Treating COVID-19 patients Treating COVID-19 patients

Help treat your eligible COVID-19 patients

REGEN-COV is an investigational therapy and has been authorized by FDA for the emergency use described below. It is not FDA approved for any use, and its safety and effectiveness have not been fully established.

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 Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner.

START TREATMENT

See below for information regarding REGEN-COV and SARS-CoV-2 variants.

AUTHORIZED USE

REGEN-COV (casirivimab with imdevimab to be administered together) is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Limitations of Authorized Use:

  • REGEN-COV (casirivimab with imdevimab) is not authorized for use in patients:
    • who are hospitalized due to COVID-19, OR
    • who require oxygen therapy due to COVID-19, OR
    • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
  • Benefit of treatment with REGEN-COV has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation

WHAT IS REGEN-COV?

REGEN-COV is an investigational combination antibody treatment for COVID-19. The prepared treatment of REGEN-COV contains two different monoclonal antibodies, casirivimab and imdevimab, that bind to separate sites of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein receptor. Casirivimab and imdevimab must be administered together after dilution by intravenous (IV) infusion only.

REGEN-COV EUA GUIDEBOOK
Vial Graphic

GETTING ACCESS TO REGEN-COV

GETTING ACCESS TO REGEN-COV

Find information on how REGEN-COV is being distributed across the country and how to locate infusion sites near you.

REGEN-COV MAY HELP
YOUR ELIGIBLE PATIENTS

If your patient (12 years of age or older and weighing at least 40 kg) with mild to moderate COVID-19 that has tested positive with direct viral testing, is within 10 days of symptom onset, and is at high risk for progressing to severe COVID-19 and/or hospitalization, they may be eligible to receive REGEN-COV.

FACT SHEETS FOR HEALTHCARE PROVIDERS

Examining samples Examining samples

REGEN-COV and COVID-19 Variants

REGEN-COV has been tested against, and was found to retain neutralization activity against, pseudoviruses expressing the spike protein substitution(s) identified in the below COVID-19 variants. It is not known how pseudovirus data correlate with clinical outcomes.

There is a potential risk of treatment failure due to the development of viral variants that are resistant to casirivimab and imdevimab administered together. Prescribing healthcare providers should consider the prevalence of SARS-CoV-2 variants in their area, where data are available, when considering treatment options.

Pseudovirus Neutralization Data for SARS-CoV-2 Variant Substitutions
(Viral Variants) with REGEN-COVa

It is not known how pseudovirus data correlate with clinical outcomes.

Location of Origin CDC Classification1
Data as of March 29, 2021.
For the most up to date information,
refer to the CDC.
Spike Protein
Substitutions Tested
REGEN-COV Retained
Neutralization Activity
(Y/N)b
United Kingdom
(B.1.1.7)
Concern Allc Yes
South Africa
(B.1.351)
Concern Alld,e Yes
California
(B.1.427/B.1.429)
Concern L452R Yes
Brazil
(P.1)
Concern K417T + E484Kf Yes
New York
(B.1.526)
Interest E484Kg,h Yes
Location of Origin: United Kingdom
(B.1.1.7)

CDC Classification1
Date as of March 29, 2021.
For the most up to date information, refer to the CDC.

Concern

Spike Protein Substitutions Tested

Allc

REGEN-COV Retained Neutralization Activity (Y/N)b

Yes

Location of Origin: South Africa
(B.1.351)

CDC Classification1
Date as of March 29, 2021.
For the most up to date information, refer to the CDC.

Concern

Spike Protein Substitutions Tested

Alld,e

REGEN-COV Retained Neutralization Activity (Y/N)b

Yes

Location of Origin: California
(B.1.427/B.1.429)

CDC Classification1
Date as of March 29, 2021.
For the most up to date information, refer to the CDC.

Concern

Spike Protein Substitutions Tested

L452R

REGEN-COV Retained Neutralization Activity (Y/N)b

Yes

Location of Origin: Brazil
(P.1)

CDC Classification1
Date as of March 29, 2021.
For the most up to date information, refer to the CDC.

Concern

Spike Protein Substitutions Tested

K417T + E484Kf

REGEN-COV Retained Neutralization Activity (Y/N)b

Yes

Location of Origin: New York
(B.1.)

CDC Classification1
Date as of March 29, 2021.
For the most up to date information, refer to the CDC.

