Giving appropriate patients another chance to fight OPDIVO

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1 For dmmr/msi-h Colorectal Cancer (CRC) All individuals depicted are models used for illustrative purposes only. Who is OPDIVO for? OPDIVO is a prescription medicine used to treat colorectal cancer (a type of colon or rectal cancer). OPDIVO is for adults and children 12 years of age and older who: Have colorectal cancer that has spread to other parts of the body (metastatic); AND Has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan; AND Have a tumor that is mismatch repair deficient (dmmr) or microsatellite instability-high (MSI-H). OPDIVO was approved based on response rate and how long patients responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO for this use. It is not known if OPDIVO is safe and effective in children less than 12 years of age for treatment of metastatic, MSI-H or dmmr, colorectal cancer. Information provided in this brochure is not a substitute for talking with your healthcare professional. Your healthcare professional is the best source of information about your disease. Giving appropriate patients another chance to fight OPDIVO It can be overwhelming to learn that your cancer has come back or spread after you have had treatments like chemotherapy. But even when those options have been unsuccessful, there may still be hope. Talk to your doctor about a different kind of treatment option OPDIVO. Proven in a clinical trial After treatment with a fluoropyrimidine, oxaliplatin, and irinotecan: 28 or 15 of 53 patients had % their tumors shrink or disappear completely 26% (14 of 53) saw their tumors shrink (partial response) 1.9% (1 of 53) saw their tumors disappear completely (complete response) OPDIVO will not work for everyone. Individual results may vary. What are the serious side effects of OPDIVO? A serious side effect is a side effect that can sometimes become life-threatening and can lead to death. They can happen anytime during treatment or even after your treatment has ended. Serious side effects may include: lung problems (pneumonitis) intestinal problems (colitis) that can lead to tears or holes in your intestine liver problems (hepatitis) hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas) OPDIVO was studied in a clinical trial of 74 people whose dmmr/msi-h CRC had spread to other parts of the body (metastatic) and who were treated with at least one prior line of therapy that would have included fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy. Of the 74 people included in the clinical trial, 53 received prior treatment with all three of the following: fluoropyrimidine, oxaliplatin, and irinotecan. This study was designed to look at overall response rate and duration of response. Overall response rate is the percentage of people who responded to treatment. These people saw their tumors either shrink (partial response) or disappear completely (complete response). Duration of response is the measure of how long the response lasts. Additional information about this study is continued on the next page. kidney problems, including nephritis and kidney failure skin problems inflammation of the brain (encephalitis) problems in other organs severe infusion reactions Please see Important Facts about OPDIVO for more information about side effects on pages

2 How long did people respond to OPDIVO (nivolumab) in the clinical trial? When the data were collected, more than half of the people who responded to OPDIVO were still responding. Of the 15 people who responded after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan The clinical trial is ongoing. The shortest response lasted 2.8 months The longest response lasted 22.1 months OPDIVO will not work for everyone. Individual results may vary. Is OPDIVO right for me? That s a conversation you need to have with your oncologist. But you should know that OPDIVO is a different kind of treatment option that may work for you. OPDIVO is a prescription medicine used to treat adults and children 12 years of age and older with a type of colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic), has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and is mismatch repair deficient (dmmr) or microsatellite instability-high (MSI-H). OPDIVO was approved based on response rate and how long patients responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO for this use. Your doctor can test for your MSI status to confirm if OPDIVO may be right for you. Ask your doctor about OPDIVO. What are the most common side effects of OPDIVO? The most common side effects of OPDIVO include: feeling tired pain in muscles, bones, and joints diarrhea cough constipation back pain rash itchy skin nausea shortness of breath decreased appetite upper respiratory tract infection weakness These are not all of the possible side effects of OPDIVO. Talk to your healthcare team for more information. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA You may also report side effects to Bristol-Myers Squibb at Please see Important Facts about OPDIVO for more information about side effects on pages

