In a study of 405 adults with Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia, 271 were treated with BLINCYTO and 134 with chemotherapy. The adults treated with BLINCYTO lived nearly twice as long 7.7 months (median overall survival) compared to 4.0 months with chemotherapy. 1, * BLINCYTO offers the possibility of a longer life 1 A guide for patients and caregivers *Median overall survival is defined as the length of time from the start of treatment that half of the patients in a treatment group are still alive. 2 INDICATION BLINCYTO (blinatumomab) is a prescription medication used to treat a certain type of acute lymphoblastic leukemia (ALL) in adults and children. ALL is a cancer of the blood and bone marrow in which a particular kind of white blood cell is growing out of control. The most important information about BLINCYTO : Call your health care provider or get emergency medical help right away if you get any of the symptoms listed in this brochure. o BLINCYTO may cause serious side effects that can be severe, life-threatening, or lead to death, including: Cytokine Release Syndrome (CRS) and infusion reactions. Neurologic problems. 1
Table of contents 3 4 5 6 7 8 9 10 11 12 13 15 You are not alone Treatment goals Immunotherapy compared to chemotherapy How have patients responded to BLINCYTO? What to know about getting treatment Your first dosing cycle Therapy at home Safety and side effects Financial assistance: Amgen Assist 360 Your care team Important Safety Information Glossary (bolded words defined) 2
You are not alone Living with acute lymphoblastic leukemia (ALL) can be difficult especially after chemotherapy. For some people, who achieve remission with chemotherapy, a relapse may occur. In other cases, a person may be treated and not reach remission. 3,4 If this sounds like you, there are options. One of those options is BLINCYTO. Most importantly, remember you are not alone. BLINCYTO may cause serious side effects that can be severe, life-threatening, or lead to death, including Cytokine Release Syndrome (CRS) and Infusion Reactions. Symptoms of CRS and infusion reactions may include: fever, tiredness or weakness, dizziness, headache, low blood pressure, nausea, vomiting, chills, face swelling, wheezing or trouble breathing, and skin rash. 3
Treatment goals Your treatment is a journey. An important step along the way is reaching complete remission with the goal of living longer. 4 Your doctor may think BLINCYTO can help you reach that goal. Compared to chemotherapy, BLINCYTO has been proven to increase your chances of complete remission and to help you live longer. 1 That s why your doctor prescribed BLINCYTO so you can have the chance for more time. BLINCYTO may cause serious side effects that can be severe, life-threatening, or lead to death, including Neurologic problems. Symptoms of neurologic problems may include: seizures, difficulty in speaking or slurred speech, loss of consciousness, trouble sleeping, confusion and disorientation, loss of balance, headache, and difficulty with facial movements, hearing, vision, or swallowing. 4
Immunotherapy compared to chemotherapy BLINCYTO is not chemotherapy. It belongs to a class of treatment called immunotherapy. Immunotherapy uses your own body (specifically your T cells) to help fight conditions such as ALL. 1,2 Basically, BLINCYTO works in 2 steps. First, it connects the T cells to specific types of cancer and healthy cells. Then, it engages your T cells so they can help fight the cancer cells. 1 Your doctor can help explain this in more detail. BLINCYTO may cause serious side effects that can be severe, life-threatening, or lead to death, including: Cytokine Release Syndrome (CRS) and Infusion Reactions. Neurologic problems. Your health care provider will check for these problems during treatment with BLINCYTO. Your health care provider may temporarily stop or completely stop your treatment with BLINCYTO if you have severe side effects. 5
BLINCYTO may help you reach milestones While complete remission is an important step, the goal of your treatment journey is living a longer life. 4 About 1/3 of adult patients with Philadelphia chromosome negative relapsed or refractory B-cell precursor ALL treated with BLINCYTO reached complete remission. And nearly 1/10 of patients (24 out of 271) reached complete remission with partial recovery of blood counts. 1 BLINCYTO may help you live longer 1 BLINCYTO is the only immunotherapy shown to help adults with Philadelphia chromosome negative relapsed or refractory B-cell precursor ALL live significantly longer than those treated with chemotherapy. 1,5-8 In a study of 405 adults with ALL, 271 were treated with BLINCYTO and 134 were treated with chemotherapy. 