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 under section 564(b)(1) of the Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Getting Started With EVUSHELD
People are considered to be moderately or severely immunocompromised if they have:
Been receiving active cancer treatment for tumors or cancers of the blood
Received an organ transplant and are taking medicine to suppress the immune system
Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system
Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome, etc)
Advanced or untreated HIV infection
Active treatment with high-dose corticosteroids or other drugs that may suppress the immune response
If you think you may be immunocompromised, talk to your healthcare provider to find out if EVUSHELD can help.
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.
You may need to receive additional doses of EVUSHELD for ongoing protection.
Viruses can change over time (mutate) and develop into a slightly different form of the virus, called a variant. The duration that EVUSHELD will protect you from infection may change with certain variants. The best timing for you to receive additional doses of EVUSHELD, if needed, is not known right now, because this depends on which SARS-CoV-2 variants will be present in the future.
Talk to your healthcare provider about receiving additional doses of EVUSHELD for ongoing protection and for further instructions.
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.
See Fact Sheet for Patients, Parents and Caregivers for more information about EVUSHELD.
Ask your doctor if EVUSHELD is right for you.