Regen-Cov: Package Insert / Prescribing Info

TREATMENT

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adult 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.

RECENT MAJOR CHANGES

REGEN-COV has been authorized by FDA for the emergency uses described above.

REGEN-COV is not FDA-approved for these uses.

REGEN-COV is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of REGEN-COV under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Contraindications

REGEN-COV is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to REGEN-COV [see Warnings and Precautions (5.1)].

Dosing

Preparation and Administration

There are TWO different formulations of REGEN-COV:

• Casirivimab and imdevimab co-formulated solution containing two antibodies in a 1:1 ratio in a vial.
• Casirivimab and imdevimab available as individual antibody solutions in separate vials supplied as follows:
  • Individual vials in individual cartons, or
  • together in a single carton (as referred to as a co-packaged carton), or
  • in a dose pack. The dose pack contains individual vials of casirivimab and imdevimab, configurations that may vary in vial size, strength and appearance and are available in dose pack configurations that include 2, 5, and 8 cartons [see Full EUA Prescribing Information, How Supplied/Storage and Handling (19)].

For treatment, intravenous infusion is strongly recommended. Subcutaneous injection is an alternative route of administration when intravenous infusion is not feasible and would lead to delay in treatment.

For post-exposure prophylaxis, either subcutaneous injection or intravenous infusion can be used.

There are differences in the way the two formulations are prepared. Carefully follow the preparation procedures below.

• Casirivimab and imdevimab co-formulated solution in a vial and casirivimab or imdevimab as individual antibody solutions in separate 11.1 mL vials may be used to prepare more than one dose simultaneously as appropriate, either in intravenous bags or in syringes for subcutaneous injection. Discard any product remaining in the vial.
• Store unopened casirivimab and imdevimab vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Unopened vials may be stored in the original carton at room temperature [up to 25°C (77°F)] and must be used within 30 days. If not used in the 30 days, discard vials.

Under the EUA, a single-dose vial may be used to prepare more than one dose.

Storage and Handling

Store unopened casirivimab and imdevimab vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Unopened vials may be stored in the original carton at room temperature [up to 25°C (77°F)] and must be used within 30 days. If not used in the 30 days, discard vials.

Warnings

There are limited clinical data available for REGEN-COV (casirivimab and imdevimab). Serious and unexpected adverse events may occur that have not been previously reported with REGEN-COV use.

Side Effects

Adverse events have been reported with REGEN-COV (casirivimab and imdevimab) [see Full EUA Prescribing Information, Clinical Trials Experience (6.1)].

Additional adverse events associated with REGEN-COV, some of which may be serious, may become apparent with more widespread use.

INSTRUCTIONS FOR HEALTH CARE PROVIDERS

As the health care provider, you must communicate to your patient or parent/caregiver, as age appropriate, information consistent with the "Fact Sheet for Patients, Parents and Caregivers" (and provide a copy of the Fact Sheet) prior to the patient receiving REGEN-COV (casirivimab and imdevimab), including:

• FDA has authorized the emergency use of REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death [see Limitations of Authorized Use (1.1)].
• FDA has authorized the emergency use of REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, 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 vaccinated3 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 medications4) and

    -

    have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Center for Disease Control and Prevention (CDC)5 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) [see Limitations of Authorized Use (1.2)].

• The patient or parent/caregiver has the option to accept or refuse REGEN-COV.
• The significant known and potential risks and benefits of REGEN-COV, and the extent to which such risks and benefits are unknown.
• Information on available alternative treatments and the risks and benefits of those alternatives, including clinical trials.
• Patients treated with REGEN-COV should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect "high touch" surfaces, and frequent handwashing) according to CDC guidelines.

For information on clinical trials that are testing the use of REGEN-COV related to COVID-19, please see www.clinicaltrials.gov.

MANDATORY REQUIREMENTS FOR REGEN-COV UNDER EMERGENCY USE AUTHORIZATION:

In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, the following items are required. Use of REGEN-COV under this EUA is limited to the following (all requirements must be met):

1. Treatment of mild to moderate COVID-19 in adult 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 severe COVID-19, including hospitalization or death [see Limitations of Authorized Use (1.1)].
2. Post-exposure prophylaxis of COVID-19 in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:

   a.

   not fully vaccinated3 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 medications4) and

   -

   have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Center for Disease Control and Prevention (CDC)5 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) [see Limitations of Authorized Use (1.2)].

3. As the health care provider, communicate to your patient or parent/caregiver, as age appropriate, information consistent with the "Fact Sheet for Patients, Parents and Caregivers" prior to the patient receiving REGEN-COV. Health care providers (to the extent practicable given the circumstances of the emergency) must document in the patient's medical record that the patient/caregiver has been:

   a.

   Given the "Fact Sheet for Patients, Parents and Caregivers",

   b.

   Informed of alternatives to receiving REGEN-COV, and

   c.

   Informed that REGEN-COV is an unapproved drug that is authorized for use under this Emergency Use Authorization.

4. Patients with known hypersensitivity to any ingredient of REGEN-COV must not receive REGEN-COV.
5. The prescribing health care provider and/or the provider's designee are/is responsible for mandatory reporting of all medication errors and serious adverse events* potentially related to REGEN-COV treatment within 7 calendar days from the onset of the event. The reports must include unique identifiers and the words "REGEN-COV use for COVID-19 under Emergency Use Authorization (EUA)" in the description section of the report.
   • Submit adverse event reports to FDA MedWatch using one of the following methods:
     • Complete and submit the report online: www.fda.gov/medwatch/report.htm, or
     • Complete and submit a postage-paid FDA Form 3500 (https://www.fda.gov/media/76299/download) and return by:
       • Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or
       • Fax (1-800-FDA-0178), or
     • Call 1-800-FDA-1088 to request a reporting form
     • Submitted reports must include in the field name, "Describe Event, Problem, or Product Use/Medication Error" a statement "REGEN-COV use for COVID-19 under Emergency Use Authorization (EUA)."
   *Serious Adverse Events are defined as:
   • death;
   • a life-threatening adverse event;
   • inpatient hospitalization or prolongation of existing hospitalization;
   • a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
   • a congenital anomaly/birth defect;
   • a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly.
6. The prescribing health care provider and/or the provider's designee is/are responsible for mandatory responses to requests from FDA for information about adverse events and medication errors following receipt of REGEN-COV.
7. OTHER REPORTING REQUIREMENTS
   • Healthcare facilities and providers must report therapeutics information and utilization data through HHS Protect, Teletracking or National Healthcare Safety Network (NHSN) as directed by the U.S. Department of Health and Human Services.
   • In addition, please provide a copy of all FDA MedWatch forms to:
     Regeneron Pharmaceuticals, Inc
     Fax: 1-888-876-2736
     E-mail: medical.information@regeneron.com
     Or call Regeneron Pharmaceuticals at 1-844-734-6643 to report adverse events.

