A TREATMENT GUIDE FOR PATIENTS

Transcription

1 A TREATMENT GUIDE FOR PATIENTS INDICATION SUTENT (sunitinib malate) is a prescription medicine used to treat adults with kidney cancer that has not spread (localized) and who are at high risk of RCC coming back again after having kidney surgery. It is not known if SUTENT is safe or effective in children. SELECTED SAFETY INFORMATION SUTENT can cause severe liver problems that can lead to death. Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems during treatment with SUTENT: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area. Your healthcare provider should do blood tests to check your liver function before you start taking and during treatment with SUTENT. Your healthcare provider may tell you to temporarily or permanently stop taking SUTENT if you develop liver problems. Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure.

2 WHAT YOU WILL FIND IN THIS BROCHURE About Kidney Cancer Surgery Learn about kidney cancer surgery, how cancer can return after surgery, and the role of adjuvant therapy 3 You ll learn more about SUTENT (sunitinib malate) as an adjuvant therapy for renal cell carcinoma (RCC), or kidney cancer. You ll find out why it can be an important option for patients with kidney cancer that has not spread (localized) and who are at high risk of RCC coming back after surgery. About SUTENT Get information about SUTENT, including clinical trial results and how SUTENT works 4 Important Safety Information Read about the risks and possible side effects of SUTENT 7 Taking SUTENT Learn about SUTENT dosing, what to avoid while taking SUTENT, and what to do if you miss a dose Tips to Help Manage Certain Side Effects Learn about ways to manage some of the common side effects of SUTENT Getting SUTENT Find information on how to get SUTENT and how to get financial support, including the Pfizer Oncology Together Co-Pay Savings Card 9 Resources & Support Learn about where to find additional help and support when you need it The terms that appear in bold throughout this brochure are defined in the glossary on page 3. SELECTED SAFETY INFORMATION SUTENT may cause serious side effects, including: H eart problems. Heart problems may include heart failure, heart attack and heart muscle problems (cardiomyopathy) that can lead to death. Tell your healthcare provider if you feel very tired, are short of breath, or have swollen feet and ankles. Your healthcare provider may stop your treatment with SUTENT if you have signs and symptoms of heart failure. Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure.

3 ABOUT KIDNEY CANCER SURGERY If you ve had or are considering kidney cancer surgery, it s important to understand the role it plays in your treatment. Surgery is often the standard approach to treat kidney cancer. The goal of kidney cancer surgery is to physically remove all of the cancer by taking out the tumor. But even after kidney cancer surgery, you may be at risk of your cancer coming back That s because it s possible that some cancer cells were too small to be detected and could have spread to other parts of the body, such as the lungs, bones, liver, or brain. These cancer cells can then grow into tumors. When this happens, it s called metastatic cancer. What determines your risk of kidney cancer returning? There are many factors that determine your risk of cancer returning, including the results of your pathology report. So, it s important to review these results with your doctor after surgery. He or she will use the pathology report to help determine if you are at high risk of recurrence, and if you are, discuss your options. A pathology report contains information based on the examination of the tumor after surgery. What is adjuvant therapy? ~ 6 of patients at high risk of cancer coming back will have a recurrence within 5 years. Adjuvant therapy is an additional treatment taken after your primary treatment, such as surgery. The goal of adjuvant therapy is to help reduce the risk of recurrence. As you read on, you ll find out more about SUTENT (sunitinib malate), the only FDAapproved adjuvant therapy for adults with kidney cancer that has not spread (localized) and who are at high risk of RCC coming back after having kidney surgery. You may be referred to an oncologist for your treatment with SUTENT. SELECTED SAFETY INFORMATION SUTENT may cause serious side effects, including: 3 Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure. Abnormal heart rhythm changes. Changes in the electrical activity of your heart called QT prolongation can cause irregular heartbeats that can be life threatening. Your healthcare provider may do electrocardiograms and blood tests (electrolytes) to watch for these problems during your treatment with SUTENT. Tell your healthcare provider immediately if: o you feel faint or lightheaded, or you pass out o you feel dizzy o you feel your heartbeat is irregular or fast

