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Do not take EVUSHELD if you have had a severe allergic reaction to EVUSHELD.
What are the important possible side effects of EVUSHELD?
Allergic reactions can happen during and after injection of EVUSHELD and can sometimes be serious or life-threatening. You may be at an increased risk of an allergic reaction to EVUSHELD if you have had a severe allergic reaction to a COVID-19 vaccine or to a vaccine component. Your healthcare provider may consult with an allergist-immunologist before giving you EVUSHELD if you have had a serious allergic reaction to a COVID-19 vaccine.
Tell your healthcare provider right away if you get any of the following signs and symptoms of an allergic reaction during or after you receive EVUSHELD:
Trouble breathing or shortness of breath
Chills
Tiredness or weakness
Fast heart rate
Chest pain or discomfort
Nausea and vomiting
Swelling of your face, lips, mouth and tongue
Hives
Wheezing
Itching
Skin flushing
Sweating
Muscle aches
You may feel lightheaded or faint
Throat tightness
In the clinical trial for EVUSHELD, more people with cardiac risk factors (including a history of heart attack) experienced serious cardiac events than those who did not receive EVUSHELD. It is not known if these events are related to EVUSHELD or to underlying medical conditions. Contact your healthcare provider or get medical attention 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. EVUSHELD is still being studied, so it is possible that all the risks are not known at this time.
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 any symptoms of COVID-19. If you develop COVID-19, your healthcare provider may recommend one of the available COVID-19 treatments.
Before you receive EVUSHELD, tell your healthcare provider about all your medical conditions, including 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 illnesses
Are taking any medications (prescription and over-the-counter medicines, vitamins and herbal products)
What if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.
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.
Please see the Fact Sheet for Patients, Parents and Caregivers for more information.
How do I report side effects with EVUSHELD?
Contact your healthcare provider if you have any side effects that bother you or do not go away. Report side effects to FDA MedWatch or call AstraZeneca at 1-800-236-9933.
You may report side effects related to AstraZeneca products by clicking here.
Do not take EVUSHELD if you have had a severe allergic reaction to EVUSHELD.
What are the important possible side effects of EVUSHELD?
Allergic reactions can happen during and after injection of EVUSHELD and can sometimes be serious or life-threatening. You may be at an increased risk of an allergic reaction to EVUSHELD if you have had a severe allergic reaction to a COVID-19 vaccine or to a vaccine component. Your healthcare provider may consult with an allergist-immunologist before giving you EVUSHELD if you have had a serious allergic reaction to a COVID-19 vaccine.
Tell your healthcare provider right away if you get any of the following signs and symptoms of an allergic reaction during or after you receive EVUSHELD:
Trouble breathing or shortness of breath
Chills
Tiredness or weakness
Fast heart rate
Chest pain or discomfort
Nausea and vomiting
Swelling of your face, lips, mouth and tongue
Hives
Wheezing
Itching
Skin flushing
Sweating
Muscle aches
You may feel lightheaded or faint
Throat tightness
In the clinical trial for EVUSHELD, more people with cardiac risk factors (including a history of heart attack) experienced serious cardiac events than those who did not receive EVUSHELD. It is not known if these events are related to EVUSHELD or to underlying medical conditions. Contact your healthcare provider or get medical attention 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. EVUSHELD is still being studied, so it is possible that all the risks are not known at this time.
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 any symptoms of COVID-19. If you develop COVID-19, your healthcare provider may recommend one of the available COVID-19 treatments.
Before you receive EVUSHELD, tell your healthcare provider about all your medical conditions, including 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 illnesses
Are taking any medications (prescription and over-the-counter medicines, vitamins and herbal products)
What if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.
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.
Please see the Fact Sheet for Patients, Parents and Caregivers for more information.
How do I report side effects with EVUSHELD?
Contact your healthcare provider if you have any side effects that bother you or do not go away. Report side effects to FDA MedWatch or call AstraZeneca at 1-800-236-9933.
You may report side effects related to AstraZeneca products by clicking here.