Pozelimab
Pozelimab is a monoclonal antibody medication that targets and inhibits the complement protein C5, preventing its cleavage into inflammatory and cell-lysing components. It is used to treat certain rare disorders caused by overactive complement system activity, such as paroxysmal nocturnal hemoglobinuria (PNH).
Pozelimab is a complement inhibitor monoclonal antibody used to treat complement-mediated disorders by blocking C5 protein activation.
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
- L04AJ11
- RxNorm
- 2663938
- Generic
- Pozelimab
- Class
- atc-l04
- Brands
- Veopoz
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- 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
- 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
avoid use during first trimester unless benefits significantly outweigh risks
regular fetal monitoring and ultrasound assessments
Use with caution and monitor for adverse effects.
pregnancy
second trimesteruse lowest effective dose
continue only if clinically indicated with careful risk-benefit assessment
routine prenatal monitoring and fetal growth assessments
Use with caution and monitor for adverse effects.
pregnancy
third trimesteruse lowest effective dose
consider timing of last dose before delivery to minimize neonatal exposure
monitor neonate for potential immune system effects
Use with caution and monitor for adverse effects.
lactation
breastfeedingno adjustment needed
discontinue breastfeeding or interrupt treatment considering importance of drug to mother
monitor infant for immune system changes and infections
Use with caution and monitor for adverse effects.
geriatric
elderly 65 and olderno specific dose adjustment
no dose adjustment required based on age alone; monitor renal function
periodic assessment of renal function and overall clinical response
pediatric_age
children 12 years and olderweight-based dosing
approved for pediatric patients 12 years and older; follow pediatric dosing guidelines
monitor growth parameters and immune function
renal_impairment
mild to moderateno dose adjustment needed
no dose adjustment required for mild to moderate renal impairment
routine monitoring of renal function
renal_impairment
severeuse with caution
use with caution; monitor closely for efficacy and safety
frequent renal function monitoring and clinical assessment
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderateno dose adjustment needed
no dose adjustment required for mild to moderate hepatic impairment
monitor liver function tests periodically
hepatic_impairment
severeuse with caution
use with caution; limited clinical data available
frequent monitoring of liver function and clinical response
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Pozelimab is a human monoclonal antibody that inhibits complement factor C5
FDA approval year
FDA approved Pozelimab for treatment of paroxysmal nocturnal hemoglobinuria (PNH)
Brand name
Commercial brand name for Pozelimab
Mechanism of action
Prevents cleavage of C5 into C5a and C5b, inhibiting complement-mediated hemolysis
Pozelimab is indicated for the treatment of adults and pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder characterized by red blood cell destruction due to complement-mediated hemolysis.
Pozelimab is a human IgG4P monoclonal antibody that binds specifically to the complement protein C5, preventing its cleavage by the C5 convertase enzyme into C5a (anaphylatoxin) and C5b. By blocking this cleavage, it prevents formation of the membrane attack complex (MAC) that causes cell lysis.
Patients should be monitored for infections, particularly with encapsulated bacteria, as complement inhibition increases susceptibility. Live vaccines should be administered prior to treatment when possible. Common side effects may include infusion-related reactions and infections.
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