Treatment

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Treatment

  1. 1. ® This guide will help you understand more about your treatment with SUTENT and gastrointestinal stromal tumor (GIST). SUTENT is used when the medicine Gleevec® (imatinib mesylate) does not stop the cancer from growing or when you cannot take Gleevec. Gleevec is a registered trademark of Novartis AG. Please see patient information.SUU00069B © 2007 Pfizer Inc. All rights reserved. Printed in USA Understanding for Your Treatment of GIST ® (sunitinib malate)
  2. 2. Please see patient information. 3 What is SUTENT® (sunitinib malate)? 3 What is cancer? 4 What is GIST? 5 How does SUTENT work? 6 Important safety information 8 What should I tell my doctor before starting treatment? 9 What are the possible side effects? 10 How to manage side effects 12 How to take SUTENT 16 Resources for you 18 Insurance help from FirstRESOURCE® 22 Answers to your questions 26 Terms to know 30 InsideYou will find helpful information on many important topics: SUTENT is a medicine that treats cancer. It comes in 12.5-mg, 25-mg, and 50-mg capsules. You take SUTENT once per day by mouth. Do not open the capsules. SUTENT has been approved by the FDA to treat patients with gastrointestinal stromal tumor (GIST). SUTENT is used when the medicine Gleevec® (imatinib mesylate) does not stop the cancer from growing or when you cannot take Gleevec. SUTENT is available by prescription only. Your doctor has prescribed SUTENT because he or she believes it is the most appropriate treatment for you. For many patients, SUTENT may slow or stop the growth of cancer and may help to shrink tumors. SUTENT may not be appropriate for all GIST patients and has not been studied in children. SUTENT may not work the same in every person. Note: Words in bold type are defined on pages 30 and 31. SUTENT ® ?(sunitinib malate) What is
  3. 3. 5 GIST is cancer that occurs in the gastrointestinal (or digestive) system. It is called a stromal tumor because the cancer starts in the stroma. This is a kind of tissue in the walls of the stomach and intestines. GIST can occur in almost any part of the digestive tract. GIST usually grows in the stomach or small intestine. GIST often grows as a single tumor. Some of the cancer cells may enter the bloodstream and spread to other parts of the body. New tumors may then develop in other organs. This is called metastasis. GIST may spread to your liver, for example. If this happens, it is still called GIST (metastatic GIST), not liver cancer. The human body is made up of countless cells. Organs, such as the stomach or intestines, are made up of special types of cells that help them do their jobs. Organs make up the body’s systems, such as the digestive system. Most organs stay healthy by getting rid of old cells that can no longer work as they should. These old cells are then replaced by new cells. This process of new cells replacing old cells is well controlled. It takes place in the body all the time. Cancer occurs when this controlled process goes out of control. This is caused by a breakdown in a cell’s genetic program. This breakdown makes the cell grow and divide when it is not supposed to. When this happens, it becomes a cancer cell. Soon a large mass of cancer cells forms. The mass is called a tumor. Some tumors can spread and threaten your health. GIST? What is cancer? What is Please see patient information.
  4. 4. 7 SUTENT may slow or stop the growth of some cancers by blocking 2 basic processes that cause tumors to grow and spread. These processes are called proliferation and angiogenesis. Proliferation This is when a cell divides, creating 2 cells where there used to be only 1. Like the other cells in your body, cancer cells divide. The difference is that cancer cells divide more times than they should, forming a tumor. SUTENT may help slow down this process. Angiogenesis This is when new blood vessels form. These new blood vessels give tumors the nutrients and oxygen they need to grow. SUTENT may help stop this process. SUTENT may help stop proliferation and angiogenesis by blocking the signals that cause them. Without these 2 processes, tumors cannot grow. Stages of proliferation Angiogenesis Tumor New blood vessel How does work? SUTENT ® (sunitinib malate) Please see patient information.