APPROVED AVAILABLE ALTERNATIVES

Veklury (remdesivir) is FDA-approved for the treatment of 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, who are not hospitalized and have mild-to-moderate COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Veklury is administered via intravenous infusion for a total treatment duration of 3 days.

Although Veklury is an approved alternative treatment of mild-to-moderate 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, FDA does not consider Veklury to be an adequate alternative to REGEN-COV for this authorized use because it may not be feasible or practical for certain patients (e.g., it requires a 3-day treatment duration).

There is no adequate, approved and available alternative to REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, 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 vaccinated3 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 medications4) and

  -

  have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per CDC5 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) [see Limitations of Authorized Use (1.2)].

Additional information on COVID-19 treatments can be found at https://www.cdc.gov/coronavirus/2019-ncov/index.html. The health care provider should visit https://clinicaltrials.gov/ to determine whether the patient may be eligible for enrollment in a clinical trial.

AUTHORITY FOR ISSUANCE OF THE EUA

The Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 pandemic.

FDA has issued this EUA, requested by Regeneron Pharmaceuticals, Inc. for the unapproved product, REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, for the treatment of mild to moderate COVID-19 in adult 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.6 As a health care provider, you must comply with the mandatory requirements of the EUA (see above).

FDA has issued this EUA, requested by Regeneron Pharmaceuticals, Inc. for the unapproved product, REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together 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 vaccinated3 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 medications4) 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)5 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) [see Limitations of Authorized Use (1.2)].

Although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that REGEN-COV (casirivimab and imdevimab) co-formulated product and REGEN-COV (casirivimab and imdevimab) supplied as individual vials to be administered together, may be effective for the treatment of COVID-19 or for post-exposure prophylaxis of COVID-19 in individuals as specified in this Fact Sheet. You may be contacted and asked to provide information to help with the assessment of the use of the product during this emergency.

This EUA for REGEN-COV will end when the Secretary determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA may no longer be needed.

6

The health care provider should visit https://clinicaltrials.gov/ to determine whether there is an active clinical trial for the product in this disease/condition and whether enrollment of the patient(s) in a clinical trial is more appropriate than product use under this EUA.

CONTACT INFORMATION

For additional information visit www.REGENCOV.com

If you have questions, please contact Regeneron at 1-844-734-6643.

FULL EUA PRESCRIBING INFORMATION

1. Indications and Usage for Regen-Cov

2. Regen-Cov Dosage and Administration

3. Dosage Forms and Strengths

REGEN-COV (casirivimab and imdevimab) is available as:

1. A single vial which contains two antibodies co-formulated in a 1:1 ratio of casirivimab and imdevimab. Co-formulated casirivimab and imdevimab is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution available as:
   • Injection: 600 mg of casirivimab and 600 mg of imdevimab per 10 mL (60 mg/60 mg per mL) in a single-dose10 vial
2. Individual antibody solutions in separate single-dose1 vials, which may be supplied in separate cartons or together in a single carton (also referred to as a co-packaged carton), or as dose pack.
   • Casirivimab is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution available as:
     • Injection: 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL)
   • Imdevimab is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution available as:
     • Injection: 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL)
   • Each REGEN-COV dose pack contains 1,200 mg of casirivimab [REGN10933] and 1,200 mg of imdevimab [REGN10987] [see How Supplied/Storage and Handling (19)]. Casirivimab and imdevimab vial labels and carton labeling may instead be labeled REGN10933 and REGN10987, respectively.

10

Under the EUA, a single-dose vial may be used to prepare more than one dose.

4. Contraindications

REGEN-COV is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to REGEN-COV [see Warnings and Precautions (5.1)].

5. Warnings and Precautions

There are limited clinical data available for REGEN-COV (casirivimab and imdevimab). Serious and unexpected adverse events may occur that have not been previously reported with REGEN-COV use.

6. Adverse Reactions/Side Effects

7 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 [see Warnings and Precautions (5.1) and Clinical Trials Experience (6.1)].

8 ADVERSE REACTIONS AND MEDICATION ERRORS REPORTING REQUIREMENTS AND INSTRUCTIONS

Clinical trials evaluating the safety of REGEN-COV (casirivimab and imdevimab) are ongoing [see Overall Safety Summary (6)].

Completion of an FDA MedWatch Form to report all medication errors and serious adverse events* occurring during REGEN-COV use and considered to be potentially related to REGEN-COV is mandatory and must be done by the prescribing healthcare provider and/or the provider's designee. These adverse events must be reported within 7 calendar days from the onset of the event:

*Serious Adverse Events are defined as:

• death;
• a life-threatening adverse event;
• inpatient hospitalization or prolongation of existing hospitalization;
• a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
• a congenital anomaly/birth defect;
• a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly.

If a serious and unexpected adverse event occurs and appears to be associated with the use of REGEN-COV, the prescribing health care provider and/or the provider's designee must complete and submit a MedWatch form to FDA using one of the following methods:

• Complete and submit the report online: www.fda.gov/medwatch/report.htm, or
• Complete and submit a postage-paid FDA Form 3500 (https://www.fda.gov/media/76299/download) and return by:
  • Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or
  • Fax (1-800-FDA-0178), or
• Call 1-800-FDA-1088 to request a reporting form

IMPORTANT: When reporting adverse events or medication errors to MedWatch, please complete the entire form with detailed information. It is important that the information reported to FDA be as detailed and complete as possible. Information that must be included:

• Patient demographics (e.g., patient initials, date of birth)
• Pertinent medical history
• Pertinent details regarding admission and course of illness
• Concomitant medications
• Timing of adverse event(s) in relationship to administration of REGEN-COV
• Pertinent laboratory and virology information
• Outcome of the event and any additional follow-up information if it is available at the time of the MedWatch report. Subsequent reporting of follow-up information should be completed if additional details become available.

