Molecule
Ublituximab 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. MedsAcross supplies Ublituximab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
Before initiating BRIUMVI, screen for Hepatitis B virus (HBV) and obtain serum quantitative immunoglobulins, aminotransferases, alkaline phosphatase, and bilirubin. Pre-medicate with methylprednisolone (or an equivalent corticosteroid) and an antihistamine (e.g., diphenhydramine) prior to each infusion. Administer BRIUMVI by intravenous infusion. First Infusion: 150 mg intravenous infusion. Second Infusion: 450 mg intravenous infusion two weeks after the first infusion. Subsequent Infusions: 450 mg intravenous infusion 24 weeks after the first infusion and every 24 weeks thereafter. Must be diluted in 0.9% Sodium Chloride Injection, USP prior to administration. Monitor patients closely during and for at least one hour after the completion of the first two infusions.
Source: US FDA prescribing information
BRIUMVI is contraindicated in patients with: Active HBV infection A history of life-threatening infusion reaction to BRIUMVI Active hepatitis B virus infection. History of life-threatening infusion reaction to BRIUMVI
Source: US FDA prescribing information
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. 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. 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.
Source: US FDA prescribing information
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Infusion Reactions Infections Reduction in Immunoglobulins Liver Injury The most common adverse reactions (≥10%) were infusion reactions and upper respiratory tract infections.
Source: US FDA prescribing information
Immunosuppressive or Immune-Modulating Therapies The concomitant usage of BRIUMVI with other immune-modulating or immunosuppressant drugs, including immunosuppressant doses of corticosteroids, may increase the risk of infection. Consider the risk of additive immune system effects when co-administering immunosuppressive therapies with BRIUMVI. When switching from therapies with immune effects, the duration and mechanism of action of these therapies should be taken into account because of potential additive immunosuppressive effects when initiating BRIUMVI.
Source: US FDA prescribing information
Store BRIUMVI vials refrigerated at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light. Do not freeze. Do not shake.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Ublituximab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Briumvi 150 mg/6 mL injectionIntravenous Cold chain | TG Therapeutics | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Ublituximab in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Ublituximab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Ublituximab, including Briumvi.
Yes. The US FDA first approved Ublituximab on 28 December 2022, according to Drugs@FDA.
Yes. Ublituximab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Ublituximab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Ublituximab is classified under ATC code L04 (Immunosuppressants).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.