FACT SHEET UPDATE
On 7/30/21, the fact sheet for patients, parents, and caregivers was updated. Click to view more, and see the latest fact sheet for patients, parents, and caregivers for more information.

REGEN-COV is an investigational medicine that may benefit certain people with COVID-19 and may help prevent certain people who have been exposed to someone who is infected with SARS-CoV-2 from getting SARS-CoV-2 infection, or may prevent certain people who are at high risk of exposure to someone who is infected with SARS-CoV-2 from getting SARS-CoV-2 infection.

REGEN-COV is now authorized for post-exposure prevention of COVID-19 in persons who are:

  • not fully vaccinated against COVID-19 (Individuals are considered to be fully vaccinated 2 weeks after their second vaccine dose in a 2-dose series or 2 weeks after a single-dose vaccine), or
  • are not expected to build up enough of an immune response to the complete COVID-19 vaccination (for example, someone with immunocompromising conditions), and
  • have been exposed to someone who is infected with SARS-CoV-2. Close contact with someone who is infected with SARS-CoV-2 is defined as being within 6 feet for a total of 15 minutes or more, providing care at home to someone who is sick, having direct physical contact with the person, sharing eating or drinking utensils, or being exposed to respiratory droplets from an infected person, or
  • someone who is at high risk of being exposed to someone who is infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons)
VIEW THE FULL FACT SHEET FOR
PATIENTS, PARENTS, AND CAREGIVERS
Doctor treating patient Doctor adjusting patient face mask

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

REGEN-COV is an investigational medicine that may benefit certain people with COVID-19 and may help prevent certain people who have been exposed to someone who is infected with SARS-CoV-2 from getting SARS-CoV-2 infection, or may prevent certain people who are at high risk of exposure to someone who is infected with SARS-CoV-2 from getting SARS-CoV-2 infection.
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 and the post-exposure prevention 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 in adults and adolescents (12 years of age and older who weigh at least 88 pounds (40 kg)) who are at high risk for severe COVID‑19, including hospitalization or death for:

  • treatment of mild to moderate symptoms of COVID-19
  • post-exposure prophylaxis of COVID-19 in persons who are:
    • not fully vaccinated against COVID-19 (Individuals are considered to be fully vaccinated 2 weeks after their second vaccine dose in a 2-dose series [such as the Pfizer or Moderna vaccines], or 2 weeks after a single-dose vaccine [such as Johnson & Johnson’s Janssen vaccine]), or,
    • are not expected to build up enough of an immune response to the complete COVID-19 vaccination (for example, someone with immunocompromising conditions, including someone who is taking immunosuppressive medications), and
      • have been exposed to someone who is infected with SARS-CoV-2. Close contact with someone who is infected with SARS-CoV-2 is defined as being within 6 feet for a total of 15 minutes or more, providing care at home to someone who is sick, having direct physical contact with the person (hugging or kissing, for example), sharing eating or drinking utensils, or being exposed to respiratory droplets from an infected person (sneezing or coughing, for example). For additional details, go to https://www.cdc.gov/​coronavirus/2019-ncov/if-you-are-sick/quarantine.html, or
      • someone who is at high risk of being exposed to someone who is infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons)

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 or to prevent COVID-19 in people who are at high risk of being exposed to someone who is infected with SARS-CoV-2. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19.

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

Contact the Combat COVID Monoclonal
Antibodies Call Center

The U.S. government has set up a call center dedicated to providing patients and HCPs with information
on monoclonal antibodies

(English) 1-877-332-6585 |
(Spanish) 1-877-366-0310

WHAT DOES IT MEAN TO BE HIGH RISK?

The following medical conditions or other factors may place adults and adolescent patients (age 12-17 years and weighing at least 88 pounds [40 kg]) at higher risk for progression to severe COVID-19:

  • Older age (for example, age ≥65 years of age)
  • Obesity or being overweight (for example, BMI >25 kg/m2, or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts)
  • Pregnancy
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease or immunosuppressive treatment
  • Cardiovascular disease (including congenital heart disease) or hypertension
  • Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
  • Sickle cell disease
  • Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
  • Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19))

Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and authorization of REGEN-COV under the EUA is not limited to the medical conditions or factors listed above.