  5. 5. 9 SUTENT® (sunitinib malate) may harm an unborn baby (cause birth defects). Do not become pregnant. If you do, tell your doctor right away. Stop taking SUTENT. Do not breastfeed while taking SUTENT. SUTENT may cause heart problems. Tell your doctor if you feel very tired, are short of breath, feel faint or dizzy, or have swollen feet and ankles. In rare cases, SUTENT may cause a hole in the stomach or bowel wall or bleeding from the tumor. This could cause symptoms such as painful, swollen abdomen, vomiting or coughing blood, and black, sticky stools. Your doctor can tell you other symptoms to watch for. SUTENT may increase blood pressure. Your doctor may check your blood pressure, and may treat you for it. SUTENT may interact with other treatments or products. Tell your doctor or nurse about each medicine, vitamin, or herbal product that you use. Do not take St. John’s Wort, eat grapefruit, or drink grapefruit juice while taking SUTENT. You may have side effects or reactions to SUTENT. For most patients, these are moderate and may be managed, though some can be serious. Your doctor may change your dose or stop your treatment. Some of the most common side effects include fatigue, diarrhea, nausea, vomiting, mouth sores, upset stomach, abdominal pain, constipation, skin or hair changes, taste changes, swelling, loss of appetite, and bleeding, such as from the nose or cuts. Call your doctor if you have any swelling or bleeding. Be sure to tell your doctor or nurse about any new side effects you have, as well as any change or increase in any side effect. What should I tell my doctorbefore starting treatment? Important safety information Tell your doctor if you are pregnant, could be pregnant, or plan to get pregnant. SUTENT may harm an unborn baby. Tell your doctor if you are breast- feeding. Do not breastfeed while you are being treated with SUTENT. Tell your doctor about all of your medical conditions, especially if you have any of the following: Heart problems High blood pressure Kidney function problems (other than cancer) Liver problems Any bleeding problems Seizures Tell your doctor about all of the medicines you take, including prescription drugs, over-the- counter drugs, vitamins, and herbal products. Some medicines can react with SUTENT and cause serious side effects, especially St. John’s Wort. Do not take St. John’s Wort while taking SUTENT. Other medicines can react with SUTENT. These include: Dexamethasone (a steroid) Medicine for: — Tuberculosis (TB) — Infections (antibiotics) — Depression — Seizures (epilepsy) — Fungal infections (antifungals) — HIV (AIDS) Keep a list of your medicines and show it to your doctor or pharmacist. Also, talk with your doctor before starting any new medicines. Please see patient information.
  6. 6. 11 What are the possible side effects? You may have side effects or reactions to SUTENT® (sunitinib malate). Most patients have moderate side effects that can be managed. In some cases, your doctor may change your dose of SUTENT or stop treatment. Be sure to talk to your doctor or nurse about any side effects or concerns that you have. Possible serious side effects Some side effects are more serious than others. It is important that you know the signs of these side effects so you can tell your doctor if any of these problems occur. Heart problems Tell your doctor if you feel very tired, are short of breath, feel faint or dizzy, or have swollen feet and ankles. Rare, life-threatening events — Hole in stomach or bowel wall (perforation) — Bleeding from the tumor Both of these side effects could cause symptoms such as painful, swollen abdomen, vomiting or coughing blood, and black, sticky stools. Your doctor can tell you other symptoms to watch for. Increased blood pressure Your doctor may check your blood pressure while you are treated with SUTENT to see if you also need treatment for high blood pressure. Common side effects Patients who take SUTENT have these side effects more often than other side effects: Feeling tired/fatigue Gastrointestinal problems — Diarrhea — Nausea — Vomiting — Mouth sores/stomatitis — Upset stomach — Abdominal pain — Constipation Skin or hair changes Taste changes Swelling Loss of appetite High blood pressure Bleeding (such as nosebleeds or bleeding from cuts) You may have had some of these side effects before starting treatment with SUTENT. Be sure to tell your doctor or nurse if there is any change or increase in your side effects. Please see patient information.
