0.097 L/kg (3.2 L in 33 kg); Adults: CAPS: 0.086 L/kg (6.01 L in 70 kg); FMF, HIDS/MKD, TRAPS: 0.09 L/kg (6.34 L in 70 kg); Gout flares: 0.085 L/kg (7.9 L in 93 kg).

Protein binding: Binds to serum IL-1 beta.

Bioavailability: Subcutaneous: 66%.

Half-life elimination: Children ≥4 years: 22.9 to 25.7 days; Adults: 26 days.

Time to peak, serum: Children ≥4 years: 2 to 7 days; Adults: ~7 days.

Clearance: Varies according to body weight:

Children ≤40 kg: SJIA: 0.11 L/day in 33 kg.

Children >40 kg and Adults: CAPS: 0.174 L/day in 70 kg.

Children, Adolescents, and Adults: FMF, HIDS/MKD, TRAPS: 0.17 L/day in 70 kg.

Adults: Gout flares: 0.23 L/day in 93 kg.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Ilaris;
  • (AR) Argentina: Ilaris;
  • (AT) Austria: Ilaris;
  • (BE) Belgium: Ilaris;
  • (BG) Bulgaria: Ilaris;
  • (BR) Brazil: Ilaris;
  • (CH) Switzerland: Ilaris;
  • (CL) Chile: Ilaris;
  • (CO) Colombia: Ilaris;
  • (CY) Cyprus: Ilaris;
  • (CZ) Czech Republic: Ilaris;
  • (DE) Germany: Ilaris;
  • (DK) Denmark: Ilaris;
  • (EE) Estonia: Ilaris;
  • (EG) Egypt: Ilaris;
  • (ES) Spain: Ilaris;
  • (FI) Finland: Ilaris;
  • (FR) France: Ilaris;
  • (GB) United Kingdom: Ilaris;
  • (GR) Greece: Ilaris;
  • (HK) Hong Kong: Ilaris;
  • (HU) Hungary: Ilaris;
  • (IE) Ireland: Ilaris;
  • (IT) Italy: Ilaris;
  • (JP) Japan: Ilaris;
  • (KR) Korea, Republic of: Ilaris;
  • (KW) Kuwait: Ilaris;
  • (LT) Lithuania: Ilaris;
  • (LU) Luxembourg: Ilaris;
  • (LV) Latvia: Ilaris;
  • (MT) Malta: Ilaris;
  • (MY) Malaysia: Ilaris;
  • (NL) Netherlands: Ilaris;
  • (NO) Norway: Ilaris;
  • (NZ) New Zealand: Ilaris;
  • (PL) Poland: Ilaris;
  • (PR) Puerto Rico: Ilaris;
  • (PT) Portugal: Ilaris;
  • (QA) Qatar: Ilaris;
  • (RO) Romania: Ilaris;
  • (RU) Russian Federation: Ilaris;
  • (SA) Saudi Arabia: Ilaris;
  • (SE) Sweden: Ilaris;
  • (SG) Singapore: Ilaris;
  • (SI) Slovenia: Ilaris;
  • (SK) Slovakia: Ilaris;
  • (SR) Suriname: Ilaris;
  • (TR) Turkey: Ilaris;
  • (TW) Taiwan: Ilaris;
  • (UA) Ukraine: Ilaris
  1. Alade SL, Brown RE, Paquet A Jr. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
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  3. Arostegui JI, Anton J, Calvo I, et al. Long-term efficacy and safety of canakinumab in active hyper-IgD syndrome (HIDS): results from an open-label study. Pediatric Rheumatology. 2015;13(supp 1):58.
  4. Babaoglu H, Varan O, Kucuk H, et al. Effectiveness of canakinumab in colchicine- and anakinra-resistant or -intolerant adult familial mediterranean fever patients: a single-center real-life study. J Clin Rheumatol. 2020;26(1):7-13. doi:10.1097/RHU.0000000000000873 [PubMed 30048391]
  5. Bosshard N, Zbinden A, Eriksson KK, Förger F. Rituximab and canakinumab use during lactation: no detectable serum levels in breastfed Infants. Rheumatol Ther. 2021;8(2):1043-1048. doi:10.1007/s40744-021-00313-z [PubMed 33999372]
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  8. Caorsi R, Lepore L, Zulian F, et al, "The Schedule of Administration of Canakinumab in Cryopyrin Associated Periodic Syndrome is Driven By the Phenotype Severity Rather Than the Age," Arthritis Res Ther, 2013, 15(1):R33. [PubMed 23442610]
  9. Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm. [PubMed 6423951]
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  11. De Benedetti F, Gattorno M, Anton J, et al. Canakinumab for the treatment of autoinflammatory recurrent fever syndromes. N Engl J Med. 2018;378(20):1908-1919. doi:10.1056/NEJMoa1706314 [PubMed 29768139]
  12. Dernoncourt A, Liabeuf S, Bennis Y, et al. Fetal and neonatal adverse drug reactions associated with biologics taken during pregnancy by women with autoimmune diseases: insights from an analysis of the World Health Organization Pharmacovigilance Database (VigiBase®). BioDrugs. 2023;37(1):73-87. doi:10.1007/s40259-022-00564-4 [PubMed 36401769]
  13. Egawa M, Imai K, Mori M, Miyasaka N, Kubota T. Placental transfer of canakinumab in a patient with muckle-wells syndrome. J Clin Immunol. 2017;37(4):339-341. doi:10.1007/s10875-017-0389-3 [PubMed 28386702]
  14. FitzGerald JD, Dalbeth N, Mikuls T, et al. 2020 American College of Rheumatology guideline for the management of gout. Arthritis Care Res (Hoboken). 2020;72(6):744-760. doi:10.1002/acr.24180 [PubMed 32391934]
  15. Furst DE, Keystone EC, Braun J, et al, "Updated Consensus Statement on Biological Agents for the Treatment of Rheumatic Diseases, 2010," Ann Rheum Dis, 2011, 70(Suppl 1)2-36. [PubMed 21339216]
  16. Ilaris (canakinumab) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; November 2024.
  17. Ilaris (canakinumab) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; November 2022.
