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Anakinra

Published: July 26, 2026Updated: July 26, 2026

Anakinra is a recombinant interleukin-1 receptor antagonist that blocks the activity of IL-1 alpha and beta, reducing inflammatory responses in the body. It is used to treat rheumatoid arthritis, cryopyrin-associated periodic syndromes (CAPS), systemic juvenile idiopathic arthritis, and adult-onset Still's disease.

Quick summary

Anakinra is an IL-1 inhibitor injection used for rheumatoid arthritis, CAPS, and other inflammatory conditions.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy

Key facts at a glance

ATC
L04AC03
RxNorm
72435
Generic
Anakinra
Class
atc-l04
Brands
Kineret
Availability
rx
Lactation
unknown
Routes
—
Forms
prefilled syringe
Regions
US, EU, CN, JP
Monitoring
—

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
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose approximately 10 times the recommended daily dose that may cause serious toxicity
Chronic overdose: cumulative doses exceeding recommended 100mg daily dosing over extended periods may lead to increased risk of infections and immunosuppressive effects
Immediate actions
discontinue medication immediately, monitor vital signs, supportive care, treat infections if they occur
Antidote
no specific antidote available(supportive care is the primary treatment approach; effectiveness depends on early intervention and symptom management)
Poison Control: 1-800-222-1222

Special Populations

10 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 and ultrasound assessments

Use with caution and monitor for adverse effects.

⚠

pregnancy

second trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

continue only if clearly needed; consider discontinuation if pregnancy confirmed

Monitor

routine prenatal care with fetal growth monitoring

Use with caution and monitor for adverse effects.

⚠

pregnancy

third trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

consider discontinuing before delivery due to potential effects on neonatal immune system

Monitor

fetal monitoring and assessment of neonatal immune function

Use with caution and monitor for adverse effects.

?

lactation

breastfeeding
unknown
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

discontinue breastfeeding or avoid anakinra due to unknown excretion in breast milk

Monitor

monitor infant for signs of infection or immune suppression

✓

pediatric_age

children 2 17 years
safe
FDA Category
N
Dose Adjustment

weight-based dosing

Key Recommendations

approved for CAPS and Still's disease; pediatric dosing is 1-2 mg/kg daily subcutaneously

Monitor

regular monitoring of blood counts and infection signs

⚠

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 closely for neutropenia

Monitor

regular CBC monitoring and infection surveillance

Use with caution and monitor for adverse effects.

✓

renal_impairment

mild to moderate
safe
FDA Category
N
Dose Adjustment

no adjustment needed

Key Recommendations

no dose adjustment required for CrCl 30-80 mL/min

Monitor

routine renal function monitoring

⚠

renal_impairment

severe
caution
FDA Category
N
Dose Adjustment

reduce dose to alternate day dosing

Key Recommendations

consider reducing dose for CrCl less than 30 mL/min; monitor drug levels if available

Monitor

close monitoring of renal function and drug tolerability

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild to moderate
caution
FDA Category
N
Dose Adjustment

no specific recommendation

Key Recommendations

limited data; use with caution

Monitor

monitor liver function tests

Use with caution and monitor for adverse effects.

✗

hepatic_impairment

severe
unsafe
FDA Category
N
Dose Adjustment

avoid

Key Recommendations

not recommended due to limited safety data

Monitor

close monitoring if use is unavoidable

Use of this medication in this population requires careful consideration of risks and benefits.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2001

FDA approval for Anakinra (Kineret)

drug_classWHO
2023

Drug class

Value:IL-1 receptor antagonist (Biologic DMARD)

Biological disease-modifying antirheumatic drug

usageFDA
2023

Primary indications

Value:Rheumatoid arthritis, Cryopyrin-associated periodic syndromes (CAPS)

Main therapeutic indications for Anakinra

administrationFDA
2023

Route of administration

Value:Subcutaneous injection

Method of drug delivery

Treats rheumatoid arthritis (as monotherapy or with DMARDs), cryopyrin-associated periodic syndromes (CAPS) including NOMID, systemic juvenile idiopathic arthritis (SJIA), adult-onset Still's disease, and acute gout flares when conventional therapies are unsuitable.

Recombinant human IL-1 receptor antagonist (IL-1Ra) that competitively blocks IL-1 alpha and beta from binding to the interleukin-1 type I receptor (IL-1RI), preventing downstream inflammatory signaling cascades.

Administered as daily subcutaneous injection. Increases infection risk; contraindicated with active infection. Common side effects include injection site reactions and headache. May cause neutropenia requiring blood monitoring. Not typically combined with TNF inhibitors due to additive immunosuppression risk.

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 July 26, 2026. · Read our editorial policy