Interest

Spike Protein Substitutions Tested

E484Kg,h

REGEN-COV Retained Neutralization Activity (Y/N)b

Yes

a As of March 18, 2021
b Defined as <2-fold reduction in susceptibility
c Pseudovirus expressing the entire variant spike protein was tested. The following changes from wild-type spike protein are found in the variant: del69-70, del145, N501Y, A570D, D614G, P681H, T716I, S982A, D1118H.
d Pseudovirus expressing the entire variant spike protein was tested. The following changes from wild-type spike protein are found in the variant: D80Y, D215Y, del241-243, K417N, E484K, N501Y, D614G, A701V.
e Casirivimab alone, but not imdevimab, had reduced activity against pseudovirus expressing K417N or E484K (which are found in this variant).
f Casirivimab alone, but not imdevimab, had reduced activity against pseudovirus expressing K417N or E484K.
g Casirivimab alone, but not imdevimab, had reduced activity against pseudovirus expressing E484K.
h Not all isolates of the New York lineage harbor E484K substitution (as of February 2021).

Healthcare providers should review the Antiviral Resistance information in Section 15 of the Fact Sheet for Healthcare Providers for details regarding specific variants and resistance, and refer to the CDC website as well as information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.

STEPS TO GETTING REGEN-COV FOR YOUR PATIENT

Find out what comes next if you have a patient with COVID-19

Confirm the mild to moderate COVID-19 diagnosis and your patient’s eligibility (see below for full authorized use).

2

Confirm that the patient is at high risk, defined as a patient who meets at least one of the criteria.

3

Find an infusion center near your patient.

4

Write the order for REGEN-COV.

5

Share educational resources with your patient so they know what to expect.

Drawing from vial Drawing from vial

WHAT TO KNOW ABOUT
DOSING & ADMINISTRATION

Casirivimab and imdevimab must be administered together after dilution by IV infusion only.

The recommended dose of REGEN-COV under the EUA is 1,200 mg of casirivimab and 1,200 mg of imdevimab administered as a single IV infusion over at least 60 minutes.

The optimal dosing regimen for treatment for COVID-19 has not yet been established. The recommended dosing regimen may be updated as data from clinical trials become available.

ADDITIONAL GUIDANCE
DOSING PREPARATION INSTRUCTIONS

EXPLORE THE DATA

The data supporting this EUA are based on the analysis of Phase 1/2 data from trial R10933-10987-COV-2067 that occurred after 799 enrolled subjects had completed at least 28 days of study duration.

REGEN-COV is also being studied in additional patient populations.

SEE CLINICAL TRIALS AND DATA

AUTHORIZED FOR EMERGENCY USE BY THE FDA

REGEN-COV has not been approved, but has been authorized for emergency use by the 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 Food Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

FDA LETTER OF AUTHORIZATION FOR EUA

EDUCATIONAL RESOURCES
IN ONE PLACE

Educational videos, downloadable information for patients and healthcare providers, and external resources.

MORE INFORMATION

FREQUENTLY
ASKED QUESTIONS

Have questions about REGEN-COV?

FAQs

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

REGEN-COV (casirivimab with imdevimab) is an unapproved investigational therapy, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with REGEN-COV use.