1 BLINCYTO extended lives more than chemotherapy. In fact, it gave them nearly double the time (7.7 months median overall survival with BLINCYTO versus 4.0 months with chemotherapy). 1, * *Median overall survival is defined as the length of time from the start of treatment that half of the patients in a treatment group are still alive. 2 BLINCYTO may cause serious side effects, including: o Infections. BLINCYTO may cause life-threatening infections that may lead to death. Tell your health care provider right away in case you develop any signs or symptoms of an infection. o Low white blood cell counts (neutropenia). Neutropenia is common with BLINCYTO treatment and may sometimes be life-threatening. Low white blood cell counts can increase your risk of infection. Your health care provider will do blood tests to check your white blood cell count during treatment with BLINCYTO. Tell your health care provider right away if you get a fever. 6
What to know about getting treatment BLINCYTO is administered by intravenous (IV) infusion into your vein by a pump. Your health care provider will decide the number of BLINCYTO treatment cycles. 9 Before you receive BLINCYTO, you will also be given a medicine to help reduce the likelihood of infusion reactions. 9 It is very important to keep the area around the IV needle clean to reduce the risk of getting an infection. Your health care provider will show you how. 9 Do not change the settings on your infusion pump, even if there is a problem with your pump or your pump alarm sounds. Any changes to your infusion pump settings may cause a dose that is too high or too low to be given Call your health care provider or nurse right away if you have any problems with your pump or your pump alarm sounds Symptoms of Cytokine Release Syndrome and infusion reactions may include: o fever, tiredness or weakness, dizziness, headache, low blood pressure, nausea, vomiting, chills, face swelling, wheezing or trouble breathing, and skin rash. 7
Your first dosing cycle 1 4 weeks ON 2 weeks OFF* BLINCYTO offers 3 dosing intervals 24 hours, 48 hours, and 7 days. A weeklong dose can mean fewer trips to the infusion center and more time at home. *Your doctor will decide your dosing intervals, whether you will be given additional cycles (up to 9 total cycles), and will adjust the time-off period accordingly. BLINCYTO may cause serious side effects, including: Abnormal liver blood test. Your health care provider will do blood tests to check your liver before you start BLINCYTO and during treatment with BLINCYTO. Inflammation of the pancreas (pancreatitis). Pancreatitis may happen in people treated with BLINCYTO and corticosteroids. It may be severe and lead to death. Tell your health care provider right away if you have severe stomach-area pain that does not go away. The pain may happen with or without nausea and vomiting. 8
Therapy at home If your doctor decides you re ready to go home with BLINCYTO : Work with your nurse or social worker to determine whether you will be treated at home or at a nearby outpatient center Talk to your health care provider about whether your IV bag will be changed at an outpatient clinic or with a home health care agency Assess your benefit coverage for outpatient treatment Carefully monitor yourself for side effects Call your doctor immediately if you experience any problems Do not change the settings on your infusion pump Keep BLINCYTO and all medicines out of the reach of children If you are having any problems with your pump, contact your health care provider immediately Intravenous (IV) bags containing BLINCYTO for infusion will arrive in a special package. Do not open the package. Do not freeze the package. The package containing BLINCYTO will be opened by your health care provider and stored in the refrigerator at 36 F to 46 F (2 C to 8 C) for up to 8 days. Do not throw away (dispose of) any BLINCYTO in your household trash. Talk with your health care provider about disposal of BLINCYTO and used supplies. 9