3 How does OPDIVO (nivolumab) work with my immune system? How is OPDIVO different from chemotherapy? OPDIVO is an immunotherapy treatment that works with the T cells of your immune system. Learning more about the treatment, including how it may work, can help you have better conversations with your healthcare team and be empowered to make more-informed treatment decisions. 1 What do my T cells do to cancer cells? Active T cell RECOGNIZE ATTACK Cancer cells Here s a closer look at how OPDIVO works inside your body: Like a radar, your immune system s T cells are always searching for threats. Once T cells recognize threats like cancer cells, they become active and attack them in order to help protect your body. 2 How does cancer escape my T cells? Sometimes, cancer cells are able to disguise themselves from T cells. If this happens, cancer cells inactivate T cells so the T cells cannot attack. This allows cancer to grow more easily. Inactive T cell Disguised cancer cells 3 How does OPDIVO work inside my body? OPDIVO may help T cells recognize and attack cancer cells again, by blocking cancer s ability to disguise itself. This allows your T cells to be active and to attack. While doing so, OPDIVO could also cause your T cells to attack healthy cells in your body. OPDIVO Active T cell RECOGNIZE ATTACK Cancer cells Healthy cells OPDIVO can cause your T cells to attack healthy cells contained within organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death, and may happen anytime during treatment or even after your treatment has ended. Please see pages 5-6 for a list of possible side effects and what to look out for. For more information, call OPDIVO-1 or visit LearnAboutOPDIVO.com Website Call to Action Please see pages 5-6 for a list of possible side effects and what to look out for. 3

4 How is OPDIVO (nivolumab) given? A dosing schedule with a single one-hour infusion every two weeks WEEK 1 AT ABOUT WEEK 6 3 Receive 1st infusion. Infusions will continue every 2 weeks. 3 Receive 1st scan. Continue treatment every 2 weeks as long as it is working and side effects are tolerable. These are general recommendations about treatment timing and dosing based on a clinical trial. Only your doctor can make specific recommendations about your treatment with OPDIVO. OPDIVO is given through intravenous (IV) infusion. The medicine is given directly into the bloodstream through a needle placed in a vein by a healthcare professional usually in the arm or hand. The infusion takes 60 minutes, though actual time in the clinic may vary. OPDIVO infusions are usually given every 2 weeks. Your doctor will decide how many treatments you need. You should stay on treatment unless the cancer grows or you have unacceptable side effects. Your healthcare provider will do blood tests to check you for side effects, and may treat you with corticosteroid or hormone replacement medicines, and delay or completely stop treatment with OPDIVO if you have side effects that are severe. Be sure to talk to your healthcare team about side effects. Frequent communication with your healthcare team is an important part of treatment. Use your 2-week appointment to let them know how you re feeling and ask any questions you may have. You may also be able to talk with others going through a similar situation. If you miss an appointment, call a healthcare provider right away. Try to schedule your appointments for the same day of the week and the same time of day to make them easier to remember. It is important for you to keep all appointments with your healthcare provider. See page 6 for information about pregnancy, nursing, health problems, and other medicines that you should discuss with your healthcare team before starting OPDIVO. Please see Important Facts about OPDIVO for more information about side effects on pages 5-6. SIGN UP for OPDIVO with You. OPDIVO with You means just that: we re here to help you better understand OPDIVO, whether you or a loved one are just considering OPDIVO or already have an OPDIVO prescription. This complimentary program includes the following resources. Sign up and you ll receive: Helpful Information Get useful tips, tools, and educational materials that can help you learn more about OPDIVO and may help support your care. Support and Advocacy Groups We can direct you to organizations that may be helpful for the challenges you may face. A Care Counselor as Close as Your Phone If you are prescribed OPDIVO and sign up for this additional resource, you ll be able to speak with a registered nurse. This personal Care Counselor can answer questions about treatment and help you to be a more informed partner with your doctor. Care Counselors cannot provide medical advice. Your healthcare professional is the best source of information about your health. If you d like to sign up for the OPDIVO with You program, or if you have general questions about OPDIVO, call OPDIVO-1 ( ) 8 AM to 8 PM ET, Monday to Friday, or visit OPDIVOwithYou.com/learn 4

