 By using a postage-paid Form FDA 3500 (available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/For ms/UCM163919.pdf) and returning by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787), or by fax (1-800-FDA-0178), or  Call 1-800-FDA-1088 to request a reporting form  Submitted reports should include in the field name, “Describe Event, Problem, or Product Use/Medication Error” the statement “Bamlanivimab treatment under Emergency Use Authorization (EUA)” *Serious Adverse Events are defined as: • 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. 5. The prescribing health care provider and/or the provider’s designee are/is to provide mandatory responses to requests from FDA for information about adverse events and medication errors following receipt of bamlanivimab. 6. OTHER REPORTING REQUIREMENTS In addition, please provide a copy of all FDA MedWatch forms to: Eli Lilly and Company, Global Patient Safety Fax: 1-317-277-0853 E-mail: [email protected] Or call Eli Lilly and Company at 1-855-LillyC19 (1-855-545-5921) to report adverse events. APPROVED AVAILABLE ALTERNATIVES There is no adequate, approved and available alternative to bamlanivimab for patients who have mild to moderate COVID-19 who are at high risk for progressing to severe COVID-19 and/or hospitalization. Additional information on COVID-19 treatments can be found at https://www.cdc.gov/coronavirus/2019-ncov/index.html. The health care provider should visit https://clinicaltrials.gov/ to determine whether the patient may be eligible for enrollment in a clinical trial. AUTHORITY FOR ISSUANCE OF THE EUA The Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 pandemic. FDA has issued this EUA, requested by Eli Lilly and Company for 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 7 Reference ID: 4699500