Table 2: Treatment-emergent Adverse Events Reported in at Least 1% of All Subjects in BLAZE-1 Preferred Placebo Bamlanivimab term N=156 700 mg 2,800 mg 7,000 mg Total % N=101 N=107 N=101 N=309 % % % % Nausea 4% 3% 4% 5% 4% Diarrhea 5% 1% 2% 7% 3% Dizziness 2% 3% 3% 3% 3% Headache 2% 3% 2% 0% 2% Pruritus 1% 2% 3% 0% 2% Vomiting 3% 1% 3% 1% 2% Hypersensitivity Including Anaphylaxis and Infusion-related Reactions: One anaphylaxis reaction and one serious infusion-related reaction were reported during infusion of bamlanivimab in ongoing, blinded trials. The infusions were stopped. Both reactions required treatment, one required epinephrine. Both events resolved. Immediate non-serious hypersensitivity events were noted for 2% of bamlanivimab- treated subjects and 1% of placebo-treated subjects in BLAZE-1. Reported events of pruritus, flushing and hypersensitivity were mild with one case of face swelling which was moderate. All events resolved [see Warnings and Precautions (5.1)]. 7 PATIENT MONITORING RECOMMENDATIONS Clinically monitor patients during infusion and observe patients for at least 1 hour after infusion is complete [see Warnings and Precautions (5.1) and Clinical Trials Experience (6.1)]. 8 ADVERSE REACTIONS AND MEDICATION ERRORS REPORTING REQUIREMENTS AND INSTRUCTIONS Clinical trials evaluating the safety of bamlanivimab are ongoing [see Overall Safety Summary (6)]. Completion of FDA MedWatch Form to report all medication errors and serious adverse events is mandatory. The prescribing healthcare provider and/or the provider’s designee are/is responsible for the mandatory reporting of all medication errors and the following selected serious adverse events occurring during bamlanivimab use and considered to be potentially related to bamlanivimab. These adverse events must be reported within 7 calendar days from the onset of the event:  death;  a life-threatening adverse event;  inpatient hospitalization or prolongation of existing hospitalization;  a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;  a congenital anomaly/birth defect;  a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly. 14