Brand Name

Briumvi

Generic Name

Ublituximab

View Brand Information

FDA approval date: December 28, 2022

Classification: CD20-directed Cytolytic Antibody

Form: Injection

What is Briumvi (Ublituximab)?

Briumvi (Ublituximab): Uses, Side Effects, Dosage, and Safety for Multiple Sclerosis

Living with a relapsing form of multiple sclerosis (MS) can feel like navigating unpredictable waves. The uncertainty of when the next relapse might occur often brings anxiety and impacts daily life. Modern MS treatments aim to bring stability and control to this journey and among the most advanced of these options is Briumvi (ublituximab).

Briumvi is a prescription medication approved to treat relapsing forms of multiple sclerosis in adults. Unlike oral pills or self-injections, Briumvi is administered as an intravenous (IV) infusion only twice a year after the initial starting doses. It belongs to a class of targeted biologic drugs known as anti-CD20 monoclonal antibodies, designed to find and eliminate specific immune cells that contribute to MS progression. For many patients, Briumvi offers a convenient and highly effective way to reduce relapses and slow the diseases advancement.

What Is Briumvi Used For?

The U.S. Food and Drug Administration (FDA) has approved Briumvi for treating several relapsing forms of multiple sclerosis (RMS), including:

Clinically Isolated Syndrome (CIS): The first neurologic episode suggestive of MS.
Relapsing-Remitting MS (RRMS): The most common type, with alternating periods of relapses and remissions.
Active Secondary Progressive MS (SPMS): A progressive form with ongoing relapses or new MRI activity.

The main goals of Briumvi therapy are to reduce the number of relapses, slow the progression of disability, and decrease new or enlarging brain lesions seen on MRI scans. Clinical studies have shown that Briumvi significantly lowers the annual relapse rate compared to other widely used MS therapies (TG Therapeutics, 2022).

How Does Briumvi Work?

Multiple sclerosis is an autoimmune condition in which the immune system mistakenly attacks the myelin sheath the protective coating around nerve fibers in the brain and spinal cord. This immune attack causes inflammation and nerve damage, disrupting communication between the brain and body.

Briumvi targets a specific group of immune cells known as B-cells, which play a central role in the autoimmune response of MS. These cells carry a surface protein called CD20, which acts as a unique identifier.

Briumvi is a lab-engineered monoclonal antibody that binds to CD20 on these B-cells. Once bound, it signals the immune system to eliminate them, helping to calm inflammation in the central nervous system while preserving most of the immune systems ability to fight infections. By selectively removing these rogue B-cells, Briumvi helps prevent further damage to the myelin sheath and reduces relapse frequency.

Briumvi Side Effects

Like all medications, Briumvi can cause side effects. The most common are infusion reactions, which typically occur during or shortly after the first treatment. These reactions are usually mild and temporary but should be closely monitored by medical staff.

Common Infusion Reactions

Fever
Chills
Headache
Fatigue
Nausea
Sore throat

To reduce the risk of these reactions, healthcare providers give pre-medications such as corticosteroids, antihistamines, or fever reducers before each infusion. Reactions are most common with the first dose and tend to lessen with subsequent treatments.

Other Common Side Effects

Upper respiratory tract infections (e.g., common cold, sinus infection)
Lower respiratory infections (e.g., bronchitis)

Serious Side Effects (Less Common)

Serious infections: Briumvi may weaken the immune system, increasing susceptibility to infection. Doctors typically screen for dormant infections like hepatitis B before treatment, as these can reactivate.
Progressive Multifocal Leukoencephalopathy (PML): A rare but potentially fatal viral brain infection. While not reported in Briumvi clinical trials, it has occurred with similar drugs in the same class.
Low immunoglobulin levels: Long-term use may reduce protective antibodies, increasing infection risk over time.

Patients should contact their doctor immediately if they experience persistent fever, signs of infection, or new or worsening neurological symptoms such as confusion, vision changes, or one-sided weakness.

Briumvi Dosage and Administration

Briumvi is administered as an intravenous (IV) infusion in a hospital or infusion center under medical supervision. The initial two doses are given two weeks apart. Subsequent maintenance infusions are scheduled every 24 weeks (about six months). Each infusion typically lasts about one hour, making it faster than most other anti-CD20 therapies.

Before starting treatment, healthcare providers will perform blood tests to check immune cell counts and screen for hepatitis B. During therapy, they may periodically monitor B-cell levels and immunoglobulin (antibody) levels to ensure continued safety and effectiveness.

After each infusion, patients are observed for a short time to monitor for any immediate reactions. Most individuals tolerate treatment well, and reactions generally become milder with subsequent infusions.

Does Briumvi Have a Generic or Biosimilar?

No, there is currently no generic or biosimilar version of Briumvi available. Because it is a complex biologic drug, the equivalent of a generic would be a biosimilar, which requires separate FDA approval. As of 2025, no biosimilar versions of ublituximab have been approved. Briumvi remains available only as a brand-name product manufactured by TG Therapeutics.

