FDA

ON JANUARY 24, 2022, THE FDA WITHDREW THE EUA FOR CASIRIVIMAB/IMDEVIMAB. THIS TREATMENT IS NO LONGER AUTHORIZED FOR USE IN ANY U.S. STATE, TERRITORY, OR JURISDICTION AND SHOULD NOT BE ADMINISTERED TO PATIENTS.

The FDA issued an Emergency Use Authorization (EUA) permitting the emergency use of casirivimab and imdevimab for the treatment of mild to moderate coronavirus disease in adult and pediatric (≥ 12 years of age; ≥40 kg) with a positive SARS-CoV-2 test who are at high risk* for progressing to severe disease or hospitalization. This EUA restricts treatment to outpatient administration only. It is not approved for use within hospitals.

*High risk is defined as:

• Have a body mass index (BMI) ≥ 35
• Are pregnant
• Have chronic kidney disease
• Have diabetes
• Have immunosuppressive disease
• Are currently receiving immunosuppressive treatment
• Have cardiovascular disease
• Have chronic lung disease (COPD, asthma)
• Are ≥ 65 years of age

Carisivimab and Imdevimab are NOT authorized for use in patients who:

• Are hospitalized due to COVID-19, or
• Require oxygen therapy due to COVID-19, or
• 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

Post-exposure Prophylaxis

• On July 30, 2021, the EUA was extended to include the use of casirivimab/imdevimab for post-exposure prophylaxis.
• Post-exposure prophylaxis is indicated for:
  • Individuals who are not fully vaccinated and report a possible exposure to SARS-CoV-2
  • Individuals who are not expected to mount an adequate immune response to SARS-CoV-2 vaccination and report a possible exposure