Page 3 – Eli Lilly and Company x The bamlanivimab covered by this authorization will be used only by healthcare providers to treat 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; x Bamlanivimab is not authorized for use in the following patient populations5: x Adults or pediatric patients who are hospitalized due to COVID-19, or x Adults or pediatric patients who require oxygen therapy due to COVID- 19, or x Adults or pediatric patients who require an increase in baseline oxygen flow rate due to COVID-19 in those patients on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity. x Bamlanivimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. x The use of bamlanivimab covered by this authorization must be in accordance with the dosing regimens as detailed in the authorized Fact Sheets. Product Description Bamlanivimab is a neutralizing IgG1 monoclonal antibody that binds to the receptor binding domain of the spike protein of SARS-CoV-2. Bamlanivimab, injection, 700 mg/20 mL, is a sterile, preservative-free aqueous solution that is to be diluted by using a 250 mL prefilled 0.9% Sodium Chloride Injection infusion solution, withdrawing and discarding 70 mL of 0.9% Sodium Chloride Injection from the infusion bag, and then transferring 20mL of 700mg/20mL bamlanivimab to the 0.9% Sodium Chloride Injection infusion bag. The authorized bamlanivimab includes a vial label and/or carton labeling that is clearly marked for “emergency use authorization”. Bamlanivimab, injection, 700 mg/20 mL, vials should be stored in unopened vials under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Diluted bamlanivimab infusion solution can be stored for up to 24 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]) or up to 7 hours at room temperature (20°C to 25°C [68°F to 77°F]) including infusion time. 5 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. Reference ID: 4699500