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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › IMMUNOSUPPRESSANTS › IMMUNOSUPPRESSANTS › Monoclonal antibodies
divozilimab
L04AG15
Forms & Strengths
- Intravenous solution: 100 mg/10 mL (10 mg/mL) in single-use vials
Adult Dosing
- Multiple sclerosis: 300 mg intravenous infusion initially, followed by a second 300 mg dose 2 weeks later
- Maintenance: 300 mg intravenous infusion every 6 months
Pediatric Dosing
- Safety and efficacy in pediatric patients (<18 years) have not been established
Indications
- Treatment of adult patients with relapsing forms of multiple sclerosis (RMS)
Mechanism of Action
- Recombinant humanized monoclonal antibody targeting CD20-expressing B cells
- Depletes circulating CD20+ B lymphocytes through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC)
- Reduces B-cell mediated inflammation, antigen presentation, and autoantibody production in multiple sclerosis
Contraindications
- Active hepatitis B infection
- History of life-threatening infusion reactions to divozilimab
- Severe active infections until resolution
Adverse Reactions
- Infusion-related reactions (headache, pruritus, throat irritation, flushing, pyrexia)
- Upper respiratory tract infections
- Urinary tract infections
- Herpes viral infections
- Neutropenia and lymphopenia
- Elevated transaminases
Drug Interactions
- Immunosuppressant therapies: Increased risk of additive immune system suppression and severe infections
- Live-attenuated vaccines: Avoid administration with or after divozilimab due to risk of disseminated infection
- CYP450 inducers/inhibitors: No clinically significant pharmacokinetic interactions anticipated based on monoclonal antibody clearance pathways
Curated Content: Needs Vetting Before Put to Clinical Use