  • Warnings and Precautions
    • Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions: Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of REGEN-COV (casirivimab with imdevimab). If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care. Infusion-related reactions have been observed with administration of REGEN-COV. These reactions may be severe or life threatening.
      • Signs and symptoms of infusion-related reactions may include: fever, difficulty breathing, reduced oxygen saturation, chills, nausea, arrythmia (eg, atrial fibrillation, tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, fatigue and diaphoresis. If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.
    • Clinical Worsening After REGEN-COV Administration: Clinical worsening of COVID-19 after administration of REGEN-COV has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrythmia (eg, atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to REGEN-COV use or were due to progression of COVID-19
    • Limitations of Benefit and Potential for Risk in Patients with Severe COVID-19: Benefit of treatment with REGEN-COV has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high-flow oxygen or mechanical ventilation with COVID-19. Therefore, REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19, OR who require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19–related comorbidity
  • Adverse Reactions:
    • Serious adverse events (SAEs) were reported in 4 (1.6%) patients in the REGEN-COV 2,400-mg group, 2 (0.8%) patients in the REGEN-COV 8,000-mg group, and 6 (2.3%) patients in the placebo group. None of the SAEs were considered to be related to study drug. SAEs that were reported as Grade 3 or 4 adverse events were pneumonia, hyperglycemia, nausea and vomiting (2,400 mg REGEN-COV), intestinal obstruction and dyspnea (8,000 mg REGEN-COV) and COVID-19, pneumonia and hypoxia (placebo). REGEN-COV is not authorized at the 8,000-mg dose (4,000 mg casirivimab and 4,000 mg imdevimab)
    • One anaphylactic reaction was reported in the clinical program. The event began within 1 hour of completion of the infusion, and required treatment including epinephrine. The event resolved. Infusion-related reactions, of Grade 2 or higher severity, were reported in 4 subjects (1.5%) in the 8,000-mg (4,000 mg casirivimab and 4,000 mg imdevimab) arm. These infusion-related reactions events were moderate in severity; and included pyrexia, chills, urticaria, pruritus, abdominal pain, and flushing. One infusion-related reaction (nausea) was reported in the placebo arm, and none were reported in the 2,400-mg (1,200 mg casirivimab and 1,200 mg imdevimab) arm. In two subjects receiving the 8,000-mg dose of REGEN-COV, the infusion-related reactions (urticaria, pruritus, flushing, pyrexia, shortness of breath, chest tightness, nausea, vomiting) resulted in permanent discontinuation of the infusion. All events resolved.
  • Patient Monitoring Recommendations: Clinically monitor patients during infusion and observe patients for at least 1 hour after infusion is complete
  • Use in Specific Populations:
    • Pregnancy: There is currently limited clinical experience in the use of REGEN-COV in COVID-19 patients who are pregnant. REGEN-COV therapy should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus
    • Lactation: There is currently no clinical experience in the use of REGEN-COV in COVID-19 patients who are breastfeeding. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for REGEN-COV and any potential adverse effects on the breastfed child from REGEN-COV or from the underlying maternal condition
AUTHORIZED USE

REGEN-COV (casirivimab with imdevimab to be administered together) is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. [see Limitations of Authorized Use]

  • 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
  • Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of REGEN-COV and mandatory requirements of the EUA and must comply with the requirements of the EUA. The FDA Letter of Authorization is available for reference, as well as the Dear Healthcare Provider Letter and Patient Fact Sheet

Limitations of Authorized Use:

  • REGEN-COV (casirivimab with imdevimab) is not authorized for use in patients:
    • who are hospitalized due to COVID-19, OR
    • who require oxygen therapy due to COVID-19, OR
    • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
  • Benefit of treatment with REGEN-COV has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation

Definition of High Risk Patients

High risk is defined as patients who meet at least one of the following criteria:

  • Have a body mass index (BMI) ≥35
  • Have chronic kidney disease
  • Have diabetes
  • Have immunosuppressive disease
  • Are currently receiving immunosuppressive treatment
  • Are ≥65 years of age
  • Are ≥55 years of age AND have
    • cardiovascular disease, OR
    • hypertension, OR
    • chronic obstructive pulmonary disease/other chronic respiratory disease
  • Are 12–17 years of age AND have
    • BMI ≥85th percentile for their age and gender 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

Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Healthcare providers should review the Antiviral Resistance information in Section 15 of the Fact Sheet for Healthcare Providers for details regarding specific variants and resistance, and refer to the CDC website as well as information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.

