Ublituximab

The precise mechanism by which ublituximab-xiiy exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ublituximab-xiiy results in cell lysis through mechanisms including antibody-dependent cellular cytolysis and complement-dependent cytolysis.

• 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. BRIUMVI is a CD20-directed cytolytic antibody 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 ( 1 , 14 ).ICD-10: G35

• BRIUMVI is contraindicated in patients with: Active HBV infection [see Dosage and Administration (2.1) and Warnings and Precautions (5.2) ] A history of life-threatening infusion reaction to BRIUMVI [see Warnings and Precautions (5.1) ] Active hepatitis B virus infection ( 4 ) History of life-threatening infusion reaction to BRIUMVI ( 4 )contraindicated

Before initiating BRIUMVI, screen for Hepatitis B virus (HBV) and obtain serum quantitative immunoglobulins, aminotransferases, alkaline phosphatase, and bilirubin ( 2.1 ). Pre-medicate with methylprednisolone (or an equivalent corticosteroid) and an antihistamine (e.g., diphenhydramine) prior to each infusion ( 2.2 ). Administer BRIUMVI by intravenous infusion. First Infusion: 150 mg intravenous infusion ( 2.3 ) Second Infusion: 450 mg intravenous infusion two weeks after the first infusion ( 2.3 ) Subsequent Infusions: 450 mg intravenous infusion 24 weeks after the first infusion and every 24 weeks thereafter ( 2.3 ) Must be diluted in 0.9% Sodium Chloride Injection, USP prior to administration ( 2.3 , 2.6 ). Monitor patients closely during and for at least one hour after the completion of the first two infusions. Post-infusion monitoring of subsequent infusions is at physician discretion unless infusion reaction and/or hypersensitivity has been observed ( 2.3 , 5.1 ). 2.1 Assessments Prior to First Dose of BRIUMVI Hepatitis B Virus Screening Prior to initiating BRIUMVI, perform Hepatitis B virus (HBV) screening. BRIUMVI is contraindicated in patients with active HBV confirmed by positive results for Hepatitis B surface antigen [HBsAg] and anti-HBV tests. For patients who are negative for HBsAg and positive for Hepatitis B core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment with BRIUMVI [see Warnings and Precautions (5.2) ] .

Infusion Reactions : Management recommendations for infusion reactions depend on the type and severity of the reaction. Permanently discontinue BRIUMVI if a life-threatening or disabling infusion reaction occurs ( 2.3 , 5.1 ). Infections : Serious, including life-threatening and fatal infections, have occurred. Delay BRIUMVI administration in patients with an active infection until the infection is resolved. Vaccination with live-attenuated or live vaccines is not recommended during treatment with BRIUMVI and after discontinuation, until B-cell repletion ( 5.2 ). Reduction in Immunoglobulins : Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with BRIUMVI, until B-cell repletion, and especially when recurrent serious infections are suspected. Consider discontinuing BRIUMVI in patients with serious opportunistic or recurrent serious infections, and if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins ( 2.1 , 5.4 ). Fetal Risk : May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for at least 6 months after stopping BRIUMVI ( 5.3 , 8.1 , 8.3 ). Liver Injury : Clinically significant liver injury has occurred. Obtain serum aminotransferases, alkaline phosphatase, and bilirubin levels before initiating BRIUMVI, and during treatment as clinically indicated. Discontinue BRIUMVI in patients with evidence of liver injury in the absence of an alternative etiology ( 5.5 ).

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Infusion Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Reduction in Immunoglobulins [see Warnings and Precautions (5.4) ] Liver Injury [see Warnings and Precautions (5.5) ] The most common adverse reactions (≥10%) were infusion reactions and upper respiratory tract infections ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact TG Therapeutics at 1-877-848-9462 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 [see Clinical Studies (14) ]. 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%). Table 2: Adverse Reactions in Adult Patients with RMS with an Incidence of at least 5% for BRIUMVI and Higher than Teriflunomide from Study 1 and Study 2 BRIUMVI 450 mg IV The first dose of BRIUMVI was given as an intravenous (IV) infusion of 150 mg.

