If a serious and unexpected adverse event occurs and appears to be associated with the use of bamlanivimab, the prescribing healthcare provider and/or the provider’s designee should complete and submit a MedWatch form to FDA using one of the following methods:  Complete and submit the report online: www.fda.gov/medwatch/report.htm, or  Use a postage-paid Form FDA 3500 (available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163 919.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 IMPORTANT: When reporting adverse events or medication errors to MedWatch, please complete the entire form with detailed information. It is important that the information reported to FDA be as detailed and complete as possible. Information to include:  Patient demographics (e.g., patient initials, date of birth)  Pertinent medical history  Pertinent details regarding adverse events and course of illness  Concomitant medications  Timing of adverse event(s) in relationship to administration of bamlanivimab  Pertinent laboratory and virology information  Outcome of the event and any additional follow-up information if it is available at the time of the MedWatch report. Subsequent reporting of follow-up information should be completed if additional details become available. The following steps are highlighted to provide the necessary information for safety tracking:  In section A, box 1, provide the patient’s initials in the Patient Identifier  In section A, box 2, provide the patient’s date of birth  In section B, box 5, description of the event: o Write “Bamlanivimab treatment under Emergency Use Authorization (EUA)” as the first line o Provide a detailed report of medication error and/or adverse event. It is important to provide detailed information regarding the patient and adverse event/medication error for ongoing safety evaluation of this unapproved drug. Please see information to include listed above.  In section G, box 1, name and address: o Provide the name and contact information of the prescribing healthcare provider or institutional designee who is responsible for the report. o Provide the address of the treating institution (NOT the healthcare provider’s office address). 9 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. 15