  7. 7. 13 You may have side effects or reactions to SUTENT® (sunitinib malate). For most patients, the side effects of SUTENT are moderate and may be managed. For others, your doctor may change your dose or stop your treatment with SUTENT. Make sure to talk to your doctor or nurse about any side effects or concerns you have. There are also steps you can take on your own to ease some of these problems. FEELING TIRED/FATIGUE. While you are taking SUTENT, you may feel tired or weak. Fatigue is common during treatment for cancer. If you feel tired or weak, these tips may help: Take short naps or breaks Eat well and drink plenty of fluids Take short walks or do light exercise Do things that are relaxing, such as listening to music or reading Managing side effects continued on following page. How to manage side effects GASTROINTESTINAL PROBLEMS. You may have problems related to your stomach or intestines. These gastrointestinal problems you may have include: Diarrhea Nausea or vomiting Mouth sores/stomatitis Upset stomach Abdominal pain Constipation DIARRHEA OR BOWEL MOVEMENT CHANGES. While taking SUTENT, you may have diarrhea or changes in your bowel movements. This may be treated with over-the- counter medicines. Ask your doctor or nurse which product may be best for you. If you have diarrhea, these tips may help: Avoid spicy foods, fatty foods, caffeine, and fruit Eat only mild foods Drink water often—but only in small sips NAUSEA OR VOMITING. You may have nausea or vomiting while taking SUTENT. If you do, tell your doctor or nurse. He or she may prescribe a medicine for this. If you have nausea or vomiting, these tips may help: Eat small meals Avoid foods that are sweet, fried, or fatty Drink lots of fluids, but in small amounts at a time Please see patient information.
  8. 8. How to manage side effects(continued) 15 You may also notice dryness, thickening, or cracking of the skin on the palms of the hands and the soles of the feet. Some patients may have blisters or a rash. This is called hand-foot syndrome. Tell your doctor or nurse if you develop these problems. He or she may give you specific treatments. These could include: Specific lotions or moisturizers Pain medicine, such as ibuprofen or acetaminophen TASTE CHANGES. You may notice a change in the way food tastes while you are taking SUTENT. This is common for people who are being treated for cancer. If you have taste changes, these tips may help: Cold or frozen foods may taste better than hot foods Flavor your food with herbs, spices, sugar, lemon, or sauces Keep a clean and healthy mouth by brushing and flossing often BLEEDING. You may have nosebleeds or bleeding from cuts when taking SUTENT. Call your doctor if you have any swelling or bleeding. OTHER SIDE EFFECTS. Patients have also had other, less common side effects when taking SUTENT. For a more complete list of all of these side effects, ask your cancer specialist, nurse, or doctor. MOUTH SORES/STOMATITIS. Stomatitis is the name for several problems of the mouth and throat. These may include mouth sores, redness, a white coating of the tongue, bleeding gums, or trouble swallowing. While taking SUTENT® (sunitinib malate), you may develop stomatitis. If you have stomatitis, these tips may help: Avoid hot, spicy, or acidic foods Eat foods that are soft Use a straw for drinking liquids Use an alcohol-free mouthwash and rinse your mouth often with water Avoid toothpastes with whiteners (ie, peroxide) UPSET STOMACH. This is common for people who are receiving treatment for cancer. While taking SUTENT, you may have this problem. If you have an upset stomach, these tips may help: Avoid heavy meals, coffee, and alcohol Reduce your stress Sleep in a more upright position, propped up on a pillow Take an antacid SKIN OR HAIR CHANGES. While taking SUTENT, you may have changes to or problems with your skin. Your skin and/or your hair color may change. This is not harmful or painful. Your natural skin and/or hair color will usually return after you stop taking SUTENT. Cracking of skin on sole of foot Photo courtesy of Cleveland Clinic Taussig Cancer Center. Please see patient information.