The following steps are highlighted to provide the necessary information for safety tracking:

1. In section A, box 1, provide the patient's initials in the Patient Identifier
2. In section A, box 2, provide the patient's date of birth or age
3. In section B, box 5, description of the event:

   a.

   Write "REGEN-COV use for COVID-19 under Emergency Use Authorization (EUA)" as the first line

   b.

   Provide a detailed report of medication error and/or adverse event. It is important to provide detailed information regarding the patient and adverse event/medication error for ongoing safety evaluation of this unapproved drug. Please see information to include listed above.

4. In section G, box 1, name and address:

   a.

   Provide the name and contact information of the prescribing health care provider or institutional designee who is responsible for the report

   b.

   Provide the address of the treating institution (NOT the health care provider's office address).

9 OTHER REPORTING REQUIREMENTS

Healthcare facilities and providers must report therapeutics information and utilization data through HHS Protect, Teletracking or National Healthcare Safety Network (NHSN) as directed by the U.S. Department of Health and Human Services.

In addition, please provide a copy of all FDA MedWatch forms to:
Regeneron Pharmaceuticals, Inc
Fax: 1-888-876-2736
E-mail: medical.information@regeneron.com
Or call Regeneron Pharmaceuticals at 1-844-734-6643 to report adverse events.

10. Drug Interactions

REGEN-COV consists of 2 monoclonal antibodies (mAbs), casirivimab and imdevimab, which are not renally excreted or metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are renally excreted or that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

11. Use In Specific Populations

12. Overdosage

Doses up to 8,000 mg (4,000 mg each of casirivimab and imdevimab, greater than 3 times the recommended dose) have been administered in clinical trials without dose-limiting toxicity. Treatment of overdose should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with REGEN-COV (casirivimab and imdevimab).

13. Regen-Cov Description

Casirivimab, a human immunoglobulin G-1 (IgG1) monoclonal antibody (mAb), is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 145.23 kDa.

Casirivimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with imdevimab. The vial stoppers are not made with natural rubber latex.

• Casirivimab: Each 2.5 mL of solution contains 300 mg of casirivimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0.
• Casirivimab: Each 11.1 mL of solution contains 1,332 mg of casirivimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.

Imdevimab, a human IgG1 mAb, is a covalent heterotetramer consisting of 2 heavy chains and 2 light chains produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture and has an approximate molecular weight of 144.14 kDa.

Imdevimab injection is a sterile, preservative-free, clear to slightly opalescent and colorless to pale yellow solution in a vial for subcutaneous use or intravenous infusion after dilution available as a 300 mg/2.5 mL (120 mg/mL) or 1,332 mg/11.1 mL (120 mg/mL) solution and must be administered with casirivimab. The vial stoppers are not made with natural rubber latex.

• Imdevimab: Each 2.5 mL of solution contains 300 mg of imdevimab, L-histidine (1.9 mg), L-histidine monohydrochloride monohydrate (2.7 mg), polysorbate 80 (2.5 mg), sucrose (200 mg), and Water for Injection, USP. The pH is 6.0.
• Imdevimab: Each 11.1 mL of solution contains 1,332 mg of imdevimab, L-histidine (8.3 mg), L-histidine monohydrochloride monohydrate (12.1 mg), polysorbate 80 (11.1 mg), sucrose (888 mg), and Water for Injection, USP. The pH is 6.0.

REGEN-COV (casirivimab and imdevimab solution) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale yellow 10 mL solution in a vial for intravenous infusion after dilution. The vial stoppers are not made with natural rubber latex.

• Each 10 mL of solution contains 600 mg of casirivimab, 600 mg of imdevimab, L-histidine (7.4 mg), L-histidine monohydrochloride monohydrate (10.9 mg), polysorbate 80 (10.0 mg), sucrose (800 mg), and Water for Injection, USP. The pH is 6.0.

14. Regen-Cov - Clinical Pharmacology

15 MICROBIOLOGY/RESISTANCE INFORMATION

16. Nonclinical Toxicology

Carcinogenicity, genotoxicity, and reproductive toxicology studies have not been conducted with casirivimab and imdevimab.

In a toxicology study in cynomolgus monkeys, casirivimab and imdevimab had no adverse effects when administered intravenously or subcutaneously. Non-adverse liver findings (minor transient increases in AST and ALT) were observed.

In tissue cross-reactivity studies with casirivimab and imdevimab using human adult and fetal tissues, no binding of clinical concern was detected.

17 ANIMAL PHARMACOLOGIC AND EFFICACY DATA

Casirivimab and imdevimab administered together has been assessed in rhesus macaque and Syrian golden hamster treatment models of SARS-CoV-2 infection. Therapeutic administration of casirivimab and imdevimab together at 25 mg/kg or 150 mg/kg into rhesus macaques (n=4 for each dosing group) 1-day post infection resulted in approximately 1-2 log10 reductions in genomic and sub-genomic viral RNA in nasopharyngeal swabs and oral swabs at Day 4 post-challenge in most animals, and reduced lung pathology relative to placebo-treated animals. Therapeutic administration of casirivimab and imdevimab together at 5 mg/kg and 50 mg/kg doses to hamsters 1-day post infection resulted in reduced weight loss relative to placebo treated animals. In the prophylactic setting in rhesus macaques, administration of 50 mg/kg casirivimab and imdevimab together prior to challenge with SARS-CoV-2 demonstrated reduction in viral RNA via nasopharyngeal, oral swabs and bronchioalveolar lavage fluid, as well as a reduction in lung inflammation. In the prophylactic setting in hamsters, administration of 0.5 mg/kg, 5 mg/kg, or 50 mg/kg casirivimab and imdevimab together prior to challenge with SARS-CoV-2 protected against weight loss, and reduced percentage of lung area showing pneumonia pathology and severity of lung inflammation, indicative of reduced morbidity in this model. The applicability of these findings to a clinical setting is not known.

