chills, nausea, headache, shortness of breath, low blood pressure, wheezing, swelling of your lips, face, or throat, rash including hives, itching, muscle aches, and dizziness. The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site. These are not all the possible side effects of bamlanivimab. Not a lot of people have been given bamlanivimab. Serious and unexpected side effects may happen. Bamlanivimab is still being studied so it is possible that all of the risks are not known at this time. It is possible that bamlanivimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. Similarly, bamlanivimab may reduce your body’s immune response to a vaccine for SARS-CoV-2. Specific studies have not been conducted to address these possible risks. Talk to your healthcare provider if you have any questions. What other treatment choices are there? Like bamlanivimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. Go to https://www.covid19treatmentguidelines.nih.gov/ for information on the emergency use of other medicines that are not approved by FDA to treat people with COVID-19. Your healthcare provider may talk with you about clinical trials you may be eligible for. It is your choice to be treated or not to be treated with bamlanivimab. Should you decide not to receive bamlanivimab or stop it at any time, it will not change your standard medical care. What if I am pregnant or breastfeeding? There is limited experience treating pregnant women or breastfeeding mothers with bamlanivimab. For a mother and unborn baby, the benefit of receiving bamlanivimab may be greater than the risk from the treatment. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. How do I report side effects with bamlanivimab? Tell your healthcare provider right away if you have any side effect that bothers you or does not go away. Report side effects to FDA MedWatch at www.fda.gov/medwatch, call 1-800-FDA-1088, or contact Eli Lilly and Company at 1-855-LillyC19 (1-855-545-5921). How can I learn more?  Ask your healthcare provider  Visit www.bamlanivimab.com  Visit https://www.covid19treatmentguidelines.nih.gov/  Contact your local or state public health department What is an Emergency Use Authorization (EUA)? The United States FDA has made bamlanivimab available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. Bamlanivimab has not undergone the same type of review as an FDA-approved or cleared product. The FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that it is reasonable to believe that the product meets certain criteria for safety, performance, and labeling and may be effective in treatment of patients during the COVID-19 pandemic. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. 2