ADDITIONAL INFORMATION FOR HEALTHCARE PROVIDERS
  • Casirivimab and imdevimab are each provided in a separate carton and vial. Casirivimab and imdevimab vial labels and carton labeling may instead be labeled REGN10933 and REGN10987, respectively.
  • Each REGEN-COV dose pack contains sufficient number of vials of casirivimab (REGN10933) and imdevimab (REGN10987) to prepare one treatment dose.
  • You may receive cartons and vials of casirivimab and imdevimab that are labeled "for intravenous infusion or subcutaneous injection." However, casirivimab and imdevimab must be administered together (although packaged separately) after dilution by intravenous (IV) infusion only
  • Store casirivimab and imdevimab together in inventory. See regencov.com/hcp/dosing/packaging for images of packaging
  • REGEN-COV may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary
  • The authorized dosage is 1200 mg of casirivimab with 1200 mg of imdevimab administered together as a single intravenous (IV) infusion as soon as possible after a positive viral test for SARS-CoV-2 and within 10 days of symptom onset. Since the optimal dosing regimen has not yet been established, it might be updated as data become available. See the Fact Sheet for Healthcare Providers for complete dosage, preparation, and administration instructions
  • The prescribing healthcare provider and/or the provider's designee are responsible for mandatory reporting of all medication errors and ALL SERIOUS ADVERSE EVENTS potentially related to REGEN-COV. These adverse events must be reported within 7 calendar days from the onset of the event
  • Healthcare facilities and providers must report therapeutics information and demonstrate adequate utilization via data reported through HHS Protect, Teletracking or National Healthcare Safety Network (NHSN) as directed by the U.S. Department of Health and Human Services
  • MedWatch adverse event reports can be submitted to the FDA here, by using a postage-paid Form FDA 3500 and returning by mail/fax, or by calling 1-800-FDA-1088 to request a reporting form. In addition, please provide a copy of all FDA MedWatch forms to Regeneron Pharmaceuticals, Inc via fax (1-888-876-2736) or email ([email protected])
IMPORTANT SAFETY INFORMATION

REGEN-COV (casirivimab with imdevimab) is an unapproved investigational therapy, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with REGEN-COV use.

  • Warnings and Precautions
    • Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions: Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of REGEN-COV (casirivimab with imdevimab). If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care. Infusion-related reactions have been observed with administration of REGEN-COV. These reactions may be severe or life threatening.
      • Signs and symptoms of infusion-related reactions may include: fever, difficulty breathing, reduced oxygen saturation, chills, nausea, arrythmia (eg, atrial fibrillation, tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, fatigue and diaphoresis. If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.
    • Clinical Worsening After REGEN-COV Administration: Clinical worsening of COVID-19 after administration of REGEN-COV has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrythmia (eg, atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to REGEN-COV use or were due to progression of COVID-19
    • Limitations of Benefit and Potential for Risk in Patients with Severe COVID-19: Benefit of treatment with REGEN-COV has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as REGEN-COV, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high-flow oxygen or mechanical ventilation with COVID-19. Therefore, REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19, OR who require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19–related comorbidity
  • Adverse Reactions:
    • Serious adverse events (SAEs) were reported in 4 (1.6%) patients in the REGEN-COV 2,400-mg group, 2 (0.8%) patients in the REGEN-COV 8,000-mg group, and 6 (2.3%) patients in the placebo group. None of the SAEs were considered to be related to study drug. SAEs that were reported as Grade 3 or 4 adverse events were pneumonia, hyperglycemia, nausea and vomiting (2,400 mg REGEN-COV), intestinal obstruction and dyspnea (8,000 mg REGEN-COV) and COVID-19, pneumonia and hypoxia (placebo). REGEN-COV is not authorized at the 8,000-mg dose (4,000 mg casirivimab and 4,000 mg imdevimab)
    • One anaphylactic reaction was reported in the clinical program. The event began within 1 hour of completion of the infusion, and required treatment including epinephrine. The event resolved. Infusion-related reactions, of Grade 2 or higher severity, were reported in 4 subjects (1.5%) in the 8,000-mg (4,000 mg casirivimab and 4,000 mg imdevimab) arm. These infusion-related reactions events were moderate in severity; and included pyrexia, chills, urticaria, pruritus, abdominal pain, and flushing. One infusion-related reaction (nausea) was reported in the placebo arm, and none were reported in the 2,400-mg (1,200 mg casirivimab and 1,200 mg imdevimab) arm. In two subjects receiving the 8,000-mg dose of REGEN-COV, the infusion-related reactions (urticaria, pruritus, flushing, pyrexia, shortness of breath, chest tightness, nausea, vomiting) resulted in permanent discontinuation of the infusion. All events resolved.
  • Patient Monitoring Recommendations: Clinically monitor patients during infusion and observe patients for at least 1 hour after infusion is complete
  • Use in Specific Populations:
    • Pregnancy: There is currently limited clinical experience in the use of REGEN-COV in COVID-19 patients who are pregnant. REGEN-COV therapy should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus
    • Lactation: There is currently no clinical experience in the use of REGEN-COV in COVID-19 patients who are breastfeeding. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for REGEN-COV and any potential adverse effects on the breastfed child from REGEN-COV or from the underlying maternal condition

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