Fact Sheet for Health Care Providers

FACT SHEET FOR HEALTH CARE PROVIDERS EMERGENCY USE AUTHORIZATION (EUA) OF BAMLANIVIMAB AUTHORIZED USE The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product bamlanivimab for the treatment of mild to moderate coronavirus disease 2019 (COVID- 19) in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. LIMITATIONS OF AUTHORIZED USE  Bamlanivimab is not authorized for use in patients: o who are hospitalized due to COVID-19, OR o who require oxygen therapy due to COVID-19, OR o 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.  Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. Bamlanivimab has been authorized by FDA for the emergency uses described above. Bamlanivimab is not FDA-approved for these uses. Bamlanivimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. This EUA is for the use of the unapproved product bamlanivimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization [see Limitations of Authorized Use]. High risk is defined as patients who meet at least one of the following criteria: • 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 1