Starting on SPRYCEL® (dasatinib) TABLE OF CONTENTS 2 4 13-18 28 YOU’VE BEEN DIAGNOSED... TALK TO YOUR DOCTOR PATIENT-TO-PATIENT ABOUT... RESOURCES 7 20-23 31 WHAT CAUSES IT? TAKING SPRYCEL® (dasatinib) ADDITIONAL SOURCES FOR INFORMATION AND SUPPORT 9 24-26 A NEW DIRECTION INDICATIONS AND IMPORTANT SAFETY INFORMATION 10 THE GOALS INDICATIONS AND USAGE SPRYCEL® (dasatinib) is a prescription medicine used to treat adults who have: SELECT IMPORTANT • Newly diagnosed Philadelphia SAFETY INFORMATION chromosome-positive (Ph+) chronic myeloid leukemia SPRYCEL may cause serious side (CML) in chronic phase. The effects, including low blood cell effectiveness of SPRYCEL in counts, bleeding, fluid retention, these patients is based on heart problems, and pulmonary 3 a study that measured two arterial hypertension. Other types of response to treatment common side effects of SPRYCEL (cytogenetic and molecular) by include diarrhea, headache, 1 year. The study is ongoing to cough, skin rash, fever, nausea, find out how SPRYCEL works tiredness, vomiting, muscle pain, over a longer period of time weakness, and infections. This • Ph+ CML who are no longer is not a complete list of all side benefitting from, or did not effects recorded in clinical studies tolerate, other treatment with SPRYCEL. Tell your healthcare including Gleevec® provider if you have any side effects (imatinib mesylate) while taking SPRYCEL. Please read pages 16-18 for additional Important Safety Information about SPRYCEL. Please read the Patient Information section of the full Prescribing Information on pages 30-31. YOU’VE BEEN DIAGNOSED WITH But it’s important to know that PHILADELPHIA with the treatments available Your doctor is your ongoing today, many people with partner in treatment. Being open CHROMOSOME- Ph+ CML may be able to about what you’re feeling, and POSITIVE (Ph+) continue living productive and asking any questions you may satisfying lives. CHRONIC have are important parts of the partnership. 4 MYELOID Know that you’re LEUKEMIA not alone And don’t forget about (CML)... You probably have many questions friends and loved ones about the disease and your The news that you have Ph+ CML treatment. The goal of this kit is It’s up to you to decide who you has probably come as a shock to help answer some of those want to talk to about your condition. to you and your loved ones. And questions. And when. But you may find that, you may find yourself feeling sad, given the chance, friends and loved depressed, or afraid. These are very Your healthcare team is the best ones may provide their own very normal reactions. resource for information. special kind of care. About 70,000 people in America are living with Ph+ CML. And around 6,000 people are newly diagnosed each year. What is Philadelphia chromosome-positive causes the bone marrow to produce more white blood cells, (Ph+) chronic myeloid even when they are not needed. CML: LET’S leukemia (CML) in These are mostly damaged chronic phase? or immature. Over time, these START extra, unhealthy white blood 5 FROM THE It’s a mouthful, that’s for sure. cells overcrowd healthy white So let’s try to break it down: blood cells, red blood cells, and BEGINNING platelets. 1. Ph+ CML, or chronic myeloid What is leukemia? leukemia, is a type of leukemia. 3. The lack of healthy blood cells It is caused by an abnormal and platelets leads to the signs Leukemia is a kind of blood chromosome in the body and symptoms of Ph+ CML. cancer that begins in the bone called the Philadelphia (or Ph) marrow. That is the soft tissue chromosome. 4. Usually, when people are in the center of your bones that diagnosed with Ph+ CML, they produces all types of blood 2. The Ph chromosome creates are in the “chronic phase.” CML cells. There are different forms what is known as the BCR-ABL symptoms are milder in the of leukemia. The kind you have is cancer gene. When you have chronic phase, compared to called Ph+ CML. Ph+ CML, the BCR-ABL protein later phases. Please read pages 16-18 for additional Important Safety Information about SPRYCEL. Please read the Patient Information section of the full Prescribing Information on pages 30-31. SPRYCEL (dasatinib) has been prescribed for over 8 years IMPORTANT SAFETY INFORMATION since initial FDA approval, with It is not known if more than 220,000 TKIS: A NEW SPRYCEL® (dasatinib) is safe and effective in children prescriptions DIRECTION IN younger than 18 years old. TREATMENT written. Before you take SPRYCEL, tell Not too long ago, people with your healthcare provider if you: 6 Ph+ CML were given traditional • have problems with your treatments such as chemotherapy. immune system Then a whole new kind of therapy • have liver problems was developed, giving patients more • have heart problems healthcare