Nipocalimab
Nipocalimab is a monoclonal antibody medication that targets and binds to the neonatal Fc receptor (FcRn), which plays a crucial role in maintaining IgG antibody levels in the body. By blocking FcRn, the medication accelerates the breakdown of IgG antibodies, thereby reducing their circulating levels. This mechanism makes it a potential treatment option for conditions driven by pathogenic IgG antibodies.
Nipocalimab reduces harmful IgG antibody levels by blocking the FcRn receptor, offering a targeted approach for autoimmune diseases.
Key facts at a glance
- ATC
- L04AL03
- RxNorm
- 2712693
- Generic
- Nipocalimab
- Class
- atc-l04
- Brands
- Imaavy
- 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
13 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks to the fetus
regular fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteruse lowest effective dose
use only if clearly needed, monitor closely
routine prenatal monitoring and fetal growth assessments
Use with caution and monitor for adverse effects.
pregnancy
third trimesterconsider timing of last dose before delivery
discuss timing with healthcare provider, potential effects on newborn immune system
monitor newborn for immunosuppression and infection risk
Use with caution and monitor for adverse effects.
lactation
breastfeedingno specific adjustment
discontinue breastfeeding or discontinue drug based on benefit-risk assessment
monitor infant for signs of immunosuppression
Use with caution and monitor for adverse effects.
pediatric_age
children under 12safety and efficacy not established
use only if benefits outweigh potential risks, consult pediatric specialist
close monitoring for efficacy and safety
pediatric_age
adolescents 12 17use adult dosing initially
monitor closely, adjust based on response and tolerability
regular growth and developmental monitoring
Use with caution and monitor for adverse effects.
geriatric
elderly over 65no specific dose adjustment required
use standard dosing, monitor for infections and immune response
regular assessment of infection, immune function, and comorbidities
renal_impairment
mild renal impairmentno dose adjustment required
standard dosing can be used
routine renal function monitoring
renal_impairment
moderate renal impairmentno dose adjustment required
standard dosing can be used
routine renal function monitoring
renal_impairment
severe renal impairmentlimited data available
use with caution, consider risks and benefits
close monitoring of renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
mild hepatic impairmentno dose adjustment required
standard dosing can be used
routine liver function monitoring
hepatic_impairment
moderate hepatic impairmentuse with caution
monitor closely, consider individual patient factors
regular hepatic function assessments
Use with caution and monitor for adverse effects.
hepatic_impairment
severe hepatic impairmentnot recommended unless benefits outweigh risks
use with extreme caution, limited safety data
close hepatic function monitoring
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Nipocalimab is a neonatal Fc receptor (FcRn) antagonist monoclonal antibody
Mechanism of action
Blocks FcRn to reduce IgG antibody recycling and lower pathogenic IgG levels
Development status
Nipocalimab is in late-stage clinical development for multiple indications
Target indications
Primary therapeutic indications in development
Nipocalimab is being investigated for the treatment of various IgG-mediated autoimmune conditions, including generalized myasthenia gravis and warm autoimmune hemolytic anemia. It may also have potential applications in other antibody-driven diseases.
As a human IgG1 monoclonal antibody, nipocalimab binds specifically to FcRn, preventing this receptor from recycling and protecting IgG antibodies. This leads to increased degradation of IgG, effectively lowering the overall levels of pathogenic antibodies in circulation.
As an FcRn antagonist, nipocalimab reduces all IgG antibodies (including protective ones), which may increase infection risk. Treatment should be supervised by specialists experienced in managing autoimmune diseases. Patients should be monitored for signs of infection and assessed for vaccination status prior to 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