  9. 9. Please see patient information. 17 important Things to remember Follow your doctor’s or nurse’s instructions on how and when to take SUTENT Make sure to tell your doctor or nurse if you are taking any other medicines, vitamins, or herbal products — This includes any supplements or over-the-counter products Take SUTENT exactly the way your doctor tells you to—do not open the capsules Try to take SUTENT at about the same time each day SUTENT can be taken with or without food Do not drink grapefruit juice or eat grapefruit because this can change the amount of SUTENT in your body Do not take St. John’s Wort while taking SUTENT If you miss a dose, take it as soon as you remember unless it is close to the time for your next dose—do not take more than 1 dose of SUTENT at a time, and tell your doctor or nurse if you miss a dose Call your doctor right away if you take too much SUTENT (more than 1 dose of SUTENT at a time) SUTENT comes in 12.5-mg, 25-mg, and 50-mg capsules that are taken once per day by mouth. Most patients take SUTENT on a dosing cycle: they take SUTENT every day for 4 weeks (28 days), then stop for 2 weeks (14 days). Patients repeat this cycle for as long as their doctor tells them to. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 Days Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Stop taking SUTENT for 2 weeks (14 days). Then start cycle again Take SUTENT every day for 4 weeks (28 days) How to take SUTENT ® (sunitinib malate)
  10. 10. Please see patient information. GIST Cancer Research Fund (GCRF) www.gistinfo.org GCRF supports GIST patients and doctors by funding GIST research. The GCRF Web site has many things for patients and caregivers, such as: Helpful GIST advice News about research and clinical trials Links to medical journals and research papers The American Cancer Society (ACS) (800) 227-2345, www.cancer.org The ACS is a resource for patients and doctors alike. The ACS Web site has news, facts, and useful tips for you and your family, including: Current news stories about cancer studies Facts about treatments Stories about cancer survivors Helpful GIST advice Links to support groups For more information about SUTENT® (sunitinib malate), talk with your doctor, nurse, or pharmacist. For general information about SUTENT, you can visit the SUTENT Web site at www.sutent.com. The resources listed below can offer you support and information about cancer. You may find that learning more about your disease and treatment or talking with other patients is helpful. These resources may also help your family and caregivers. GIST Support International (GSI) (215) 340-9374, www.gistsupport.org GSI supports GIST patients and their families and friends, and has information on current GIST research. The GSI Web site offers many things, such as: Contact with GIST patients, caregivers, and health care providers by e-mail Helpful GIST advice for you Resources Resources continued on following page. 19
  11. 11. Resources for you(continued) Please see patient information. The National Comprehensive Cancer Network (NCCN) (888) 909-6226, www.nccn.org The NCCN Web site has cancer treatment information for doctors. It may help you to better understand your doctor’s decisions about your cancer care. On the NCCN Web site, you can find: Treatment guidelines for doctors Open clinical trials for new treatments Cancer hospitals around the United States Pfizer Oncology (212) 733-2323, www.pfizeroncology.com Pfizer Oncology offers cancer patients and their caregivers several useful resources. Visit the Pfizer Oncology Web site for: Information about insurance and Medicare Help with paying for your medicine Facts about cancer and treatment Advice about making treatment decisions Information about clinical trials American Society of Clinical Oncology (ASCO) (703) 299-0150, www.asco.org The ASCO Web site offers up-to-date information about cancer, important cancer meetings, and clinical trials, as well as: Current information about cancer studies Helpful cancer advice Useful cancer glossary Links to support services and groups CancerCare (800) 813-4673, www.cancercare.org The CancerCare Web site provides support services to people affected by cancer, with: Helpful cancer advice and counseling Facts about cancer Free financial services The National Cancer Institute (NCI) (800) 422-6237, www.cancer.gov The NCI Web site has many facts about cancer, treatments, and clinical trials. You can also find other useful topics, such as: How to pay for cancer treatment Choosing hospice and home care Finding support groups You can find more information on cancer and support groups on the Internet at www.sutent.com 21
  12. 12. Please see patient information. 23 from FirstRESOURCE® Insurance help What is FirstRESOURCE? FirstRESOURCE is a free support program from Pfizer Oncology. It can help make the insurance process simpler for you. If you need to take a Pfizer cancer medicine, FirstRESOURCE offers these services: Patient Assistance Program—to help eligible patients who have no prescription drug coverage, or don’t have enough of it, get Pfizer cancer medicines Reimbursement information—to help verify your insurance coverage and guide you and your doctor through the insurance process with health plans and Medicare Appeals assistance—to help appeal denied claims for Pfizer cancer medicines FirstRESOURCE provides these services for all Pfizer cancer medicines, including SUTENT® (sunitinib malate). FirstRESOURCE is easy to access and use. To find out more, call the counselors at (877) 744-5675. If you don’t have insurance or don’t have enough insurance FirstRESOURCE provides SUTENT through the Patient Assistance Program for those who meet the program’s criteria and who: Have no insurance May not have enough insurance to cover SUTENT To find out if you qualify, call FirstRESOURCE. Or ask your health care provider to call. Before calling, please be ready with your: Date of birth Address Insurance policy number(s) Household income and size When you apply, you’ll receive an enrollment form. You and your health care provider must complete it. Return the completed form to: FirstRESOURCE PO Box 339 San Bruno, CA 94066-0339 You may also fax it to (800) 708-3430. Insurance help continued on following page.