5 Important Facts about OPDIVO (nivolumab) This is a summary of important information that you need to know about OPDIVO. Your healthcare team can work with you to help answer any questions you may have about OPDIVO. Keep this information in a safe place, so you can refer to it before and during your treatment. Look out for the following icons as you read: Talk to your healthcare team Call a healthcare provider right away Helpful information to remember What is OPDIVO? OPDIVO is a prescription medicine used to treat colorectal cancer (a type of colon or rectal cancer). OPDIVO is for adults and children 12 years of age and older who: Have colorectal cancer that has spread to other parts of the body (metastatic); AND Has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan; AND Have a tumor that is mismatch repair deficient (dmmr) or microsatellite instability-high (MSI-H). OPDIVO was approved based on response rate and how long patients responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO for this use. It is not known if OPDIVO is safe and effective in children less than 12 years of age for treatment of metastatic, MSI-H or dmmr, colorectal cancer. OPDIVO is a medicine that may treat certain cancers by working with your immune system. It can cause your immune system to attack normal organs and tissues in any area of your body, and can affect the way these organs work. What are the serious side effects of OPDIVO? A serious side effect is a side effect that can sometimes become life-threatening and can lead to death. They can happen anytime during treatment or even after your treatment has ended. Get medical help immediately if you develop any of these symptoms or they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for side effects during treatment with OPDIVO, and may treat you with corticosteroid or hormone replacement medicines. If you have a serious side effect, your healthcare team may need to delay or completely stop your treatment. Lung problems (pneumonitis) Things to look out for may include: new or worsening cough chest pain shortness of breath Intestinal problems (colitis) that can lead to tears or holes in your intestine Things to look out for may include: diarrhea (loose stools) or more bowel movements than usual blood in your stools or dark, tarry, sticky stools severe stomach area (abdomen) pain or tenderness Liver problems (hepatitis) Things to look out for may include: yellowing of your skin or the whites pain on the right side of your stomach of your eyes area (abdomen) severe nausea or vomiting drowsiness dark urine (tea colored) bleeding or bruising more easily than normal feeling less hungry than usual Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas) Things to look out for may include: headaches that will not go away or unusual headaches extreme tiredness weight gain or weight loss dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness hair loss feeling cold constipation voice gets deeper excessive thirst or lots of urine Kidney problems, including nephritis and kidney failure Things to look out for may include: decrease in the amount of urine swelling in your ankles blood in your urine loss of appetite Skin problems Things to look out for may include: rash skin blistering itching ulcers in the mouth or other mucous membranes (continued on page 6) 5

6 Important Facts about OPDIVO (nivolumab) continued Inflammation of the brain (encephalitis) Things to look out for may include: headache memory problems sleepiness tiredness or weakness seeing or hearing things that are not confusion really there (hallucinations) What are the most common side effects of OPDIVO? The most common side effects of OPDIVO include: feeling tired cough pain in muscles, constipation bones, and joints back pain diarrhea These are not all of the possible side effects of OPDIVO. Talk to your healthcare team for more information. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA You may also report side effects to Bristol-Myers Squibb at How will I receive OPDIVO? rash itchy skin nausea shortness of breath seizures stiff neck Problems in other organs Things to look out for may include: changes in eyesight severe or persistent muscle or joint pains severe muscle weakness Severe infusion reactions Things to look out for may include: chills or shaking difficulty breathing itching or rash dizziness flushing feeling like passing out Talk to your healthcare team right away if you get any of the symptoms of a severe infusion reaction during or after an infusion of OPDIVO. What should I discuss with my healthcare team about pregnancy and nursing before starting OPDIVO? Tell your healthcare team if you are pregnant or plan to become pregnant. OPDIVO can harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control during and for at least 5 months after the last dose of OPDIVO. Talk to your healthcare team about birth control methods that you can use during this time. Tell your healthcare team right away if you become pregnant during treatment. Tell your healthcare team if you are breastfeeding or plan to breastfeed. It is not known if OPDIVO passes into your breast milk. Do not breastfeed during treatment. What should I discuss with my healthcare team before starting OPDIVO? Talk to your healthcare team about all of your health problems or concerns, including if you: have immune system problems such as Crohn s disease, ulcerative colitis, or lupus have had an organ transplant have lung or breathing problems have liver problems have any other medical conditions Talk to your healthcare team about all of the medicines you are taking, including: prescription medicines over-the-counter medicines vitamins herbal supplements OPDIVO is a prescription medicine that is given as an intravenous (IV) infusion by your healthcare team. decreased appetite upper respiratory tract infection weakness An IV infusion is when medicine is given directly into the bloodstream through a needle placed in a vein by a healthcare professional - usually in the arm or hand. 60 minutes intravenous (IV) infusion time, though actual time in the clinic may vary. OPDIVO is usually given every 2 weeks. Your doctor will decide how many treatment cycles you will receive, and do blood tests to check you for side effects. Call your doctor right away to reschedule your appointment if you miss any of your appointments. For more information, please see U.S. Full Prescribing Information and Medication Guide for OPDIVO, or talk to your healthcare team. 6

