HCP-Patient Counseling Guide

What to expect during a COVID-19 neutralizing antibody treatment infusion If you’ve recently been diagnosed with the COVID-19 virus, your doctor may offer you a new drug called bamlanivimab (bam-la-NIV-i-mab). The research so far shows that for certain people, taking this drug may help limit the amount of virus in the body. This may help their symptoms improve sooner — and they may be less likely to need to go to the 1 hospital. But bamlanivimab is a new drug that’s still being studied, so there’s a lot that scientists don’t know about the benefits and risks. In this easy-to-read guide, you’ll learn about this new drug and what to expect before, during, and after treatment. Important facts about bamlanivimab: Bamlanivimab is investigational, which means it’s still being studied. Bamlanivimab has not been approved, but has been authorized for emergency use by the United States Food and Drug Administration (FDA), to treat 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 (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. FDA has authorized bamlanivimab for emergency use only during the COVID-19 pandemic. Bamlanivimab is authorized 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 (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. This guide is not a substitute for the official fact sheet. For information on the authorized use of bamlanivimab and mandatory requirements under the Emergency Use Authorization, please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers. 1 New England Journal of Medicine: SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19, nejm.org/doi/full/10.1056/NEJMoa2029849 Page 1 | PP-BM-US-0009 November 2020 ©Lilly USA, LLC 2020. All rights reserved.