4 ABOUT SUTENT (sunitinib malate) 4 How SUTENT was studied SUTENT was studied in a clinical trial involving 65 adult patients who were at high risk of RCC coming back after kidney cancer surgery. For approximately year after kidney cancer surgery, 39 patients took SUTENT, while 36 took a placebo, or sugar pill. The main objective of the trial was to measure disease-free survival (DFS). DFS is the length of time after cancer treatment that a patient lives without the signs or symptoms of cancer. This is one way to check how effective treatment is. Along with DFS, the study also looked at overall survival (OS). This is the total time patients remain alive after treatment. By the end of the study, 4 out of 65 people (3) who participated had died. At the time data was collected, there was not enough information available to predict SUTENT s impact on OS. Understanding clinical trial results Patients taking SUTENT experienced a median* DFS of 6.8 years compared with 5.6 years for those taking placebo. That means SUTENT was shown to:. YEARS LONGER 4 LESS RISK *Median is a type of average. Give patients more time without evidence of cancer. Patients taking SUTENT showed no evidence of cancer for, on average,. years longer than those taking placebo. Lower the risk of cancer recurrence. Patients taking SUTENT were 4 less likely to have a recurrence compared to those taking placebo. Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure. Understanding clinical trial results (continued) At 5 years, 3 patients taking SUTENT had experienced a DFS event compared with 44 patients taking placebo. That means: Patients taking SUTENT experienced about fewer DFS events. DFS events included recurrence of cancer or death. Patients taking SUTENT experienced a 5-year DFS rate of 59.3 compared with 5.3 for those taking placebo. That means: Patients taking SUTENT were more likely to be disease-free after 5 years. SUTENT is not a cure, and not all patients will experience the same results. SELECTED SAFETY INFORMATION SUTENT may cause serious side effects, including: High blood pressure. High blood pressure is common with SUTENT and may sometimes be severe. Follow your healthcare provider s instructions about having your blood pressure checked regularly. Call your healthcare provider if your blood pressure is high or if you have any of the following signs or symptoms of high blood pressure: o severe headache o lightheadedness o dizziness o change in vision Your healthcare provider may prescribe medicine for you to treat high blood pressure, if needed. Your healthcare provider may temporarily stop your treatment with SUTENT until your high blood pressure is controlled.

5 3- In the clinical trial, patients taking SUTENT (sunitinib malate) as adjuvant therapy started it within 3 to weeks after surgery. Talk to your doctor before or soon after surgery to determine if SUTENT is an option for you. SELECTED SAFETY INFORMATION SUTENT may cause serious side effects, including: B leeding problems. Bleeding is common with SUTENT (sunitinib malate), but SUTENT can also cause severe bleeding problems that can lead to death. Call your healthcare provider right away if you have any of these symptoms or a serious bleeding problem during treatment with SUTENT, including: op ainful, swollen o bloody urine stomach (abdomen) o headache or change o vomiting blood in your mental status o black, sticky stools o coughing up blood Your healthcare provider: o c an tell you about other symptoms to watch for om ay do blood tests if needed and monitor you for bleeding 5 Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure.

