AstraZeneca Pharmaceuticals LP
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.
EVUSHELD (tixagevimab) injection; (cilgavimab) injection, co-packaged for intramuscular use
Original EUA Authorized Date: 12/2021
Revised EUA Authorized Date: 11/2022
———–RECENT MAJOR CHANGES ———-
Microbiology (12.4): updated neutralizing data 12/2022
Microbiology (12.4): updated neutralizing data 11/2022
Emergency Use Authorization (1): updated
Microbiology (12.4): updated neutralizing data 10/2022
initial dosage and repeat dosing 06/2022
Microbiology (12.4): updated neutralizing data 06/2022
Warnings and Precautions (5.2): addition of new warning 05/2022
Dosage and Administration (2.3) 05/2022
————-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):
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., anti-infectives).
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. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
LIMITATIONS OF AUTHORIZED USE
See Full Fact Sheet for Healthcare Providers for examples of medical conditions or treatments that may result in moderate to severe immune 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)
————-DOSAGE AND ADMINISTRATION ————
The dosage of EVUSHELD for emergency use is:
See Full Fact Sheet for Healthcare Providers for detail on preparation and administration. (2)
————–DOSAGE FORMS AND STRENGTHS ———
EVUSHELD is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to EVUSHELD. (4)
————–WARNINGS AND PRECAUTIONS ————-
————-ADVERSE REACTIONS —————
Most common adverse events (all grades, incidence ≥3%) are headache, fatigue, and cough. (6.1)
You or your designee must report all SERIOUS ADVERSE EVENTS or MEDICATION ERRORS potentially related to EVUSHELD (1) by submitting FDA Form 3500 online, (2) by downloading this form and then submitting by mail or fax, or (3) contacting the FDA at 1-800-FDA-1088 to request this form. Please also provide a copy of this form to AstraZeneca by Fax at 1-866-742-7984 or call 1-800-236-9933. (6.4)
See PATIENT AND PARENTS/CAREGIVER FACT SHEET.
*Sections or subsections omitted from the EUA are not listed
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