PATIENT CONSENT FORM FOR COVID-19 PREVENTIONAL PURPOSE OF INFORMED CONSENT
I understand that I have been referred by an authorized, licensed prescriber to receive Evusheld (Tixagevimab and Cilgavimab). The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for this injection. Evusheld is for pre-exposure prevention of COVID-19 infection in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) at high risk for severe disease and who are unable to receive a COVID-19 vaccine.
Evusheld should not be used as, or considered, a replacement for vaccination.
1. I understand that the FDA has authorized emergency use of Evusheld for the purposes of preventing COVID-19 infection.
2. I understand that consent for this treatment is voluntary. I have the option to accept or refuse administration of Evusheld, including the option to refuse the injection.
3. I understand that I will given a copy of the applicable FDA’s Fact Sheet for Patients and Parents/Caregivers. I can access this Fact Sheet myself before my appointment at the FDA or Evusheld website. I have been given the opportunity to discuss it with my physician and have obtained a prescription order.
4. I have been informed by my physician of the potential risks and benefits of Evusheld and the extent to which such risks and benefits are unknown.
5. My physician has informed me of any available alternative treatments and the risks and benefits of those alternatives.
6. I understand that if I have received a COVID19 vaccine that I should not receive
Evusheld until 2 weeks after I received the vaccine.
7. I have been informed that Evusheld is not guaranteed to prevent me from getting COVID-19 and that I should still follow all other safety measures to prevent infection.
8. I understand that my Pine Brook Clinician will be able to answer any questions or concerns I may still have, and that I should ask these questions before treatment.
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 preexposure prophylaxis for prevention of COVID-19 in persons who are:
- 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 (such as severe allergic 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 physician, and my Pine Brook Clinician, before I receive EVUSHELD?
Tell your healthcare providers if you:
Have any allergies
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 highrisk 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. You may need to receive additional doses of EVUSHELD for ongoing protection. Viruses can change over time (mutate) and develop into a slightly different form of the virus, called a variant. The duration that EVUSHELD will protect you from infection may change with certain variants. The best timing for you to receive additional doses of EVUSHELD, if needed, is not known right now, because this depends on which SARS-CoV-2 variants will be present in the future. Talk to your healthcare provider about receiving additional doses of
EVUSHELD for ongoing protection and for further instructions. You can keep up-todate with the latest information by visiting http://www.evusheld.com.
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. Tell your healthcare provider right away if you get any of the following signs and symptoms of allergic reactions: fever, chills, nausea, headache, shortness of breath, low or high blood pressure, rapid or slow heart rate, chest discomfort or pain, weakness, confusion, feeling tired, wheezing, swelling of your lips, face, or throat, rash including hives, itching, muscle aches, dizziness and sweating. These reactions may be severe or life threatening.
Cardiac (heart) events: Serious cardiac adverse events have happened, but were not common, in people who received EVUSHELD and also in people who did not receive EVUSHELD in the clinical trial studying pre-exposure prophylaxis for prevention of COVID-19. In people with risk factors for cardiac events (including a history of heart attack), more people who received EVUSHELD experienced serious cardiac events than people who did not receive EVUSHELD. It is not known if these events are related to EVUSHELD or underlying medical conditions. Contact your healthcare provider or get medical help 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. 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-preparednessand-response/mcm-legal-regulatory-and-policy-framework/emergency-useauthorization 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.
The FDA has granted Emergency Use Authorization (EUA) to permit investigational therapies in patients with confirmed or suspected COVID-19. Investigational therapies are not approved for any indication. They are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the authorization is terminated or revoked sooner.
By checking below and signing, I certify that I have read and understand the information provided to me and consent to receive Evusheld. I hereby authorize Pine Brook Pharmacy Clinic and its agents to administer Evusheld and to perform such additional procedures as are considered necessary to monitor and provide care for the duration of this treatment course.