Serious side effects 9 BLINCYTO may cause serious side effects that can be severe, life-threatening, or may even lead to death. These include: Cytokine Release Syndrome (CRS) and infusion reactions, and Neurologic problems. Symptoms of CRS and infusion reactions may include: Fever Tiredness or weakness Dizziness Headache Low blood pressure Nausea Vomiting Chills Face swelling Wheezing or trouble breathing Skin rash Symptoms of neurologic problems include: Seizures Difficulty in speaking or slurred speech Loss of consciousness Confusion and disorientation Loss of balance Trouble sleeping and headache Difficulty with facial movements, hearing, vision, or swallowing Make sure to contact your doctor immediately if you experience any side effects while taking BLINCYTO. Tell your health care provider right away if you develop an infection or a fever. Tell your health care provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of BLINCYTO. What are the possible side effects of BLINCYTO? BLINCYTO may cause serious side effects, including: Infections. BLINCYTO may cause lifethreatening infections that may lead to death. Tell your health care provider right away if you develop any signs or symptoms of an infection Infections Fever Headache Low red blood cell count (anemia) Low white blood cell counts (neutropenia) Abnormal liver blood tests Inflammation of the pancreas (pancreatitis) The most common side effects of BLINCYTO include: Low platelet count (thrombocytopenia) Reactions related to infusion of the medicine, such as face swelling, low blood pressure, and high blood pressure (infusion-related reactions) 10
Support, Simplified: Amgen Assist 360 We re here for you. Discover how Amgen Assist 360 can help refer you to resources most important to you* Support, Simplified To learn more and enroll, call 888-4ASSIST (888-427-7478) Monday to Friday, 9:00 a.m. to 8:00 p.m. EST. * Some services provided through independent, charitable patient assistance programs. Amgen has no control over independent, third-party programs and provides referrals as a courtesy only. 11
Your care team Health care providers should be only one part of your support network. Your loved ones will be a huge help in your treatment journey. Friends and family want to be there for you, but may not know how. Let them know it s okay to ask questions and check in. And remember, you can ask for help, too. They are there for you. In addition to your personal caregivers, there are patient support groups that can provide invaluable support throughout the treatment process, such as the Leukemia & Lymphoma Society at www.lls.org. You may also want to reach out to the: American Cancer Society cancer.org National Cancer Institute cancer.gov 12
INDICATION BLINCYTO (blinatumomab) is a prescription medication used to treat a certain type of acute lymphoblastic leukemia (ALL) in adults and children. ALL is a cancer of the blood and bone marrow in which a particular kind of white blood cell is growing out of control. What is the most important information I should know about BLINCYTO? Call your health care provider or get emergency medical help right away if you get any of the symptoms listed below: o BLINCYTO may cause serious side effects that can be severe, life-threatening, or lead to death, including: Cytokine Release Syndrome (CRS) and infusion reactions. Symptoms of CRS and infusion reactions may include: fever, tiredness or weakness, dizziness, headache, low blood pressure, nausea, vomiting, chills, face swelling, wheezing or trouble breathing, and skin rash. Neurologic problems. Symptoms of neurologic problems may include: seizures, difficulty in speaking or slurred speech, loss of consciousness, trouble sleeping, confusion and disorientation, loss of balance, headache, and difficulty with facial movements, hearing, vision, or swallowing. o Your health care provider will check for these problems during treatment with BLINCYTO. Your health care provider may temporarily or completely stop your treatment with BLINCYTO if you have severe side effects. Who should not receive BLINCYTO? Do not receive BLINCYTO if you are allergic to blinatumomab or to any of the ingredients of BLINCYTO. What should I avoid while receiving BLINCYTO? Do not drive, operate heavy machinery, or do other dangerous activities while you are receiving BLINCYTO because BLINCYTO can cause neurological symptoms such as dizziness, seizures, and confusion. Before you receive BLINCYTO, tell your health care provider about all of your medical conditions, including if you: have a history of neurological problems, such as seizures, confusion, trouble speaking or loss of balance have an infection have ever had an infusion reaction after receiving BLINCYTO or other medications have a history of radiation treatment to the brain, or chemotherapy treatment are scheduled to receive a vaccine. You should not receive a live vaccine within 2 weeks before you start treatment with BLINCYTO, during treatment, and until your immune system recovers after you receive your last cycle of BLINCYTO. If you are not sure about the type of vaccine, ask your health care provider. are pregnant or plan to become pregnant. BLINCYTO may harm your unborn baby. Tell your health care provider if you become pregnant during treatment with BLINCYTO. o If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with BLINCYTO. o Females who are able to become pregnant should use an effective form of birth control during treatment with BLINCYTO, and for at least 48 hours after the last dose of BLINCYTO. are breastfeeding or plan to breastfeed. It is not known if BLINCYTO passes into your breast milk. You should not breastfeed during treatment with BLINCYTO and for at least 48 hours after your last treatment. Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 13
