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FREQUENTLY ASKED QUESTIONS
Questions about receiving EVUSHELD
EVUSHELD is an unapproved 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 the 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 consists of 2 investigational medicines, tixagevimab and cilgavimab.
You will receive 1 dose of EVUSHELD, consisting of 2 separate injections.
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.
Talk to your healthcare provider about receiving additional doses of EVUSHELD for ongoing protection and for further instructions.
Use of EVUSHELD does not replace vaccination against COVID-19. 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 until at least 2 weeks after COVID-19 vaccination. Talk to your doctor to find out if EVUSHELD is right for you.
Questions about side effects, warnings, and precautions
Do not take EVUSHELD if you have had a severe allergic reaction to EVUSHELD or any ingredient in EVUSHELD.
Possible side effects of EVUSHELD are:
Allergic reactions. Allergic reactions can happen during and after injection of EVUSHELD. Tell your healthcare provider right away if you get any of the following signs and symptoms of allergic reactions: fever, chills, nausea, headache, shortness of breath, low or high blood pressure, rapid or slow heart rate, chest discomfort or pain, weakness, confusion, feeling tired, wheezing, swelling of your lips, face, or throat, rash including hives, itching, muscle aches, dizziness and sweating. These reactions may be severe or life-threatening.
Cardiac (heart) events. Serious cardiac adverse events have happened, but were not common, in people who received EVUSHELD and also in people who did not receive EVUSHELD in the clinical trial studying pre-exposure prophylaxis for prevention of COVID-19. In people with risk factors for cardiac events (including a history of heart attack), more people who received EVUSHELD experienced serious cardiac events than people who did not receive EVUSHELD. It is not known if these events are related to EVUSHELD or underlying medical conditions. Contact your healthcare provider or get medical help right away if you get any symptoms of cardiac events, including pain, pressure, or discomfort in the chest, arms, neck, back, stomach or jaw, as well as shortness of breath, feeling tired or weak (fatigue), feeling sick (nausea), or swelling in your ankles or lower legs.
The side effects of getting any medicine by intramuscular injection may include pain, bruising of the skin, soreness, swelling, and possible bleeding or infection at the injection site.
These are not all the possible side effects of EVUSHELD. Not a lot of people have been given EVUSHELD. Serious and unexpected side effects may happen. EVUSHELD is still being studied, so it is possible that all of the risks are not known at this time.
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 until at least 2 weeks after COVID-19 vaccination.
If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.
Tell your healthcare provider if you:
Have any allergies
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)
Questions about availability & access
The FDA has made EVUSHELDTM (tixagevimab co-packaged with cilgavimab) available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.
EVUSHELD for pre-exposure prophylaxis for prevention of coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus has not undergone the same type of review as an FDA-approved product. In issuing an EUA under the COVID-19 public health emergency, the FDA has determined, among other things, that based on the total amount of scientific evidence available including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19, or a serious or life-threatening disease or condition caused by COVID-19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved and available alternatives.
All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. The EUA for EVUSHELD is in effect for the duration of the COVID-19 declaration justifying emergency use of EVUSHELD, unless terminated or revoked (after which EVUSHELD may no longer be used under the EUA).
EVUSHELD can be administered by your healthcare provider.
Vaccines to prevent COVID-19 are approved or available under Emergency Use Authorization. Use of EVUSHELD does not replace vaccination against COVID-19. For more information about other medicines authorized for treatment or prevention of COVID-19 go to the FDA website for more information.
It is your choice to receive or not receive EVUSHELD. Should you decide not to receive EVUSHELD, it will not change your standard medical care.
EVUSHELD is not authorized for post-exposure prophylaxis of COVID-19.
Questions about what EVUSHELD is made from
The vial stoppers are not made with natural rubber latex.
The EVUSHELD solutions for injection do not contain preservatives.
Each EVUSHELD co-packaged carton contains 2 vials.
Active ingredient: Each of the vials contains either: tixagevimab or cilgavimab
Inactive ingredients: Each vial contains L- histidine, L- histidine hydrochloride monohydrate, polysorbate 80, sucrose, water.