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

18.1 Treatment of Mild to Moderate COVID-19 (COV-2067)

The data supporting this EUA are based on the analysis of Phase 1/2/3 from trial, COV-2067 (NCT04425629). This is a randomized, double-blinded, placebo-controlled clinical trial evaluating REGEN-COV (casirivimab and imdevimab) for the treatment of subjects with mild to moderate COVID-19 (subjects with COVID-19 symptoms who are not hospitalized). Cohort 1 enrolled adult subjects who were not hospitalized and had 1 or more COVID-19 symptoms that were at least mild in severity. Treatment was initiated within 3 days of obtaining a positive SARS-CoV-2 viral infection determination. Subjects in the Phase 3 primary efficacy analysis met the criteria for high risk for progression to severe COVID-19, as shown in Section 2.

In the Phase 3 trial, 4,567 subjects with at least one risk factor for severe COVID-19 were randomized to a single intravenous infusion of 600 mg of casirivimab and 600 mg of imdevimab (n=838), 1,200 mg of casirivimab and 1,200 mg of imdevimab (n=1,529), 4,000 mg of casirivimab and 4,000 mg of imdevimab (n=700), or placebo (n=1,500) groups. The two REGEN-COV doses at the start of Phase 3 were 4,000 mg and 1,200 mg of each component; however, based on Phase 1/2 efficacy analyses showing that the 4,000 mg and 1,200 mg doses of each component were similar, the Phase 3 portion of the protocol was amended to compare 1,200 mg dose of each component vs. placebo and 600 mg dose of each component vs. placebo. Comparisons were between subjects randomized to the specific REGEN-COV dose and subjects who were concurrently randomized to placebo.

At baseline, in all randomized subjects with at least one risk factor, the median age was 50 years (with 13% of subjects ages 65 years or older), 52% of the subjects were female, 84% were White, 36% were Hispanic or Latino, and 5% were Black or African American. In subjects with available baseline symptom data, 15% had mild symptoms, 42% had moderate, 42% had severe symptoms, and 2% reported no symptoms at baseline; the median duration of symptoms was 3 days; mean viral load was 6.2 log10 copies/mL at baseline. The baseline demographics and disease characteristics were well balanced across the casirivimab and imdevimab and placebo treatment groups.

The primary endpoint was the proportion of subjects with ≥1 COVID-19-related hospitalization or all-cause death through Day 29, in subjects with a positive SARS-CoV-2 RT-qPCR result from nasopharyngeal (NP) swab at randomization, and with at least one risk factor for severe COVID-19, i.e., the modified full analysis set (mFAS). In the mFAS, events (COVID-19-related hospitalization or all-cause death through Day 29) occurred in 7 (1.0%) subjects treated with 600 mg of casirivimab and 600 mg of imdevimab compared to 24 (3%) subjects concurrently randomized to placebo, demonstrating a 70% reduction in COVID-19-related hospitalization or all-cause death compared to placebo (p=0.0024). Events occurred in 18 (1.3%) subjects treated with 1,200 mg of casirivimab and 1,200 mg of imdevimab compared to 62 (5%) subjects concurrently randomized to placebo, demonstrating a 71% reduction compared to placebo (REGEN-COV 1% vs placebo 5%, p<0.0001). In the 1,200 mg analysis, there was 1 death each in the REGEN-COV and placebo arm (p=1.0); and in 2,400 mg analysis, there were 1 and 3 deaths, respectively, in the REGEN-COV and placebo arms (p=0.3721). Overall, similar effects were observed for 600 mg of casirivimab and 600 mg of imdevimab and 1,200 mg of casirivimab and 1,200 mg of imdevimab doses, indicating the absence of a dose effect; therefore the 600 mg of casirivimab and 600 mg of imdevimab dose is authorized and the 1,200 mg of casirivimab and 1,200 mg of imdevimab dose is no longer authorized under this EUA (See Table 11). Results were consistent across subgroups of patients defined by nasopharyngeal viral load >106 copies/mL at baseline or serologic status.

Table 11: Proportion of subjects with ≥1 COVID-19-related hospitalization or all-cause death through day 29 (COV-2067)

	600 mg of casirivimab and 600 mg of imdevimab (intravenous)	Placebo	1,200 mg of casirivimab and 1,200 mg of imdevimab (intravenous)	Placebo
	n=736	n=748	n=1,355	n=1,341
# of subjects with at least 1 event (COVID-19-related hospitalization or all-cause death)	7 (1.0%)	24 (3.2%)	18 (1.3%)	62 (4.6%)
Risk reduction	70% (p=0.0024)		71% (p<0.0001)

Treatment with REGEN-COV resulted in a statistically significant reduction in the LS mean viral load (log10 copies/mL) from baseline to Day 7 compared to placebo (-0.71 log10 copies/mL for 600 mg dose of casirivimab and 600 mg of imdevimab and -0.86 log10 copies/mL for 2,400 mg; p<0.0001). Reductions were observed in the overall mFAS population and in other subgroups, including those with baseline viral load >106 copies/mL or who were seronegative at baseline. Consistent effects were observed for the individual doses, indicating the absence of a dose effect. Figure 1 shows the mean change from baseline in SARS-COV-2 viral load to Day 15.

Figure 1: Change from Baseline in SARS-COV-2 Viral Load (log10 copies/mL) to Day 15 (COV-2067)

REGEN-COV 1.2 g IV = 600 mg of casirivimab and 600 mg of imdevimab administered intravenously
REGEN-COV 2.4 g IV = 1,200 mg of casirivimab and 1,200 mg of imdevimab administered intravenously

The median time to symptom resolution, as recorded in a trial-specific daily symptom diary, was 10 days for REGEN-COV-treated subjects, as compared with 14 days for placebo-treated subjects (p=0.0001 for 600 mg of casirivimab and 600 mg of imdevimab vs. placebo; p<0.0001 for 1,200 mg of casirivimab and 1,200 mg of imdevimab vs. placebo). Symptoms assessed were fever, chills, sore throat, cough, shortness of breath/difficulty breathing, nausea, vomiting, diarrhea, headache, red/watery eyes, body aches, loss of taste/smell, fatigue, loss of appetite, confusion, dizziness, pressure/tight chest, chest pain, stomachache, rash, sneezing, sputum/phlegm, runny nose. Time to COVID-19 symptom resolution was defined as time from randomization to the first day during which the subject scored 'no symptom' (score of 0) on all of the above symptoms except cough, fatigue, and headache, which could have been 'mild/moderate symptom' (score of 1) or 'no symptom' (score of 0).

