Vaccine Information: EVUSHELD (Page 7 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Each EVUSHELD co-packaged carton contains two vials (Table 8):

1 single-dose vial of tixagevimab injection as a sterile, preservative-free, clear to opalescent and colorless to slightly yellow solution.
1 single-dose vial of cilgavimab injection as a sterile, preservative-free, clear to opalescent and colorless to slightly yellow solution.
Table 8 EVUSHELD co-packaged carton contents

Carton

(2 vials per pack)

Components

1 vial of Tixagevimab

150 mg/1.5 mL (100 mg/mL)

(dark grey cap)

1 vial of Cilgavimab

150 mg/1.5 mL (100 mg/mL)

(white cap)

NDC 0310-7442-02

NDC 0310-8895-01

NDC 0310-1061-01

Storage and Handling

Store unopened vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Discard any unused portion.

DO NOT FREEZE. DO NOT SHAKE.

17 PATIENT COUNSELING INFORMATION

As a prescribing healthcare practitioner, you must communicate to the patient, parent and caregiver information consistent with the “FACT SHEET FOR PATIENTS, PARENTS OR CAREGIVERS” and provide them with a copy of this Fact Sheet prior to administration of EVUSHELD.

Dosing

Inform individuals that they will need to receive additional doses of EVUSHELD every 6 months if ongoing protection is needed [see Dosage and Administration (2.1), and Clinical Pharmacology (12.3)].

Cardiovascular Events

Inform individuals that a higher proportion of subjects who received EVUSHELD versus placebo reported cardiovascular serious adverse events (myocardial infarctions and heart failure). Advise individuals to seek immediate medical attention if they experience any signs or symptoms suggestive of a cardiovascular event [see Warnings and Precautions (5.4)].

For additional information, please visit the website or call the telephone number provided below.

To access the most recent EVUSHELD Fact Sheets, please scan the QR code provided below.

Website

Telephone number

http://www.evusheld.com

QR code 1

1-800-236-9933

18 MANUFACTURER INFORMATION

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

Manufactured by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

AZ logo 1
(click image for full-size original)

©AstraZeneca 2022. All rights reserved.

Fact Sheet for Patients, Parents And Caregivers

Emergency Use Authorization (EUA) of EVUSHELD™ (tixagevimab co-packaged with cilgavimab) for Coronavirus Disease 2019 (COVID-19)

You are being given this Fact Sheet because your healthcare provider believes it is necessary to provide you with EVUSHELD (tixagevimab co-packaged with cilgavimab) for pre exposure-prophylaxis for prevention of coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus.

This Fact Sheet contains information to help you understand the potential risks and potential benefits of taking EVUSHELD, which you have received or may receive.

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to make EVUSHELD available during the COVID-19 pandemic (for more details about an EUA please see “What is an Emergency Use Authorization?” at the end of this document). EVUSHELD is not an FDA-approved medicine in the United States.

Read this Fact Sheet for information about EVUSHELD. Talk to your healthcare provider if you have any questions. It is your choice to receive or not receive EVUSHELD.

What is COVID-19?

COVID-19 is caused by a virus called a coronavirus. You can get COVID-19 through close contact with another person who has the virus.

COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your other medical conditions to become worse. Older people and people of all ages with severe, long-lasting (chronic) medical conditions like heart disease, lung disease, and diabetes, for example, seem to be at higher risk of being hospitalized for COVID-19.

What is EVUSHELD (tixagevimab co-packaged with cilgavimab)?

EVUSHELD is an investigational 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 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 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).

What should I tell my healthcare provider before I receive EVUSHELD?

Tell your healthcare provider 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 illness
Are taking any medications (prescription, over-the-counter, vitamins, or herbal products)

How will I receive EVUSHELD?

EVUSHELD consists of two investigational medicines, tixagevimab and cilgavimab.
You will receive 1 dose of EVUSHELD, consisting of 2 separate injections (tixagevimab and cilgavimab).
EVUSHELD will be given to you by your healthcare provider as 2 intramuscular injections, given one after the other.

Viruses can change over time (mutate) and develop into a slightly different form of the virus, called a variant. Based on what we know about current SARS-CoV-2 variants, you will need to receive additional doses of EVUSHELD every 6 months if ongoing protection is needed. Talk to your healthcare provider for more information.

Who should generally not take EVUSHELD?

Do not take EVUSHELD if you have had a severe allergic reaction to EVUSHELD or any ingredient in EVUSHELD.

What are the important possible side effects of EVUSHELD?

Possible side effects of EVUSHELD are:

Allergic reactions. Allergic reactions can happen during and after injection of EVUSHELD and can sometimes be serious or life-threatening. You may have an increased risk of allergic reaction with EVUSHELD if you have had a severe allergic reaction to a COVID-19 vaccine. EVUSHELD contains polysorbate 80, an ingredient in some COVID-19 vaccines. Also, polysorbate 80 is similar to polyethylene glycol (PEG), an ingredient in other COVID-19 vaccines. Your healthcare provider may consult with a healthcare provider who specializes in allergy and immunology before giving you EVUSHELD if you have had a serious allergic reaction to a COVID-19 vaccine.
Your healthcare provider will monitor you for allergic reactions during and for at least 1 hour after you receive EVUSHELD. 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
hives
wheezing
chills
itching
tiredness or weakness
skin flushing
fast heart rate
sweating
chest pain or discomfort
muscle aches
nausea and vomiting
swelling of your face, lips, mouth and tongue
you feel lightheaded or faint
throat tightness

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.

What other prevention choices are there?

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 https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization 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.

What if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.

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 at www.fda.gov/medwatch or call 1-800-FDA-1088 or call AstraZeneca at 1-800-236-9933.

Additional Information

If you have questions, visit the website or call the telephone number provided below.

To access the most recent EVUSHELD Fact Sheets, please scan the QR code provided below.

Website

Telephone number

http://www.evusheld.com

QR code 2

1-800-236-9933

How can I learn more about COVID-19?

Ask your healthcare provider.
Visit https://www.cdc.gov/COVID19
Contact your local or state public health department.

What is an Emergency Use Authorization?

The United States FDA has made EVUSHELD (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 Services (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).

What are the ingredients in EVUSHELD?

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.

AZlogo_2
(click image for full-size original)

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

Manufactured by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

©AstraZeneca 2022. All rights reserved.

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