HCP-Patient Counseling Guide

What to Expect during a COVID-19 Neutralizing Antibody Treatment Infusion | 8 Pages

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.

Who is this drug for? Bamlanivimab is a treatment option for people with 2 COVID-19 who: • Are age 12 or older What is COVID-19? • Weigh 88 pounds or more COVID-19 is a disease caused • Have had mild to moderate symptoms for 10 days by a type of virus called a or less coronavirus. Common symptoms • Are at high risk to get very sick from COVID-19 include fever, cough, and having trouble breathing. This drug is not for people who are already in the hospital because of their COVID-19 symptoms. Some people with COVID-19 have many symptoms, and some have Am I at high risk? few or no symptoms. And though For adults, bamlanivimab may be an option if you: most people get better within 2 weeks, some people are very sick • Are age 65 or older for a long time — or even die. • Have obesity, with a body mass index (BMI) of 35 or higher There’s no way to know for • Have diabetes, chronic kidney disease, or a sure who will get very sick with condition that weakens the immune system COVID-19, but some people are at higher risk, including older • Take medication that weakens the immune system adults and people with certain 4 • Are age 55 or older and have heart disease, high health conditions. blood pressure, or a long-term lung disease For pediatric patients age 12-17, bamlanivimab may be an option if you: 9 • Have obesity, with a BMI higher than 85 percent of patients your same age or gender • Have heart disease, sickle cell disease, or a long-term lung disease • Have a developmental condition like cerebral palsy • Regularly use medical technology, like a ventilator or feeding tube If you’re not sure whether bamlanivimab is right for you, talk with your doctor. For more detailed information about risk, see the Fact Sheet for Healthcare Providers at bamlanivimab.com. 2 U.S. Food and Drug Administration: http://pi.lilly.com/eua/bamlanivimab-eua-fda-authorization- letter.pdf 3 U.S. Centers for Disease Control and Prevention: https://www.cdc.gov/healthyweight/bmi/calculator.html 4 U.S. Centers for Disease Control and Prevention: cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms Page 2 | PP-BM-US-0009 November 2020 ©Lilly USA, LLC 2020. All rights reserved.

What are the side effects? Before you take bamlanivimab, tell Side effects can range from mild to serious and your doctor if you: 5 may include: • Have any allergies, diseases, • Wheezing (noisy breathing that may sound like or health conditions whistling) or trouble breathing • Are pregnant or plan to get • Swollen lips, face, or throat pregnant • Flu-like symptoms (fever, sweating, chills, • Are breastfeeding or plan to cough, sore throat, headache, or muscle pain) start breastfeeding • Upset stomach (nausea, vomiting, or diarrhea) • Are taking any medicines, • Itching, swelling, rash, or hives including prescription drugs, • Dizziness or low blood pressure over-the-counter drugs, • Changes in your heartbeat vitamins, or herbal products. Tell your doctor or nurse right away if you have any side effects during or after your infusion. Some of these side effects may be signs of a serious allergic reaction. Keep in mind that only a limited number of people have taken bamlanivimab, and scientists are still learning about its side effects and risks. Serious and unexpected side effects may happen. It’s also possible that bamlanivimab could make it harder for your body to fight off a future COVID-19 infection — and it could make a future COVID-19 vaccine less effective for you. Scientists haven’t done specific studies to address these possible risks. If you have any questions, talk with your doctor. What if I’m pregnant or breastfeeding? Scientists haven’t treated many pregnant or breastfeeding people with bamlanivimab. It’s possible that the drug may have more benefits than risks for them and their babies. Talk to your doctor about your options and your specific situation. 5 U.S. Food and Drug Administration: http://pi.lilly.com/eua/bamlanivimab-eua-fda-authorization-letter.pdf Page 3 | PP-BM-US-0009 November 2020 ©Lilly USA, LLC 2020. All rights reserved.

How does the drug work? When there’s a virus in your body, like COVID-19, your immune system makes antibodies to fight it off. But it takes time for your body to make antibodies for a new virus — and in the meantime, you could get very sick. Bamlanivimab is a neutralizing antibody drug. That means it contains man-made antibodies that are similar to the antibodies of patients who recovered from COVID-19. Scientists think that these antibodies may help limit the amount of COVID-19 virus in your body. This could 6 give your body more time to learn how to make its own antibodies. Is this drug safe? Scientists aren’t sure yet. They’re still studying the drug in clinical trials, and there’s a lot they don’t know about the benefits and risks. Because of the COVID-19 pandemic, the FDA has given a temporary Emergency Use Authorization for doctors to use bamlanivimab with 7 certain patients. This means that based on the results of the research so far, the FDA has found that the drug may have more benefits than risks in treating COVID-19 during the pandemic. 6 Coronavirus Prevention Network: https://coronaviruspreventionnetwork.org/coronavirus-vaccine-and-antibody-science/ 7 U.S. Food and Drug Administration: http://pi.lilly.com/eua/bamlanivimab-eua-fda-authorization-letter.pdf Page 4 | PP-BM-US-0009 November 2020 ©Lilly USA, LLC 2020. All rights reserved.

