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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › IMMUNOSUPPRESSANTS › IMMUNOSUPPRESSANTS › Monoclonal antibodies
ublituximab
L04AG14
Forms & Strengths
- Intravenous infusion: 150 mg/15 mL (10 mg/mL) single-dose vial
Adult Dosing
- Initial dose: 150 mg intravenous infusion
- Second dose: 450 mg intravenous infusion 2 weeks after the initial dose
- Subsequent doses: 450 mg intravenous infusion every 24 weeks
- Pre-medicate with a corticosteroid and an antihistamine prior to each infusion
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
Indications
- Treatment of relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults
Mechanism of Action
- Glycoengineered monoclonal antibody that targets CD20-expressing B cells
- Induces cell lysis through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC)
Contraindications
- Known active hepatitis B virus infection
- History of a life-threatening infusion reaction to ublituximab
Adverse Reactions
- Infusion reactions (pruritus, headache, chills, fever, nausea, fatigue)
- Upper respiratory tract infections
- Urinary tract infections
- Insomnia
- Depression
Drug Interactions
- Immunosuppressant therapies: potential for increased immunosuppression and additive infection risk; use with other potent immunosuppressants is generally not recommended
- Live vaccines: vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell recovery
Curated Content: Needs Vetting Before Put to Clinical Use