  13. 13. Insurance help from FirstRESOURCE® (continued) Please see patient information. 25 Pfizer and its agents cannot guarantee the accuracy of information provided by insurers, nor do they guarantee insurance reimbursement. Because many factors influence reimbursement, program staff cannot anticipate or resolve all issues raised by program callers. Pfizer reserves the right to modify or discontinue the program, without notice, at any time. If you have insurance coverage If your doctor prescribes SUTENT® (sunitinib malate) for you, FirstRESOURCE can: Help make the insurance process easier for you Help make sure you get the best possible coverage from your insurance plan Below is a list of services that FirstRESOURCE provides. The counselors can: Verify your insurance benefits Help you with prior authorization for SUTENT, if needed Assist with the appeals process when a claim is denied or when SUTENT is not covered Look for other options if you are without coverage Refer you to patient support programs Answer any questions you may have about your SUTENT coverage If you need help, call FirstRESOURCE. Be prepared when you call. A counselor may ask for your: Diagnosis or condition Health care provider’s name, address, or phone number Insurance policy number and other information from your insurance card Contact us To speak with the staff at FirstRESOURCE, call (877) 744-5675. Choose option 1 for SUTENT. Choose option 2 for other Pfizer cancer medicines. Call Monday through Friday from 9 AM to 8 PM ET. After these hours, please leave a message. Provide your name, phone number, and why you are calling. A counselor will call you back on the next business day.
  14. 14. Please see patient information. 27 While you are taking SUTENT® (sunitinib malate), you may have questions or concerns about your treatment. Listed here are a few common questions about SUTENT and answers you may find useful. Remember: Your doctor or nurse can talk with you about any questions or concerns you have. Q: What is SUTENT? A: SUTENT is an anticancer drug that you take by mouth. SUTENT is used when the medicine Gleevec does not stop the cancer from growing or when you cannot take Gleevec. Q: What are the benefits of taking SUTENT? A: SUTENT may slow or stop the growth of your cancer. It may also help shrink your tumors. SUTENT may not work the same for every person. Q: How do I know if SUTENT is working? A: When you visit your doctor, you will have special scans or tests to check the size of your tumors. Your doctor or nurse will discuss these tests with you. The scans and tests may show if the tumors are growing, staying the same size, or shrinking. questions Answers to your Q: What serious side effects might I have while taking SUTENT? A: SUTENT may cause heart problems. Tell your doctor if you feel very tired, are short of breath, feel faint or dizzy, or have swollen feet and ankles. In rare cases, SUTENT may cause a hole in the stomach or bowel wall or bleeding from the tumor. This could cause symptoms such as painful, swollen abdomen, vomiting or coughing blood, and black, sticky stools. Your doctor can tell you other symptoms to watch for. Make sure to talk to your doctor or nurse about any side effects or concerns you have. Q: What other side effects might I have while taking SUTENT? A: Some of the most common side effects include fatigue, diarrhea, nausea, vomiting, mouth sores, upset stomach, abdominal pain, constipation, skin or hair changes, taste changes, swelling, loss of appetite, and bleeding, such as from the nose or cuts. Call your doctor if you have any swelling or bleeding. Be sure to tell your doctor or nurse about any new side effects you have, as well as any change or increase in any side effect. Questions continued on following page.
