Golimumab
Golimumab is a human monoclonal antibody that targets and neutralizes tumor necrosis factor alpha (TNFα), a key protein that drives inflammation in the body. It is prescribed to treat various autoimmune inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.
A biologic agent that suppresses inflammation by blocking TNFα, used to treat autoimmune diseases.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L04AB06
- RxNorm
- 819300
- Generic
- Golimumab
- Class
- atc-l04
- Brands
- Simponi
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- prefilled syringe, injection
- 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
- 50mg once monthly
- Maximum
- consult physician
- Frequency
- once monthly
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 50mg once monthly
- Maximum
- consult physician
- Frequency
- once monthly
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 50mg once monthly
- Maximum
- consult physician
- Frequency
- once monthly
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks; discuss with healthcare provider
regular prenatal monitoring
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks; TNF-alpha inhibitors cross placenta
regular fetal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid if possible
discontinue treatment prior to delivery if possible; discuss with healthcare provider
regular fetal monitoring; assess newborn for infections
Use with caution and monitor for adverse effects.
lactation
breastfeedingnot recommended
do not breastfeed during treatment and for at least 6 months after last dose
monitor infant for infections
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderlyno specific dosage adjustment
use with caution; increased risk of infections
regular assessment for infections
Use with caution and monitor for adverse effects.
pediatric_age
under 18 yearsnot recommended
not approved for use in patients under 18 years of age
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
mild moderateno dosage adjustment required
no dose adjustment needed for mild to moderate renal impairment
standard monitoring
hepatic_impairment
mild moderateno dosage adjustment required
no dose adjustment needed for mild to moderate hepatic impairment
standard monitoring
Statistics and clinical data
Drug class
Biologic disease-modifying antirheumatic drug
FDA approval year
FDA approval for Simponi
Common uses
Approved therapeutic indications
Route of administration
Method of drug delivery
Treats autoimmune inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. It is typically used when other treatments have not been effective.
Golimumab is a monoclonal antibody that binds to both soluble and transmembrane forms of TNFα, preventing TNFα from binding to its receptors. By blocking this interaction, it inhibits the biological activity of TNFα, reducing the inflammatory response that damages tissues in autoimmune conditions.
As an immunosuppressant, golimumab increases susceptibility to infections including serious infections like tuberculosis. Patients should be screened for infections and malignancies before starting treatment. It is administered by subcutaneous injection. Live vaccines should be avoided during treatment.
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