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REGEN-COV for COVID-19:
Emergency Use Authorization (EUA)

REGEN-COV (casirivimab with imdevimab) is an investigational medicine that may treat COVID-19.
It is still being studied and there is limited information known about its safety and effectiveness. The U.S. Food and Drug Administration (FDA) has authorized the emergency use of REGEN-COV for the treatment of COVID-19 under an EUA.

FACT SHEETS FOR PATIENTS AND CAREGIVERS

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WHAT IS REGEN-COV?

WHAT IS REGEN-COV?

REGEN-COV is an investigational medicine used to treat mild to moderate symptoms of COVID-19 in non-hospitalized adults and adolescents (12 years of age and older who weigh at least 88 pounds [40 kg]), and who are at high risk for developing severe COVID-19 symptoms or the need for hospitalization. REGEN-COV is investigational because it is still being studied. There is limited information known about the safety and effectiveness of using REGEN-COV to treat people with COVID-19.

The FDA has authorized the emergency use of REGEN-COV for the treatment of COVID-19 under an Emergency Use Authorization (EUA).

WHAT DOES IT MEAN TO BE HIGH RISK?

  • If you have one of the following:
    • Overweight (body mass index [BMI] of 35 or higher)
    • Chronic kidney disease
    • Diabetes
    • Immunosuppressive disease
    • Are currently receiving immunosuppressive treatment
    • If you are age 65 years or older

OR

  • If you are age 55 years or older and have one of the following:
    • Cardiovascular disease, OR
    • Hypertension, OR
    • Chronic obstructive pulmonary disease or other chronic respiratory disease
  • If you are 12-17 years of age and have one of the following:
    • A BMI equal to or greater than 85th percentile based on CDC growth charts, OR
    • Sickle cell disease, OR
    • Congenital or acquired heart disease, OR
    • Neurodevelopmental disorders, for example, cerebral palsy, OR
    • A medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
    • Asthma, reactive airway or other chronic respiratory disease that requires daily medication for control

NEED TREATMENT?
START THE PROCESS.

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TALK TO YOUR DOCTOR
ABOUT YOUR CONDITION

If you believe you might be eligible to receive REGEN-COV, contact your healthcare provider to discuss whether this type of treatment might be right for you.

LEARN ABOUT AVAILABLE COVID-19 TREATMENT OPTIONS
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MAKE AN APPOINTMENT
WITH AN INFUSION CENTER

U.S. states and territories are partnering with the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), and the National Infusion Center Association (NICA),* to provide a list of infusion site locations by state infusion locations that have received shipments of REGEN-COV under the FDA EUA authority within the past several weeks.

NICA INFUSION CENTER LOCATOR ASPR INFUSION CENTER LOCATOR
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GET YOUR TREATMENT;
IT'S COVERED

As the U.S. government is paying for this product, REGEN-COV is free of charge to requesting treatment sites. Patients will not incur any charges for the product, but, dependent on coverage, may be charged for the cost of administration.

COVERAGE OF MONOCLONAL ANTIBODY PRODUCTS TO TREAT COVID-19
PATIENT INFUSION DAY GUIDE

*IMPORTANT INFORMATION: Infusion sites displayed in this tool have been authorized to administer antibody treatments for COVID-positive patients under Emergency Use Authorization. These antibody therapies are restricted to certain high-risk patients and require a drug order (similar to a prescription) from a healthcare provider (HCP) for eligible patients. HCPs must verify eligibility of their patients and verify the availability of doses at an authorized infusion site before they refer an eligible patient to schedule an appointment to receive treatment at an authorized infusion site. Please note that the inclusion of a site does not imply current availability of doses. More states and locations are regularly being added to both resources. Any questions related to distribution should be directed to AmerisourceBergen Corporation.

The development and manufacturing of casirivimab and imdevimab has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) under OT number: HHSO100201700020C.

IMPORTANT SAFETY INFORMATION

Warnings and important possible side effects of REGEN-COV (casirivimab with imdevimab)

  • Allergic reactions: Allergic reactions can happen during and after infusion with REGEN-COV. 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.
  • Worsening symptoms after treatment: You may experience new or worsening symptoms after infusion, including fever, difficulty breathing, rapid or slow heart rate, tiredness, weakness or confusion. If these occur, contact your healthcare provider or seek immediate medical attention as some of these events have required hospitalization. It is unknown if these events are related to treatment or are due to the progression of COVID-19.

The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

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

It is possible that REGEN-COV could interfere with your body’s own ability to fight off a future infection of SARS-CoV-2. Similarly, REGEN-COV may reduce your body’s immune response to a vaccine for SARS-CoV-2. Specific studies have not been conducted to address these possible risks. Talk to your healthcare provider if you have any questions.

Pregnancy and breastfeeding

There is limited experience treating pregnant women or breastfeeding mothers with REGEN-COV (casirivimab with imdevimab). For a mother and unborn baby, the benefit of receiving REGEN-COV may be greater than the risk from the treatment. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.

AUTHORIZED USE

REGEN-COV (casirivimab with imdevimab) is an investigational medicine used to treat mild to moderate symptoms of COVID-19 in non-hospitalized adults and adolescents (12 years of age and older who weigh at least 88 pounds [40 kg]), and who are at high risk for developing severe COVID-19 symptoms or the need for hospitalization. REGEN-COV is investigational because it is still being studied. There is limited information known about the safety and effectiveness of using REGEN-COV to treat people with COVID-19.

  • REGEN-COV has not been approved, but has been authorized for emergency use by FDA
  • This use is 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

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

  • Have any allergies
  • Are pregnant or plan to become pregnant
  • Are breastfeeding or plan to breastfeed
  • Have any serious illnesses
  • Are taking any medications (prescriptions, over-the-counter drugs, vitamins, and herbal products)
Receiving REGEN-COV (casirivimab with imdevimab)
  • REGEN-COV consists of two investigational medicines, casirivimab and imdevimab, given together as a single intravenous infusion (through a vein).
  • You will receive one dose of REGEN-COV by intravenous infusion. The infusion will take 20 to 52 minutes or longer. Your healthcare provider will determine the duration of your infusion.

Please see the Fact Sheet for Patients, Parents and Caregivers for more information.

IMPORTANT SAFETY INFORMATION

Warnings and important possible side effects of REGEN-COV (casirivimab with imdevimab)

  • Allergic reactions: Allergic reactions can happen during and after infusion with REGEN-COV. 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.
  • Worsening symptoms after treatment: You may experience new or worsening symptoms after infusion, including fever, difficulty breathing, rapid or slow heart rate, tiredness, weakness or confusion. If these occur, contact your healthcare provider or seek immediate medical attention as some of these events have required hospitalization. It is unknown if these events are related to treatment or are due to the progression of COVID-19.

The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

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

It is possible that REGEN-COV could interfere with your body’s own ability to fight off a future infection of SARS-CoV-2. Similarly, REGEN-COV may reduce your body’s immune response to a vaccine for SARS-CoV-2. Specific studies have not been conducted to address these possible risks. Talk to your healthcare provider if you have any questions.

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