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Tralokinumab

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

Tralokinumab is a biologic medication that targets and blocks interleukin-13 (IL-13), a key protein involved in the inflammatory process of atopic dermatitis. It is prescribed for adults with moderate-to-severe atopic dermatitis who have not responded adequately to other topical treatments.

Quick summary

Tralokinumab is an IL-13 inhibitor monoclonal antibody used to treat moderate-to-severe atopic dermatitis in adults.

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

Key facts at a glance

ATC
D11AH07
RxNorm
2589225
Generic
Tralokinumab
Class
atc-d11
Brands
Adbry
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: Limited data available; doses significantly exceeding recommended regimen may increase risk of adverse effects
Chronic overdose: No specific cumulative toxicity threshold established; prolonged supratherapeutic dosing may increase immunogenicity risk
Immediate actions
Monitor vital signs, supportive care, observe for allergic reactions
Antidote
No specific antidote available(Supportive care is mainstay of management)
Poison Control: 1-800-222-1222

Special Populations

8 groups
⚠

pregnancy

first trimester
caution
FDA Category
C
Dose Adjustment

use only if benefits outweigh risks

Key Recommendations

avoid use during pregnancy unless benefits outweigh risks, discuss with healthcare provider

Monitor

regular prenatal monitoring

Use with caution and monitor for adverse effects.

⚠

pregnancy

second third trimester
caution
FDA Category
C
Dose Adjustment

use only if benefits outweigh risks

Key Recommendations

monoclonal antibodies may cross placenta in later pregnancy, weigh risks and benefits

Monitor

regular prenatal monitoring, consider fetal growth assessment

Use with caution and monitor for adverse effects.

⚠

lactation

breastfeeding
caution
FDA Category
N
Dose Adjustment

no specific adjustment

Key Recommendations

use with caution, limited data on excretion in breast milk

Monitor

monitor infant for any adverse effects

Use with caution and monitor for adverse effects.

✗

pediatric_age

under 18 years
contraindicated
FDA Category
N
Dose Adjustment

not applicable

Key Recommendations

not approved for use in patients under 18 years of age

Monitor

not applicable

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

✓

geriatric

65 years and older
safe
FDA Category
N
Dose Adjustment

no dose adjustment required

Key Recommendations

can be used in elderly patients, monitor for infections

Monitor

routine monitoring for infections and response to therapy

✓

renal_impairment

mild to moderate
safe
FDA Category
N
Dose Adjustment

no dose adjustment required

Key Recommendations

no specific dose adjustment needed, as monoclonal antibodies are not renally cleared

Monitor

routine clinical monitoring

⚠

renal_impairment

severe
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

limited data available, use with caution

Monitor

enhanced clinical monitoring

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild to moderate
caution
FDA Category
N
Dose Adjustment

use with caution

Key Recommendations

limited data available, use with caution

Monitor

routine clinical monitoring

Use with caution and monitor for adverse effects.

Statistics and clinical data

drug_classFDA
2023

Drug class

Value:Monoclonal antibody (IL-13 inhibitor)

Biological drug classification

prescribingFDA
2023

FDA approval year

Value:2021

Regulatory approval information

usageFDA
2023

Primary indication

Value:Atopic dermatitis (moderate-to-severe)

Therapeutic indication

mechanismFDA
2023

Mechanism of action

Value:Interleukin-13 (IL-13) inhibitor

Pharmacological mechanism

Moderate-to-severe atopic dermatitis (eczema) in adults who are candidates for systemic therapy, particularly when other treatments such as topical corticosteroids have been insufficient.

Tralokinumab is a human IgG4 monoclonal antibody that specifically binds to interleukin-13 (IL-13), preventing it from interacting with its receptors (IL-13Rα1 and IL-13Rα2). By blocking IL-13 signaling, it reduces the Type 2 inflammatory response that drives the symptoms of atopic dermatitis.

Administered as subcutaneous injections. May increase risk of infections and hypersensitivity reactions. Clinical monitoring is recommended during treatment. Should not be used in combination with other immunosuppressants without medical guidance.

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