For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the CDC website.

GET STARTED WITH REGEN-COV

1 1

TALK TO YOUR DOCTOR
ABOUT YOUR CONDITION

Contact your healthcare provider to discuss whether REGEN-COV might be right for you.

LEARN ABOUT AVAILABLE COVID-19 TREATMENT OPTIONS
2 2

DISCUSS THE MOST APPROPRIATE MEANS OF RECEIVING REGEN-COV WITH YOUR HEALTHCARE PROVIDER. IF NECESSARY, MAKE AN APPOINTMENT WITH AN ADMINISTRATION 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 administration site locations that have received shipments of REGEN-COV under the FDA EUA authority within the past several weeks.

Patients should feel free to contact Regeneron Medical Information at 1-844-734-6643 or at [email protected]​regeneron.com with any inquiries.

NICA ADMINISTRATION SITE LOCATOR ASPR ADMINISTRATION SITE LOCATOR
3 3

GET YOUR TREATMENT;
IT'S COVERED

The U.S. government is paying for REGEN-COV. It is free to patients. You will not incur charges for REGEN-COV but, depending on coverage, you may be charged for the cost of administration.

COVERAGE OF MONOCLONAL ANTIBODY PRODUCTS
PATIENT/CAREGIVER GUIDE

*IMPORTANT INFORMATION: Treatment sites displayed in this tool have been authorized to administer antibody treatments for appropriate 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 their patients’ eligibility and the availability of doses at an authorized administration site before they refer their eligible patients to schedule an appointment to receive REGEN-COV. Please note that the inclusion of a site does not imply current availability of doses. More locations are regularly being added to both resources.

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

Important possible side effects of REGEN-COV (casirivimab and 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, feeling faint, 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 symptoms occur, contact your healthcare provider or seek immediate medical attention as some of these symptoms have required hospitalization. It is unknown if these symptoms 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. The side effects of getting any medicine by subcutaneous injection may include pain, bruising of the skin, soreness, swelling, and possible infection at the injection 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. For a mother and unborn baby, the benefit of receiving REGEN-COV may be greater than the risk of using the product. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.

AUTHORIZED USE

REGEN-COV (casirivimab and imdevimab) is an investigational medicine used in adults and adolescents (12 years of age and older who weigh at least 88 pounds (40kg)) who are at high risk for severe COVID-19, including hospitalization or death for:

  • treatment of mild to moderate symptoms of COVID-19
  • post-exposure prophylaxis of COVID-19 in persons who are:
    • not fully vaccinated against COVID-19 (Individuals are considered to be fully vaccinated 2 weeks after their second vaccine dose in a 2-dose series or 2 weeks after a single-dose vaccine), or
    • are not expected to build up enough of an immune response to the complete COVID-19 vaccination (for example, someone with immunocompromising conditions), and
      • have been exposed to someone who is infected with SARS-CoV-2. Close contact with someone who is infected with SARS-CoV-2 is defined as being within 6 feet for a total of 15 minutes or more, providing care at home to someone who is sick, having direct physical contact with the person, sharing eating or drinking utensils, or being exposed to respiratory droplets from an infected person, or
      • someone who is at high risk of being exposed to someone who is infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons)

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 or to prevent COVID-19 in people who are at high risk of being exposed to someone who is infected with SARS-CoV-2. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of 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

Do not take REGEN-COV if you have had a severe allergic reaction to REGEN-COV

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

  • Have any allergies
  • Have had a severe allergic reaction including anaphylaxis to REGEN-COV previously
  • Have received a COVID-19 vaccine
  • Have any serious illnesses
  • Are pregnant or plan to become pregnant
  • Are breastfeeding or plan to breastfeed
  • Are taking any medications (prescriptions, over-the-counter drugs, vitamins, and herbal products)

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

IMPORTANT SAFETY INFORMATION

Important possible side effects of REGEN-COV (casirivimab and 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, feeling faint, 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 symptoms occur, contact your healthcare provider or seek immediate medical attention as some of these symptoms have required hospitalization. It is unknown if these symptoms 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. The side effects of getting any medicine by subcutaneous injection may include pain, bruising of the skin, soreness, swelling, and possible infection at the injection 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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