  18. Ilaris powder for injection (canakinumab) [prescribing information]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; January 2017.
  19. Ilaris powder for injection (canakinumab) [prescribing information]. West Sussex, United Kingdom: Novartis Europharm Limited. February 2017.
  20. İlgen U, Eyüpoğlu Ş, Yayla ME, Küçükşahin O. Fetal exposure to canakinumab: a report of three pregnancies. Clin Rheumatol. 2022;41(4):1261-1263. doi:10.1007/s10067-022-06060-y [PubMed 35018583]
  21. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313.
  22. Ito S. Drug therapy for breast-feeding women. NEJM. 2000;343(2):118-126. doi:10.1056/NEJM200007133430208 [PubMed 10891521]
  23. Jamilloux Y, Gerfaud-Valentin M, Henry T, Sève P. Treatment of adult-onset Still's disease: a review. Ther Clin Risk Manag. 2014;11:33-43. doi:10.2147/TCRM.S64951 [PubMed 25653531]
  24. Koné-Paut I, Lachmann HJ, Kuemmerle-Deschner JB, et al, "Canakinumab in CAPS Study Group. Sustained Remission of Symptoms and Improved Health-Related Quality of Life in Patients With Cryopyrin-Associated Periodic Syndrome Treated With Canakinumab: Results of a Double-Blind Placebo-Controlled Randomized Withdrawal Study," Arthritis Res Ther, 2011, 13(6):R202. [PubMed 22152723]
  25. Kuemmerle-Deschner JB, Hachulla E, Cartwright R, et al, "Two-Year Results From an Open-Label, Multicentre, Phase III Study Evaluating the Safety and Efficacy of Canakinumab in Patients With Cryopyrin-Associated Periodic Syndrome Across Different Severity Phenotypes," Ann Rheum Dis, 2011, 70(12):2095-102. [PubMed 21859692]
  26. Lachmann HJ, Kone-Paut I, Kuemmerle-Deschner JB, et al, “Use of Canakinumab in the Cryopyrin-Associated Periodic Syndrome,” N Engl J Med, 2009, 360(23):2416-25. [PubMed 19494217]
  27. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  28. NCT 00685373, “Efficacy and Safety of ACZ885 in Patients With the Following Cryopyrin-Associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease”, Unpublished data. Available at http://clinicaltrials.gov/ct2/show/NCT00685373?term=NCT+00685373&rank=1. Date Accessed: October 29, 2011
  29. Ozen S, Demirkaya E, Erer B, et al. EULAR recommendations for the management of familial Mediterranean fever. Ann Rheum Dis. 2016;75(4):644-651. doi:10.1136/annrheumdis-2015-208690 [PubMed 26802180]
  30. Refer to manufacturer’s labeling.
  31. Richette P, Doherty M, Pascual E, et al. 2016 updated EULAR evidence-based recommendations for the management of gout. Ann Rheum Dis. 2017;76(1):29-42. doi: 10.1136/annrheumdis-2016-209707. [PubMed 27457514]
  32. Ruperto N, Brunner H, Horneff G, et al, “Efficacy and Safety of Canakinumab, a Longacting Fully Human Anti-Interleukin-1ß Antibody, in Systemic Juvenile Idiopathic Arthritis With Active Systemic Features: Results From a Phase III Study,” Pediatric Rheumatology, 2011, 9(Suppl 1):021.
  33. Ruperto N, Brunner HI, Quartier P, et al, "Two Randomized Trials of Canakinumab in Systemic Juvenile Idiopathic Arthritis," N Engl J Med, 2012, 367(25):2396-406. [PubMed 23252526]
  34. Ruperto N, Quartier P, Wulffraat N, et al; Paediatric Rheumatology International Clinical Trials Organisation. A phase II, multicenter, open-label study evaluating dosing and preliminary safety and efficacy of canakinumab in systemic juvenile idiopathic arthritis with active systemic features. Arthritis Rheum. 2012;64(2):557-567. doi:10.1002/art.33342 [PubMed 21953497]
  35. Schlesinger N, Alten RE, Bardin T, et al. Canakinumab for acute gouty arthritis in patients with limited treatment options: results from two randomised, multicentre, active-controlled, double-blind trials and their initial extensions. Ann Rheum Dis. 2012;71(11):1839-1848. doi: 10.1136/annrheumdis-2011-200908. [PubMed 22586173]
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  37. Sibley CH, Chioato A, Felix S, et al. A 24 month open-label study of canakinumab in neonatal-onset multisystem inflammatory disease. Ann Rheum Dis. 2015;74(9):1714-1719. [PubMed 24906637]
  38. Torene R, Nirmala N, Obici L, et al. Canakinumab reverses overexpression of inflammatory response genes in tumour necrosis factor receptor-associated periodic syndrome. Ann Rheum Dis. 2017;76(1):303-309. [PubMed 27474763]
  39. Weber E, Millet A, Beghin D, et al. Safety of canakinumab during pregnancy: seven new cases. Rheumatology (Oxford). 2022;61(8):e229-e231. doi:10.1093/rheumatology/keac177 [PubMed 35325056]
  40. Youngstein T, Hoffmann P, Gül A, et al. International multi-centre study of pregnancy outcomes with interleukin-1 inhibitors. Rheumatology (Oxford). 2017;56(12):2102-2108. doi:10.1093/rheumatology/kex305 [PubMed 28968868]
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