least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization [see Limitations of Authorized Use]. • The patient or parent/caregiver has the option to accept or refuse bamlanivimab. • The significant known and potential risks and benefits of bamlanivimab, and the extent to which such potential risks and benefits are unknown. • Information on available alternative treatments and the risks and benefits of those alternatives, including clinical trials. • Patients treated with bamlanivimab should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect “high touch” surfaces, and frequent handwashing) according to CDC guidelines. For information on clinical trials that are testing the use of bamlanivimab for COVID-19, . please see www.clinicaltrials.gov 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 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization [see Limitations of Authorized Use]. 2. As the healthcare provider, communicate to your patient or parent/caregiver, 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* potentially related to bamlanivimab treatment 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: , or www.fda.gov/medwatch/report.htm 6 Reference ID: 4699500