What is BRIUMVI used for?

1 INDICATIONS 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. 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 ,

How does BRIUMVI work?

11 DESCRIPTION Ublituximab-xiiy is a recombinant chimeric monoclonal IgG1 antibody with reduced fucose content directed against CD20-expressing B-cells.

What pharmaceutical form is BRIUMVI available in?

BRIUMVI: Koncentrat do sporządzania roztworu do infuzji 150 mg/6 ml (dożylna)

Is BRIUMVI OTC or prescription only?

BRIUMVI requires a doctor's prescription.

What are the side effects of BRIUMVI?

6 ADVERSE REACTIONS 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 SUSPECTE

Who should NOT take BRIUMVI?

4 CONTRAINDICATIONS 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 )

Does BRIUMVI interact with other medications?

7 DRUG INTERACTIONS 7.1 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

Can BRIUMVI be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS 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.briumvipregna

Who manufactures BRIUMVI?

Neuraxpharm Pharmaceuticals, S.L. (Hiszpania)

What ATC class does BRIUMVI belong to?

BRIUMVI: ATC L04AG14. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

BRIUMVI

150 mg/6 ml, Koncentrat do sporządzania roztworu do infuzji

INN: Ublituximabum

Data updated: 2026-04-13

Available in:

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Form

Koncentrat do sporządzania roztworu do infuzji

Dosage

150 mg/6 ml

Route

dożylna

Storage

16.2 Storage and Handling 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.

User Reviews

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