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EUA) of REGEN-COVTM (Casirivimab and Imdevimab

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EUA) of REGEN-COVTM (Casirivimab and Imdevimab FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE AUTHORIZATION (EUA) OF REGEN-COVTM (casirivimab and imdevimab) AUTHORIZED USE 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. Limitations of Authorized Use • REGEN-COV (casirivimab and 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. • 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 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, 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 vaccinated1 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 medications2) and 1 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 2 See this website for more details: https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully- vaccinated-people.html Page 1 of 52 - have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC)3 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)]. Limitations of Authorized Use • Post-exposure prophylaxis with REGEN-COV (casirivimab and imdevimab) is not a substitute for vaccination against COVID-19. • REGEN-COV (casirivimab and imdevimab) is not authorized for pre-exposure prophylaxis for prevention of COVID-19. RECENT MAJOR CHANGES • Dosage and Administration (Box, Section 2.4, Section 3, Section 19): addition of co-packaged carton Revised 09/2021 • Dosage and Administration (Section 2.4): addition of 5% Dextrose as diluent Revised 09/2021 • Antiviral Resistance (Box and Section 15): addition of information on susceptibility of SARS-CoV-2 variants to REGEN-COV (Tables 9 and 10) Revised 08/2021 • Authorized Use: addition of new indication for post-exposure prophylaxis of COVID-19 Revised 07/2021 • Dosage and Administration (Box, and Section 2.2): updated authorized dosage for post-exposure prophylaxis of COVID-19 Revised 07/2021 • Authorized Use: expanded the definition of progression of severe COVID-19 to include death Revised 06/2021 • Dosage and Administration (Box, and Section 2.2): updated authorized dosage Revised 06/2021 • Dosage and Administration (Box, Section 2.2 and 2.4): updated with subcutaneous route of administration as an alternative for those who cannot receive intravenous infusion Revised 06/2021 • Dosage and Administration (Box, Section 2.2 and 2.4): updated with co-formulation Revised 06/2021 • Warnings: Hypersensitivity Including Anaphylaxis and Infusion- Related Reactions (Section 5.1): addition of vasovagal reactions Revised 06/2021 • Overall Safety Summary, Clinical Trials Experience (Section 6.1): addition of Phase 3 results and safety with subcutaneous dosing Revised 06/2021 • Clinical Trial Results and Supporting Data for EUA, Mild to Moderate COVID-19 (Section 18.1): addition of Phase 3 data for the authorized dose Revised 06/2021 • Dosage and Administration (Box and Section 2.1): updated 3 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 Page 2 of 52 high risk criteria for patient selection Revised 05/2021 • Dose Preparation and Administration Instructions (Section 2.4): provides updated minimum infusion times based on size of infusion bag used Revised 03/2021 • New proprietary name: REGEN-COV Revised 02/2021 • Warnings: Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions (Section 5.1) – addition of new symptoms Revised 02/2021 • Warnings: Clinical Worsening After REGEN-COV Administration (Section 5.2) – new warning added Revised 02/2021 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. Treatment This EUA is for the 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 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 [see Limitations of Authorized Use (1.1)]. Post-Exposure Prophylaxis This EUA is for the 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, 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 vaccinated1 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 medications2) 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)3 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)]. Page 3 of 52 Criteria for Identifying High Risk Individuals The following medical conditions or other factors may place adults and pediatric patients (age 12-17 years and weighing at least 40 kg) at higher risk for progression to severe COVID-19: • Older age (for example, age ≥65 years of age) • Obesity or being overweight (for example, BMI >25 kg/m2, or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm) • Pregnancy • Chronic kidney disease • Diabetes • Immunosuppressive disease or immunosuppressive treatment • Cardiovascular disease (including congenital heart disease) or hypertension • Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension) • Sickle cell disease • Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies) • Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)) Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and authorization of REGEN-COV under the EUA is not limited to the medical conditions or factors listed above. For additional information on
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