Vaccine Information: EVUSHELD

EVUSHELD- azd7442
AstraZeneca Pharmaceuticals LP

HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA)

These highlights of the EUA do not include all the information needed to use EVUSHELD™ under the EUA. See the FULL FACT SHEET FOR HEALTHCARE PROVIDERS for EVUSHELD.

EVUSHELD (tixagevimab) injection; (cilgavimab) injection, co-packaged for intramuscular use

Original EUA Authorized Date: 12/2021

————-EUA FOR EVUSHELD —————

The U.S. Food and Drug Administration has issued an EUA for the emergency use of the unapproved product EVUSHELD (tixagevimab co-packaged with cilgavimab), SARS-CoV-2 spike protein-directed attachment inhibitor, for the pre-exposure prophylaxis of coronavirus disease 2019 (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 (e.g., severe allergic 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. (1)

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.

See Full Fact Sheet for Healthcare Providers for examples of medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination, the justification for emergency use of drugs during the COVID-19 pandemic, information on available alternatives, and additional information on COVID-19. (1)

————-DOSAGE AND ADMINISTRATION ————

The dosage of EVUSHELD for emergency use is 150 mg of tixagevimab and 150 mg of cilgavimab administered as two separate consecutive intramuscular injections. See Full Fact Sheet for Healthcare Providers for detail on preparation and administration. (2)

————–DOSAGE FORMS AND STRENGTHS ———

Injection:

tixagevimab 150 mg/1.5 mL (100 mg/mL) in a single-dose vial. (3)
cilgavimab 150 mg/1.5 mL (100 mg/mL) in a single-dose vial. (3)

————–CONTRAINDICATIONS ———————-

EVUSHELD is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to any component of EVUSHELD. (4)

————–WARNINGS AND PRECAUTIONS ————-

Hypersensitivity Including Anaphylaxis: Serious hypersensitivity reactions, including anaphylaxis, have been observed with IgG1 monoclonal antibodies like 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. (5.1)
Clinically Significant Bleeding Disorders: As with any other intramuscular injection, EVUSHELD should be given with caution to individuals with thrombocytopenia or any coagulation disorder. (5.2)
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, and there was no clear temporal pattern. 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. (5.3)

————-ADVERSE REACTIONS —————

Most common adverse events (all grades, incidence ≥3%) are headache, fatigue, and cough. (6.1)

You or your designee must report all SERIOUS ADVERSE EVENTS or MEDICATION ERRORS potentially related to EVUSHELD (1) by submitting FDA Form 3500 online, (2) by downloading this form and then submitting by mail or fax, or (3) contacting the FDA at 1-800-FDA-1088 to request this form. Please also provide a copy of this form to AstraZeneca by Fax at 1-866-742-7984 or call 1-800-236-9933. (6.4)

See PATIENT AND PARENTS/CAREGIVER FACT SHEET.

TABLE OF CONTENTS*

1 EMERGENCY USE AUTHORIZATION

2 DOSAGE AND ADMINISTRATION

2.1 Dosage for Emergency Use of EVUSHELD

2.2 Dosage Adjustment in Specific Populations

2.3 Dose Preparation and Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Including Anaphylaxis

5.2 Clinically Significant Bleeding Disorders

5.3 Cardiovascular Events

6 ADVERSE REACTIONS

6.1 Adverse Reactions from Clinical Studies

6.4 Required Reporting for Serious Adverse Events and Medication Errors

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

8.8 Other Specific Populations

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and Pharmacology

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

18 MANUFACTURER INFORMATION

*Sections or subsections omitted from the EUA are not listed

FULL FACT SHEET FOR HEALTHCARE PROVIDERS

1 EMERGENCY USE AUTHORIZATION

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product EVUSHELD (tixagevimab co-packaged with cilgavimab) for the pre-exposure prophylaxis of coronavirus disease 2019 (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 1or
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 (e.g., severe allergic 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.

Medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination include but are not limited to 1:

Active treatment for solid tumor and hematologic malignancies
Receipt of solid-organ transplant and taking immunosuppressive therapy
Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200/mm3 , history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
Active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents)

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.

Justification for Emergency Use of Drugs During the COVID-19 Pandemic

There is currently an outbreak of COVID-19 caused by SARS-CoV-2, a novel coronavirus. The Secretary of HHS has declared that:

A public health emergency related to COVID-19 has existed since January 27, 2020.
Circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic (March 27, 2020 declaration).

An EUA is a FDA authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the United States under certain circumstances including, but not limited to, when the Secretary of HHS declares that there is a public health emergency that affects the national security or the health and security of United States citizens living abroad, and that involves biological agent(s) or a disease or condition that may be attributable to such agent(s). Criteria for issuing an EUA include:

The biological agent(s) can cause a serious or life-threatening disease or condition;
Based on the totality of the available scientific evidence (including data from adequate and well-controlled clinical trials, if available), it is reasonable to believe that
The product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition; and
The known and potential benefits of the product — when used to diagnose, prevent, or treat such disease or condition — outweigh the known and potential risks of the product, taking into consideration the material threat posed by the biological agent(s);
There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the serious or life-threatening disease or condition.

Information Regarding Available Alternatives for the EUA Authorized Use

There are no adequate, approved and available alternatives to EVUSHELD for the pre-exposure prophylaxis of COVID-19 in individuals who may not mount an adequate immune response to COVID-19 vaccination or for whom COVID-19 vaccination is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine or its components.

For information on clinical studies of EVUSHELD and other therapies for the prophylaxis of COVID-19, see www.clinicaltrials.gov.

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