Ublituximab
Pronunciation: (yoo-blih-TUKS-ih-mab).
- Generic name
- Ublituximab
- Brand names
- Briumvi, Ubliximab, Ublitux
- Drug class
- Monoclonal Antibody; Anti-CD20 Agent
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What Ublituximab is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Ublituximab works
Ublituximab is a glycoengineered chimeric monoclonal antibody that targets the CD20 antigen on B lymphocytes. By binding to CD20, it induces B-cell lysis through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), leading to depletion of circulating B cells implicated in the pathogenesis of multiple sclerosis. (1)
What Ublituximab is used for
Relapsing forms of multiple sclerosis (RMS)
Relapsing forms of multiple sclerosis (RMS) (1)
Clinically isolated syndrome (CIS)
Clinically isolated syndrome (CIS) (1)
Relapsing-remitting disease (RRMS)
Relapsing-remitting disease (RRMS) (1)
Active secondary progressive disease (SPMS)
Active secondary progressive disease (SPMS) (1)
Before taking Ublituximab
Do not take / not appropriate for
- hypersensitivity to ublituximab or its excipients, and active severe infections. (Contraindication) (1)
- Pre-screen for hepatitis B and monitor for reactivation. (Contraindication) (1)
Tell your clinician about
(1)How to take Ublituximab
- General Instructions: Ublituximab is administered by a healthcare professional as an intravenous infusion. Do not self-administer.. Adult Dosing: The initial dose is 150 mg IV on Day 1, followed by 450 mg IV on Day 15, then 450 mg IV every 24 weeks thereafter.. Pediatric Dosing: Safety and efficacy in children under 18 years have not been established; not recommended for pediatric use.. Administration: Infusions are given over several hours in a healthcare setting. Patients are monitored for infusion reactions during and after administration.. When To Stop: Treatment may be stopped if you develop a severe infusion reaction, serious infection, or other serious side effects. Always consult your healthcare provider before discontinuing.. Storage: Healthcare professionals will store and prepare the medication. Do not store at home.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
If you miss an infusion appointment, contact your healthcare provider as soon as possible to reschedule. Do not attempt to make up the dose on your own.
Overdose
In case of suspected overdose, seek immediate medical attention. Supportive care and monitoring for infusion reactions and infections are recommended, as there is no specific antidote. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Infusion-related reactions
Incidence: Reported in the clinician-authored database; frequency not established
Infections
Incidence: Reported in the clinician-authored database; frequency not established
Headache
Incidence: Reported in the clinician-authored database; frequency not established
Diarrhea
Incidence: Reported in the clinician-authored database; frequency not established
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Neutropenia
Incidence: Reported in the clinician-authored database; frequency not established
Progressive multifocal leukoencephalopathy (PML)
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
UPDATED (2026-08-07, FDA label — no formal boxed warning exists for Briumvi, confirmed by direct label check, but these are prominent labeled risks for this drug specifically, not just 'similar drugs') — serious
Symptoms: UPDATED (2026-08-07, FDA label — no formal boxed warning exists for Briumvi, confirmed by direct label check, but these are prominent labeled risks for this drug specifically, not just 'similar drugs'): serious infusion reactions can occur, especially with the first dose. Hepatitis B virus (HBV) may reactivate during or after treatment and can cause serious liver problems, including liver failure or death; screening for HBV and baseline liver-related blood tests are done before starting. Progressive multifocal leukoencephalopathy (PML) — a rare, serious brain infection caused by the JC virus that typically occurs only in people with a weakened immune system and usually leads to death or severe disability — has been observed in patients treated with anti-CD20 antibodies, including ublituximab, and other MS therapies. May cause decreased immunoglobulin levels, increasing infection risk. Use in pregnancy is a decision for the treating clinician (see special populations); effective contraception is recommended during treatment and for 6 months after the last dose.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindications include hypersensitivity to ublituximab or its excipients, and active severe infections. Caution is advised in patients with chronic infections (e.g., hepatitis B), immunosuppression, or history of severe infusion reactions. Pre-screen for hepatitis B and monitor for reactivation.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Ublituximab may interact with immunosuppressive agents, increasing the risk of infections. Live vaccines should be avoided during and after treatment. Inform your healthcare provider of all medications and supplements you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
There are no data on the developmental risk of ublituximab in pregnant women; case reports from pregnancies occurring during clinical trials are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. The FDA label advises that females of reproductive potential use effective contraception while receiving ublituximab and for 6 months after the last dose. Discuss family planning and any pregnancy with the clinician managing your MS treatment. (1)
Breastfeeding
There are no data on whether ublituximab is present in human breast milk, its effects on a breastfed infant, or its effects on milk production. The developmental and health benefits of breastfeeding should be weighed against the mother's clinical need for ublituximab and any potential effects on the infant — discuss with your healthcare provider. (1)
Children
Frequency: Not applicable.. Weight Based: Not recommended for pediatric use.. Max Daily Dose: Not applicable.. Max Single Dose: Not applicable.. Age Restrictions: Safety not established in children. (1)
Renal_impairment
The FDA label states there were no clinically meaningful differences in how ublituximab behaves in the body based on mild kidney or mild liver impairment. However, the effect of moderate-to-severe kidney impairment or moderate-to-severe liver impairment on ublituximab is unknown — this is a genuine gap in the evidence, not confirmation that no adjustment is needed. Tell the clinician managing your treatment about any significant kidney or liver disease. (1)
Hepatic_impairment
The FDA label states there were no clinically meaningful differences in how ublituximab behaves in the body based on mild kidney or mild liver impairment. However, the effect of moderate-to-severe kidney impairment or moderate-to-severe liver impairment on ublituximab is unknown — this is a genuine gap in the evidence, not confirmation that no adjustment is needed. Tell the clinician managing your treatment about any significant kidney or liver disease. (1)
Monitoring
(1)Storage
This is a healthcare-professional-administered infusion; storage and preparation are handled by the treating facility. The FDA label specifies vials are stored refrigerated at 2-8°C (36-46°F) in the outer carton to protect from light, must not be frozen or shaken; the prepared infusion solution is stable refrigerated for up to 24 hours or at room temperature (up to 25°C) for an additional 8 hours.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Relapsing forms of multiple sclerosis (RMS)
Dose summary: CORRECTED — an earlier draft of this field stated a single 1500 mg dose, which does not match this medicine's actual regimen (already correctly described elsewhere on this page): 150 mg IV on Day 1, 450 mg IV on Day 15, then 450 mg IV every 24 weeks thereafter.
