Important Update
On January 26th, 2023, the U.S. Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for EVUSHELD to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. Based on this revision, EVUSHELD is not currently authorized for use in the U.S. until further notice by the Agency.
The U.S. Government recommends that facilities and providers with unexpired EVUSHELD retain all product in the event that SARS-CoV-2 variants which are neutralized by EVUSHELD become more prevalent in the U.S. in the future.
Please refer to the HHS website for expiry extension information.
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EVUSHELD is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to EVUSHELD.
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.
Risk of Cross-Hypersensitivity with COVID-19 Vaccines
Risk of cross-hypersensitivity with COVID-19 vaccines exist as 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.
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 EVUSHELD. 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.
Clinically Significant Bleeding Disorders
As with any other intramuscular injection, EVUSHELD should be given with caution to individuals with thrombocytopenia or any coagulation disorder.
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 at baseline. A causal relationship between EVUSHELD and these events has not been established.
The most common adverse events are headache, fatigue and cough.
Pregnancy
There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. EVUSHELD should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.
Lactation
There are no available data on the presence of tixagevimab or cilgavimab in human milk or animal milk, the effects on the breastfed infant, or the effects of the drug on milk production. Maternal IgG is known to be present in human milk.
Pediatric Use
EVUSHELD is not authorized for use in pediatric individuals under 12 years of age or weighing less than 40 kg. The safety and effectiveness of EVUSHELD have not been established in pediatric individuals.
EVUSHELD is authorized for use under an EUA for the pre-exposure prophylaxis of COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg):
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
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
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.
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.
EVUSHELD is not authorized for use in individuals:
For treatment of COVID-19, or
For post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2
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
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
In individuals who have received a COVID-19 vaccine, EVUSHELD should be administered at least two weeks after vaccination
Please see the Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers.
Under the EUA, all serious adverse events and medication errors potentially related to EVUSHELD use must be reported within 7 calendar days from the healthcare provider’s awareness of the event.
Serious adverse event reports and medication error reports should be submitted to FDA’s MedWatch program by:
Completing and submitting the form online
Completing and submitting a postage-paid FDA Form 3500 and returning by:
Mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or
Fax (1-800-FDA-0178) or
Contacting the FDA at 1-800-FDA-1088 to request a reporting form.
The prescribing healthcare provider and/or your designee must report all SERIOUS ADVERSE EVENTS and MEDICATION ERRORS potentially related to EVUSHELD within 7 calendar days from the healthcare provider's awareness of the event (1) by submitting FDA Form 3500 online (2) by downloading FDA Form 3500 and then submitting by mail or fax, or (3) contacting the FDA at 1-800-FDA-1088 to request this form.
In addition, please fax a copy of all FDA MedWatch forms to AstraZeneca at 1-866-742-7984.
You may report side effects related to AstraZeneca products by clicking here.
EVUSHELD is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to EVUSHELD.
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.
Risk of Cross-Hypersensitivity with COVID-19 Vaccines
Risk of cross-hypersensitivity with COVID-19 vaccines exist as 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.
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 EVUSHELD. 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.
Clinically Significant Bleeding Disorders
As with any other intramuscular injection, EVUSHELD should be given with caution to individuals with thrombocytopenia or any coagulation disorder.
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 at baseline. A causal relationship between EVUSHELD and these events has not been established.
The most common adverse events are headache, fatigue and cough.
Pregnancy
There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. EVUSHELD should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.
Lactation
There are no available data on the presence of tixagevimab or cilgavimab in human milk or animal milk, the effects on the breastfed infant, or the effects of the drug on milk production. Maternal IgG is known to be present in human milk.
Pediatric Use
EVUSHELD is not authorized for use in pediatric individuals under 12 years of age or weighing less than 40 kg. The safety and effectiveness of EVUSHELD have not been established in pediatric individuals.
EVUSHELD is authorized for use under an EUA for the pre-exposure prophylaxis of COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg):
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
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
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.
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.
EVUSHELD is not authorized for use in individuals:
For treatment of COVID-19, or
For post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2
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
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
In individuals who have received a COVID-19 vaccine, EVUSHELD should be administered at least two weeks after vaccination
Please see the Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers.
Under the EUA, all serious adverse events and medication errors potentially related to EVUSHELD use must be reported within 7 calendar days from the healthcare provider’s awareness of the event.
Serious adverse event reports and medication error reports should be submitted to FDA’s MedWatch program by:
Completing and submitting the form online
Completing and submitting a postage-paid FDA Form 3500 and returning by:
Mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or
Fax (1-800-FDA-0178) or
Contacting the FDA at 1-800-FDA-1088 to request a reporting form.
The prescribing healthcare provider and/or your designee must report all SERIOUS ADVERSE EVENTS and MEDICATION ERRORS potentially related to EVUSHELD within 7 calendar days from the healthcare provider's awareness of the event (1) by submitting FDA Form 3500 online (2) by downloading FDA Form 3500 and then submitting by mail or fax, or (3) contacting the FDA at 1-800-FDA-1088 to request this form.
In addition, please fax a copy of all FDA MedWatch forms to AstraZeneca at 1-866-742-7984.
You may report side effects related to AstraZeneca products by clicking here.