How will I take the drug? You only need to take the drug 1 time. It’s usually given at a hospital, clinic, or infusion center, and the appointment takes about 3 to 4 hours. The treatment is an intravenous (IV) infusion, meaning the drug goes directly into your blood over about 1 hour. A nurse will insert a small needle into a vein in your arm to 8 give you the drug. Does the infusion hurt? With any infusion treatment, you may feel a pinch or sting when the needle first goes in, but the feeling often goes 9 If you feel any pain during the away after a few seconds. infusion, tell the nurse right away. After the infusion, some people may have pain, bleeding, bruising, soreness, or swelling in the place where the needle went in. In some cases, this may lead to more serious problems, like an infection. If you’re not sure whether what you’re feeling after the infusion is normal, it’s always okay to call your doctor or the infusion center and check. Is this drug the same as a vaccine? No. Vaccines help your body make its own antibodies over time. Antibody drugs give you 10 antibodies that may start working more quickly to help your body fight a virus. Bamlanivimab is not a vaccine. It does not have any COVID-19 virus in it. 8 U.S. Food and Drug Administration: http://pi.lilly.com/eua/bamlanivimab-eua-fda-authorization-letter.pdf 9 American Academy of Allergy, Asthma, and Immunology: https://www.aaaai.org/conditions-and-treatments/library/immune-deficiencies-library/ivig 10 Coronavirus Prevention Network: https://coronaviruspreventionnetwork.org/coronavirus-vaccine-and-antibody-science/ Page 5 | PP-BM-US-0009 November 2020 ©Lilly USA, LLC 2020. All rights reserved.

How can I get ready for my appointment? Plan for the infusion appointment to take about 3 to 4 hours. Most people are able to go home the same day, unless they have very serious 11 side effects from the infusion. Before your appointment, make sure to get a good night’s sleep, drink plenty of water, and eat a light meal. Wear warm, comfortable clothes, including a shirt with sleeves you can roll up over your elbows. It’s also 12 important to wear a mask to help prevent the spread of COVID-19. Ask the clinic staff if there’s anything else you need to know. They may ask patients with COVID-19 to take some extra steps to help keep the virus from spreading. You may want to ask questions like: • What do I need to bring with me? • When I arrive, should I call instead of coming into the waiting room? • Will I need someone to give me a ride home after the infusion? To help prevent the spread of COVID-19, friends and family usually can’t be with you during the infusion. If you have any concerns about this, talk 13 with the clinic staff before your appointment. What should I bring with me? The clinic staff can give you more specific information, but you may 14 want to bring: • An extra sweater or blanket • Water and snacks • Things to keep you busy, like books, magazines, music, games, or a laptop, tablet, or phone 11 Eli Lilly and Company: http://pi.lilly.com/eua/bamlanivimab-eua-factsheet-hcp.pdf 12 National Infusion Center Association: https://infusioncenter.org/how-to-prepare-for-your-infusion/ 13 National Infusion Center Association: https://infusioncenter.org/infusion_resources/covid-19/ 14 National Infusion Center Association: https://infusioncenter.org/how-to-prepare-for-your-infusion/ Page 6 | PP-BM-US-0009 November 2020 ©Lilly USA, LLC 2020. All rights reserved.

What is it like to get the infusion? Starting the infusion When you get to the hospital, clinic, or infusion center, a nurse will show you to a chair where you can sit comfortably during the infusion process. The nurse will clean your arm with a special liquid that kills germs. Then they’ll insert a small needle into a vein and start the flow of medicine. During the infusion Once the infusion has started, it takes about 1 hour. From time to time, a nurse will come to check on you and measure your temperature, breathing, and heart rate. When the infusion is over, you’ll need to stay for a couple of hours so the nurse can keep checking on you to make sure you’re feeling okay. To help prevent the spread of COVID-19, the nurse and other 15 clinic staff will wear masks, gloves, and face shields. They may also limit the time they spend near you during the infusion — but they’re still there for you if you need them. If you have any questions or concerns during the infusion process, don’t hesitate to ask the clinic staff. It’s their job to explain what’s happening and make sure you feel comfortable. 15 National Infusion Center Association: https://infusioncenter.org/infusion_resources/covid-19/ Page 7 | PP-BM-US-0009 November 2020 ©Lilly USA, LLC 2020. All rights reserved.

What happens after my appointment? In the days and weeks after your infusion, your doctor or the clinic staff will keep checking with you to see how you feel and which COVID-19 symptoms How soon does the you have. treatment start working? They may also ask you to come in again to do Everyone is different, so there’s another COVID-19 test or to take samples of blood no way to know for sure. In from your arm. clinical trials, people who took bamlanivimab started to see their If you have any new symptoms or side effects, tell symptoms improve after about your doctor right away. You can also report side 6 days, on average, compared effects to FDA MedWatch at www.fda.gov/medwatch to 8 days for people who took an or by calling 1-800-FDA-1088. 16 infusion with no medicine in it. Even after the treatment, you could still pass COVID-19 to other people. It’s important to stay away from other people for as long as your doctor tells you to. 16 Eli Lilly and Company: http://pi.lilly.com/eua/bamlanivimab-eua-factsheet-hcp.pdf Page 8 | PP-BM-US-0009 November 2020 ©Lilly USA, LLC 2020. All rights reserved.

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