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Dear HCP Letter FDA Letter of Authorization
Fact Sheets
HCP English HCP Español Patient English Paciente Español
FOR U.S. RESIDENTS AND HEALTHCARE
PROFESSIONALS ONLY

FACT SHEET UPDATE:
On 9/9/21, the fact sheet for healthcare providers was updated. As of 9/9/21,
the fact sheet for healthcare providers has been updated. Click to view
information on the addition of co-packaged cartons of individual vials of
casirivimab and imdevimab and the addition of 5% Dextrose as a diluent when
administering REGEN-COV via IV infusion. See the latest fact sheet for
healthcare providers for more information.
Toggle

(Effective September 9, 2021) Changes include but are not limited to:

Dosage and Administration (Box, Section 2.4, Section 3, Section 19): addition of
co-packaged carton of individual vials of casirivimab and imdevimab

Dosage and Administration (Section 2.4): addition of 5% Dextrose as diluent

VIEW THE FULL FACT SHEET
FOR HEALTHCARE PROVIDERS

VIEW THE FULL FACT SHEET FOR
PATIENTS, PARENTS, AND CAREGIVERS



REGEN-COV™ (CASIRIVIMAB AND IMDEVIMAB) HAS BEEN GRANTED AN EMERGENCY USE
AUTHORIZATION BY THE U.S. FOOD AND DRUG ADMINISTRATION


LEARN ABOUT HOW REGEN-COV MAY HELP.

Find detailed information on the full websites:

I AM A U.S.
PATIENT OR CAREGIVER
I AM A U.S.
HEALTHCARE PROVIDER

REGEN-COV has not been FDA approved, but has been authorized for emergency use
by the FDA under an Emergency Use Authorization (EUA). Its safety and efficacy
have not been fully evaluated by any health authority.

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.

This site is intended for United States (U.S.) residents only.

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 and 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

 * Contraindication:
   REGEN-COV is contraindicated in individuals with previous severe
   hypersensitivity reactions, including anaphylaxis, to REGEN-COV
 * Warnings and Precautions:
   * Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions:
     Serious hypersensitivity reactions, including anaphylaxis, have been
     observed with administration of REGEN-COV. If signs or symptoms of a
     clinically significant hypersensitivity reaction or anaphylaxis occur,
     immediately discontinue administration and initiate appropriate medications
     and/or supportive therapy. Hypersensitivity reactions occurring more than
     24 hours after the infusion have also been reported with the use of
     REGEN-COV under EUA. Infusion-related reactions, occurring during the
     infusion and up to 24 hours after the infusion, 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,
       arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), chest
       pain or discomfort, weakness, altered mental status, headache,
       bronchospasm, hypotension, hypertension, angioedema, throat irritation,
       rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g.,
       pre-syncope, syncope), dizziness, fatigue and diaphoresis. Consider
       slowing or stopping the infusion and administer appropriate medications
       and/or supportive care if an infusion-related reaction occurs
   * 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, arrhythmia (e.g., 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: 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. 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
   * Post-exposure prophylaxis with REGEN-COV is not a substitute for
     vaccination against COVID-19
 * Adverse Reactions:
   * COV-2067 (Treatment): Infusion-related reactions (adverse event assessed as
     causally related by the investigator) of grade 2 or higher severity have
     been observed in 10/4,206 (0.2%) of those who received REGEN-COV at the
     authorized dose or a higher dose. Three subjects receiving the 8,000 mg
     dose of REGEN-COV, and one subject receiving the 1,200 mg casirivimab and
     1,200 mg imdevimab, had infusion-related reactions (urticaria, pruritus,
     flushing, pyrexia, shortness of breath, chest tightness, nausea, vomiting,
     rash) which resulted in permanent discontinuation of the infusion. All
     events resolved. Anaphylactic reactions have been reported in the clinical
     program in subjects receiving REGEN-COV. The events began within 1 hour of
     completion of the infusion, and in at least one case required treatment
     including epinephrine. The events resolved
   * COV-2069 (Post-exposure prophylaxis): In subjects who were SARS-CoV-2
     negative at baseline (Cohort A), injection site reactions (all grade 1 and
     2) occurred in 55 subjects (4%) in the REGEN-COV group and 19 subjects (2%)
     in the placebo group. The most common signs and symptoms of injection site
     reactions which occurred in at least 1% of subjects in the REGEN-COV group
     were erythema and pruritus. Hypersensitivity reactions occurred in 2
     subjects (0.2%) in the REGEN-COV group and all hypersensitivity reactions
     were grade 1 in severity. In subjects who were SARS-CoV-2 positive at
     baseline (Cohort B), injection site reactions, all of which were grade 1 or
     2, occurred in 6 subjects (4%) in the REGEN-COV group and 1 subject (1%) in
     the placebo group. The most common signs and symptoms of injection site
     reactions which occurred in at least 1% of subjects in the REGEN-COV group
     were ecchymosis and erythema
   * COV-2093 (Subcutaneous Dosing): Injection site reactions occurred in 12%
     and 4% of subjects following single dose administration in the REGEN-COV
     and placebo groups, respectively. Remaining safety finding following
     subcutaneous administration in the REGEN-COV group were similar to the
     safety findings observed with intravenous administration in COV-2067. With
     repeat dosing, injection site reactions occurred in 252 subjects (35%) in
     the REGEN-COV group and 38 subjects (16%) in the placebo group; all
     injection site reactions were grade 1 or 2 in severity. Hypersensitivity
     reactions occurred in 8 subjects (1%) in the REGEN-COV group; and all
     hypersensitivity reactions were grade 1 or 2 in severity. There were no
     cases of anaphylaxis.
 * Patient Monitoring Recommendations: Clinically monitor patients during dose
   administration and observe patients for at least 1 hour after intravenous
   infusion or subcutaneous dosing is complete
 * Use in Specific Populations:
   * Pregnancy: There are insufficient data to evaluate a drug-associated risk
     of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
     REGEN-COV should only be used during pregnancy if the potential benefit
     outweighs the potential risk for the mother and the fetus
   * Lactation: There are no available data on the presence of casirivimab
     and/or imdevimab in human milk or animal milk, the effects on the breastfed
     infant, or the effects of the drug on milk production. 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

