Briumvi (Ublituximab-xiiy)

Mechanism of Action & Indications

Briumvi is a glycoengineered anti-CD20 monoclonal antibody that selectively depletes CD20-positive B cells, reducing relapse rates in relapsing forms of MS (RRMS, active SPMS, clinically isolated syndrome). Its enhanced antibody-dependent cellular cytotoxicity (ADCC) provides a 25–30x increase in B-cell depletion efficacy compared to earlier anti-CD20 therapies.

Dosing & Administration

  • First infusion: 150 mg IV over 4 hours
  • Second infusion (2 weeks later): 450 mg IV over 1 hour
  • Subsequent infusions (every 24 weeks): 450 mg IV over 1 hour.
  • Premedication: Administer methylprednisolone (100 mg IV/oral equivalent) + antihistamine 30–60 minutes before infusion to mitigate reactions.

https://briumvihcp.com/wp-content/uploads/2024/10/BRIUMVI-Infusion-Rate-Card.pdf

Key Safety Considerations

  1. Infusion-related reactions (IRRs):
    1. Occur in ~50% of patients (most common: headache, fever, chills).
    2. Management: Slow/interrupt infusion, restart at half-rate post-resolution.
  2. Infections & Immunosuppression:
    1. Screen for HBV (HBsAg, HBcAb) before initiation—contraindicated in active HBV.
    2. Avoid live vaccines ≥4 weeks pre-treatment and until B-cell repletion.
  3. Monitoring:
    1. Check serum immunoglobulins pre-treatment; monitor for hypogammaglobulinemia.
    2. Pregnancy testing recommended pre-infusion (FDA Category not yet assigned).

https://briumvihcp.com/wp-content/uploads/2024/10/BRIUMVI-Infusion-Rate-Card.pdf

Efficacy Highlights

  • ULTIMATE I/II trials: Briumvi reduced annualized relapse rate (ARR) by 50% vs. teriflunomide (0.09 vs. 0.18).
  • Fewer T1/T2 gadolinium-enhancing lesions vs. comparator.

Nursing & Patient Education

  • Patient counseling: Emphasize infection vigilance, IRR symptoms, and vaccination timing.
  • Infusion prep: Use aseptic technique; inspect for particulates/discoloration.

Briumvi’s shorter infusion time (vs. other anti-CD20 therapies) and biannual dosing may improve adherence and clinic workflow[1]. Ongoing monitoring for long-term safety (e.g., malignancy risk) is warranted.

References:

[1] https://pmc.ncbi.nlm.nih.gov/articles/PMC10553037/
[2] https://www.drugs.com/dosage/briumvi.html
[3] https://www.medicines.org.uk/emc/files/pil.100167.pdf
[4] http://impofy.com/importance-of-research-in-nursing/
[5] https://briumvihcp.com/study-design/
[6] https://briumvihcp.com/dosing-administration/
[7] https://www.drugs.com/briumvi.html
[8] https://quizlet.com/285368449/chapter-1-flash-cards/
[9] https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761238s000lbl.pdf