Key Takeaways

Briumvi (ublituximab) represents an important advancement in the treatment of relapsing multiple sclerosis. By selectively targeting CD20-positive B-cells, it helps reduce relapses, limit brain inflammation, and slow disease progression all with a manageable twice-yearly infusion schedule.

While infusion reactions and infection risks require monitoring, these effects can be safely managed with appropriate medical supervision. For many patients, Briumvi offers both convenience and powerful efficacy, helping them regain control over their condition and improve long-term outcomes.

Always discuss with your neurologist whether Briumvi is appropriate for your specific form of MS and overall health profile.

References

Mayo Clinic. (2024). Ublituximab-xiiy (Intravenous Route). MayoClinic.org
National Multiple Sclerosis Society. (n.d.). Briumvi® (ublituximab-xiiy). NationalMSSociety.org
TG Therapeutics, Inc. (2022). BRIUMVI (ublituximab-xiiy) Prescribing Information. FDA.gov

Approved To Treat

Multiple Sclerosis (MS)

Top Global Experts

Save this treatment for later

Not sure about your diagnosis?

Check Your Symptoms

Related Clinical Trials

A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis

Enrollment Status: Recruiting

Publish Date: October 08, 2025

Intervention Type: Biological

Study Phase: Phase 3

Summary: The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.

A Post-marketing Study Evaluating the Presence and Concentration of BRIUMVI™ in Breast Milk (PROVIDE)

Enrollment Status: Recruiting

Publish Date: October 06, 2025

Intervention Type: Other

Summary: The primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS).

REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)

Enrollment Status: Recruiting

Publish Date: October 06, 2025

Intervention Type: Other

Summary: The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting

View All Clinical Trials

Related Latest Advances

Hypogammaglobulinemia and infections in patients with multiple sclerosis treated with anti-CD20 monoclonal antibodies: a systematic review and meta-analysis of observational studies.

Journal: Expert opinion on drug safety

Published: October 13, 2025

Efficacy and safety of ublituximab for relapsing multiple sclerosis patients: current evidence and expert opinion.

Journal: Journal of neurology

Published: July 28, 2025

Neutropenia Associated With B Cell-Depleting Therapies in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder.

Journal: Neurology(R) neuroimmunology & neuroinflammation

Published: June 19, 2025

View All Latest Advances

Brand Information

BRIUMVI (ublituximab)

1INDICATIONS AND USAGE

BRIUMVI is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

2DOSAGE FORMS AND STRENGTHS

Injection: 150 mg/6 mL (25 mg/mL) clear to opalescent, colorless to slightly yellow solution in a single-dose vial.

3CONTRAINDICATIONS

BRIUMVI is contraindicated in patients with:

Active HBV infection
A history of life-threatening infusion reaction to BRIUMVI

4ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

Infusion Reactions
Infections
Reduction in Immunoglobulins
Liver Injury

4.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In active-controlled clinical trials (Study 1 and Study 2), 545 patients with RMS received BRIUMVI

The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections. Table 2 summarizes the adverse reactions that occurred in RMS trials (Study 1 and Study 2). The most common cause of discontinuation in patients treated with BRIUMVI was infection (1.3%).

Infusion Reactions

The incidence of infusion reactions was highest with the first infusion (43%), decreasing with subsequent infusions (10% with second, 8% with third infusion). Three (0.6%) patients treated with BRIUMVI reported serious infusion reactions. Most frequently reported symptoms (greater than 5%) included pyrexia, chills, headache, and influenza-like illness

Laboratory Abnormalities

Decreased Immunoglobulins

BRIUMVI decreased total immunoglobulins with the greatest decline seen in IgM levels. The proportion of BRIUMVI-treated patients at baseline reporting IgG, IgA, and IgM below the LLN was 6.3%, 0.6%, and 1.1%, respectively. Following treatment, the proportion of BRIUMVI-treated patients reporting IgG, IgA, and IgM below the LLN at 96 weeks was 6.5%, 2.4%, and 20.9%, respectively.

Decreased Neutrophil Levels

In Studies 1 and 2, decreased neutrophil counts (<LLN) occurred in 15% of BRIUMVI-treated patients compared to 22% in teriflunomide-treated patients. The majority of decreased neutrophil counts were observed once for a given patient treated with BRIUMVI, and were between 1.0 and 1.5 × 10

4.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of BRIUMVI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hepatobiliary Disorders: Liver injury

5DESCRIPTION

Ublituximab-xiiy is a recombinant chimeric monoclonal IgG1 antibody with reduced fucose content directed against CD20-expressing B-cells. The molecular weight of the antibody is approximately 147 kDa.

BRIUMVI (ublituximab-xiiy) injection for intravenous infusion is a sterile, clear to opalescent, colorless to slightly yellow, preservative-free solution. Each mL of solution contains 25 mg ublituximab-xiiy, 0.4 mg hydrochloric acid, 0.7 mg polysorbate 80, 9.0 mg sodium chloride, 6.4 mg sodium citrate, and Water for Injection, USP. The pH is 6.5.

