Prescription medicine
Ublituximab Brand names: Briumvi
Ublituximab (Briumvi) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ublituximab FDA label on DailyMed (effective February 19, 2026); every ublituximab label on DailyMed.
Highlights of the record
FDA label of February 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBRIUMVI 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.
Forms and strengths
- 150 mg/6ml
Injection (solution) (concentrate).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,781 through July 30, 2026
What is ublituximab used for?
From the label: indications and usageBRIUMVI 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 ).
Conditions named in the indications of ublituximab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: CD20-directed Cytolytic Antibody.
Source: FDA drug label (BRIUMVI), TG Therapeutics, Inc., effective February 19, 2026 (SPL set 3a77cd8c-811b-407c-9140-d0c5c26435c2), via openFDA; the full label on DailyMed
What does the patient leaflet for ublituximab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about BRIUMVI?BRIUMVI can cause serious side effects, including: Infusion reactions. Infusion reactions are one of the most common side effects of BRIUMVI. Infusion reactions can be serious and may require you to be hospitalized. You will be monitored during your infusion and may be monitored after each infusion of BRIUMVI for signs and symptoms of an infusion reaction. Tell your healthcare provider if you get any of these symptoms: fever chills headache flu-like symptoms fast heartbeat hives itchy skin dizziness feeling faint swelling of tongue or throat trouble breathing wheezing nausea abdominal pain throat irritation redness of the face or skin These infusion reactions can happen over 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get an infusion reaction, your healthcare provider may need to stop or slow down the rate of your infusion. Infections. Infections are a common side effect, and upper respiratory tract infections are one of the most common side effects of BRIUMVI . BRIUMVI increases your risk of getting infections caused by bacteria or viruses that may be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or painful urination. Your healthcare provider should delay your treatment with BRIUMVI until your infection is gone. Hepatitis B virus (HBV) reactivation: Before starting treatment with BRIUMVI, your healthcare provider will do blood tests to check for hepatitis B viral infection. […]
Source: FDA drug label (BRIUMVI), TG Therapeutics, Inc., effective February 19, 2026 (SPL set 3a77cd8c-811b-407c-9140-d0c5c26435c2), via openFDA; the full label on DailyMed
Is there a generic for ublituximab (Briumvi)?
No generic ublituximab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ublituximab label say about other medicines?
The ublituximab label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | warnings and precautions | In Studies 1 and 2 [see Clinical Studies (14) ], patients received methylprednisolone (or an equivalent steroid), an antihistamine, and possibly other pre-medication (i.e., acetaminophen) to reduce the risk of infusion reactions prior to each infusion. |
| Methylprednisolone | warnings and precautions | In Studies 1 and 2 [see Clinical Studies (14) ], patients received methylprednisolone (or an equivalent steroid), an antihistamine, and possibly other pre-medication (i.e., acetaminophen) to reduce the risk of infusion reactions prior to each infusion. |
| Teriflunomide | warnings and precautions | Decrease in immunoglobulin M (IgM) was reported in 0.6% of patients treated with BRIUMVI compared to none of the patients treated with teriflunomide in RMS clinical trials [see Adverse Reactions (6.1) ]. |
Source: FDA drug label (BRIUMVI), TG Therapeutics, Inc., effective February 19, 2026 (SPL set 3a77cd8c-811b-407c-9140-d0c5c26435c2), via openFDA; the full label on DailyMed
What do FAERS reports show for ublituximab?
The FDA Adverse Event Reporting System holds 3,781 reports that list ublituximab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 62 are coded as a death and 449 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,782, against a median of 10 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ublituximab?
2 other medicines are given the same way (intravenous) and in the same FDA class as ublituximab or labeled mainly for the same use (multiple sclerosis), the same class first. Multiple sclerosis lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Alemtuzumab | Multiple sclerosis | none listed | n/a | No current entry |
| Natalizumab | Multiple sclerosis | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other cd20-directed cytolytic antibodys
- the pharmacologic class, with prices and generics
- Ublituximab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other