Renal context: The FDA label reports no clinically meaningful pharmacokinetic differences based on age, sex, body weight, presence of anti-drug antibodies, mild renal impairment, or mild hepatic impairment. However, the effect of moderate-to-severe renal impairment or moderate-to-severe hepatic impairment on ublituximab's pharmacokinetics is unknown — no dose adjustment is defined for that population, and this is a genuine evidence gap rather than reassurance of safety. (1)
Frequently asked questions
What is ublituximab used for?
Ublituximab is used to treat adults with relapsing forms of multiple sclerosis (MS), helping to reduce relapses and slow disability progression.
How is ublituximab administered?
It is given as an intravenous (IV) infusion by a healthcare professional, typically in a clinic or hospital.
What are the most common side effects?
The most common side effects are infusion-related reactions (fever, chills, headache), upper respiratory infections, and fatigue.
Can I receive vaccines while on ublituximab?
You should not receive live vaccines during or after treatment with ublituximab. Discuss all vaccinations with your healthcare provider.
Is ublituximab safe during pregnancy or breastfeeding?
Ublituximab is not recommended during pregnancy or breastfeeding unless clearly needed. Discuss risks and benefits with your doctor.
What should I do if I miss a dose?
Contact your healthcare provider as soon as possible to reschedule your missed infusion. Do not try to make up the dose yourself.
Are there any serious risks with ublituximab?
Serious risks include severe infusion reactions, infections, and rare brain infections (PML). Report any unusual symptoms to your doctor immediately.
What happens if I take too much Ublituximab?
If an overdose of Ublituximab is suspected, it is crucial to seek immediate emergency medical attention. Symptoms of overdose may vary and could include severe infusion-related reactions or exacerbated side effects. Healthcare providers will monitor for adverse reactions and provide supportive care as needed. Do not attempt to self-treat an overdose.
Can I drink alcohol while taking Ublituximab?
While there are no specific contraindications against alcohol consumption with Ublituximab, it is generally advisable to limit or avoid alcohol. Alcohol can potentially exacerbate certain side effects, such as fatigue or gastrointestinal upset, and may also impair immune function, which is already affected by Ublituximab. Always consult your healthcare provider for personalized advice regarding alcohol use.
Is Ublituximab safe during pregnancy?
Ublituximab's pregnancy category requires careful consideration. It is essential to consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The potential risks and benefits of Ublituximab use during pregnancy should be thoroughly discussed with a healthcare professional, as the drug may have implications for fetal development. Effective contraception is often recommended during treatment.
What is the mechanism of action of Ublituximab?
Ublituximab is a glycoengineered chimeric monoclonal antibody that targets the CD20 antigen on B lymphocytes. By binding to CD20, it induces B-cell lysis through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), leading to depletion of circulating B cells implicated in the pathogenesis of multiple sclerosis. (1)
What is the generic name of Ublituximab?
The generic name is Ublituximab. It is sold under brand names including Briumvi, Ubliximab, Ublitux.
What class of drug is Ublituximab?
Ublituximab is classed as: Monoclonal Antibody; Anti-CD20 Agent.
References
- Ublituximab — Prescribing InformationGap: No authority detail in research notes. · Gap: No country or region detail in research notes. · dated Gap: No document date in research notes. · accessed 2026-08-03 · source 1
- Ublituximab-xiiy injection — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 2
- BRIUMVI — FDA approval record (Drugs@FDA BLA761238)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 3
- Ublituximab — RxNorm normalized drug concept (RXCUI 2626349)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 4
Brand names by country
Single-ingredient Ublituximab names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- BRIUMVI150 mg/6mL · tg therapeutics, inc.