6 HOW SUTENT (sunitinib malate) MAY WORK HOW CANCER CELLS MAY SPREAD WHEN CANCER CELLS SPREAD WHEN CANCER CELLS SPREAD VESSEL GROWTH VESSEL GROWTH PRE-SURGERY Renal cell carcinoma is a cancer that is often treated with surgery. The goal of surgery is to physically remove all of the tumor. To do this, the surgeon may take out all or part of the kidney. 6 POST-SURGERY PRE-SURGERY matter how much Renal cellno carcinoma of the is is a cancer thatkidney is removed, often treated withthere is a surgery. risk Thethat goalsome cancer cells remain in the of surgery is to body. These cancer physically remove cells are too small to all of the tumor. To be surgeon detected. do this, the may take out all or part of the kidney. POST-SURGERY UNSEEN CELLS The unseen cancer No matter how much cells may move to of the kidney is removed, there is a other parts of the body through risk that some cancer cells remain in the the bloodstream or body. These cancer lymphatic system. cells are too small to be detected. UNSEEN CELLS The unseen cancer cells may move to other parts of the body through the bloodstream or lymphatic system. Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure. New blood vessels are New blood vessels are needed to give these needed unseen to give these unseen cancer cells a constant cancer cells a constant supply of oxygen andsupply of oxygen and nutrients. When this nutrients. When this happens, cancer cellshappens, can cancer cells can turn into tumors. turn into tumors. BLOCKING VESSEL GROWTH BLOCKING VESSEL GROWTH Animal and laboratory Animal and laboratory studies suggest that SUTENT studies suggest that SUTENT blocks new blood vessels blocks new blood vessels from forming. This may from forming. This may prevent unseen cancer cells unseen cancer cells prevent from turning into tumors. from turning into tumors. SELECTED SAFETY INFORMATION SUTENT may cause serious side effects, including: S erious stomach and intestinal problems that can sometimes lead to death. Some people have had tears in their stomach or intestine (perforation) or have developed an abnormal opening between the stomach and intestine (fistula). Get medical help right away if you get stomach-area (abdominal) pain that does not go away or is severe during treatment with SUTENT.

7 INDICATION AND IMPORTANT SAFETY INFORMATION INDICATION SUTENT (sunitinib malate) is a prescription medicine used to treat adults with kidney cancer that has not spread (localized) and who are at high risk of RCC coming back again after having kidney surgery. It is not known if SUTENT is safe or effective in children. IMPORTANT SAFETY INFORMATION SUTENT can cause severe liver problems that can lead to death. Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems during treatment with SUTENT: o itching o yellow eyes or skin o dark urine o pain or discomfort in the right upper stomach area Your healthcare provider should do blood tests to check your liver function before you start taking and during treatment with SUTENT. Your healthcare provider may tell you to temporarily or permanently stop taking SUTENT if you develop liver problems. SUTENT may cause serious side effects, including: Heart problems. Heart problems may include heart failure, heart attack and heart muscle problems (cardiomyopathy) that can lead to death. Tell your healthcare provider if you feel very tired, are short of breath, or have swollen feet and ankles. Your healthcare provider may stop your treatment with SUTENT if you have signs and symptoms of heart failure. Abnormal heart rhythm changes. Changes in the electrical activity of your heart called QT prolongation can cause irregular heartbeats that can be life threatening. Your healthcare provider may do electrocardiograms and blood tests (electrolytes) to watch for these problems during your treatment with SUTENT. Tell your healthcare provider immediately if: o you feel faint or lightheaded, or you pass out o you feel dizzy o you feel your heartbeat is irregular or fast High blood pressure. High blood pressure is common with SUTENT and may sometimes be severe. Follow your healthcare provider s instructions about having your blood pressure checked regularly. Call your healthcare provider if your blood pressure is high or if you have any of the following signs or symptoms of high blood pressure: o severe headache o lightheadedness o dizziness o change in vision Your healthcare provider may prescribe medicine for you to treat high blood pressure, if needed. Your healthcare provider may temporarily stop your treatment with SUTENT until your high blood pressure is controlled. 7 Please see additional Important Safety Information on pages 8-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure.