7 Glossary Complete Response (CR) The disappearance of any measurable sign of cancer, such as tumors, in response to treatment. This does not necessarily mean the cancer has been cured. Also called complete remission. dmmr An abbreviation for deficient mismatch repair. Cells in your body have a mismatch repair (MMR) system, which can fix inconsistencies in their DNA. dmmr means that this system is deficient, or not functioning properly. This can result in tumors with microsatellite instability (see MSI-H). Duration of Response (DOR) The measure of how long a response to treatment lasts. Immunotherapy Treatment that can enhance the ability of the body s immune system to fight disease. MSI-H An abbreviation for microsatellite instability-high. Microsatellites are sections of DNA arranged in a certain order within a cell. The order can change when cells make mistakes repairing themselves. A cell is considered MSI-H when many sections are out of order. Overall Response Rate (ORR) Also known as the Objective Response Rate. The percentage of patients who had a positive response to treatment and saw their tumors either shrink (called a partial response) or disappear completely (called a complete response). Partial Response (PR) The decrease in the size of a tumor or the amount of cancer in the body in response to treatment. Also called partial remission. T cell A type of white blood cell in the immune system that protects the body from infection and may help the body fight cancer. Financial Resources Patient Access, Reimbursement and Co-Pay Support Available through Bristol-Myers Squibb Access Support Bristol-Myers Squibb is committed to helping patients gain access to their prescribed BMS medications. That s why we offer the BMS Access Support program, which provides resources to help patients understand their insurance coverage and find information on sources of financial support, including co-pay assistance for eligible commercially insured patients. For more information, ask your doctor, visit BMS Access Support, or call BMS Access Support at , 8 AM to 8 PM ET, Monday-Friday. Other Patient Resources * Colon Cancer Alliance ccalliance.org The mission of Colon Cancer Alliance is to empower a nation of advocates who work with us to offer support for patients, raise awareness of preventative measures, and inspire efforts to fund critical research. Michael s Mission michaelsmission.org Michael s Mission is a non-profit organization focused on working to improve the research of and treatment options for those suffering from colorectal cancer through education and patient support. Raymond Foundation TheRaymondFoundation.org The Raymond Foundation is passionate in their efforts to research colorectal cancer. The Foundation encourages outreach, patient and caregiver education, and empowerment services. * Bristol-Myers Squibb does not endorse these organizations. The information/links provided by Bristol-Myers Squibb are meant for informational purposes only and are not meant to replacea physician s medical advice. For more information, please see U.S. Full Prescribing Information and Medication Guide for OPDIVO (nivolumab), or talk to your healthcare team. Bristol-Myers Squibb is committed to helping patients throughout their treatment Bristol-Myers Squibb Company. All rights reserved. OPDIVO, Access Support, and the related logos are trademarks of Bristol-Myers Squibb Company. 1506US /17 7