POPULATION FOR ANTIBODY TREATMENT High risk is defined as patients who meet at least one of the following criteria: This EUA is for the use of the unapproved product • Have a body mass index (BMI) bamlanivimab for the treatment of mild to moderate† ≥35 COVID-19 in adults and pediatric patients with positive • Have chronic kidney disease results of direct SARS-CoV-2 viral testing who are 12 • Have diabetes years and older weighing at least 40 kg, and who are • Have immunosuppressive at high risk for progressing to severe COVID-19 and/or disease hospitalization. • Are currently receiving immunosuppressive treatment Limitations of Benefit in Patients with Severe • Are ≥65 years of age • Are ≥55 years of age AND have COVID-19 • cardiovascular disease, OR Benefit of treatment with bamlanivimab has • hypertension, OR not been observed in patients hospitalized due • chronic obstructive to COVID-19. Monoclonal antibodies, such as pulmonary disease/ bamlanivimab, may be associated with worse other chronic respiratory clinical outcomes when administered to hospitalized disease. patients with COVID-19 requiring high flow oxygen or • Are 12 – 17 years of age AND mechanical ventilation. Therefore, bamlanivimab is have not authorized for use in patients: • BMI ≥85th percentile for their age and gender • who are hospitalized due to COVID-19, OR based on CDC growth charts, https://www. • who require oxygen therapy due to COVID-19, OR cdc.gov/growthcharts/ • who require an increase in baseline oxygen flow clinical_charts.htm, OR rate due to COVID-19 in those on chronic oxygen • sickle cell disease, OR therapy due to underlying non-COVID-19 related • congenital or acquired comorbidity. heart disease, OR • neurodevelopmental disorders, for example, For more information, reference the Fact Sheet for cerebral palsy, OR Healthcare Providers. • a 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 disease that requires daily medication for control. Lilly Bamlanivimab Antibody Playbook | 5 PP-BM-US-0024
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