Ansuvimab

1 INDICATIONS AND USAGE EBANGA is indicated for the treatment of infection caused by Orthoebolavirus zairense (formerly Zaire ebolavirus) in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2) and Clinical Studies (14) ]. EBANGA (ansuvimab-zykl) is an Orthoebolavirus zairense glycoprotein (EBOV GP)-directed human monoclonal antibody indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection. ( 1 ) Limitation of Use • The efficacy of EBANGA has not been established for other species of the Orthoebolavirus and Orthomarburgvirus genera . • Orthoebolavirus zairense can change over time, and factors such as emergence of resistance or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating Orthoebolavirus zairense strains when deciding whether to use EBANGA. Limitations of Use: The efficacy of EBANGA has not been established for other species of the Orthoebolavirus and Orthomarburgvirus genera. Orthoebolavirus zairense can change over time, and factors such as emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating Orthoebolavirus zairense strains when deciding whether to use EBANGA.