REGEN-COV™ (casirivimab and imdevimab) is an investigational medicine used in adults and adolescents (12 years of age and older who weigh at least 88 pounds (40kg)) 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 prophylaxis 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 or 2 weeks after a single-dose 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), 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, sharing eating or drinking utensils, or being exposed to respiratory droplets from an infected person, 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.