Adverse events - Briumvi UK
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Adverse events

This promotional website is intended for UK healthcare professionals.

Briumvi® (ublituximab) is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.1 

BRIUMVI®
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Adverse events

BRIUMVI® safety profile: adverse reactions1

The most important and frequently reported adverse reactions are infusion-related reactions (45.3%) and infections (55.8%).

Summary of adverse reactions that have been reported in association with the use of ublituximab1

 

1 Symptoms reported as IRRs within 24 hours of the infusion are described below in ‘Infusion-related reactions’.

  • There were no cases of progressive multifocal leukoencephalopathy (PML) reported in the ULTIMATE I and II trials.2
    • In the post marketing/real world setting there has been one reported case [Sept 2025]
  • Three neoplasms occurred in total, two in the BRIUMVI® group (uterine and endometrial) and one in the teriflunomide group (tongue).2
  • Rates of discontinuation were similar in both arms, with ~90% of patients completing the 2-year treatment across both the ULTIMATE I and II trials.2
aSymptoms reported as IRRs within 24 hours of the infusion are described under in ‘Infusion-related reactions’.
bUpper respiratory tract infections occurred in 33.6% of patients treated with BRIUMVI® and 31.8% of of patients treated with teriflunomide.1 Lower respiratory tract infections occurred in 5.1% of patients treated with BRIUMVI® and 4.0% of of patients treated with teriflunomide.1
In the ULTIMATE I and II trials, IRRs were primarly mild to moderate in severity and decrased with each infusion2 <8.6% of patients experienced IRRs from the second infusion onwards1
  • In the two clinical trials, the overall infection rates of BRIUMVI® (55.8%) and teriflunomide (54.4%) were similar.1
  • The infections were predominantly mild to moderate in severity and consisted primarily of respiratory tract–related infections (mostly nasopharyngitis and bronchitis) .1,b
  • Serious infections were 5.0% and 2.9% for BRIUMVI® and teriflunomide, espectively.1
  • Three infection-related deaths occurred in patients on BRIUMVI® (post-measles encephalitis, pneumonia, and postoperative salpingitis following an ectopic pregnancy).1
  • IRRs can occur and may include pyrexia, chills, headache, tachycardia, nausea, abdominal pain, throat irritation, erythema, and anaphylactic reaction. They can happen during infusion or up to 24 hours after infusion.1
  • 0.4% of patients experienced IRRs that were serious. There were no fatal IRRs.1
  • A total of six patients discontinued treatment due to IRRs (five patients with grade 2 infusion reactions and one patient with a grade 4 infusion reaction).2
  • Premedicate with an oral or IV corticosteroid and antihistamine to reduce the frequency and severity of IRRs.1 The addition of an antipyretic (e.g. paracetamol) may also be considered.a ,1

aIn the trials, oral paracetamol (650 mg or equivalent) was used as an intervention only in subjects who experienced fever or pyrexia after their Week 1 dose, or as clinically warranted at the discretion of the physician.

bUndesirable effects: very common (≥1/10): upper respiratory tract infections, respiratory tract infections, IRRs. Common (≥1/100 to <1/10): herpes virus infections, lower respiratory tract infections, neutropenia, pain in the extremities. 

For more information on important warnings related to IRRs click here Adverse events

See Summary of Product Characteristics for the complete list of adverse events.

BRIUMVI® (ublituximab) 150 mg concentrate for solution for infusion

BRIUMVI® (ublituximab) is indicated for the treatment of adult patients with relapsing forms of MS (RMS) with active disease defined by clinical or imaging features.1

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Reporting forms and information can be found at: https://yellowcard.mhra.gov.uk/. Adverse events should also be reported to Neuraxpharm by email: info-uk@neuraxpharm.com.

NXUK/0225/02 Date of preparation: October 2025

 References
1BRIUMVI®. Summary of Product Characteristics.
2Steinman L, Fox E, Hartung H-P, et al. N Engl J Med. 2022;387(8):704–714 and Supplementary Appendix. doi:10.1056/NEJMoa2201904
Abbreviations: IRRs, infusion-related reactions; IV, intravenous; MedDRA, Medical Dictionary for Regulatory Affairs.