19. How is Regen-Cov supplied

20 PATIENT COUNSELING INFORMATION

Patients treated with REGEN-COV (casirivimab and imdevimab) should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect "high touch" surfaces, and frequent handwashing) according to CDC guidelines. Also see Fact Sheet for Patients, Parents and Caregivers.

21 CONTACT INFORMATION

For additional information visit www.REGENCOV.com

If you have questions, please contact Regeneron at 1-844-734-6643.

Manufactured by:
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY 10591-6707
©2021 Regeneron Pharmaceuticals, Inc. All rights reserved.
Revised: 12/2021

FACT SHEET FOR PATIENTS, PARENTS AND CAREGIVERS
EMERGENCY USE AUTHORIZATION (EUA) OF REGEN-COV™ (casirivimab and imdevimab) FOR CORONAVIRUS DISEASE 2019 (COVID-19)

You are being given a medicine called REGEN-COV (casirivimab and imdevimab) for the treatment or post-exposure prevention of coronavirus disease 2019 (COVID-19). SARS-CoV-2 is the virus that causes COVID-19. This Fact Sheet contains information to help you understand the potential risks and potential benefits of taking REGEN-COV.

Receiving REGEN-COV may benefit certain people with COVID-19 and may help prevent certain people who have been exposed to someone who is infected with SARS-CoV-2 from getting SARS-CoV-2 infection, or may prevent certain people who are at high risk of exposure to someone who is infected with SARS-CoV-2 from getting SARS-CoV-2 infection.

Read this Fact Sheet for information about REGEN-COV. Talk to your healthcare provider if you have questions. It is your choice to receive REGEN-COV or stop at any time.

WHAT IS COVID-19?

COVID-19 is caused by a virus called a coronavirus, SARS-CoV-2. People can get COVID-19 through contact with another person who has the virus.

COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your other medical conditions to become worse. People of all ages with severe, long-lasting (chronic) medical conditions like heart disease, lung disease, and diabetes, for example, and other conditions including obesity, seem to be at higher risk of being hospitalized for COVID-19. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19.

WHAT ARE THE SYMPTOMS OF COVID-19?

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

WHAT IS REGEN-COV (casirivimab and imdevimab)?

REGEN-COV is an investigational medicine used in adults and adolescents (12 years of age and older who weigh at least 88 pounds (40 kg)) who are at high risk for severe COVID-19, including hospitalization or death for:

• treatment of mild to moderate symptoms of COVID-19
• post-exposure prevention of COVID-19 in persons who are:
  • not fully vaccinated against COVID-19 (Individuals are considered to be fully vaccinated 2 weeks after their second vaccine dose in a 2-dose series [such as the Pfizer or Moderna vaccines], or 2 weeks after a single-dose vaccine [such as Johnson & Johnson's Janssen vaccine]), or,
  • are not expected to build up enough of an immune response to the complete COVID-19 vaccination (for example, someone with immunocompromising conditions, including someone who is taking immunosuppressive medications), and
    • have been exposed to someone who is infected with SARS-CoV-2. Close contact with someone who is infected with SARS-CoV-2 is defined as being within 6 feet for a total of 15 minutes or more, providing care at home to someone who is sick, having direct physical contact with the person (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). For additional details, go to https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html, or
    • someone who is at high risk of being exposed to someone who is infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons).

REGEN-COV is investigational because it is still being studied. There is limited information known about the safety and effectiveness of using REGEN-COV to treat people with COVID-19 or to prevent COVID-19 in people who are at high risk of being exposed to someone who is infected with SARS-CoV-2. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19.

The FDA has authorized the emergency use of REGEN-COV for the treatment of COVID-19 and the post-exposure prevention of COVID-19 under an Emergency Use Authorization (EUA). For more information on EUA, see the "What is an Emergency Use Authorization (EUA)?" section at the end of this Fact Sheet.

WHO SHOULD NOT TAKE REGEN-COV?

Do not take REGEN-COV if you have had a severe allergic reaction to REGEN-COV.

WHAT SHOULD I TELL MY HEALTH CARE PROVIDER BEFORE I RECEIVE REGEN-COV?

Tell your healthcare provider about all of your medical conditions, including if you:

• Have any allergies
• Have had a severe allergic reaction including anaphylaxis to REGEN-COV previously
• Have received a COVID-19 vaccine
• Have any serious illnesses
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed
• Are taking any medications (prescription, over-the-counter, vitamins, and herbal products)

HOW WILL I RECEIVE REGEN-COV (casirivimab and imdevimab)?

• REGEN-COV consists of two investigational medicines, casirivimab and imdevimab, given together at the same time through a vein (intravenous or IV) or injected in the tissue just under the skin (subcutaneous injections). Your healthcare provider will determine the most appropriate way for you to be given REGEN-COV.
• Treatment: If you are receiving an intravenous infusion, the infusion will take 20 to 50 minutes or longer. Your healthcare provider will determine the duration of your infusion.
  • If your healthcare provider determines that you are unable to receive REGEN-COV as an intravenous infusion which would lead to a delay in treatment, then as an alternative, REGEN-COV can be given in the form of subcutaneous injections. If you are receiving subcutaneous injections, your dose will be provided as multiple injections given in separate locations around the same time.
• Post-exposure prevention: If you are receiving subcutaneous injections, your dose will be provided as multiple injections given in separate locations around the same time. If you are receiving an intravenous infusion, the infusion will take 20 to 50 minutes or longer.
  • After the initial dose, if your healthcare provider determines that you need to receive additional doses of REGEN-COV for ongoing protection, the additional intravenous or subcutaneous doses would be administered monthly.