Treatment:

REGEN-COV 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 progression to severe COVID-19, including
hospitalization or death.

Limitations of Authorized Use (Treatment)

 * 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
 * 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

Post-Exposure Prophylaxis:

REGEN-COV is authorized in adult and pediatric individuals (12 years of age and
older weighing at least 40 kg) for post-exposure prophylaxis of COVID-19 in
individuals who are at high risk for progression to severe COVID-19, including
hospitalization or death, and are:

 * not fully vaccinated or who are not expected to mount an adequate immune
   response to complete SARS-CoV-2 vaccination (for example, individuals with
   immunocompromising conditions including those taking immunosuppressive
   medications) and
   * have been exposed to an individual infected with SARS-CoV-2 consistent with
     close contact criteria per Centers for Disease Control and Prevention
     (CDC), or
   * who are at high risk of exposure to an individual 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)

Limitations of Authorized Use (Post-Exposure Prophylaxis)

 * Post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination
   against COVID-19.
 * 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

These uses are 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 uses 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

Criteria for Identifying High Risk Individuals

Please refer to the Fact Sheet for Healthcare Providers for criteria for
identifying high risk individuals.

SARS-CoV-2 Viral Variants

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 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.

Reporting Adverse Events

 * 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
   submitting 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 (medical.information@regeneron.com)

*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).
See this website for more details:
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html#vaccinated

†See this website for more details:
https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html

‡Close contact with an infected individual 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). See this
website for additional details:
https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html

1. Centers for Medicare & Medicaid Services. Monoclonal Antibody COVID-19
Infusion.
https://www.cms.gov/medicare/covid-19/monoclonal-antibody-covid-19-infusion.
Accessed August 25, 2021.

2. Medicaid. Coronavirus Disease 2019 (COVID-19).
https://www.medicaid.gov/resources-for-states/disaster-response-toolkit/coronavirus-disease-2019-covid-19/index.html.
Accessed August 25, 2021.

3. Health Resources & Services Administration. FAQs for COVID-19 Claims
Reimbursement to Health Care Providers and Facilities for Testing, Treatment and
Vaccine Administration.
https://www.hrsa.gov/coviduninsuredclaim/frequently-asked-questions. Accessed
August 25, 2021.

4. Update: Change in the Distribution Process of COVID-19 mAbs. Office of the
Assistant Secretary for Preparedness and Response U.S. Department of Health and
Human Services. ASPR Slide Deck. Accessed September 13, 2021.

1. O’Brien MP, Forleo Neto E, Musser BJ. Subcutaneous REGEN-COV antibody
combination to prevent COVID-19. N Engl J Med. Published online August 4, 2021.
doi: 10.1056/NEJMoa2109682.

1. COVID-19 Treatment Guidelines Panel. Coronavirus disease 2019 (COVID-19)
treatment guidelines. National Institutes of Health.

https://www.covid19treatmentguidelines.nih.gov/. Accessed August 17th, 2021.

