ABOUT EVUSHELD

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to make EVUSHELD available during the COVID-19 pandemic. EVUSHELD is not an FDA-approved medicine in the United States.

EVUSHELD for pre-exposure prophylaxis for preventing COVID-19 infection

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EVUSHELD is an investigational medicine used in adults and adolescents (12 years of age and older who weigh at least 88 pounds [40 kg]) for pre-exposure prophylaxis for prevention of COVID-19 in persons who are:

  • Not currently infected with SARS-CoV-2 and who have not had recent known close contact with someone who is infected with SARS-CoV-2 and
    • Who have moderate to severe immune compromise due to a medical condition or have received immunosuppressive medicines 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 to a COVID-19 vaccine(s) or COVID-19 vaccine ingredient(s).

EVUSHELD is investigational because it is still being studied. There is limited information known about the safety and effectiveness of using EVUSHELD for pre-exposure prophylaxis for prevention of COVID-19. EVUSHELD is not authorized for post-exposure prophylaxis for prevention of COVID-19.

The FDA has authorized the emergency use of EVUSHELD for pre-exposure prophylaxis for prevention of COVID-19 under an Emergency Use Authorization (EUA).

EVUSHELD is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of EVUSHELD, unless the authorization is terminated or revoked sooner.

Getting Started With EVUSHELD

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How do I know if I am immunocompromised?

Medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination include but are not limited to:

  • Active treatment for solid tumor and hematologic malignancies

  • Hematologic malignancies associated with poor responses to COVID-19 vaccines regardless of current treatment status (e.g., chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia)

  • Receipt of solid-organ transplant or an islet 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., common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome)

  • Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)

  • Active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, and biologic agents that are immunosuppressive or immunomodulatory e.g., B-cell depleting agents)

This is not an exhaustive list. If you think you may be immunocompromised, talk to your healthcare provider to learn about your options and find out if EVUSHELD may be right for you.

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How will I receive EVUSHELD?

  • EVUSHELD consists of 2 investigational medicines, tixagevimab and cilgavimab.

  • You will receive 1 dose of EVUSHELD, consisting of 2 separate injections (tixagevimab and cilgavimab).

  • EVUSHELD will be given to you by your healthcare provider as 2 intramuscular injections, given one after the other.

Viruses can change over time (mutate) and develop into a slightly different form of the virus, called a variant. Based on what we know about current SARS-CoV-2 variants, you will need to receive additional doses of EVUSHELD every 6 months if ongoing protection is needed.

Talk to your healthcare provider for more information.

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What should I tell my healthcare provider before I receive EVUSHELD?

Tell your healthcare provider if you:

  • Have any allergies, including if you have had a severe allergic reaction to a COVID-19 vaccine

  • Have low numbers of blood platelets (which help blood clotting), a bleeding disorder, or are taking anticoagulants (to prevent blood clots)

  • Have had a heart attack or stroke, have other heart problems, or are at high risk of cardiac (heart) events

  • Are pregnant or plan to become pregnant

  • Are breastfeeding a child

  • Have any serious illness

  • Are taking any medications (prescription, over-the-counter, vitamins, or herbal products)

Use of EVUSHELD does not replace vaccination against COVID-19. For more information about other medications authorized for treatment or prevention of COVID-19, visit the FDA website.

It is possible that EVUSHELD may reduce your body's immune response to a COVID-19 vaccine. If you have received a COVID-19 vaccine, you should wait to receive EVUSHELD at least 2 weeks after COVID-19 vaccination.

EVUSHELD may not be effective at preventing COVID-19 caused by certain SARS-CoV-2 variants. If you are exposed to these variants, your chance of developing COVID-19 is higher than from other variants. Tell your healthcare provider right away, and test for COVID-19.

If you develop COVID-19, your healthcare provider may recommend one of the available COVID-19 treatments.

See Fact Sheet for Patients, Parents and Caregivers for more information about EVUSHELD.

Ask your doctor if EVUSHELD is right for you.

IMPORTANT SAFETY INFORMATION