6CLINICAL STUDIES

The efficacy of BRIUMVI was demonstrated in two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks [Study 1 (NCT03277261) and Study 2 (NCT03277248)]. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg for the first infusion, 450 mg two weeks after the first infusion for the second infusion/second dose, and 450 mg every 24 weeks after the first infusion for subsequent doses (third infusion and beyond) with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. Neurological evaluations were performed at baseline, every 12 weeks, and at the time of a suspected relapse. Brain MRI scans were performed at baseline and at Weeks 12, 24, 48, and 96.

The primary outcome of both Study 1 and Study 2 was the annualized relapse rate (ARR) over the treatment period. Additional outcome measures included: the total number of MRI T1 Gd-enhancing lesions by Week 96, the total number of new or enlarging MRI T2 hyperintense lesions by Week 96, and time to confirmed disability progression for at least 12 weeks. Disability progression was defined as an increase of greater than or equal to 1.0 point from the baseline EDSS score that was attributable to MS when the baseline score was 5.5 or less, and greater than or equal to 0.5 points when the baseline score was above 5.5. Confirmed disability progression was evaluated in a pooled analysis of Studies 1 and 2. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit 12 weeks after the initial documentation of neurological worsening.

In Study 1, 274 patients were randomized to BRIUMVI and 275 to teriflunomide. Of those randomized to BRIUMVI, 88% completed the 96-week treatment period; of those randomized to teriflunomide, 92% completed the 96-week treatment period. The baseline demographic and disease characteristics were balanced between the two treatment groups. At baseline, the mean age was 37 years, 97% were White, and 63% were female.

In Study 2, 272 patients were randomized to BRIUMVI and 273 to teriflunomide. Of those randomized to BRIUMVI, 93% completed the 96-week treatment period; of those randomized to teriflunomide, 88% completed the 96-week treatment period. The baseline demographic and disease characteristics were balanced between the two treatment groups. At baseline, the mean age was 35 years, 99% were White, and 65% were female.

In Study 1 and Study 2, BRIUMVI significantly lowered the ARR compared to teriflunomide. BRIUMVI statistically significantly reduced the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions in both studies compared to teriflunomide. There was no statistically significant difference in disability progression confirmed at 12 weeks between BRIUMVI-treated and teriflunomide-treated patients.

Results for Study 1 and Study 2 are presented in Table 3.

In exploratory analyses of Study 1 and Study 2, a similar effect of BRIUMVI on the ARR was observed in subgroups defined by gender, prior non-steroid MS therapy, baseline disability (EDSS 3.5 or lower versus greater than 3.5), the number of relapses in the 2 years prior to study enrollment, and number of Gd-enhancing lesions at baseline.

7PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Infusion Reactions

Inform patients about the signs and symptoms of infusion reactions and that infusion reactions can occur up to 24 hours after infusion. Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion reactions

Infection

Advise patients to contact their healthcare provider for any signs of infection during treatment or after the last infusion. Signs can include fever, chills, constant cough, or dysuria

Advise patients that BRIUMVI may cause reactivation of hepatitis B infection and that monitoring will be required if they are at risk

Advise patients that PML has happened with drugs that are similar to BRIUMVI and may happen with BRIUMVI. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes

Vaccination

Advise patients to complete any required live or live-attenuated vaccinations at least 4 weeks and, whenever possible, non-live vaccinations at least 2 weeks prior to initiation of BRIUMVI. Administration of live-attenuated or live vaccines is not recommended during BRIUMVI treatment and until B-cell recovery

Fetal Risk

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BRIUMVI and for 6 months after the last BRIUMVI dose. Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant during treatment with BRIUMVI

Pregnancy Registry

Instruct patients that if they are pregnant or plan to become pregnant while taking BRIUMVI they should inform their healthcare provider

Encourage patients to enroll in the BRIUMVI Pregnancy Registry if they become pregnant while taking BRIUMVI or within 6 months following the last dose of BRIUMVI

Liver Injury

Inform patients that liver injury has been reported with anti-CD20 B-cell depleting therapies, including BRIUMVI. Instruct patients treated with BRIUMVI to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. A blood test should be obtained before patients start therapy, and during treatment as clinically indicated

8PRINCIPAL DISPLAY PANEL

NDC 73150-150-06

Briumvi™

(ublituximab-xiiy) injection

150 mg/6 mL

(25 mg/mL)

For Intravenous Infusion

After Dilution.

Discard Unused Portion.

Attention: Dispense the enclosed Medication

Rx only

Contains one 6 mL
single-dose vial.

TG Therapeutics

9PRINCIPAL DISPLAY PANEL

NDC 73150-150-06

Briumvi™

(ublituximab-xiiy) injection

Rx only

150 mg/6 mL (25 mg/mL)

For Intravenous Infusion After Dilution.

Single-Dose Vial. Discard Unused Portion.

No preservative. Dosage:

See prescribing information.

TG Therapeutics

PRINCIPAL DISPLAY PANEL NDC 73150-150-06 Briumvi™ (ublituximab-xiiy) injection Rx only 150 mg/6 mL (25 mg/mL) For Intravenous Infusion After Dilution. Single-Dose Vial. Discard Unused Portion. No pr