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EVUSHELD STORAGE, DOSING & ADMINISTRATION GUIDE

EVUSHELD STORAGE, DOSING . & ADMINISTRATION GUIDE . EVUSHELD is a combination of 2 long-acting monoclonal antibodies (LAABs), tixagevimab and cilgavimab. AUTHORIZED USE. EVUSHELDTM (tixagevimab co-packaged with cilgavimab) is authorized for use under an Emergency Use Authorization (EUA) for the pre-exposure prophylaxis of 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 SARS-CoV-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 ( , severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).

ADVERSE EVENTS and MEDICATION ERRORS potentially related to EVUSHELD within 7 calendar days from the healthcare provider’s awareness of the event (1) by submitting FDA Form 3500 online, (2) by downloading FDA Form 3500 and then submitting by mail or fax, or (3) contacting the FDA at 1-800-FDA-1088 to request this form.

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