Included In This Lesson
Outline
What is the Generic Name
ATOLTIVIMAB, MAFTIVIMAB, AND ODESIVIMAB-EBGN
What is the Trade Name for ATOLTIVIMAB, MAFTIVIMAB, AND ODESIVIMAB-EBGN
Inmazeb
What is the Indication for ATOLTIVIMAB, MAFTIVIMAB, AND ODESIVIMAB-EBGN
- 1 INDICATIONS AND USAGE INMAZEB is indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection [see Dosage and Administration (2.2) , and Clinical Studies (14) ] . INMAZEB is a combination of Zaire ebolavirus glycoprotein-directed human monoclonal antibodies (atoltivimab, maftivimab, and odesivimab), indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection. ( 1 ) Limitation of Use The efficacy of INMAZEB has not been established for other species of the Ebolavirus and Marburgvirus genera . Zaire ebolavirus 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 Zaire ebolavirus strains when deciding whether to use INMAZEB. Limitations of Use The efficacy of INMAZEB has not been established for other species of the Ebolavirus and Marburgvirus genera. Zaire ebolavirus 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 Zaire ebolavirus strains when deciding whether to use INMAZEB.
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References: https://open.fda.gov/
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