Section 04 · Monograph
Ublituximab
Reviewed Nov 2026FDA label
BriumviAnti-CD20 mAb
- Forms
- IV: 150mg/6mL (25mg/mL)
- Dose
- 150mg IV Day 1, 450mg IV Day 15, then 450mg IV every 24 weeks
- MOA
- Depletes CD20+ B-cells
Indications
- Relapsing forms of multiple sclerosis (clinically isolated syndrome, relapsing-remitting, active secondary progressive) in adultsFDA-labeled
Mechanism of Action
- Glycoengineered anti-CD20 monoclonal antibody that depletes CD20-expressing B cells with enhanced antibody-dependent cellular cytotoxicity
Full Dosing
Adult / usual
- Initial dose 150mg IV (about 4-hour infusion); 450mg IV 2 weeks later (about 1 hour); then 450mg IV every 24 weeks starting 24 weeks after the first infusion
- Premedicate with a corticosteroid (e.g., methylprednisolone 100mg or equivalent) and an antihistamine before each infusion
- Observe patients for at least 1 hour after the first two infusions
Contraindications
- Active hepatitis B virus infection
- History of life-threatening infusion reaction to ublituximab
Drug Interactions
- Avoid live or live-attenuated vaccines; give non-live vaccines at least 2 weeks before treatment
- Additive immunosuppression with other immunosuppressive therapies
Adverse Effects
- Infusion reactions (most common)
- Infections including upper respiratory and herpes viruses; hepatitis B reactivation
- Progressive multifocal leukoencephalopathy (PML) risk
- Reduced immunoglobulins; neutropenia
- Possible increased malignancy risk
Monitoring Parameters
- Hepatitis B and infection screening before treatment
- Immunoglobulin levels periodically
- Infusion monitoring and new neurologic symptoms (PML)
Pregnancy & Lactation
- Potential neonatal B-cell depletion; delay live vaccines in exposed infants; use effective contraception during and for about 6 months after treatment
- Unknown whether present in milk