WHAT ARE THE IMPORTANT POSSIBLE SIDE EFFECTS OF REGEN-COV (casirivimab and imdevimab)?

Possible side effects of REGEN-COV are:

• Allergic reactions. Allergic reactions can happen during and after infusion or injection of REGEN-COV. Tell your healthcare provider right away or seek immediate medical attention 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 or injection, including fever, difficulty breathing, rapid or slow heart rate, tiredness, weakness or confusion. If these symptoms occur, contact your healthcare provider or seek immediate medical attention as some of these symptoms have required hospitalization. It is unknown if these symptoms are related to treatment or are due to the progression of COVID-19.

The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site. The side effects of getting any medicine by subcutaneous injection may include pain, bruising of the skin, soreness, swelling, and possible infection at the injection site.

These are not all the possible side effects of REGEN-COV. Not a lot of people have been given REGEN-COV. Serious and unexpected side effects may happen. REGEN-COV is still being studied so it is possible that all of the risks are not known at this time.

It is possible that REGEN-COV could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. Similarly, REGEN-COV may reduce your body's immune response to a vaccine for SARS-CoV-2. Specific studies have not been conducted to address these possible risks. Talk to your healthcare provider if you have any questions.

WHAT OTHER TREATMENT CHOICES ARE THERE?

Like REGEN-COV (casirivimab and imdevimab), FDA may allow for the emergency use of other medicines to treat people with COVID-19. Go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization for information on the emergency use of other medicines that are not approved by FDA that are used to treat people with COVID-19. Your healthcare provider may talk with you about clinical trials you may be eligible for.

It is your choice to be treated or not to be treated with REGEN-COV. Should you decide not to receive REGEN-COV or stop it at any time, it will not change your standard medical care.

WHAT OTHER PREVENTION CHOICES ARE THERE?

Vaccines to prevent COVID-19 are also available under Emergency Use Authorization. Use of REGEN-COV does not replace vaccination against COVID-19. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19.

WHAT IF I AM PREGNANT OR BREASTFEEDING?

There is limited experience using REGEN-COV (casirivimab and imdevimab) in pregnant women or breastfeeding mothers. For a mother and unborn baby, the benefit of receiving REGEN-COV may be greater than the risk of using the product. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.

HOW DO I REPORT SIDE EFFECTS WITH REGEN-COV (casirivimab and imdevimab)?

Tell your healthcare provider right away if you have any side effect that bothers you or does not go away.

Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088 or call 1-844-734-6643.

HOW CAN I LEARN MORE?

• Ask your health care provider.
• Visit www.REGENCOV.com
• Visit https://www.covid19treatmentguidelines.nih.gov/
• Contact your local or state public health department.

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?

The United States FDA has made REGEN-COV (casirivimab and imdevimab) available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.

REGEN-COV has not undergone the same type of review as an FDA-approved product. In issuing an EUA under the COVID-19 public health emergency, the FDA must determine, among other things, that based on the totality of scientific evidence available, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19, or a serious or life-threatening disease or condition caused by COVID-19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved and available alternatives. All of these criteria must be met to allow for the medicine to be used in the treatment of COVID-19 or prevention of COVID-19 during the COVID-19 pandemic.

The EUA for REGEN-COV is in effect for the duration of the COVID-19 declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).

Manufactured by:
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY 10591-6707

©2022 Regeneron Pharmaceuticals, Inc. All rights reserved.
Revised: 01/2022

PRINCIPAL DISPLAY PANEL - 300 mg/2.5 mL Vial Label - Casirivimab

701208

12345-00

Casirivimab
Injection

NDC 61755-026-00
Rx only

300 mg/2.5 mL (120 mg/mL)

For Intravenous Infusion after Dilution
For use under Emergency Use Authorization (EUA)
MUST ADMINISTER WITH IMDEVIMAB
Mfd by: Regeneron Pharmaceuticals, Inc.

LOT/EXP

PRINCIPAL DISPLAY PANEL - 300 mg/2.5 mL Vial Label - Casirivimab - Roche

Casirivimab
120 mg/mL
concentrate for solution
for infusion

300 mg/2.5 mL

IV after dilution

Must administer with
imdevimab

Roche

EXP
Lot

10238448 IE (EG)

PRINCIPAL DISPLAY PANEL - 300 mg/2.5 mL Vial Carton - Casirivimab

NDC 61755-026-01

Rx only

Casirivimab
Injection

300 mg/2.5 mL (120 mg/mL)

For Intravenous Infusion after Dilution

For use under Emergency Use Authorization (EUA)

MUST ADMINISTER WITH IMDEVIMAB

Contains 1 Single-Dose Vial

Discard unused portion

PRINCIPAL DISPLAY PANEL - 300 mg/2.5 mL Vial Box - Casirivimab

Casirivimab (REGN10933)

300 mg/2.5 mL (120 mg/mL)

NDC 61755-026-01

PRINCIPAL DISPLAY PANEL - 300 mg/2.5 mL Modified Vial Label - REGN10933

701208

Subject Number

Solution for intravenous infusion or subcutaneous injection.
Administer in accordance with protocol instructions.
Store refrigerated at 2°C–8°C (36°F–46°F)
in original carton to protect from light.

Keep Out of Reach of Children. For Clinical Trial Use Only.

Caution: New Drug - Limited by Federal (or United States)
law to investigational use. Regeneron Pharmaceuticals, Inc.
Tarrytown, NY 10591 USA Tel: +1 914-847-7000

Lot

PRINCIPAL DISPLAY PANEL - 300 mg/2.5 mL Modified Vial Carton - REGN10933

Subject Number
Investigator
Date Dispensed

Contains:
1 vial Solution for intravenous infusion or subcutaneous injection

Administer in accordance with protocol instructions.

Store refrigerated at 2°C–8°C (36°F–46°F) in the original carton to
protect from light.

Keep Out of Reach of Children. For Clinical Trial Use Only.

Caution: New Drug - Limited by Federal (or United States) law to
investigational use.

Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591 USA
Tel: +1 914-847-7000

PRINCIPAL DISPLAY PANEL - 1332 mg/11.1 mL Vial Label - Casirivimab

701210

12345-00

Casirivimab
Injection

NDC 61755-024-00
Rx only

1332 mg/11.1 mL (120 mg/mL)

For Intravenous Infusion after Dilution
For use under Emergency Use Authorization (EUA)
MUST ADMINISTER WITH IMDEVIMAB
Mfd by: Regeneron Pharmaceuticals, Inc.

PRINCIPAL DISPLAY PANEL - 1332 mg/11.1 mL Vial Label - Casirivimab - Roche

Casirivimab 120 mg/mL
concentrate for solution for
infusion

1332 mg/11.1 mL

IV after dilution

Must administer with
imdevimab

Roche

EXP
Lot

10238449 IE (EG)

PRINCIPAL DISPLAY PANEL - 1332 mg/11.1 mL Vial Carton - Casirivimab

NDC 61755-024-01

Rx only

Casirivimab
Injection

1332 mg/11.1 mL (120 mg/mL)

For Intravenous Infusion after Dilution

For use under Emergency Use Authorization (EUA)

MUST ADMINISTER WITH IMDEVIMAB

Contains 1 Single-Dose Vial

Discard unused portion

PRINCIPAL DISPLAY PANEL - 1332 mg/11.1 mL Vial Box - Casirivimab

Casirivimab (REGN10933)

1332 mg/11.1 mL (120 mg/mL)

NDC 61755-024-01

PRINCIPAL DISPLAY PANEL - 1332 mg/11.1 mL Initial Clinical Vial Label - REGN10933

701210

Subject Number

Solution for intravenous administration.
Administer in accordance with protocol instructions.
Store refrigerated at 2°C–8°C (36°F-46°F)
in the original carton to protect from light.
Keep Out of Reach of Children. For Clinical Trial Use Only.

Caution: New Drug – Limited by Federal (or United States) law
to investigational use. Regeneron Pharmaceuticals, Inc.
Tarrytown, NY 10591 USA Tel: +1 914-847-7000

PRINCIPAL DISPLAY PANEL - 1332 mg/11.1 mL Initial Clinical Vial Carton - REGN10933

Ref No. XXXXXXX

Lot XXXXXXXXXX

120 mg/mL 11.1 mL

REGN10933

PRINCIPAL DISPLAY PANEL - 300 mg/2.5 mL Vial Label - Imdevimab

701208

12345-00

Imdevimab
Injection

NDC 61755-027-00
Rx only

300 mg/2.5 mL (120 mg/mL)

For Intravenous Infusion after Dilution
For use under Emergency Use Authorization (EUA)
MUST ADMINISTER WITH CASIRIVIMAB
Mfd by: Regeneron Pharmaceuticals, Inc.

LOT/EXP

PRINCIPAL DISPLAY PANEL - 300 mg/2.5 mL Vial Label - Imdevimab - Roche

Imdevimab
120 mg/mL
concentrate for solution
for infusion

300 mg/2.5 mL

IV after dilution

Must administer with
casirivimab

Roche

EXP
Lot

10238451 IE (EG)

PRINCIPAL DISPLAY PANEL - 300 mg/2.5 mL Vial Carton - Imdevimab

NDC 61755-027-01

Rx only

Imdevimab
Injection

300 mg/2.5 mL (120 mg/mL)

For Intravenous Infusion after Dilution

For use under Emergency Use Authorization (EUA)

MUST ADMINISTER WITH CASIRIVIMAB

Contains 1 Single-Dose Vial

Discard unused portion

PRINCIPAL DISPLAY PANEL - 300 mg/2.5 mL Vial Box - Imdevimab

Imdevimab (REGN10987)

300 mg/2.5 mL (120 mg/mL)

NDC 61755-027-01

PRINCIPAL DISPLAY PANEL - 300 mg/2.5 mL Modified Vial Label - REGN10987

701208

Subject Number

Solution for intravenous infusion or subcutaneous injection.
Administer in accordance with protocol instructions.
Store refrigerated at 2°C–8°C (36°F–46°F)
in original carton to protect from light.

Keep Out of Reach of Children. For Clinical Trial Use Only.

Caution: New Drug - Limited by Federal (or United States)
law to investigational use. Regeneron Pharmaceuticals, Inc.
Tarrytown, NY 10591 USA Tel: +1 914-847-7000

Lot

PRINCIPAL DISPLAY PANEL - 300 mg/2.5 mL Modified Vial Carton - REGN10987

Subject Number
Investigator
Date Dispensed

Contains:
1 vial Solution for intravenous infusion or subcutaneous injection

Administer in accordance with protocol instructions.

Store refrigerated at 2°C–8°C (36°F–46°F) in the original carton to
protect from light.

Keep Out of Reach of Children. For Clinical Trial Use Only.

Caution: New Drug - Limited by Federal (or United States) law to
investigational use.

Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591 USA
Tel: +1 914-847-7000

PRINCIPAL DISPLAY PANEL - 1332 mg/11.1 mL Vial Label - Imdevimab

701210

12345-00

Imdevimab
Injection

NDC 61755-025-00
Rx only

1332 mg/11.1 mL (120 mg/mL)

For Intravenous Infusion after Dilution
For use under Emergency Use Authorization (EUA)
MUST ADMINISTER WITH CASIRIVIMAB
Mfd by: Regeneron Pharmaceuticals, Inc.

PRINCIPAL DISPLAY PANEL - 1332 mg/11.1 mL Vial Label - Imdevimab - Roche

Imdevimab 120 mg/mL
concentrate for solution for
infusion

1332 mg/11.1 mL

IV after dilution

Must administer with
casirivimab

Roche

EXP
Lot

10238452 IE (EG)

PRINCIPAL DISPLAY PANEL - 1332 mg/11.1 mL Vial Carton - Imdevimab

NDC 61755-025-01

Rx only

Imdevimab
Injection

1332 mg/11.1 mL (120 mg/mL)

For Intravenous Infusion after Dilution

For use under Emergency Use Authorization (EUA)

MUST ADMINISTER WITH CASIRIVIMAB

Contains 1 Single-Dose Vial

Discard unused portion

PRINCIPAL DISPLAY PANEL - 1332 mg/11.1 mL Vial Box - Imdevimab

Imdevimab (REGN10987)

1332 mg/11.1 mL (120 mg/mL)

NDC 61755-025-01

PRINCIPAL DISPLAY PANEL - 1332 mg/11.1 mL Initial Clinical Vial Label - REGN10987

701210

Subject Number

Solution for intravenous administration.
Administer in accordance with protocol instructions.
Store refrigerated at 2°C–8°C (36°F–46°F)
in original carton to protect from light.
Keep Out of Reach of Children. For Clinical Trial Use Only.