Privacy Policy Terms of Use Contact Us Sitemap

09/2021 REC.21.09.0024

Copyright ©2021, Regeneron Pharmaceuticals, Inc.
All rights reserved.
Questions or comments? Call 1-877-734-6777 to contact Regeneron Pharmaceuticals,
Inc.
777 Old Saw Mill River Road,
Tarrytown, NY 10591

IMPORTANT SAFETY INFORMATION

REGEN-COV (casirivimab and 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

 * Contraindication:
   REGEN-COV is contraindicated in individuals with previous severe
   hypersensitivity reactions, including anaphylaxis, to REGEN-COV
 * Warnings and Precautions:
   * Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions:
     Serious hypersensitivity reactions, including anaphylaxis, have been
     observed with administration of REGEN-COV. If signs or symptoms of a
     clinically significant hypersensitivity reaction or anaphylaxis occur,
     immediately discontinue administration and initiate appropriate medications
     and/or supportive therapy. Hypersensitivity reactions occurring more than
     24 hours after the infusion have also been reported with the use of
     REGEN-COV under EUA. Infusion-related reactions, occurring during the
     infusion and up to 24 hours after the infusion, 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,
       arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), chest
       pain or discomfort, weakness, altered mental status, headache,
       bronchospasm, hypotension, hypertension, angioedema, throat irritation,
       rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g.,
       pre-syncope, syncope), dizziness, fatigue and diaphoresis. Consider
       slowing or stopping the infusion and administer appropriate medications
       and/or supportive care if an infusion-related reaction occurs
   * 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, arrhythmia (e.g., 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: 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. 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
   * Post-exposure prophylaxis with REGEN-COV is not a substitute for
     vaccination against COVID-19
 * Adverse Reactions:
   * COV-2067 (Treatment): Infusion-related reactions (adverse event assessed as
     causally related by the investigator) of grade 2 or higher severity have
     been observed in 10/4,206 (0.2%) of those who received REGEN-COV at the
     authorized dose or a higher dose. Three subjects receiving the 8,000 mg
     dose of REGEN-COV, and one subject receiving the 1,200 mg casirivimab and
     1,200 mg imdevimab, had infusion-related reactions (urticaria, pruritus,
     flushing, pyrexia, shortness of breath, chest tightness, nausea, vomiting,
     rash) which resulted in permanent discontinuation of the infusion. All
     events resolved. Anaphylactic reactions have been reported in the clinical
     program in subjects receiving REGEN-COV. The events began within 1 hour of
     completion of the infusion, and in at least one case required treatment
     including epinephrine. The events resolved
   * COV-2069 (Post-exposure prophylaxis): In subjects who were SARS-CoV-2
     negative at baseline (Cohort A), injection site reactions (all grade 1 and
     2) occurred in 55 subjects (4%) in the REGEN-COV group and 19 subjects (2%)
     in the placebo group. The most common signs and symptoms of injection site
     reactions which occurred in at least 1% of subjects in the REGEN-COV group
     were erythema and pruritus. Hypersensitivity reactions occurred in 2
     subjects (0.2%) in the REGEN-COV group and all hypersensitivity reactions
     were grade 1 in severity. In subjects who were SARS-CoV-2 positive at
     baseline (Cohort B), injection site reactions, all of which were grade 1 or
     2, occurred in 6 subjects (4%) in the REGEN-COV group and 1 subject (1%) in
     the placebo group. The most common signs and symptoms of injection site
     reactions which occurred in at least 1% of subjects in the REGEN-COV group
     were ecchymosis and erythema
   * COV-2093 (Subcutaneous Dosing): Injection site reactions occurred in 12%
     and 4% of subjects following single dose administration in the REGEN-COV
     and placebo groups, respectively. Remaining safety finding following
     subcutaneous administration in the REGEN-COV group were similar to the
     safety findings observed with intravenous administration in COV-2067. With
     repeat dosing, injection site reactions occurred in 252 subjects (35%) in
     the REGEN-COV group and 38 subjects (16%) in the placebo group; all
     injection site reactions were grade 1 or 2 in severity. Hypersensitivity
     reactions occurred in 8 subjects (1%) in the REGEN-COV group; and all
     hypersensitivity reactions were grade 1 or 2 in severity. There were no
     cases of anaphylaxis.
 * Patient Monitoring Recommendations: Clinically monitor patients during dose
   administration and observe patients for at least 1 hour after intravenous
   infusion or subcutaneous dosing is complete
 * Use in Specific Populations:
   * Pregnancy: There are insufficient data to evaluate a drug-associated risk
     of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
     REGEN-COV should only be used during pregnancy if the potential benefit
     outweighs the potential risk for the mother and the fetus
   * Lactation: There are no available data on the presence of casirivimab
     and/or imdevimab in human milk or animal milk, the effects on the breastfed
     infant, or the effects of the drug on milk production. 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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