  15. 15. Answers to your questions(continued) Q: Will my skin and/or hair change color? A: Color change is not harmful or painful. If you have light or fair skin, you may see a yellow tint in your skin. If your skin is darker, it may lighten all over or in patches. Your hair may lighten in patches. Q: Will my natural skin and hair color come back? A: Your natural skin and hair color will usually return after stopping treatment with SUTENT® (sunitinib malate). Q: What signs or symptoms should I watch for? A: You should call your doctor or nurse as soon as possible if you have any of these: Severe fatigue, diarrhea, nausea, loss of appetite, or vomiting A rise in your blood pressure Shortness of breath Swollen feet and ankles Painful or swollen abdomen, vomiting blood, or black, sticky stools Please see patient information. 29 Q: Will SUTENT react with any other drugs I’m taking or products I’m using? A: SUTENT may interact with other treatments or drugs you use every day. Tell your doctor or nurse about each medicine, vitamin, or herbal product that you use. Do not take St. John’s Wort. Grapefruit may affect the way SUTENT works in your body. Do not eat it or drink grapefruit juice while taking SUTENT. See page 9 for more information. Q: Where can I find information about insurance coverage for SUTENT? A: FirstRESOURCE® can help make the insurance process easier for you. FirstRESOURCE is a free program from Pfizer. If you have questions about or problems with your coverage, you may call FirstRESOURCE at (877) 744-5675.
  16. 16. Please see patient information. Angiogenesis (an-jee-o-JEN-ih-sis) The growth of new blood vessels from existing ones. Tumors use this process to receive nutrients from the bloodstream and to metastasize. Gastrointestinal (GASS-tro-in-TESS-tin-nul) Relating to your stomach and intestines. Gastrointestinal stromal tumor (GIST) (GASS-tro-in-TESS-tin-nul STRO-mul TOO-mor) GIST is a cancer that occurs in the digestive system. It can grow at all levels of the gastrointestinal tract (though most often in the stomach and small intestine). Hand-foot syndrome (hand-foot SIN-drome) Dryness, thickening, or cracking of the skin on the palms of the hands and soles of the feet. It can sometimes include blisters or a rash. Termsto know 31 For more information, visit www.sutent.com Metastasis (muh-TAHS-tuh-sis) The spread of cancer from one part of the body to another through the lymphatic system or bloodstream. Proliferation (pro-liff-er-AY-shun) When cells divide and multiply quickly. Tumors form when cancer cells proliferate. Stomatitis (stow-muh-TIE-tiss) Sores or swelling on the lining of the mouth; often a side effect of cancer therapy. Tumor (TOO-mor) A mass of cancer cells.
