Monoclonal Antibodies

Bebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

The dosage in adults (18 years and older) and pediatric patients (≥12 years of age and weighing at least 40 kg) is bebtelovimab 175 mg. Bebtelovimab should be administered as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Under this EUA, bebtelovimab must be administered as a single intravenous injection over at least 30 seconds.

Patients must be clinically monitored during administration and observe patients after IV infusion.