DOSING & ADMINISTRATION

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.

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EVUSHELD’s Storage, Dosing and Administration Guide

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RECOMMENDED DOSAGE

Remove Carton from Refrigerator Storage

Each EVUSHELD carton contains two vials; one of each antibody. Each vial contains an overfill to allow the withdrawal of 150 mg (1.5 mL)

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. For individuals with a history of a severe hypersensitivity reaction to a COVID-19 vaccine, consider consultation with an allergist-immunologist prior to EVUSHELD administration.

Initial Dosing

The initial dosage of EVUSHELD in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) is 300 mg of tixagevimab and 300 mg of cilgavimab administered as two separate consecutive intramuscular (IM) injections.

2 VIALS:

tixagevimab solution

Tixagevimab SolutionTixagevimab SolutionTixagevimab Solution

150 mg/1.5 mL + 150 mg/1.5 mL =

300 mg/3 mL

2 VIALS:

cilgavimab solution

Cilgavimab SolutionCilgavimab SolutionCilgavimab Solution

150 mg/1.5 mL + 150 mg/1.5 mL =

300 mg/3 mL

Repeat Dosing

The repeat dosage of EVUSHELD in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) is 300 mg of tixagevimab and 300 mg of cilgavimab administered every 6 months. Repeat dosing should be timed from the date of the most recent EVUSHELD dose.

Table 1: Dosage of 300 mg of Tixagevimab and 300 mg of Cilgavimab

Initial Dosage of 300 mg of Tixagevimab and 300 mg of Cilgavimab
Initial Dosage of 300 mg of Tixagevimab and 300 mg of Cilgavimab

*300 mg of tixagevimab and 300 mg of cilgavimab are to be administered as separate, consecutive intramuscular injections

Dosing for Individuals Who Initially Received 150 mg of Tixagevimab and 150 mg of Cilgavimab

Individuals who have already received the previously authorized dose (150 mg of tixagevimab and 150 mg of cilgavimab) should receive an additional EVUSHELD dose as soon as possible, with the dose based on the following criteria: 

  • If the patient received their initial dose ≤ 3 months ago, the patient should receive a dose of 150 mg of tixagevimab and 150 mg of cilgavimab, refer to Table 2.

  • If the patient received their initial dose > 3 months ago, the patient should receive a dose of 300 mg of tixagevimab and 300 mg of cilgavimab, refer to Table 1.

Tixagevimab Solution Tixagevimab Solution

1 VIAL: tixagevimab solution 150 mg/1.5 mL

Cilgavimab SolutionCilgavimab Solution

1 VIAL: cilgavimab solution 150 mg/1.5 mL

1 VIAL: tixagevimab solution (150 mg/1.5 mL)

Tixagevimab SolutionTixagevimab Solution

150 mg/1.5 mL

1 VIAL: cilgavimab solution (150 mg/1.5 mL)

Cilgavimab SolutionCilgavimab Solution

150 mg/1.5 mL

Table 2: Dosage of 150 mg of Tixagevimab and 150 mg of Cilgavimab

EVUSHELD Antibody Dosage
EVUSHELD Antibody Dosage

*150 mg of tixagevimab and 150 mg of cilgavimab are to be administered as separate, consecutive intramuscular injections

Tixagevimab and cilgavimab are each supplied in individual single-dose vials. Do not shake the vials.

There are limited clinical data available for EVUSHELD. Serious and unexpected adverse events may occur that have not been previously reported with EVUSHELD use.

EVUSHELD is contraindicated in individuals with previous hypersensitivity reactions, including anaphylaxis to EVUSHELD.

As with any intramuscular injection, EVUSHELD should be given with caution to individuals with thrombocytopenia or any coagulation disorder.

Consider the risks and benefits prior to initiating EVUSHELD in individuals at high risk for cardiovascular events, and advise individuals to seek immediate medical attention if they experience any signs or symptoms suggestive of a cardiovascular event.

As a prescribing healthcare practitioner, you must communicate to the patient, parent and caregiver information consistent with the Fact Sheet for Patients, Parents and Caregivers and provide them with a copy of this Fact Sheet prior to administration of EVUSHELD.

STEP-BY-STEP PROCESS

Dosing Physician Hand

1.

EVUSHELD must be prepared by a qualified healthcare provider.

