FDA

• ON JANUARY 24, 2022, THE FDA WITHDREW THE EUA FOR BAMLANIVIMAB/ETESEVIMAB. 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 use of monoclonal combination 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 for hospitalized patients.
• Bamlanivimab and Etesevimab MUST be administered together after dilution by IV infusion under this EUA.
• *High risk is defined as any of the following:
  • Have a body mass index (BMI) ≥ 35
  • Have chronic kidney disease
  • Have diabetes
  • Have immunosuppressive disease
  • Are currently receiving immunosuppressive treatment
  • Are ≥65 years of age
  • Cardiovascular disease OR
  • Hypertension OR
  • COPD/other chronic respiratory diseases
  • Are 12 – 17 years of age AND have one of the following
    • BMI ≥85th percentile for their age and gender-based on CDC growth charts (https://www.cdc.gov/growthcharts/clinical_charts.htm), OR
    • Sickle cell disease, OR
    • Congenital or acquired heart disease, OR
    • Neurodevelopmental disorders, for example, cerebral palsy, OR
    • Medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
    • Asthma, reactive airway or other chronic respiratory diseases requiring daily medication for control.
• Bamlanivimab/etesevimab 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