Mandatory Requirements for Bamlanivimab Administration Under Emergency Use Authorization In order to mitigate the risks of using this unapproved product under the EUA and to optimize the potential benefit of bamlanivimab, the following items are required. Use of bamlanivimab under this EUA is limited to the following (all requirements must be met): 1. 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 40kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. 2. Healthcare providers must communicate to patients or parents/caregivers, as age appropriate, information consistent with the Fact Sheet for Patients, Parents and Caregivers prior to the patient receiving bamlanivimab. Healthcare providers (to the extent practicable given the circumstances of the emergency) must document in the patient’s medical record that the patient/caregiver has been: a. Given the Fact Sheet for Patients, Parents and Caregivers, b. Informed of alternatives to receiving authorized bamlanivimab, and c. Informed that bamlanivimab is an unapproved drug that is authorized for use under this Emergency Use Authorization. 3. Patients with known hypersensitivity to any ingredient of bamlanivimab must not receive bamlanivimab. 4. The prescribing health care provider and/or the provider’s designee are/is responsible for mandatory reporting of all medication errors and serious adverse events* occurring within 7 calendar days from the onset of the event. The reports should include unique identifiers and the words “Bamlanivimab treatment under Emergency Use Authorization (EUA)” in the description section of the report. • Submit adverse event reports to FDA MedWatch 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/UCM163919.pdf) and return it 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)” Lilly Bamlanivimab Antibody Playbook | 7 PP-BM-US-0024