Ublituximab

BRIUMVI

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Pronunciation: yoo-bli-TUX-i-mab (bree-UM-vee)

Ublituximab ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Ublituximab ballicule

Ublituximab BRIUMVI mascot mnemonic cartoon — Visual mnemonic: Ublituximab mascot
**“You be lit, tux man! – Bree envy”**

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.

Ublituximab molecular structure (skeletal formula) — Molecular structure: Ublituximab

FDA-approved for

Relapsing forms of multiple sclerosis (2022)

FDA label

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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

Available strengths

inj 150 mg/6 mL

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

Cost

Ublituximab (BRIUMVI)

Strength		#/mo	generic $/unit	CostPlus
150 mg/6 mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Ublituximab is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

NO BOXED WARNINGS

Principal riskInfusion reactions, and hypogammaglobulinemia with prolonged use

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryN/A (post-2015 labeling)

Defining liabilityInfusion reactions and serious opportunistic infections

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