Ustekinumab
Ustekinumab is a monoclonal antibody that targets and blocks specific proteins involved in inflammation. It is used to treat autoimmune conditions like psoriasis, psoriatic arthritis, and inflammatory bowel disease by reducing the immune system's overactive response that causes these conditions.
Ustekinumab treats autoimmune inflammatory conditions by blocking IL-12 and IL-23 cytokines.
Key facts at a glance
- ATC
- L04AC05
- RxNorm
- 847083
- Generic
- Ustekinumab
- Class
- atc-l04
- Brands
- Steqeyma, Wezlana, Otulfi, Selarsdi, Pyzchiva, Yesintek, Imuldosa, Starjemza, Stelara
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection, 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
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
use only if benefits outweigh potential risks to fetus; discontinue if pregnancy occurs unless clearly needed
regular prenatal care and fetal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesterconsider discontinuation near end of pregnancy
consider risks vs benefits; may cross placenta particularly in third trimester
monitor newborn for infections due to immunosuppression
Use with caution and monitor for adverse effects.
lactation
breastfeedinguse with caution
discontinue breastfeeding or discontinue drug; limited data on human milk transfer
monitor infant for infections
pediatric_age
6 to 17 yearsweight-based dosing
approved for plaque psoriasis in pediatric patients 6 years and older; use recommended weight-based dosing
regular assessment of efficacy and adverse effects
pediatric_age
under 6 yearsnot established
not recommended for children under 6 years; limited safety and efficacy data
close monitoring if used off-label
Use with caution and monitor for adverse effects.
geriatric
elderlyno specific dose adjustment
use with caution; higher susceptibility to infections
monitor for infections and malignancy
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderateno dose adjustment expected
no formal dose adjustment required; limited clinical trial data
standard monitoring
renal_impairment
severeuse with caution
limited data in severe renal impairment; use only if benefits outweigh risks
monitor renal function and adverse effects
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderateno specific dose adjustment
limited data; use with caution
monitor liver function
Use with caution and monitor for adverse effects.
hepatic_impairment
severeuse with caution
not studied in severe hepatic impairment; use only if benefits outweigh risks
close monitoring of liver function and clinical status
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
First FDA approval for Stelara
Drug class
Biologic immunosuppressive agent
Common uses
Autoimmune and inflammatory conditions
Mechanism of action
Biological target and pathway
Ustekinumab is indicated for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in adults and pediatric patients where appropriate.
Ustekinumab binds to the p40 protein subunit shared by IL-12 and IL-23 cytokines, preventing these pro-inflammatory cytokines from interacting with their receptors and thereby reducing inflammatory and immune responses.
Administered via subcutaneous injection or intravenous infusion. Patients should be screened for tuberculosis before starting treatment. Live vaccines should be avoided during treatment. Common side effects include upper respiratory infections, headache, and fatigue. May increase risk of infections and malignancy.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
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.
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