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)
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Frequently Asked Questions

Answers to important questions about REGEN-COV and COVID-19.

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Below you’ll find answers to our most commonly asked questions. If you don’t find the answers you’re looking for, talk to your doctor or download the patient fact sheet for more information.

FACT SHEETS FOR PATIENTS AND CAREGIVERS

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FREQUENTLY ASKED QUESTIONS

COVID-19 is caused by a virus called a coronavirus, SARS-COV-2. People can get COVID-19 through 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 worsen. People of all ages with severe, long lasting (chronic) medical conditions like heart disease, lung disease, or diabetes, for example, and other conditions including obesity, seem to be at higher risk of being hospitalized for COVID-19. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19.

The symptoms of COVID-19 include fever, cough, and shortness of breath, which may appear 2 to 14 days after exposure. Serious illness including breathing problems can occur and may cause your other medical conditions to become worse. For additional information about COVID-19 symptoms, refer to the CDC.

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 (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, 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)

REGEN-COV consists of two investigational medicines, casirivimab and imdevimab, given together at the same time through a vein (intravenous or IV) or injected in the tissue just under the skin (subcutaneous injections). Your healthcare provider will determine the most appropriate way for you to be given REGEN-COV.

  • Treatment: If you are receiving an intravenous infusion, the infusion will take 20 to 50 minutes or longer. Your healthcare provider will determine the duration of your infusion.
    • If your healthcare provider determines that you are unable to receive REGEN-COV as an intravenous infusion which would lead to a delay in treatment, then as an alternative, REGEN-COV can be given in the form of subcutaneous injections. If you are receiving subcutaneous injections, your dose will be provided as multiple injections given in separate locations around the same time.
  • Post-exposure prevention: If you are receiving subcutaneous injections, your dose will be provided as multiple injections given in separate locations around the same time. If you are receiving an intravenous infusion, the infusion will take 20 to 50 minutes or longer.
    • After the initial dose, if your healthcare provider determines that you need to receive additional doses of REGEN-COV for ongoing protection, the additional intravenous or subcutaneous doses would be administered monthly.

In clinical trials there was no difference in treatment outcomes between the intravenous infusion and subcutaneous injection of REGEN-COV. Your healthcare provider will determine the most appropriate means for you to receive REGEN-COV.

Possible side effects of REGEN-COV are:

  • Allergic reactions: Allergic reactions can happen during and after infusion or injection of 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.

Vaccines to prevent COVID-19 are also available under Emergency Use Authorization. Use of REGEN-COV does not replace vaccination against COVID-19. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19. REGEN-COV is for a specific patient population. Talk to your doctor to see if REGEN-COV is right for you.

Even if you’ve received a COVID-19 vaccine, you can still receive REGEN-COV if your doctor thinks it is appropriate. Use of REGEN-COV does not replace vaccination against COVID-19.

Many factors may place you at high risk for exposure to COVID-19. (See What Is REGEN-COV? above.) Talk to your doctor to find out if you may be at high risk.

The CDC recommends 90 days between monoclonal antibody treatment and COVID-19 vaccination, but there are other things to consider in determining when to receive the vaccine.

Talk to your doctor about when you should receive the COVID-19 vaccine if you have received REGEN-COV.

Use of REGEN-COV does not replace vaccination against COVID-19. 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.

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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