Ublituximab
BRIUMVI
What it isGlycoengineered anti-CD20 antibody; relapsing multiple sclerosis.
Why this oneGlycoengineering allows a one-hour infusion, far shorter than the other anti-CD20 agents.
What limits itInfusion reactions, and hypogammaglobulinemia with prolonged use. Screen for hepatitis B.
FDA-approved for
- Relapsing forms of multiple sclerosis (2022)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Relapsing forms of multiple sclerosis (clinically isolated syndrome, relapsing-remitting, active secondary progressive) | Adults | First infusion 150 mg IV; second 450 mg IV two weeks later | 450 mg IV 24 weeks after first infusion, then every 24 weeks | 450 mg per infusion |
Renal Undefined
Hepatic Undefined
Infusions must be separated by at least 5 months
Instructions
- IV infusion; dilute in 0.9% NaCl
- Screen for hepatitis B before first dose (contraindicated in active HBV)
- Obtain serum immunoglobulins and liver function tests before starting
- Pre-medicate with methylprednisolone 100 mg IV + an antihistamine ~30–60 min before each infusion
- Complete vaccinations ≥4 wk (live) / ≥2 wk (non-live) before initiation
- Observe ≥1 h after first two infusions
Contraindications
- Active hepatitis B virus infection
- A history of life-threatening infusion reaction to BRIUMVI
Cautions
- Infusion reactions
- Infections (incl. hepatitis B reactivation)
- Reduction in immunoglobulins
- Liver injury
- Complete immunizations before starting; live-vaccine precautions
Adverse reactions
- Infusion reactions
- Upper respiratory tract infections
Pregnancy No human data; monoclonal antibody may cross placenta and cause B-cell depletion in the in-utero-exposed infant
Lactation No data; human IgG excreted in milk
NO BOXED WARNINGS
Principal riskInfusion reactions, and hypogammaglobulinemia with prolonged use
Classes and tags
Clinical profile
Mechanism of action: Ublituximab ballicule
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