Ublituximab
Ublituximab is a monoclonal antibody that targets CD20, a protein found on the surface of B lymphocytes. It is used to treat relapsing forms of multiple sclerosis (MS) by binding to B cells and reducing their numbers, which helps decrease the immune system's attack on the central nervous system.
Ublituximab is an anti-CD20 monoclonal antibody infusion used to treat relapsing forms of multiple sclerosis by depleting B cells.
Key facts at a glance
- ATC
- L04AG14
- RxNorm
- 2626349
- Generic
- Ublituximab
- Class
- atc-l04
- Brands
- Briumvi
- 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
9 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks; females of reproductive potential should use effective contraception during treatment and for at least 6 months after last dose
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second third trimesteravoid if possible
continue avoidance; if exposed during pregnancy, register patient in pregnancy registry
comprehensive fetal ultrasound monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding
do not breastfeed during treatment and for at least 6 months after last dose
none
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children adolescentsnot established
safety and efficacy not established in patients under 18 years of age
not applicable
geriatric
elderly 65no specific adjustment required
use with caution; no dose adjustment needed based on age alone
standard clinical monitoring
Use with caution and monitor for adverse effects.
renal_impairment
mild moderateno adjustment required
no dose adjustment needed; monoclonal antibodies are not renally excreted
routine renal function monitoring
renal_impairment
severelimited data
use with caution; limited clinical data in severe renal impairment
close monitoring of renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
mild moderatelimited data
use with caution; limited clinical data in hepatic impairment
monitor liver function tests
Use with caution and monitor for adverse effects.
hepatic_impairment
severenot recommended
use not recommended; no clinical data available
liver function monitoring
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Classification based on mechanism of action
FDA approval year
FDA approval for Briumvi
Primary indication
Therapeutic indication
Mechanism of action
Primary pharmacologic action
Ublituximab is indicated for the treatment of relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.
Ublituximab is a monoclonal antibody that binds to the CD20 antigen present on pre-B and mature B lymphocytes. While the exact therapeutic mechanism in MS is unknown, it is presumed to work by depleting B cells, which play a role in the inflammatory processes that damage the central nervous system in multiple sclerosis.
Ublituximab is administered as an intravenous infusion. Common side effects may include infusion-related reactions, upper respiratory infections, and lower respiratory infections. Patients should be monitored for infections and appropriate screening may be required before starting treatment. Vaccination status should be reviewed prior to initiation as live vaccines are not recommended 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