Certolizumab Pegol
Certolizumab pegol is a biologic medication that targets and neutralizes tumor necrosis factor alpha (TNFα), a key protein involved in inflammation. It is used to treat autoimmune inflammatory conditions by reducing the immune system's overactive inflammatory response.
A TNF inhibitor biologic used to treat various autoimmune inflammatory conditions by blocking the inflammatory cytokine TNFα.
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
- L04AB05
- RxNorm
- 709271
- Generic
- Certolizumab Pegol
- Class
- atc-l04
- Brands
- Cimzia
- 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
- 400mg at weeks 0, 2, and 4 (loading dose), then 200mg every 2 weeks or 400mg every 4 weeks (maintenance)
- Maximum
- consult physician
- Frequency
- every 2 weeks or every 4 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- Not FDA-approved for pediatric use
- Maximum
- consult physician
- Frequency
- not applicable
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg at weeks 0, 2, and 4 (loading dose), then 200mg every 2 weeks or 400mg every 4 weeks (maintenance)
- Maximum
- consult physician
- Frequency
- every 2 weeks or every 4 weeks
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
first trimesterno specific adjustment
use only if benefits outweigh potential risks to fetus
standard prenatal care
Use with caution and monitor for adverse effects.
pregnancy
second third trimesterno specific adjustment
minimal placental transfer reported but continue only if needed
standard prenatal monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingcompatible with breastfeeding
monitor infant for infections
geriatric
elderlyno dose adjustment required
use with caution due to increased infection risk
regular monitoring for infections
Use with caution and monitor for adverse effects.
pediatric_age
under 18 yearsnot established
not approved for use in patients under 18 years
not applicable
renal_impairment
severeno dose adjustment required based on pharmacokinetics
use with caution and monitor closely
monitor renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate severeno specific adjustment based on pharmacokinetics
use with caution in moderate to severe hepatic impairment
monitor liver function tests
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Biologic disease-modifying antirheumatic drug targeting tumor necrosis factor-alpha
FDA first approval
Initial FDA approval date for Certolizumab Pegol (Cimzia)
Common uses
FDA-approved therapeutic indications
Mechanism of action
Binds to and neutralizes tumor necrosis factor-alpha (TNF-α)
Certolizumab pegol is approved for treating rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and plaque psoriasis in patients who have not responded adequately to conventional therapies.
Certolizumab pegol is a monoclonal antibody fragment that binds with high affinity to human TNFα, selectively neutralizing this pro-inflammatory cytokine and preventing it from triggering inflammatory responses that cause tissue damage and symptoms in autoimmune conditions.
As an immunosuppressant, certolizumab pegol increases risk of serious infections and malignancies. It is contraindicated in active infections and should not be used with other TNF inhibitors or biologics. Patients should be screened for tuberculosis before starting treatment. Pregnant women should only use it if clearly needed due to potential risks.
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