Visually Inspect the Vials

2.

Visually inspect the vials for particulate matter and discoloration.

Tixagevimab and cilgavimab are clear to opalescent, colorless to slightly yellow solutions. Discard the vials if the solution is cloudy, discolored, or visible particles are observed.

Two Separate Syringes

3.

Withdraw the appropriate amount of tixagevimab solution and the appropriate amount of cilgavimab solution into TWO separate syringes. Discard unused portion in vials.

Different Injection Sites

4.

Administer the IM injections at different injection sites, preferably one in each of the gluteal muscles, one after the other.

For the 300 mg tixagevimab and 300 mg cilgavimab dose, ensure that the administration sites are appropriate for the volume (3 mL per injection).

Monitor After Injection

5.

Clinically monitor individuals after injections and observe for at least 1 hour.

Administration of EVUSHELD should be done under the supervision of a healthcare provider with appropriate medical support to manage severe hypersensitivity reactions. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur while taking EVUSHELD, immediately discontinue administration and initiate appropriate medications and/or supportive care.

STORAGE

Refrigerate Unopened Vials

  • Refrigerate unopened vials at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light

  • Do not freeze. Do not shake

  • This product is preservative-free and therefore, the prepared syringes should be administered immediately

  • If immediate administration is not possible, and the prepared tixagevimab and cilgavimab syringes need to be stored, the total time from vial puncture to administration must not exceed 4 hours:

    • in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF), or

    • at room temperature up to 25°C (77°F)

DOSAGE ADJUSTMENT IN SPECIFIC POPULATIONS

No dosage adjustment is recommended in pregnant or lactating individuals, in geriatrics, and in individuals with renal impairment.

Please see Fact Sheet for Healthcare Providers for complete dosing and administration instructions.

Click below to watch EVUSHELD's
HCP Educational Video

IMPORTANT SAFETY INFORMATION
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EVUSHELD has been granted an Emergency Use Authorization (EUA) by FDA. There are limited clinical data available and serious and unexpected adverse events may occur that have not been previously reported with EVUSHELD use.

Contraindications

EVUSHELD is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to EVUSHELD.

Warnings and Precautions

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

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. For individuals with a history of severe hypersensitivity to a COVID-19 vaccine, consider consultation with an allergist-immunologist prior to EVUSHELD administration.

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. Consider the risks and benefits prior to initiating EVUSHELD in individuals at high risk for cardiovascular events, and advise individuals to seek immediate medical attention if they experience any signs or symptoms suggestive of a cardiovascular event.

Adverse Reactions

The most common adverse events are headache, fatigue and cough.

Use in Specific Populations

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.

SARS-CoV-2 VIRAL VARIANT

There is a potential risk of treatment failure due to the development of viral variants that are resistant to tixagevimab and cilgavimab administered together. Prescribing healthcare providers should consider the prevalence of SARS-CoV-2 variants in their area, where data are available, when considering prophylactic treatment options.

AUTHORIZED USE FOR EVUSHELD

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.

LIMITATIONS OF AUTHORIZED USE

  • 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

  • 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.

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 has been granted an Emergency Use Authorization (EUA) by FDA. There are limited clinical data available and serious and unexpected adverse events may occur that have not been previously reported with EVUSHELD use.

Contraindications

EVUSHELD is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to EVUSHELD.

Warnings and Precautions

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

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. For individuals with a history of severe hypersensitivity to a COVID-19 vaccine, consider consultation with an allergist-immunologist prior to EVUSHELD administration.

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. Consider the risks and benefits prior to initiating EVUSHELD in individuals at high risk for cardiovascular events, and advise individuals to seek immediate medical attention if they experience any signs or symptoms suggestive of a cardiovascular event.

Adverse Reactions

The most common adverse events are headache, fatigue and cough.

Use in Specific Populations

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.

SARS-CoV-2 VIRAL VARIANT

There is a potential risk of treatment failure due to the development of viral variants that are resistant to tixagevimab and cilgavimab administered together. Prescribing healthcare providers should consider the prevalence of SARS-CoV-2 variants in their area, where data are available, when considering prophylactic treatment options.

AUTHORIZED USE FOR EVUSHELD

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.

LIMITATIONS OF AUTHORIZED USE

  • 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

  • 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.

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.

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