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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › IMMUNOSUPPRESSANTS › IMMUNOSUPPRESSANTS › Complement inhibitors
vilobelimab
L04AJ10
Forms & Strengths
- Intravenous infusion: 200 mg / 2 mL solution in a single-dose vial
Adult Dosing
- Severe or critical COVID-19: 800 mg administered as an intravenous infusion every 4 days for a total of up to 6 doses
- Pre-medication with an antihistamine and corticosteroid is recommended prior to infusion to reduce infusion-related reactions
Pediatric Dosing
- Safety and effectiveness in pediatric patients below 18 years of age have not been established
Indications
- Treatment of COVID-19 in hospitalized adults when initiated within 48 hours of invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO)
Mechanism of Action
- Recombinant human chimeric monoclonal IgG4kappa antibody that specifically binds to the complement factor C5a
- Prevents cleavage of C5a and blocks its interaction with the C5a receptor, reducing C5a-mediated inflammation, neutrophil activation, and tissue damage
Contraindications
- History of severe hypersensitivity reactions, anaphylaxis, or systemic reactions to vilobelimab or any of its excipients
Adverse Reactions
- Infusion-related reactions (including flushing, dyspnea, tachycardia, hypotension)
- Infections (including pneumonia, sepsis, urinary tract infection)
- Thromboembolic events (including pulmonary embolism, deep vein thrombosis)
- Elevated liver enzymes and bilirubin
- Delirium and confusional states
Drug Interactions
- No formal clinical drug-interaction studies have been conducted with vilobelimab
- Concomitant immunosuppressive agents or other biologics may increase the risk of severe infections and should be used with caution
Curated Content: Needs Vetting Before Put to Clinical Use