Caution: New Drug – Limited by Federal (or United States) law
to investigational use. Regeneron Pharmaceuticals, Inc.
Tarrytown, NY 10591 USA Tel: +1 914-847-7000

PRINCIPAL DISPLAY PANEL - 1332 mg/11.1 mL Initial Clinical Vial Carton - REGN10987

Ref No. XXXXXXX

Lot XXXXXXXXXX

120 mg/mL 11.1 mL

REGN10987

PRINCIPAL DISPLAY PANEL - 600 mg/10 mL Vial Label

702310

13443-00

NDC 61755-039-00
Rx only

REGEN-COV™
(casirivimab and imdevimab)
Injection

600 mg / 600 mg per 10 mL
(60 mg / 60 mg per mL)

For use under Emergency Use Authorization (EUA)
One 10 mL Single-Dose Vial. Discard unused portion.
Mfd by: Regeneron Pharmaceuticals, Inc.

PRINCIPAL DISPLAY PANEL - 600 mg/10 mL Vial Carton

NDC 61755-039-01
Rx only

REGEN-COV™
(casirivimab and imdevimab)
Injection

600 mg / 600 mg per 10 mL
(60 mg / 60 mg per mL)

Refer to FDA-authorized Fact Sheets for detailed instructions
on dosage, preparation, and route of administration.

For use under Emergency Use Authorization (EUA)

One 10 mL Single-Dose Vial. Discard unused portion.

PRINCIPAL DISPLAY PANEL - Dose Pack - 61755-035-02

NDC 61755-035-02

REGEN-COV™
[casirivimab (REGN10933) with imdevimab (REGN10987)]

This dose pack provides one complete dose, and contains:

• 1 vial of casirivimab 1332 mg/11.1 mL (120 mg/mL)
• 1 vial of imdevimab 1332 mg/11.1 mL (120 mg/mL)

Must dilute and administer together via intravenous infusion.

Refer to FDA-authorized Fact Sheet for detailed preparation
and administration instructions.

For Use under Emergency Authorization (EUA).

Do not open this dose pack until time of dose preparation.
Store dose pack refrigerated between 2°C - 8°C (36°F to 46°F).
Do Not Freeze.

Dose Pack Lot #: XXX

13451

REGENERON

Bar code for Manufacturer internal use only.
TEL: +1 844-734-6643

PRINCIPAL DISPLAY PANEL - Dose Pack - 61755-036-08

NDC 61755-036-08

REGEN-COV™
[casirivimab (REGN10933) with imdevimab (REGN10987)]

This dose pack provides one complete dose, and contains:

• 4 vials of casirivimab 300 mg/2.5 mL (120 mg/mL)
• 4 vials of imdevimab 300 mg/2.5 mL (120 mg/mL)

Must dilute and administer together via intravenous infusion.

Refer to FDA-authorized Fact Sheet for detailed preparation
and administration instructions.

For Use under Emergency Authorization (EUA).

Do not open this dose pack until time of dose preparation.
Store dose pack refrigerated between 2°C - 8°C (36°F to 46°F).
Do Not Freeze.

Dose Pack Lot #: XXX

13452

REGENERON

Bar code for Manufacturer internal use only.
TEL: +1 844-734-6643

PRINCIPAL DISPLAY PANEL - Dose Pack - 61755-037-05

NDC 61755-037-05

REGEN-COV™
[casirivimab (REGN10933) with imdevimab (REGN10987)]

This dose pack provides one complete dose, and contains:

• 1 vial of casirivimab 1332 mg/11.1 mL (120 mg/mL)
• 4 vials of imdevimab 300 mg/2.5 mL (120 mg/mL)

Must dilute and administer together via intravenous infusion.

Refer to FDA-authorized Fact Sheet for detailed preparation
and administration instructions.

For Use under Emergency Authorization (EUA).

Do not open this dose pack until time of dose preparation.
Store dose pack refrigerated between 2°C - 8°C (36°F to 46°F).
Do Not Freeze.

Dose Pack Lot #: XXX

13453

REGENERON

Bar code for Manufacturer internal use only.
TEL: +1 844-734-6643

PRINCIPAL DISPLAY PANEL - Dose Pack - 61755-038-05

NDC 61755-038-05

REGEN-COV™
[casirivimab (REGN10933) with imdevimab (REGN10987)]

This dose pack provides one complete dose, and contains:

• 4 vials of casirivimab 300 mg/2.5 mL (120 mg/mL)
• 1 vial of imdevimab 1332 mg/11.1 mL (120 mg/mL)

Must dilute and administer together via intravenous infusion.

Refer to FDA-authorized Fact Sheet for detailed preparation
and administration instructions.

For Use under Emergency Authorization (EUA).

Do not open this dose pack until time of dose preparation.
Store dose pack refrigerated between 2°C - 8°C (36°F to 46°F).
Do Not Freeze.

Dose Pack Lot #: XXX

13454

REGENERON

Bar code for Manufacturer internal use only.
TEL: +1 844-734-6643

PRINCIPAL DISPLAY PANEL - Kit Carton - 042-02

Casirivimab and
Imdevimab 120 mg/mL
concentrate for solution for
infusion

120 mg/mL

For intravenous use after dilution

2 vials of 20 mL

Roche

10238447

PRINCIPAL DISPLAY PANEL - Kit Carton - 045-02

Casirivimab and
Imdevimab 120 mg/mL
concentrate for solution for infusion

120 mg/mL

For intravenous use after dilution

2 vials of 6 mL

Roche

10238450