- The FDA issued an Emergency Use Authorization (EUA) permitting the use of bamlanivimab 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.
- FDA issued a EUA (2/4/21) for the combination of bamlanivimab and etesevimab.
- *High risk is defined as:
- 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
- ≥ 55 years of age AND must have one of the following
- 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 that require daily medication for control.
Bamlanivimab 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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