A medicine to block the amount of acid produced in the stomach (H2 blocker): about 10 hours before about 2 hours after

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Thomas Melton
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1 TRACKING JOURNAL

2 YOUR TRACKING JOURNAL Throughout your treatment with TASIGNA (nilotinib), your doctor will prescribe regular tests to see if your treatment is working. It s important to keep up with your regular testing, and track your test results. This tracking journal provides space to record your test results, as well as jot down any questions or notes you may have for your doctor. Tracking your test results will help you see whether you re reaching your treatment milestones, and will help you have more informed conversations with your doctor. Please see Important Safety Information, including Boxed WARNING on pages Please click here for full Prescribing Information and Medication Guide. MY INFORMATION My Name Emergency Contact Name Relationship Phone Number My Health Care Providers Name Phone Number Name Phone Number Name Phone Number My Pharmacy Pharmacy Name Pharmacist Name Phone Number

3 KEEP TRACK OF YOUR RESULTS Regular testing is important for tracking your progress with TASIGNA (nilotinib). Be sure to request your test results from your doctor. Don t forget to discuss what your results mean, as well as any questions or concerns you may have about your progress. Understanding your results and tracking your progress over time will help you see if you re reaching the milestones your doctor determined for you, and will also keep you engaged with your treatment. PERIODIC TESTING: AN OVERVIEW Your doctor may prescribe the following tests: Hematologic tests This is a simple blood test that counts the number of white blood cells, red blood cells, and platelets in your blood. If your blood cell counts have returned to within the normal range, you have achieved what is called a complete hematologic response (CHR). You may sometimes see this test referred to as a complete blood count (CBC) test.

4 (Continued) PERIODIC TESTING: AN OVERVIEW Cytogenetic tests In cytogenetic testing, laboratory technicians look at samples of your bone marrow under a microscope and count the number of cells that contain the Philadelphia (Ph) chromosome. This practice is called karyotyping, and typically 20 cells are analyzed. If no cells with the Ph chromosome are found, it is called a complete cytogenetic response (CCyR). According to national guidelines, an appropriate response after three months of treatment with TASIGNA (nilotinib), is partial cytogenetic response (PCyR). This means only 1% to 35% of cells have the Philadelphia Chromosome. Another appropriate response is CCyR at 12 months, which means no cells that were analyzed contained the abnormal Philadelphia chromosome. Molecular tests A PCR (polymerase chain reaction) test requires a sample of blood. It is the most sensitive kind of test available for monitoring response to Ph+ CML treatment. A PCR test can fi nd 1 leukemic cell in at least 100,000 normal cells. You may sometimes see this test referred to as IS-PCR, or IS RQ-PCR. Both are acceptable. The IS stands for International scale (IS), and getting your PCR analyzed at a lab using the IS is important because your results will be reliable and can be used to determine if you ve met certain molecular milestones. RQ-PCR stands for real-time quantitative polymerase chain reaction. According to guidelines, a response you may achieve is major molecular response (MMR). MMR means that the amount of BCR-ABL found in the bone marrow sample or blood sample is very low.

5 (Continued) PERIODIC TESTING: AN OVERVIEW HEMATOLOGIC RESPONSES CYTOGENETIC RESPONSES MOLECULAR RESPONSES LAB TESTS Complete blood count test Bone marrow cytogenetic testing RQ-PCR POSSIBLE RESPONSES Complete Hematologic Response: Blood counts are within the normal range Minor Cytogenetic Response: More than 35% Ph+ cells Early Molecular Response (EMR): At 3 to 6 months, BCR-ABL is 10% (using IS) Partial Cytogenetic Response (PCyR): 1%-35% Ph+ cells Major Molecular Response (MMR): BCR-ABL 0.1% (using IS) Complete Cytogenetic Response (CCyR): No Ph+ cells Complete Molecular Response (CMR): No BCR-ABL protein detected BE SURE TO... Ask about your CBC test results and record levels not within the normal range Ask about your cytogenetic results and record the % if Ph+ cells detected Ask about your PCR test results and record the % of BCR-ABL detected DATE TEST TYPE TEST RESULTS CHANGE FROM LAST VISIT EXAMPLE NEXT STEPS 5/20 bone marrow cytogenetic test 15% BCR-ABL Decrease by 10% IS-P CR test scheduled for 8/20

6 DATE TEST TYPE TEST RESULTS CHANGE FROM LAST VISIT NEXT STEPS DATE TEST TYPE TEST RESULTS CHANGE FROM LAST VISIT NEXT STEPS

7 DATE TEST TYPE TEST RESULTS CHANGE FROM LAST VISIT NEXT STEPS DATE TEST TYPE TEST RESULTS CHANGE FROM LAST VISIT NEXT STEPS

8 DATE TEST TYPE TEST RESULTS CHANGE FROM LAST VISIT NEXT STEPS DATE TEST TYPE TEST RESULTS CHANGE FROM LAST VISIT NEXT STEPS

9 YOUR NOTES Before your appointment, use the space below, or the notes app on your smartphone or tablet, to make a list of any questions you would like to discuss with your doctor. Remember to bring the list to your appointment and jot down the answers. Not only can this help you remember important information, it can spur additional questions that may help you better understand your treatment.

