PEMGARDA™ AUTHORIZED FOR EMERGENCY USE

PEMGARDA is an investigational medicine that is authorized for use for pre-exposure prophylaxis to help prevent COVID-19 in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) who:

• are not currently infected with SARS-CoV-2 and who have not been known to be exposed to someone who is infected with SARS-CoV-2 and
• have moderate-to-severe immune compromise because of a medical condition or because they receive medicines or treatments that suppress the immune system and they are unlikely to have an adequate response to COVID-19 vaccination.

PEMGARDA is investigational because it is still being studied. There is limited information about the safety and effectiveness of using PEMGARDA for prevention of COVID-19. The FDA has authorized the emergency use of PEMGARDA for pre-exposure prophylaxis to help prevent COVID-19 under an Emergency Use Authorization (EUA).

PEMGARDA is not authorized:

• to treat COVID-19
• to prevent COVID-19 after being around someone infected with SARS-CoV-2 (post-exposure prophylaxis)
• for use in children under 12 years of age or weighing less than 88 pounds (40 kg)

Pre-exposure prophylaxis to help prevent COVID-19 with PEMGARDA does not take the place of receiving COVID-19 vaccination in people who can be vaccinated for COVID-19. If your healthcare provider recommends it, you should receive a COVID-19 vaccination.

If you have received a COVID-19 vaccine, you should wait at least 2 weeks after vaccination to receive PEMGARDA.

Reference: PEMGARDA [Fact Sheet for Patients, Parents, and Caregivers]. Waltham, MA; Invivyd, Inc: 2024.

Contact your healthcare provider to discuss if PEMGARDA is right for you. If PEMGARDA is right for you, your healthcare provider will need to write a prescription.

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PEMGARDA for the pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents (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 are unlikely to mount an adequate response to COVID-19 vaccination.

Medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination include:

• Active treatment for solid tumor and hematologic malignancies
• Hematologic malignancies associated with poor responses to COVID-19 vaccines regardless of current treatment status (e.g., chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia)
• Receipt of solid-organ transplant or an islet 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 immunosuppressive therapy)
• Moderate or severe primary immunodeficiency (e.g., common variable immunodeficiency disease, severe combined immunodeficiency, 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, and biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents)

Reference: PEMGARDA [Fact Sheet for Healthcare Providers]. Waltham, MA; Invivyd, Inc: 2024.

Tell your healthcare provider about all of your medical conditions, including if you:

• have any allergies, including if you have had a severe allergic reaction to a COVID-19 vaccine or to PEMGARDA.
• are pregnant or plan to become pregnant. It is not known if PEMGARDA can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if PEMGARDA can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive PEMGARDA.
• have any serious illnesses.
• take any medicines including prescription, over-the-counter, vitamins, and herbal products.

Reference: PEMGARDA [Fact Sheet for Patients, Parents, and Caregivers]. Waltham, MA; Invivyd, Inc: 2024.

Do not take PEMGARDA if you have had a severe allergic reaction to PEMGARDA or any ingredient in PEMGARDA. Please see the Fact Sheet for Patients, Parents, and Caregivers for a complete list of ingredients in PEMGARDA.

Reference: PEMGARDA [Fact Sheet for Patients, Parents, and Caregivers]. Waltham, MA; Invivyd, Inc: 2024.

PEMGARDA may cause serious side effects, including:

• A serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and can happen during or after your infusion of PEMGARDA. In case you have a severe allergic reaction to PEMGARDA and need medical help right away, you will receive PEMGARDA in a healthcare setting. Your healthcare provider will monitor you for allergic reactions during your infusion and for at least 2 hours after you are finished receiving PEMGARDA. Your healthcare provider will stop PEMGARDA right away if you develop signs or symptoms of anaphylaxis or severe allergic reaction. Tell your healthcare provider right away if you get any of the following signs or symptoms of anaphylaxis during or after your infusion of PEMGARDA:
  • itching
  • flushing
  • hives
  • skin redness
  • swelling of your face, lips, mouth, tongue, throat, hands, or feet
  • sweating

  • dizziness
  • ringing in the ears
  • wheezing
  • trouble breathing
  • chest discomfort
  • fast heartbeat

Reference: PEMGARDA [Fact Sheet for Patients, Parents, and Caregivers]. Waltham, MA; Invivyd, Inc: 2024.

