August 2, 2021
REGEN-COV Treatment Approved for Emergency Use as Post-Exposure Prophylaxis in Certain Adults and Pediatric Individuals
On July 30, the US Food and Drug Administration expanded authorization of the COVID-19 treatment REGEN-COV (casirivimab and imdevimab) to include emergency use as post-exposure prophylaxis in certain adults and pediatric individuals. Read the FDA announcement letter and the revised Fact Sheet for Health Care Providers Emergency Use Authorization (EUA) of REGEN-COV (casirivimab and imdevimab). A summary of key updates and considerations follows.
- REGEN-COV may only be used 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 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).
- The monoclonal antibodies that comprise REGEN-COV, casirivimab and imdevimab, may only be administered together.
- REGEN-COV may only be administered in settings in which health care 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.
- REGEN-COV is authorized for either intravenous infusion or subcutaneous injection when administered for post-exposure prophylaxis under this authorization.
- The use of REGEN-COV covered by this authorization must be in accordance with the authorized Fact Sheets.
- Post-exposure prophylaxis with REGEN-COV (casirivimab with imdevimab) is not intended to be a substitute for vaccination against COVID-19.
- REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19.
1 Individuals are considered to be fully vaccinated two weeks after their second vaccine dose in a two-dose series (such as the Pfizer or Moderna vaccines), or two weeks after a single-dose vaccine (such as the Johnson & Johnson/ 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
3 Close contact with an infected individual is defined as: being within six 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