10 YOUR NOTES

11 YOUR NOTES

12 IMPORTANT SAFETY INFORMATION INDICATIONS AND IMPORTANT SAFETY INFORMATION TASIGNA (nilotinib) Indications TASIGNA is a prescription medicine used to treat adults who have: Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (cytogenetic and molecular) Ph+ CML in chronic phase and accelerated phase who are no longer benefi ting from, or did not tolerate, other treatment including GLEEVEC (imatinib mesylate). The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (hematologic and cytogenetic) IMPORTANT SAFETY INFORMATION ABOUT TASIGNA (nilotinib) Capsules What is the most important information to know about prescription TASIGNA? TASIGNA can cause QT prolongation, a possible life-threatening heart problem. QT prolongation causes an irregular heartbeat, which may lead to sudden death. Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation. Your doctor should check your heart with a test called an electrocardiogram (ECG): o Before starting TASIGNA o 7 days after starting TASIGNA o With any dose changes o Regularly during TASIGNA treatment Do not take TASIGNA if you have long QTc syndrome or low levels of potassium or magnesium in your blood

13 (Continued) IMPORTANT SAFETY INFORMATION TASIGNA can interact with many medicines and supplements. This may increase your chance for serious and life-threatening side effects. Do not take any other medicine while taking TASIGNA unless your doctor tells you it is okay to do so Food and grapefruit products increase the amount of TASIGNA in your body. This may increase your chance for serious and life-threatening side effects. Take TASIGNA on an empty stomach. Avoid eating food for at least 2 hours before the dose is taken, and avoid eating food for at least 1 hour after the dose is taken. Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA Before taking TASIGNA, tell your doctor about all of your medical conditions, including if you: Have a heart disorder or are taking medication for the heart Have had a stroke or other problems due to decreased blood fl ow to the brain Have problems with decreased blood fl ow to your legs Have an irregular heartbeat Have QT prolongation or a family history of it Have liver problems Have had a pancreas disorder known as pancreatitis Know that you suffer from low blood levels of electrolytes, such as potassium or magnesium Have had a surgical procedure involving the removal of the entire stomach (total gastrectomy) Are lactose-intolerant. The TASIGNA capsules contain lactose. Most patients who have mild or moderate lactose intolerance can take TASIGNA Have bleeding problems Are pregnant or plan to become pregnant. TASIGNA may harm your unborn baby. Women should not become pregnant while taking TASIGNA. Talk to your health care provider right away if you are pregnant or plan to become pregnant

14 (Continued) IMPORTANT SAFETY INFORMATION Are breastfeeding or plan to breastfeed. It is not known if TASIGNA passes into your breast milk. You and your doctor should decide if you will take TASIGNA or breastfeed. You should not do both. It is not known if TASIGNA is safe and effective in children. TASIGNA may cause serious side effects, including: Low blood counts: Low blood counts are common with TASIGNA. Your doctor will check your blood counts regularly during treatment with TASIGNA. Symptoms of low blood counts include: o Unexplained bleeding or bruising o Blood in urine or stool o Unexplained weakness QT prolongation: Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA.These can be symptoms of QT prolongation, a possible life-threatening heart problem Decreased blood flow to the leg, heart, or brain: People who have recently been diagnosed with Ph+ CML and take TASIGNA may develop decreased blood fl ow to the leg, the heart, or brain. Get medical help right away if you suddenly develop any of the following symptoms: o Chest pain or discomfort o Numbness or weakness o Problems walking or speaking o Leg pain o Your leg feels cold o Change in the skin color of your leg Liver damage: Symptoms include yellow skin and eyes Pancreas inflammation (pancreatitis): Symptoms include sudden stomach area pain with nausea and vomiting

15 (Continued) IMPORTANT SAFETY INFORMATION Bleeding in the brain: Symptoms include sudden headache, changes in your eyesight, not being aware of what is going on around you and becoming unconscious Tumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have: o Kidney failure and the need for dialysis treatment o An abnormal heart beat Your doctor may do blood tests to check you for TLS Bleeding: Call your doctor right away if you develop signs and symptoms of bleeding Fluid Retention: Your body may hold too much fl uid (fl uid retention). Symptoms of fl uid retention include shortness of breath, rapid weight gain, and swelling Common side effects Most patients experience side effects at some time. Some common side effects you may experience include: Low blood count Nausea Rash Headache Tiredness Itching Vomiting Diarrhea Cough Constipation Muscle and joint pain Runny or stuffy nose, sneezing, sore throat Fever Night sweats

16 (Continued) IMPORTANT SAFETY INFORMATION Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of TASIGNA. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Take TASIGNA exactly as your doctor tells you to take it. Do not change your dose or stop taking TASIGNA unless your doctor tells you TASIGNA is a long-term treatment Your doctor may change your dose. Your doctor may have you stop TASIGNA for some time or lower your dose if you have side effects with it If you need to take antacids (medicines to treat heartburn) do not take them at the same time that you take TASIGNA. If you take: A medicine to block the amount of acid produced in the stomach (H2 blocker): Take these medicines about 10 hours before you take TASIGNA, or about 2 hours after you take TASIGNA An antacid that contains aluminum hydroxide, magnesium hydroxide, and simethicone to reduce the amount of acid in the stomach: Take these medicines about 2 hours before or about 2 hours after you take TASIGNA Please see the full Prescribing Information, including the Boxed WARNING and the TASIGNA Medication Guide.

17 Novartis Pharmaceuticals Corporation East Hanover, New Jersey Novartis 8/16 AM

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