8 8 IMPORTANT SAFETY INFORMATION (CONTINUED) Bleeding problems. Bleeding is common with SUTENT (sunitinib malate), but SUTENT can also cause severe bleeding problems that can lead to death. Call your healthcare provider right away if you have any of these symptoms or a serious bleeding problem during treatment with SUTENT, including: o painful, swollen stomach (abdomen) o vomiting blood o black, sticky stools o bloody urine o headache or change in your mental status o coughing up blood Your healthcare provider: o can tell you about other symptoms to watch for o may do blood tests if needed and monitor you for bleeding Serious stomach and intestinal problems that can sometimes lead to death. Some people have had tears in their stomach or intestine (perforation) or have developed an abnormal opening between the stomach and intestine (fistula). Get medical help right away if you get stomach-area (abdominal) pain that does not go away or is severe during treatment with SUTENT. Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells and may lead to death. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS. Please see additional Important Safety Information on pages 9-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure. Thrombotic microangiopathy (TMA) including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS). TMA is a condition that involves injury to the smallest blood vessels and blood clots can happen while taking SUTENT. TMA is accompanied by a decrease in red cells and cells that are involved with clotting. TMA may harm your body s organs such as the brain and kidneys, and can sometimes lead to death. Your healthcare provider may tell you to stop taking SUTENT if you develop TMA. Protein in your urine. Some people who have taken SUTENT have developed protein in their urine, and in some cases, kidney problems that can lead to death. Your healthcare provider will check you for this problem. If there is too much protein in your urine, your healthcare provider may tell you to stop taking SUTENT. Serious skin and mouth reactions. Treatment with SUTENT has caused severe skin reactions that can lead to death, including: o severe rash with blisters or peeling of the skin. o painful sores or ulcers on the skin, lips, or inside the mouth. o tissue damage (necrotizing fasciitis). If you have any signs or symptoms of severe skin reactions, stop taking SUTENT and call your healthcare provider or get medical help right away. Thyroid problems. Your healthcare provider may do tests to check your thyroid function during SUTENT treatment. Tell your healthcare provider if you have any of the following signs and symptoms during your treatment with SUTENT: o tiredness that gets worse and does not go away o loss of appetite o problems with heat o feeling nervous or agitated, tremors o sweating o nausea or vomiting o diarrhea o fast heart rate o weight gain or weight loss o feeling depressed o irregular menstrual periods or no menstrual periods o headache o hair loss

9 IMPORTANT SAFETY INFORMATION (CONTINUED) 9 Low blood sugar (hypoglycemia). Low blood sugar can happen with SUTENT (sunitinib malate), and may cause you to become unconscious, or you may need to be hospitalized. Low blood sugar with SUTENT may be worse in people who have diabetes and take antidiabetic medicines. Your healthcare provider should check your blood sugar levels regularly during treatment with SUTENT and may need to adjust the dose of your antidiabetic medicines. Signs and symptoms of low blood sugar may include: o headache o drowsiness o weakness o dizziness o confusion o irritability o hunger o fast heartbeat o sweating o feeling jittery Call your healthcare provider right away if you have any signs or symptoms of severe low blood sugar during your treatment with SUTENT. Jaw-bone problems (osteonecrosis). Severe jaw-bone problems have happened in some people who take SUTENT. Certain risk factors such as taking a bisphosphonate medicine or having dental disease may increase your risk of getting osteonecrosis. Your healthcare provider may tell you to see your dentist before you start taking SUTENT. Your healthcare provider may tell you to avoid dental procedures, if possible, during your treatment with SUTENT, especially if you are receiving a bisphosphonate medicine into a vein (intravenous). Wound healing problems. Wounds may not heal properly during SUTENT treatment. Tell your healthcare provider if you have or plan to have any surgery before starting or during treatment with SUTENT. o Your healthcare provider may tell you to temporarily stop taking SUTENT if you are planning to have certain types of surgery. o Your healthcare provider should tell you when you may start taking SUTENT again after surgery. Please see additional Important Safety Information on page. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure. Fetal harm. SUTENT can harm your unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant. You and your partner should use effective birth control (contraception) during and after treatment with SUTENT. o Females should continue to use birth control for at least 4 weeks after their last dose of SUTENT. o Males should continue to use birth control for at least 7 weeks after their last dose of SUTENT. Before taking SUTENT tell your healthcare provider about all of your medical conditions, including if you: have any heart problems have high blood pressure have thyroid problems have a history of low blood sugar or diabetes have kidney function problems (other than cancer) have liver problems have any bleeding problem plan to have any surgery or dental procedures have seizures have or have had pain in the mouth, teeth, or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with SUTENT and for at least 4 weeks ( month) after the last dose. are pregnant or plan to become pregnant. SUTENT can harm your unborn baby.