provider right away treatment options. This new therapy • are lactose intolerant if you are pregnant or plan to is called tyrosine kinase inhibitors • have any other medical become pregnant (TKIs). conditions • are breast-feeding or plan to • are pregnant or planning to breast-feed. It is not known Once people with chronic phase become pregnant. SPRYCEL if SPRYCEL passes into your Ph+ CML start treatment, they can harm your unborn baby. breast milk or if it can harm your may feel well enough to continue Sexually active female patients baby. You and your healthcare their day-to-day activities such of childbearing potential provider should decide if you will as working, spending time with taking SPRYCEL should take SPRYCEL or breast-feed. family, running errands, etc. avoid pregnancy. Talk to your You should not do both Please read pages 16-18 for additional Important Safety Information about SPRYCEL. Please read the Patient Information section of the full Prescribing Information on pages 30-31. IMPORTANT SAFETY It’s important to THE GOALS OF INFORMATION ABOUT LOW remember that 7 TREATMENT BLOOD CELL COUNTS CML is a chronic WITH ® SPRYCEL (dasatinib) may cause disease. Do your SPRYCEL low red blood cell counts (anemia), part and take your low white blood cell counts (dasatinib) (neutropenia), and low platelet medication daily, counts (thrombocytopenia). as prescribed by The immediate goal of treatment is Your healthcare provider will do your doctor. to reduce any symptoms of CML blood tests to check your blood you may have. The longer-term goal cell counts regularly during your is to decrease cancer cells to a level treatment with SPRYCEL. Call your that is not detectable by testing. healthcare provider right away if This may slow down the disease you have a fever or any signs of an from progressing. infection while taking SPRYCEL. Please read pages 16-18 for additional Important Safety Information about SPRYCEL. Please read the Patient Information section of the full Prescribing Information on pages 30-31. TALK TO YOUR You may find it helpful to keep a 8 HEALTHCARE pen and paper or journal nearby TEAM ABOUT so that you can make note of any Talk to your doctor SIDE EFFECTS side effect you might feel. right away if you This is also a great way to keep have any side Your doctor and your healthcare track of any questions that come effects. Don’t wait team need to know about any side to your mind. By writing these for your symptoms effect of treatment that bothers you things down, you’ll be able to have or that does not go away. No matter everything you need handy when to get worse! how small the change may seem, you speak with your doctor or other they will want to know about it. member of your healthcare team. Please read pages 16-18 for Important Safety Information about SPRYCEL. Please read the Patient Information section of the full Prescribing Information on pages 30-31. SIDE EFFECTS Call your healthcare provider This kind of bleeding is also ® OF SPRYCEL right away if you have a fever or known as thrombocytopenia. any signs of an infection while (dasatinib) taking SPRYCEL. If your doctor suspects you have bleeding, he or she will probably Here are some side effects of Low blood cell counts are also do a physical exam and blood tests. SPRYCEL® (dasatinib) that you known as myelosuppression. should be aware of. It is not a Fluid retention complete list of all side effects Bleeding recorded in clinical studies. SPRYCEL may cause your body to SPRYCEL may cause severe hold too much fluid. In severe cases, Low blood cell counts bleeding that can lead to death. fluid may build up in the lining of your lungs, the sac around your heart, or 9 Call your healthcare provider your stomach cavity. SPRYCEL may cause low red blood right away if you have: cell counts (anemia), low white blood • unusual bleeding or bruising Call your healthcare provider cell counts (neutropenia), and low of your skin right away if you get any of these platelet counts (thrombocytopenia). • bright red or dark, symptoms during treatment with Your healthcare provider will do tar-like stools SPRYCEL: blood tests to check your blood • a decrease in your level of • swelling all over your body cell counts regularly during your consciousness, headache, • weight gain treatment with SPRYCEL. or change in speech • shortness of breath and cough (continued on next page) Please read pages 16-18 for additional Important Safety Information about SPRYCEL. Please read the Patient Information section of the full Prescribing Information on pages 30-31. Talk to your doctor right away if you have any side effects. Don’t wait for your symptoms SIDE EFFECTS to get worse! OF SPRYCEL® (dasatinib) cont’d Fluid retention in your lungs is 10 also known as pleural effusion.