Vaccine Information: EVUSHELD

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: 01/2023

———–RECENT MAJOR CHANGES ———-

Limitations of Authorized Use: updated based on variant

susceptibility 01/2023

Microbiology (12.4): updated neutralizing data 01/2023

Microbiology (12.4): updated neutralizing data 12/2022

Microbiology (12.4): updated neutralizing data 11/2022

Emergency Use Authorization (1): updated examples

10/2022

Warnings and Precautions (5.3, 17): addition of a new

warning 10/2022

Microbiology (12.4): updated neutralizing data 10/2022

Dosage and Administration (2.1, 17): modification of

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

Adverse Reactions (6.1, 12.3): addition of TACKLE data

02/2022

————-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):

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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

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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

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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 to a COVID-19 vaccine(s) and/or COVID-19 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., 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

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EVUSHELD is not authorized for use in individuals:

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For treatment of COVID-19, or

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For post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2.

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EVUSHELD is authorized for use only when the combined frequency of non-susceptible variants nationally is less than or equal to 90%, based on available information including variant susceptibility to EVUSHELD and national variant frequencies.

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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.

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In individuals who have received a COVID-19 vaccine, EVUSHELD should be administered at least two weeks after vaccination.

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:

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Initial dose: 300 mg of tixagevimab and 300 mg of cilgavimab administered as two separate consecutive intramuscular injections. (2.1)

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Dosing for Individuals Who Initially Received 150 mg of Tixagevimab and 150 mg Cilgavimab

For individuals who initially received 150 mg tixagevimab and 150 mg cilgavimab:

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Initial dose ≤3 months prior: 150 mg tixagevimab and 150 mg cilgavimab.

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Initial dose >3 months prior: 300 mg tixagevimab and 300 mg cilgavimab. (2.1)

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Repeat dose: 300 mg of tixagevimab and 300 mg of cilgavimab every 6 months. Repeat dosing should be timed from the date of the most recent EVUSHELD dose. (2.1)

See Full Fact Sheet for Healthcare Providers for detail on preparation and administration. (2)

————–DOSAGE FORMS AND STRENGTHS ———

Injection:

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tixagevimab 150 mg/1.5 mL (100 mg/mL) in a single-dose vial. (3)

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cilgavimab 150 mg/1.5 mL (100 mg/mL) in a single-dose vial. (3)

————–CONTRAINDICATIONS ———————-

EVUSHELD is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to EVUSHELD. (4)

————–WARNINGS AND PRECAUTIONS ————-

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Hypersensitivity Including Anaphylaxis: Serious hypersensitivity reactions, including anaphylaxis, have been observed with EVUSHELD. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive therapy. Clinically monitor individuals after injections and observe for at least 1 hour. (5.1)

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Risk of Cross-Hypersensitivity with COVID-19 Vaccines:EVUSHELD contains polysorbate 80, which is in some COVID-19 vaccines and is structurally similar to polyethylene glycol (PEG), an ingredient in other COVID-19 vaccines. For individuals with a history of severe hypersensitivity reaction to a COVID-19 vaccine, consider consultation with an allergist-immunologist prior to EVUSHELD administration. (5.2)

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Risk for COVID-19 Due to SARS-CoV-2 Viral Variants Not Neutralized by EVUSHELD: Certain SARS-CoV-2 viral variants may not be neutralized by monoclonal antibodies such as tixagevimab and cilgavimab, the components of EVUSHELD. EVUSHELD may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants. Inform individuals of the increased risk, compared to other variants, for COVID-19 due to SARS-CoV-2 viral variants not neutralized by EVUSHELD. If signs and symptoms of COVID-19 occur, advise individuals to test for COVID-19 and seek medical attention, including starting treatment for COVID-19 as appropriate. (5.3)

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Clinically Significant Bleeding Disorders: As with any other intramuscular injection, EVUSHELD should be given with caution to individuals with thrombocytopenia or any coagulation disorder. (5.4)

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Cardiovascular Events: A higher proportion of subjects who received EVUSHELD versus placebo reported myocardial infarction and cardiac failure serious adverse events. All of the subjects with events had cardiac risk factors and/or a prior history of cardiovascular disease, and there was no clear temporal pattern. A causal relationship between EVUSHELD and these events has not been established. Consider the risks and benefits prior to initiating EVUSHELD in individuals at high risk for cardiovascular events, and advise individuals to seek immediate medical attention if they experience any signs or symptoms suggestive of a cardiovascular event. (5.5)

————-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.

Revised: 01/2023