Fact sheet for healthcare providers: emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab)

Abstract: FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR EVUSHELD™ (tixagevimab co-packaged with cilgavimab) HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA) These highlights of the EUA do not include all the information needed to use EVUSHELD™ under the EUA. See the FULL FACT SHEET FOR HEALTHCARE PROVIDERS for EVUSHELD. compromise and an inadequate immune response to COVID-19 vaccination, the justification for emergency use of drugs during the COVID-19 pandemic, information on available alternatives, and additional information on COVID-19. (1) EVUSHELD (tixagevimab) injection; (cilgavimab) injection, copackaged for intramuscular use Original EUA Authorized Date: 12/2021 ------------------------DOSAGE AND ADMINISTRATION----------------------The dosage of EVUSHELD for emergency use is 150 mg of tixagevimab and 150 mg of cilgavimab administered as two separate consecutive intramuscular injections. See Full Fact Sheet for Healthcare Providers for detail on preparation and administration. (2) ----------------------------------EUA FOR EVUSHELD----------------------------The U.S. Food and Drug Administration has issued an EUA for the emergency use of the unapproved product EVUSHELD (tixagevimab co-packaged with cilgavimab), SARS-CoV-2 spike protein-directed attachment inhibitor, for the pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and pediatric individuals (12 years of age and older weighing at least 40 kg): • Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARSCoV-2 and • Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination or • For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID19 vaccine component(s). EVUSHELD may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which EVUSHELD belongs (i.e., antiinfectives). EVUSHELD has been authorized by FDA for the emergency use described above. EVUSHELD is not FDA-approved for any use, including use for pre-exposure prophylaxis of COVID-19. (1) EVUSHELD is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of EVUSHELD under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner. LIMITATIONS OF AUTHORIZED USE • EVUSHELD is not authorized for use in individuals: o For treatment of COVID-19, or o For post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2. • Pre-exposure prophylaxis with EVUSHELD is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate to severe immune compromise who may derive benefit from COVID-19 vaccination, should receive COVID-19 vaccination. • In individuals who have received a COVID-19 vaccine, EVUSHELD should be administered at least two weeks after..