FACT SHEET FOR HEALTHCARE PROVIDERS:EMERGENCY USE ...

1 | PageFACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR EVUSHELD (tixagevimabco-packaged with cilgavimab)HIGHLIGHTS OFEMERGENCY USE AUTHORIZATION(EUA)These highlights of the EUAdo not include all the information needed to use EVUSHELD under the EUA. See the FULL FACT SHEET FOR HEALTHCARE PROVIDERSfor (tixagevimab) injection;(cilgavimab) injection,co-packagedfor intramuscular useOriginal EUA Authorized Date: 12/2021---------------------------RECENT MAJOR CHANGES--------------------------Dosage and Administration( , 17): modification ofinitial dosageand repeat dosing02/2022 Adverse Reactions ( , ): addition of TACKLE data02/2022 Microbiology ( ): updated neutralizing data02/2022----------------------------- -----EUA FOR EVUSHELD-----------------------------The Food and Drug Administrationhas issued an EUA for the emergency use of the unapproved product EVUSHELD (tixagevimab co-packaged withcilgavimab), SARS-CoV-2 spike protein-directed attachment inhibitor, for the pre-exposureprophylaxis ofcoronavirus disease 2019 (COVID-19) in adults and pediatric individuals (12 years of age and olderweighing at least 40 kg).

Receipt of solid-organ transplant and taking immunosuppressive therapy Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy) Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)

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  Transplantation, Immunosuppressive

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