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to BRIUMVI during pregnancy. Eligible patients are women who become pregnant either while taking BRIUMVI or within 6 months following their last dose of BRIUMVI. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-411-4546 or visiting www.briumvipregnancyregistry.com. Risk Summary There are no data on the developmental risk associated with the use of BRIUMVI in pregnant women. Data from case reports of pregnancies occurring during clinical trials with BRIUMVI are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Although there are no data on ublituximab-xiiy, monoclonal antibodies can be actively transported across the placenta, and BRIUMVI may cause immunosuppression in the in-utero exposed infant [see Clinical Considerations , Warnings and Precautions (5.2 , 5.3) , and Clinical Pharmacology (12.1 , 12.2) ]. In pregnant transgenic huCD20 mice, a pharmacologically relevant animal model, weekly intravenous administration of ublituximab-xiiy during organogenesis resulted in no adverse pregnancy or embryofetal outcomes (see Data ) .

Metabolism

Ublituximab-xiiy exposures increased proportionally over a dose range of 150 mg (0.33 times approved recommended dosage) to 600 mg (1.33 times the approved recommended dosage) in patients with RMS. Following administration of the approved recommended dosage of BRIUMVI, the geometric mean steady-state AUC was 3000 mcg/mL per day (CV=28%) and the mean maximum concentration was 139 mcg/mL (CV=15%).

• Dec 28, 2022BLABLA761238Tg Therapeutics, Inc

1. 1Infusion Related Reaction1,39438%
2. 2Fatigue2226.1%
3. 3Headache1183.2%
4. 4Malaise1093.0%
5. 5Pain1032.8%
6. 6Multiple Sclerosis Relapse902.5%
7. 7Urinary Tract Infection902.5%
8. 8Illness892.4%
9. 9Inappropriate Schedule Of Product Administration872.4%
10. 10Asthenia862.4%
11. 11Gait Disturbance832.3%
12. 12Drug Ineffective772.1%
13. 13Maternal Exposure During Pregnancy752.1%
14. 14Nasopharyngitis732.0%
15. 15Product Dose Omission Issue732.0%

The 10 most recently updated of 48 ClinicalTrials.gov registrations naming Ublituximab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
  Active not recruiting · Phase 3 · Interventional · 1,100 enrolled · TG Therapeutics, Inc.
  NCT04130997updated 2026-05-29
• A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
  Recruiting · Observational · 2,000 enrolled · TG Therapeutics, Inc.
  NCT06433752updated 2026-05-29
• Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
  Recruiting · Phase 3 · Interventional · 800 enrolled · TG Therapeutics, Inc.
  NCT05877963updated 2026-05-28
• A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
  Active not recruiting · Phase 3 · Interventional · 360 enrolled · TG Therapeutics, Inc.
  NCT07211633updated 2026-05-28
• A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk
  Recruiting · Observational · 16 enrolled · TG Therapeutics, Inc.
  NCT06143514updated 2026-05-14
• Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
  Not yet recruiting · Phase 2 · Phase 3 · Interventional · 240 enrolled · TG Therapeutics, Inc.
  NCT07220252updated 2026-05-12
• A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
  Recruiting · Observational · 728 enrolled · TG Therapeutics, Inc.
  NCT06433765updated 2026-05-12
• Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis
  Recruiting · Phase 4 · Interventional · 50 enrolled · Johns Hopkins University
  NCT07389590updated 2026-05-06
• Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis
  Recruiting · Interventional · 30 enrolled · University of Maryland, Baltimore
  NCT06864936updated 2026-05-06
• Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy
  Recruiting · Phase 2 · Interventional · 30 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT07103746updated 2026-04-08

Frequently asked questions

How does Ublituximab work?

The precise mechanism by which ublituximab-xiiy exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ublituximab-xiiy results in cell lysis through mechanisms including antibody-dependent cellular cytolysis and complement-dependent cytolysis.

What is Ublituximab used for?

According to FDA labeling, Ublituximab carries indications including: 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. BRIUMVI is a CD20-directed cytolytic antibody 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 ( 1 , 14 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ublituximab?

Ublituximab is classified as Monoclonal antibodies, CD20-directed Cytolytic Antibody, Antibody-Receptor Interactions, B Lymphocyte Stimulator-directed Antibody Interactions, CD20-directed Antibody Interactions, Increased Cellular Death.

What are the brand names for Ublituximab?

Ublituximab is marketed under brand names including Briumvi.

What are the contraindications for Ublituximab?

Ublituximab labeling lists contraindications including: BRIUMVI is contraindicated in patients with: Active HBV infection [see Dosage and Administration (2.1) and Warnings and Precautions (5.2) ] A history of life-threatening infusion reaction to BRIUMVI [see Warnings and Precautions (5.1) ] Active hepatitis B virus infection ( 4 ) History of life-threatening infusion reaction to BRIUMVI ( 4 ). Always consult the full prescribing information and a clinician.