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FREQUENTLY ASKED QUESTIONS

Answers to important questions about REGEN-COV.

Access icon

ACCESS AND REIMBURSEMENT

An EUA allows the U.S. Food and Drug Administration (FDA) to help strengthen the nation’s public health protections against chemical, biological, radiological and nuclear (CBRN) defense threats by facilitating the availability and use of therapies needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act, the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

Details on infusion centers where antibody therapies, including REGEN-COV, may be available can be found on the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) and the National Infusion Center Association (NICA)* site locators.

*IMPORTANT INFORMATION: Infusion 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 eligibility of their patients and verify the availability of doses at an authorized infusion site before they refer an eligible patient to schedule an appointment to receive treatment at an authorized infusion site. Please note that the inclusion of a site does not imply current availability of doses. More states and locations are regularly being added. If not yet listed, ambulatory centers or other administration sites should contact their state health departments.

To order REGEN-COV, treatment sites should contact AmerisourceBergen Corporation directly at [email protected]. Treatment sites should also review the ASPR direct ordering process guide and can fill out a C19 Therapies Direct Order Request.

REGEN-COV is free of charge to requesting treatment sites, as the United States government is paying for the product. The combination therapy must be administered via a single intravenous (IV) infusion. Therefore, claims may be submitted for the reimbursement of the drug administration only.

Coverage and reimbursement of COVID-19-related treatments and procedures may vary from payer to payer; therefore, it is important that providers clarify and confirm any coding/billing requirements with respective payers.

Treatment sites must order REGEN-COV directly from AmerisourceBergen Corporation, the drug’s sole distributor. Approval of sites to receive product will be determined by AmerisourceBergen Corporation in conjunction with the United States government.

Packaging and preparation icon

PACKAGING AND PREPARATION

New REGEN-COV dose packs are now available. Each REGEN-COV dose pack contains sufficient number of vials of casirivimab and imdevimab to prepare one treatment dose.

Previously, because of the rapid timing of the EUA and to meet the needs of the public health emergency, we were using the same vials and packaging used as part of the clinical trial. These vials and packaging may still be in circulation.

As of March 2021, all distributed lots of REGEN-COV have an expiry date that is no earlier than 2022. The expiration date for the material shipped from the distributor can be found on the packing list. For the specific expiration dating for a lot please reach out to the distributor or to Regeneron medical information at 1-844-734-6643 or to [email protected].

The vial and vial stopper for casirivimab and imdevimab are not made with natural latex rubber.

Prepared IV bags of casirivimab and imdevimab do not require protection from ambient light.

If immediate administration is not possible, store the diluted REGEN-COV infusion solution in the refrigerator between 2°C to 8°C (36°F to 45°F) for no more than 36 hours or at room temperature up to 25°C (77°F) for no more than 4 hours. If refrigerated, allow the infusion solution to equilibrate to room temperature for approximately 30 minutes prior to administration.

Clinical data icon

CLINICAL DATA

The combination of casirivimab and imdevimab makes up REGEN-COV, Regeneron’s investigational anti-viral antibody cocktail being studied in COVID-19. It consists of two noncompeting, virus-neutralizing monoclonal antibodies.

Casirivimab and imdevimab bind simultaneously to different, non-overlapping epitopes on severe acute respiratory syndrome 2 (SARS-CoV-2) Spike (S) glycoprotein.

Those who have received a COVID-19 vaccine can still receive monoclonal antibody therapy if they meet the authorized use criteria for REGEN-COV. Please consider the proximate risk for each patient when considering REGEN-COV use. Please consult the latest guidelines from the CDC.

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.a 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.

  • B.1.1.7 (United Kingdom origin). REGEN-COV retained neutralization activity against all spike protein substitutions.b
  • B.1.351 (South Africa origin). REGEN-COV retained neutralization activity against all spike protein substitutions.c,d
  • B.1.427/B.1.429 (California origin). REGEN-COV retained neutralization activity against the L452R spike protein substitution.
  • P.1 (Brazil origin). REGEN-COV retained neutralization activity against the K417T + E484K spike protein substitution.e
  • B.1.526 (New York origin). REGEN-COV retained neutralization activity against the E484K spike protein substitution.f,g

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 press release 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.

a As of March 18, 2021
b 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.
c 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.
d Casirivimab alone, but not imdevimab, had reduced activity against pseudovirus expressing K417N or E484K (which are found in this variant).
e Casirivimab alone, but not imdevimab, had reduced activity against pseudovirus expressing K417N or E484K.
f Casirivimab alone, but not imdevimab, had reduced activity against pseudovirus expressing E484K.
g Not all isolates of the New York lineage harbor E484K substitution (as of February 2021).

Safety icon

SAFETY INFORMATION AND REPORTING

Prescribing healthcare professionals 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. MedWatch adverse event reports can be submitted to the FDA online 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]). See the Fact Sheet for Healthcare Providers for detailed information about the obligation to report medication errors and serious adverse events.

REGEN-COV 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 therapy. 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, fatigue, arrythmia (eg, atrial fibrillation, tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, 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.

The safety of REGEN-COV is based on analysis from one phase 1/2 trial of 799 ambulatory (non-hospitalized) patients with COVID-19.

  • 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.

REGEN-COV (casirivimab with imdevimab) 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 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.

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. Health care 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.

Clinical trials icon

CLINICAL TRIALS

For more information on clinical trials that are testing the use of REGEN-COV in COVID-19, please visit www.clinicaltrials.gov.

Please refer to the Clinical Information page for more information. Clinical investigators, hospitals or clinical sites interested in joining the REGEN-COV clinical program can email Regeneron at [email protected].

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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