  17. 17. PATIENT INFORMATION SUTENT Read the patient information leaflet that comes with SUTENT before you start taking it. Read the leaflet each time you get a refill. There may be new information. This leaflet does not replace talking with your doctor about your condition or treatment. If you have any questions about SUTENT, ask your doctor or pharmacist. What is the most important information I should know about SUTENT? • SUTENT may harm an unborn baby (cause birth defects). Do not become pregnant. If you do become pregnant, tell your doctor right away. Stop taking SUTENT. What is SUTENT? SUTENT is a medicine that treats 2 kinds of cancer. 1. GIST (gastrointestinal stromal tumor). This is a rare cancer of the stomach, bowel, or esophagus. SUTENT is used when the medicine Gleevec! (imatinib mesylate) did not stop the cancer from growing OR when you cannot take Gleevec! . 2. Advanced kidney cancer (advanced renal cell carcinoma or RCC). SUTENT may slow or stop the growth of cancer. It may help shrink tumors. SUTENT has not been studied in children. What should I tell my doctor before taking SUTENT? Tell your doctor about all your medical conditions. Be sure to tell your doctor if you: • are pregnant, could be pregnant, or plan to get pregnant. SUTENT may harm an unborn baby. • are breast-feeding. Do not breast-feed while you are being treated with SUTENT. • have any heart problems • have high blood pressure • have kidney function problems (other than cancer) • have liver problems • have any bleeding problem • have seizures SUTENT and other medicines Tell your doctor about all your medicines. Include prescription medicines, over- the-counter drugs, vitamins, and herbal products. Some medicines can react with SUTENT and cause serious side effects. Especially tell your doctor if you take: • St. John’s Wort. Do not take St. John’s Wort while taking SUTENT. • Dexamethasone • (a steroid) Medicine for: • tuberculosis (TB) • seizures (epilepsy) • infections (antibiotics) • fungal infections (antifungals) ur doctor or pharmacist. Talk with your • your blood pressure. You may need treatment for high blood pressure. AB-0361-1.0 • depression • HIV (AIDS) Keep a list of your medicines. Show it to yo doctor before starting any new medicines. W f SUTENT? Possible serious side effects include: Heart Problems. Tell your do hat are possible side effects o • ctor if you feel very tired, are short of breath, or have swollen feet and ankles. Rare life-threatening events: hole in stomach or bowel wall (perforation) or bleeding from the tumor. Both of these side effects could cause symptoms such as painful, swollen abdomen, vomiting blood, and black, sticky stools. Your doctor can tell you other symptoms to watch for. Increased blood pressure. Your doctor may check• L Common side effects: • Feeling tired • Diarrhea, nausea, vomiting, mouth sores, upset stomach, abdominal pain, and constipation. Talk with your doctor about ways to handle these problems.(su TENT) • The medicine in SUTENT is yellow, so it may make your skin look yellow. Your skin and hair may get lighter. • Your skin may become dry, get thicker, or crack. You may get blisters or a rash on the palms of your hands and soles of your feet. • Taste changes • Swelling • Loss of appetite • High blood pressure • Bleeding, such as nosebleeds or bleeding from cuts. Call your doctor if you have any swelling or bleeding. There are other side effects. For a more complete list, ask your cancer specialist nurse or doctor. How should I take SUTENT? • SUTENT comes in 12.5 mg, 25 mg, and 50 mg capsules you take by mouth. Do not open the capsules. • d.Take SUTENT once a day with or without foo • Take it exactly the way your doctor tells you. • Do not drink grapefruit juice or eat grapefruit. They may change the amount of r body.SUTENT in you • Dosing cycle: • Take SUTENT for 4 weeks (28 days) THEN • Stop for 2 weeks (14 days) • Repeat this cycle as long as your doctor tells you • Your doctor may check your blood before each dosing cycle. If you miss a dose, take it as soon as you remember. Do not take it if it is clos to you • e r next dose. Just take the next dose at your regular time. Do not take more t the missed . children. rmation ant information about SUTENT. For more T, talk with your doctor or pharmacist. You can visit our ron Caramel gelatin capsule shell: yellow iron oxide, black iron oxide Printing k: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide y: than 1 dose of SUTENT at a time. Tell your doctor or nurse abou dose. • Call your doctor right away, if you take too much SUTENT How do I store SUTENT? • Keep SUTENT and all medicines out of the reach of • Store SUTENT at room temperature. General information about SUTENT Doctors can prescribe medicines for conditions that are not in this patient info leaflet. Use SUTENT only for what your doctor prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. This leaflet gives the most import information about SUTEN website at www.SUTENT.com. What is in SUTENT? Active ingredient: sunitinib malate Inactive ingredients: mannitol, croscarmellose sodium, povidone (K-25), agnesium stearate Orange gelatin capsule shell: titanium dioxide, red im oxide in Distributed b Pfizer Labs Division of Pfizer Inc New York, NY 10017 Rx only Gleevec! is a registered trademark of Novartis Pharmaceuticals Corp

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