10 IMPORTANT SAFETY INFORMATION (CONTINUED) Females who are able to become pregnant: o Your healthcare provider should do a pregnancy test before you start treatment with SUTENT (sunitinib malate). o You should use effective birth control (contraception) during treatment and for at least 4 weeks after your last dose of SUTENT. o Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with SUTENT. Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 7 weeks after your last dose of SUTENT. SUTENT may cause fertility problems in males and females. Tell your healthcare provider if this is a concern for you. Tell all of your healthcare providers and dentists that you are taking SUTENT. They should talk to the healthcare provider who prescribed SUTENT for you, before you have any surgery, or medical or dental procedure. Tell your healthcare provider about all the medicines you take, including prescription medicines and over-thecounter medicines, vitamins, and herbal supplements. Using SUTENT with certain other medicines can cause serious side effects. You may have an increased risk of severe jaw-bone problems (osteonecrosis) if you take SUTENT and a bisphosphonate medicine. Especially tell your healthcare provider if you are taking or have taken an osteoporosis medicine. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Do not drink grapefruit juice or eat grapefruit. They may cause you to have too much SUTENT in your body. Do not take St. John s Wort. It may cause you to have too little SUTENT in your body. Common side effects of SUTENT include: tiredness weakness diarrhea pain, swelling, or sores inside of your mouth nausea loss of appetite indigestion vomiting stomach-area (abdominal) pain blisters or rash on the palms of your hands and soles of your feet high blood pressure taste changes low platelet counts The medicine in SUTENT is yellow, and it may make your skin look yellow. Your skin and hair may get lighter in color. SUTENT may also cause other skin problems including: dryness, thickness, or cracking of the skin. These are not all of the possible side effects of SUTENT. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report adverse events related to Pfizer products by calling If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit or call -8-FDA-88. Please see additional Important Safety Information on pages 7-9. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure.

11 HOW TO TAKE SUTENT (sunitinib malate) Recommended dosage If you are prescribed SUTENT as adjuvant therapy, the recommended dose is 5 mg taken orally once a day. SUTENT is taken in 6-week cycles - SUTENT is taken every day for the first 4 weeks (days to 8) of this cycle - It is stopped for the next weeks (days 9 to 4) to complete this cycle - Then the next 6-week cycle begins - SUTENT is taken for a total of nine 6-week cycles or as prescribed by your doctor Important things to remember SUTENT may be taken with or without food - Do not take St. John s Wort. This may cause you to have too little SUTENT in your body - Do not eat grapefruit or drink grapefruit juice. These may cause you to have too much SUTENT in your body If you miss a dose of SUTENT by less than hours, take the missed dose right away. If you miss a dose of SUTENT by more than hours, just take your next dose at your regular time. Do not make up the missed dose. Tell your healthcare provider about any missed dose Call your healthcare provider right away if you take too much SUTENT If you re experiencing side effects, your doctor may adjust your dose SUTENT is not for everyone. Only you and your healthcare team can determine if SUTENT is right for you. Do not change your dose or stop taking SUTENT unless your doctor tells you to. Your doctor may do blood tests before each cycle of treatment to check you for side effects. If you experience side effects with the standard dose of SUTENT, your doctor may recommend changing your dose or stopping it for a period of time. This decision is based on individual patient safety and tolerability. Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure.

