Briumvi™ (ublituximab-xiiy) is now available for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
The CD20-directed cytolytic antibody therapy was approved based on data from two phase 3 trials that showed treatment with Briumvi led to a significant reduction in annualized relapse rate over a 96-week period compared with teriflunomide. The most common adverse reactions reported with treatment included infusion reactions and upper respiratory tract infections.
Briumvi is administered as an intravenous infusion under the close supervision of an experienced health care professional with access to appropriate medical support to manage severe reactions, such as serious infusion reactions. Prior to initiating therapy, patients should undergo hepatitis B virus screening and serum immunoglobulin testing. Any necessary vaccines should also be administered at least 4 weeks (for live or live-attenuated) or 2 weeks (nonlive) prior to starting Briumvi.
Additionally, patients should be assessed for active infection before every infusion and pregnancy testing is recommended for females of reproductive potential. Premedication with methylprednisolone (or an equivalent corticosteroid) and an antihistamine (eg, diphenhydramine) can help reduce the frequency and severity of infusion reactions.
Following the first infusion of Briumvi, a second infusion is administered 2 weeks later; a subsequent infusion is administered 24 weeks after the first infusion and then every 24 weeks thereafter. Patients should be monitored closely for at least 1 hour after completing the first 2 infusions; for subsequent infusions, monitoring is at physician discretion.
Briumvi is supplied as a 150mg/6mL single-dose vial containing a preservative-free solution for intravenous use.
To help patients gain access to treatment, TG Therapeutics has established the Briumvi Patient Support program.
- TG Therapeutics announces commercial launch of Briumvi™ (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis. News release. January 26, 2023. https://www.globenewswire.com/news-release/2023/01/26/2595890/8790/en/TG-Therapeutics-Announces-Commercial-Launch-of-BRIUMVI-ublituximab-xiiy-for-the-Treatment-of-Adult-Patients-with-Relapsing-Forms-of-Multiple-Sclerosis.html.
- Briumvi. Package insert. TG Therapeutics; 2022. Accessed January 26, 2023. https://www.tgtherapeutics.com/label-prescribing-info/uspi-briumvi.pdf.