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Canakinumab

Published: July 26, 2026Updated: August 27, 2026

Canakinumab is a monoclonal antibody that targets interleukin-1 beta (IL-1β), a key driver of inflammation in the body. It is used to treat certain rare auto-inflammatory conditions where excessive IL-1 activity causes recurrent symptoms such as fever, rash, joint pain, and fatigue. This medication is administered by subcutaneous injection and is classified as an immunosuppressant.

Quick summary

Canakinumab is an IL-1β inhibitor used to treat auto-inflammatory diseases by reducing inflammation in the body.

Medically reviewed by WellAlly Editorial TeamLast reviewed August 27, 2026Editorial policy

Key facts at a glance

ATC
L04AC08
RxNorm
1114117
Generic
Canakinumab
Class
atc-l04
Brands
Ilaris
Availability
otc
Pregnancy
C
Lactation
unknown
Half-life (h)
624
Onset (min)
0
Duration (h)
1344
Routes
subcutaneous
Forms
solution for injection, lyophilized powder for reconstitution
Regions
United States, European Union, Canada, Japan, Australia, Switzerland, United Kingdom
Monitoring
infection signs, complete blood count, neutrophil count, liver function tests

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
150mg every 8 weeks
Maximum
consult physician
Frequency
every 8 weeks (subcutaneous injection)
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
4mg/kg every 4 weeks
Maximum
consult physician
Frequency
every 4 weeks (subcutaneous injection)
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
150mg every 8 weeks
Maximum
consult physician
Frequency
every 8 weeks (subcutaneous injection)
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Doses exceeding 600mg may lead to increased risk of serious infections and immune suppression
Chronic overdose: Prolonged use at supratherapeutic doses may result in severe immunosuppression and increased infection risk
Immediate actions
Discontinue medication, monitor vital signs, supportive care, evaluate for infections
Antidote
No specific antidote available(Treatment is supportive and symptomatic; no specific reversal agent exists)
Poison Control: 1-800-222-1222

Special Populations

11 groups
⚠

pregnancy

first trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if benefits outweigh potential risks to fetus

Monitor

regular fetal monitoring

Use with caution and monitor for adverse effects.

⚠

pregnancy

second trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if benefits outweigh potential risks

Monitor

regular fetal monitoring and ultrasound

Use with caution and monitor for adverse effects.

⚠

pregnancy

third trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

discontinue before delivery if possible

Monitor

fetal monitoring close to delivery

Use with caution and monitor for adverse effects.

⚠

lactation

breastfeeding
caution
FDA Category
N
Dose Adjustment

no adjustment

Key Recommendations

discontinue breastfeeding or discontinue drug

Monitor

monitor infant for infections

Use with caution and monitor for adverse effects.

✓

pediatric_age

children 2-4 years
safe
FDA Category
N
Dose Adjustment

weight-based dosing

Key Recommendations

approved for CAPS and SJIA in patients 2 years and older

Monitor

regular monitoring for infections

✓

pediatric_age

children 4-18 years
safe
FDA Category
N
Dose Adjustment

weight-based dosing

Key Recommendations

approved for CAPS, SJIA, and FMF

Monitor

regular monitoring for infections and efficacy

⚠

geriatric

elderly 65 years and older
caution
FDA Category
N
Dose Adjustment

no specific adjustment

Key Recommendations

use with caution due to increased infection risk

Monitor

close monitoring for infections and adverse reactions

Use with caution and monitor for adverse effects.

?

renal_impairment

mild moderate
unknown
FDA Category
N
Dose Adjustment

no adjustment needed

Key Recommendations

use with caution, limited data available

Monitor

monitor renal function

?

renal_impairment

severe
unknown
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

limited data, use only if benefits outweigh risks

Monitor

monitor renal function and for infections

?

hepatic_impairment

mild moderate
unknown
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

limited data available

Monitor

monitor hepatic function

⚠

hepatic_impairment

severe
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

use only if benefits outweigh risks

Monitor

monitor hepatic function closely

Use with caution and monitor for adverse effects.

Statistics and clinical data

drug_classWHO
2023

Drug class

Value:Monoclonal antibody (IL-1β inhibitor)

Biological immunomodulatory agent

prescribingFDA
2023

FDA approval year

Value:2009

Initial FDA approval for Canakinumab

usageFDA
2023

Common uses

Value:Cryopyrin-associated periodic syndromes (CAPS), Systemic juvenile idiopathic arthritis (SJIA), Adult-onset Still's disease, Gouty arthritis, Familial Mediterranean Fever

Therapeutic indications

mechanismFDA
2023

Mechanism of action

Value:Interleukin-1 beta (IL-1β) inhibitor

Pharmacological mechanism

Canakinumab is primarily used to treat cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome and Muckle-Wells syndrome. It is also approved for systemic juvenile idiopathic arthritis (SJIA) in children, adult-onset Still's disease, and periodic fever syndromes such as TRAPS and hyper-IgD syndrome (HIDS/MKD). Additionally, it may be used for gout flares when conventional therapies are unsuitable.

Canakinumab is a human monoclonal antibody that specifically binds to and neutralizes interleukin-1 beta (IL-1β), a cytokine that plays a central role in promoting inflammation. By blocking IL-1β, the medication reduces the inflammatory response that causes the symptoms of auto-inflammatory conditions. It does not directly suppress the entire immune system but specifically targets the IL-1 pathway.

Canakinumab should be used under the supervision of a specialist familiar with auto-inflammatory diseases. It may increase the risk of infections, including serious infections, and should not be used in patients with active infections. Live vaccines should be avoided during treatment. Common side effects may include injection site reactions, upper respiratory infections, and headache. Patients should be monitored for signs of infection and blood counts during treatment.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed August 27, 2026. · Read our editorial policy