Briumvi (ublituximab)

Drug Overview

Briumvi (ublituximab) is a CD20 monoclonal antibody approved for treating relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It works by depleting B cells, which play a role in MS-related nerve damage.

Patient Education Before Administration

  • Screening & Premedication:
    • Confirm no active infections (delay infusion if present)
    • Pregnancy test required for females of reproductive potential
    • Administer premedication 30–60 minutes before infusion:
        • Methylprednisolone 100 mg IV (or equivalent corticosteroid)
        • Antihistamine (e.g., diphenhydramine).
        • Optional antipyretic (e.g., acetaminophen)
    • Verify vaccination status: Live vaccines must be given ≥4 weeks before starting Briumvi.
  • Patient Counseling:
    • Report signs of infection (fever, chills)
    • Avoid live vaccines during and after treatment
    • Use contraception during and for ≥6 months post-treatment

Administration Guidelines

  • Preparation:
      • Dilute in 250 mL 0.9% sodium chloride
      • Do not shake the vial; inspect for particulates
  • Infusion Protocol:

Infusion

Dose

Rate

Duration

Monitoring

First

150 mg

Slow titration

4 hours

≥1 hour post-infusion

Second (Week 2)

450 mg

Fixed rate

1 hour

≥1 hour post-infusion

Subsequent (Q24W)

450 mg

Fixed rate

1 hour

Per physician discretion

  • Key Steps:
    • Use in-line filter (0.2 µm)
    • Monitor for infusion reactions (e.g., fever, chills, hypotension)
    • Observe the patient for at least one hour after the completion of the first two infusions.

Managing Infusion Reactions & Side Effects

  • Common Reactions:
    • Infusion-related: Fever, chills, headache, nausea
    • Infections: Increased risk of URI, UTI, herpes zoster
    • Hepatitis B Reactivation: Screen before initiation
  • Interventions:
    • For mild reactions: Slow infusion rate, administer antihistamines/steroids
    • For severe reactions: Stop infusion, initiate emergency protocols
    • Post-infusion observation: Mandatory for first two doses

Post-Administration Monitoring & Education

  • Lab Monitoring:
      • B-cell counts (repletion may take months)
      • LFTs (if signs of hepatitis)
  • Patient Follow-Up:
      • Report delayed reactions (e.g., rash, fatigue)
      • Avoid live vaccines until immune recovery

References:

[1] https://ec.europa.eu/health/documents/community-register/2023/20231009160716/anx_160716_en.pdf
[2] https://www.drugs.com/dosage/briumvi.html
[3] https://www.youtube.com/watch?v=bctTKygOj6o
[4] https://www.drugs.com/briumvi.html
[5] https://www.briumvi.com/wp-content/uploads/2023/02/BRIUMVI-Day-1-Med-Guide-Patient-Brochure-Digital-3-002.pdf
[6] https://quizlet.com/841982726/class-6-chapter-30-medications-flash-cards/
[7] https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761238s000lbl.pdf
[8] https://ivxhealth.com/therapies/briumvi/
[9] https://www.tgtherapeutics.com/label-prescribing-info/uspi-briumvi.pdf