12 COMMON SUTENT (sunitinib malate) SIDE EFFECTS AND WAYS TO HELP MANAGE THEM It s important that you know and understand the side effects you may experience while taking SUTENT. Some of these side effects you and your doctor may be able to manage. Other side effects may not be manageable. If you re having some side effects, your doctor may decide to adjust or stop your treatment. That s why it s important to tell your healthcare team about ANY side effects you are experiencing. Always talk to your doctor about any side effects you have as soon as you notice them. Do not wait until they become serious. The following pages include common side effects of SUTENT and ways to help manage them. Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure.

13 COMMON SUTENT (sunitinib malate) SIDE EFFECTS AND WAYS TO HELP MANAGE THEM Tiredness or weakness While on treatment, you may feel tired or weak. Fatigue is common during treatment. But it may also be a sign of a more serious medical problem. Call your doctor or nurse for a full evaluation if you feel tired or weak while on your treatment. Diarrhea Diarrhea is defined as 3 or more loose or watery stools/bowel movements in one day. If you have these symptoms, call your doctor or nurse. It is important for you and your doctor to try to manage diarrhea as soon as it begins. TIPS TIPS Take short naps or breaks Eat well and drink plenty of fluids Take short walks or do light exercise if you feel up to it Ask your doctor or nurse if you can be treated with over-the-counter medications Try yogurt containing probiotics Eat foods containing fiber especially soluble fiber, which can be found in oatmeal, beans, and apples Eat small but frequent meals Avoid spicy foods, fatty foods, caffeine, and raw fruit Drink lots of fluids 3 Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure.

14 COMMON SUTENT (sunitinib malate) SIDE EFFECTS AND WAYS TO HELP MANAGE THEM Mouth pain While on your treatment, you may develop mouth pain. Your symptoms may include mouth sores, redness, a white coating of the tongue, blood in the mouth, or trouble swallowing. Call your doctor or nurse if you experience any of these problems. Mouth pain as a result of treatment does not usually pose a health risk. However, blistering and peeling on the inside of your mouth may be a sign of a more serious side effect. If you develop mouth pain, tell your doctor immediately. He or she may tell you to stop your treatment. Nausea/vomiting It is best to call your doctor or nurse at the first sign of nausea or vomiting. Nausea is defined as feeling as if you are about to throw up. It is especially important to speak with your doctor or nurse if these symptoms keep you from taking your oral medications. Your doctor may prescribe a medicine for these symptoms. TIPS TIPS Eat small meals 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 mixed with baking soda or salt Avoid toothpastes with whiteners (ie, peroxide) and use a soft toothbrush Ask your doctor if there are over-the-counter or prescription medications that may help you manage your condition Avoid foods that are sweet, fried, or fatty Drink lots of fluids, but in small amounts If you vomit, start with small amounts of water, broth, or other clear liquids when you are ready to eat again 4 Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure.

15 COMMON SUTENT (sunitinib malate) SIDE EFFECTS AND WAYS TO HELP MANAGE THEM Loss of appetite Indigestion While on treatment, you may experience indigestion, also known as dyspepsia. TIPS While on treatment, you may have less desire to eat. But maintaining good nutrition and a healthy weight are important to your treatment. Protein and calories are even more vital to someone with your condition. TIPS Avoid talking while you chew, or eating too fast Drink beverages after, rather than during, meals Avoid late-night eating Try to relax after meals Avoid spicy foods Avoid alcohol Eat several small meals a day 5 or 6 isn t out of the question Eat when you are hungry Enjoy snacks and try to make them nutritious. Find calories and protein in dried fruits, nuts, cheeses, and even milkshakes Add gravy, butter, or cheese to your favorite foods for added protein and calories Drink fluids between meals rather than filling up with them during meals If the smell of a certain food is bothering you, it may help to eat it cold or at room temperature If you re having trouble tasting your favorite foods, try adding herbs or condiments Stomach pain While on treatment, you may experience stomach-area pain. Stomach-area pain is common for patients who are being treated. Call your doctor or nurse if you have stomach-area pain. TIPS Avoid heavy meals, coffee, and alcohol Sleep in a more upright position, propped up on a pillow Ask your doctor if there are over-the-counter or prescription medications that may help you manage your condition 5 Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure.

