Inebilizumab
Inebilizumab is a monoclonal antibody that targets CD19, a protein found on the surface of B lymphocytes. It is approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD), immunoglobulin G4-related disease (IgG4-RD), and generalized myasthenia gravis (gMG). By binding to and depleting B cells, it reduces the autoimmune activity that drives inflammation and symptoms in these conditions.
Inebilizumab is a B-cell-depleting monoclonal antibody used to treat NMOSD, IgG4-RD, and gMG.
Key facts at a glance
- ATC
- L04AG10
- RxNorm
- 2373951
- Generic
- Inebilizumab
- Class
- atc-l04
- Brands
- Uplizna
- 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 pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteruse only if clearly needed
consider risks vs benefits carefully
fetal growth monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteruse only if clearly needed
avoid near delivery if possible
fetal monitoring and assessment for neonatal complications
Use with caution and monitor for adverse effects.
lactation
breastfeedinguse with caution
breastfeeding not recommended during treatment and for 6 months after last dose
monitor infant for infections
Use with caution and monitor for adverse effects.
geriatric
elderlyno specific adjustment required
use with caution due to increased susceptibility to infections
monitor for infections and immunogenicity
Use with caution and monitor for adverse effects.
pediatric_age
childrennot established
not recommended for use in pediatric patients due to limited data
not applicable
renal_impairment
mildno adjustment needed
no dose adjustment required for mild renal impairment
routine monitoring
renal_impairment
moderate to severeno specific adjustment established
use with caution as not extensively studied
monitor renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
mildno specific adjustment
use with caution
monitor liver function
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate to severenot established
not recommended due to limited data
monitor liver function closely
Statistics and clinical data
FDA approval year
FDA approval for Neuromyelitis Optica Spectrum Disorder (NMOSD)
Drug class
Monoclonal antibody classification
Common uses
Therapeutic indication
Mechanism of action
Pharmacological mechanism
Inebilizumab is indicated for neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive, immunoglobulin G4-related disease (IgG4-RD), and generalized myasthenia gravis (gMG). It is administered as an intravenous infusion given by a healthcare professional.
Inebilizumab binds to CD19, a cell surface antigen present on pre-B and mature B lymphocytes. By targeting these B cells, it reduces the population of these immune cells, thereby decreasing the autoimmune-mediated inflammation and damage associated with NMOSD, IgG4-RD, and gMG.
Common adverse reactions include infusion-related reactions, upper respiratory tract infections, and urinary tract infections. Patients should be monitored for infections and have immunizations updated before treatment. Due to its immunosuppressive effects, there is an increased risk of infections and potential for progressive multifocal leukoencephalopathy (PML). Pregnancy should be avoided during treatment and for a period after the last infusion.
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