• Allergic and infusion-related reactions. Allergic and infusion-related reactions are common and can sometimes be severe or life-threatening. Allergic and infusion-related reactions can happen during and after your infusion of PEMGARDA. You may have an increased risk of allergic reaction with PEMGARDA if you have had a severe allergic reaction to a COVID-19 vaccine. PEMGARDA 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 PEMGARDA if you have had a serious allergic reaction to a COVID-19 vaccine. Your healthcare provider will monitor you for allergic reactions during the infusion and for at least 2 hours after you receive PEMGARDA. Tell your healthcare provider right away if you get any of the following signs or symptoms of an allergic or infusion-related reaction during or after your infusion of PEMGARDA:

The side effects of receiving any medicine by vein (IV) may include pain, redness, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

The most common side effects in people treated with PEMGARDA who have moderate-to-severe immune compromise include allergic and infusion-related reactions, infusion site reactions, common cold, viral infection, flu-like illness, tiredness, headache and nausea.

These are not all the possible side effects of PEMGARDA. Not a lot of people have been given PEMGARDA. Serious and unexpected side effects may happen. PEMGARDA is still being studied, so it is possible that all of the risks are not known at this time.

Reference: PEMGARDA [Fact Sheet for Patients, Parents, and Caregivers]. Waltham, MA; Invivyd, Inc: 2024.

Yes, PEMGARDA is now authorized and available for emergency use (Emergency Use Authorization). Talk to your healthcare provider to learn if PEMGARDA is right for you. 

• You will receive 1 dose of PEMGARDA.
• PEMGARDA will be given to you through an infusion in a vein (intravenous [IV] infusion). It will take about 60 minutes to finish the infusion.
• You will receive PEMGARDA in a healthcare setting.
• You will be observed by a healthcare provider during your infusion and for at least 2 hours after your infusion is finished.

You may need to receive additional doses of PEMGARDA for ongoing protection from COVID-19. 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 may need to receive additional doses of PEMGARDA every 3 months.

Reference: PEMGARDA [Fact Sheet for Patients, Parents, and Caregivers]. Waltham, MA; Invivyd, Inc: 2024.

• Contact your healthcare provider to discuss if PEMGARDA is right for you. If PEMGARDA is right for you, your healthcare provider will need to write you a prescription. Click here to view the Infusion Center Locator.
• Any pharmacy that is licensed to fill infusion prescriptions can order PEMGARDA through commercial channels. PEMGARDA is not distributed by the US Government and there is no allocation process for sites by federal or state health authorities.
• Generally, there are three requirements before an infusion of PEMGARDA can be scheduled:
  • A licensed physician, advanced practice registered nurse (APRN), or physician assistant must write a prescription for PEMGARDA for you.
  • Approval from your insurance company (Private or Managed Medicare), including potentially the completion of a Prior Authorization or Medical Necessity Form with your healthcare provider’s signature. Providers may submit claims to traditional Medicare Part B without prior authorization requirements when used as pre-exposure prophylaxis for COVID-19 prevention.
  • An infusion site must have:
    • the capabilities to prepare and administer PEMGARDA using sterile techniques.
    • the ability to treat anaphylaxis and activate the emergency medical system (EMS).
    • the ability to monitor for at least two hours after infusion.
• For patient support, please call 844-220-5938.

Reference: Centers for Medicare and Medicaid Services. COVID-19 Vaccines and Monoclonal Antibodies. Updated April 2024. Accessed May 8, 2024. https://www.cms.gov/medicare/payment/part-b-drugs/vaccine-pricing

The Centers for Medicare and Medicaid Services (CMS) has published that there’s no cost sharing for people with Medicare for COVID-19 monoclonal antibody products or their administration. This means patients do not pay a copay/coinsurance or deductible permanently for covered monoclonal antibody products used as pre-exposure prophylaxis for prevention of COVID-19.

Reference: Centers for Medicare and Medicaid Services. COVID-19 Monoclonal Antibodies. Updated April 2024. Accessed May 8, 2024. https://www.cms.gov/monoclonal

Patients can now access financial assistance for PEMGARDA through the Invivyd Patient Savings Program. Learn about the process for enrollment and eligibility criteria, terms, and conditions by visiting https://www.pemgarda.com/patient/savings/.

The United States FDA has made PEMGARDA 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.

PEMGARDA for pre-exposure prophylaxis to help prevent COVID-19 has not undergone the same type of review as an FDA-approved product. In issuing an EUA under the relevant COVID-19 declaration, 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, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing 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 the product to be used during the COVID-19 pandemic. The EUA for PEMGARDA is in effect for the duration of the COVID-19 declaration justifying emergency use of PEMGARDA, unless terminated or revoked (after which PEMGARDA may no longer be used under the EUA).

Reference: PEMGARDA [Fact Sheet for Patients, Parents, and Caregivers]. Waltham, MA; Invivyd, Inc: 2024.