FACT SHEET UPDATE
As of 6/3/21, the fact sheet for patients, parents, and caregivers has been updated. Click to view more, and see the latest fact sheet for patients, parents, and caregivers for more information.

HOW WILL I RECEIVE REGEN-COV (casirivimab and 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 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 together in the form of subcutaneous injection (medicine is injected in the tissue just under the skin). One dose will consist of 4 subcutaneous injections given in separate locations around the same time.
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 (casirivimab and 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).

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.

NEED TREATMENT?
START THE PROCESS.

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 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
3 3

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, depending on coverage, may be charged for the cost of administration.

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

*IMPORTANT INFORMATION: Treatment 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 their patients' eligibility and the availability of doses at an authorized treatment site before they refer their eligible patients to schedule an appointment to receive treatment. Please note that the inclusion of a site does not imply current availability of doses. More 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 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 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. 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 from the treatment. 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 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 and 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 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 together in the form of subcutaneous injection (medicine is injected in the tissue just under the skin). One dose will consist of 4 subcutaneous injections given in separate locations around the same time.

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 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 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. 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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