Bamlanivimab and Etesevimab

Kathryn Dzintars, Pharm.D., BCPS
Bamlanivimab and Etesevimab is a topic covered in the Johns Hopkins HIV Guide.

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INDICATIONS

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

-- To view the remaining sections of this topic, please or --

INDICATIONS

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

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Last updated: January 31, 2022