BLINCYTO may cause serious side effects, including: o Infections. BLINCYTO may cause life-threatening infections that may lead to death. Tell your health care provider right away in case you develop any signs or symptoms of an infection. o Low white blood cell counts (neutropenia). Neutropenia is common with BLINCYTO treatment and may sometimes be life-threatening. Low white blood cell counts can increase your risk of infection. Your health care provider will do blood tests to check your white blood cell count during treatment with BLINCYTO. Tell your health care provider right away if you get a fever. o Abnormal liver blood test. Your health care provider will do blood tests to check your liver before you start BLINCYTO and during treatment with BLINCYTO. o Inflammation of the pancreas (pancreatitis). Pancreatitis may happen in people treated with BLINCYTO and corticosteroids. It may be severe and lead to death. Tell your health care provider right away if you have severe stomach-area pain that does not go away. The pain may happen with or without nausea and vomiting. Your health care provider will do blood tests during treatment to check for side effects. The most common side effects of BLINCYTO include: o infections o fever o headache o low red blood cell count (anemia) o low white blood cell count (neutropenia) o low white blood cell count with fever (febrile neutropenia) o low platelet count (thrombocytopenia) o reactions related to infusion of the medicine such as face swelling, low blood pressure, high blood pressure (infusion-related reactions) These are not all the possible side effects of BLINCYTO. Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please read the Medication Guide before you receive BLINCYTO and before each BLINCYTO infusion and discuss it with your doctor. Please click here to see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for BLINCYTO. 14
Glossary 2 Acute lymphoblastic leukemia (ALL): A blood cancer in which the bone marrow makes too many lymphoblasts a certain type of white blood cell. Chemotherapy: A treatment that uses drugs to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Often called chemo. Complete remission: The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete response. Immunotherapy: A type of medicine that uses your body s own immune system to help fight conditions such as cancer. Infusion: A method of putting fluids, including drugs, into the bloodstream. Also called intravenous infusion. IV (Intravenous): A way of giving a drug through a needle into a vein. Relapse: The return of a disease or the signs and symptoms of a disease after a period of improvement. Remission: A decrease in or disappearance of signs and symptoms of cancer. In partial remission, some, but not all, signs and symptoms of cancer have disappeared. T cell: A type of white blood cell that is part of the immune system. It helps protect the body from infection and may help fight cancer. 15
References: 1. BLINCYTO (blinatumomab) Prescribing Information, Amgen. 2. National Cancer Institute. NCI Dictionary of Cancer Terms. https://www.cancer.gov/publications/dictionaries/cancer-terms. Accessed July 14, 2017. 3. American Cancer Society. What happens after treatment for acute lymphocytic leukemia? https://www.cancer.org/cancer/acute-lymphocytic-leukemia/after-treatment/ follow-up.html. Accessed August 11, 2017. 4. American Cancer Society. Typical treatment of acute lymphocytic leukemia. https://www.cancer.org/cancer/ acute-lymphocytic-leukemia/treating/typical-treatment.html. Accessed August 11, 2017. 5. Data on file, Amgen; December 2014. 6. Data on file, Amgen; April 2016. 7. Kantarjian H, Stein A, Gökbuget N, et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med. 2017;376:836-847. 8. Kantarjian H, DeAngelo DJ, Stelljes M, et al. Inotuzumab ozogamicin versus standard therapy for acute lymphoblastic leukemia. N Engl J Med. 2016;375:740-753. 9. BLINCYTO (blinatumomab) Medication Guide, Amgen. Please see accompanying BLINCYTO full Prescribing Information including Medication Guide. BLINCYTO is a registered trademark of Amgen Inc. 2018 Amgen Inc. All rights reserved. USA-103-051147(1) 16