16 COMMON SUTENT (sunitinib malate) SIDE EFFECTS AND WAYS TO HELP MANAGE THEM Blisters or rash Some patients may have blisters or a rash on the palms of their hands or soles of their feet. This is called hand-foot syndrome. Tell your doctor or nurse if you start to develop skin problems. He or she may give you specific treatments, which may include lotions, moisturizers, or pain medicines. TIPS Wear loose clothes Use sunscreen Clean hands and feet with lukewarm water and gently pat dry Apply creams containing lanolin or urea to the hands and feet liberally and often Avoid tight-fitting shoes and jewelry or rubbing pressure on the hands and feet High blood pressure High blood pressure is common with SUTENT, and may sometimes be severe. Follow your healthcare provider s instructions about having your blood pressure checked regularly. Call your healthcare provider if your blood pressure is high or if you have any of the following signs or symptoms of high blood pressure: Severe headache Lightheadedness Dizziness Change in vision Your healthcare provider may prescribe medicine for you to treat high blood pressure, if needed. Your healthcare provider may temporarily stop your treatment with SUTENT until your high blood pressure is controlled. If you have high blood pressure, here are some healthy lifestyle choices that may be able to help but check with your healthcare provider first: TIPS Get regular exercise Keep your weight under control Lower your alcohol intake Lower the amount of sodium you eat in your food 6 Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure.

17 COMMON SUTENT (sunitinib malate) SIDE EFFECTS AND WAYS TO HELP MANAGE THEM Low platelet counts While on treatment, you may experience low platelet counts. Platelets play a role in preventing bleeding and repairing damaged blood vessels. Bleeding is common with SUTENT, but SUTENT can also cause severe bleeding problems that can lead to death. Call your healthcare provider right away if you have any of these symptoms or a serious bleeding problem during treatment with SUTENT, including: Painful stomach (abdomen) Vomiting blood Black, sticky stools Bloody urine To help manage your bleeding, your doctor may prescribe: Vitamin K injections Blood plasma or platelet transfusions Medication for platelet problems Headache or change in your mental status Coughing up blood Here are a few tips to help you avoid bleeding: TIPS Ask your doctor before drinking alcohol or taking new medications. These can make bleeding problems worse Use an extra soft toothbrush, and don t floss if your gums bleed Blow your nose gently using a soft tissue Be careful using scissors, knives, needles, or other sharp tools Take steps to prevent burns while cooking Shave with an electric razor Avoid contact sports and other activities that might cause injury 7 Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure.

18 COMMON SUTENT (sunitinib malate) SIDE EFFECTS AND WAYS TO HELP MANAGE THEM Taste changes While on treatment, foods you usually enjoy may taste bland, different, or bad. Call your doctor or nurse if you experience taste changes. TIPS Skin or hair changes Skin conditions as a result of your treatment do not usually pose health risks. However, a rash, dry, thick, callusing, cracking, widespread blistering, or peeling or damage of the skin may be a sign of a more serious side effect. Call your doctor right away if you experience these symptoms. Treatment with SUTENT may also cause changes in skin or hair color. Because your medicine inside the capsule is yellow, it may make your skin and hair look yellow or get lighter in color. While this side effect usually poses no health risks, yellow skin can be a sign of a more serious side effect. If you develop yellow skin, please call your doctor right away. Hair loss was not observed as a common side effect in the clinical trial. Try cold or frozen foods, as they may taste better than hot foods Flavor your food with herbs, seasonings, or sauces Keep a clean and healthy mouth by brushing and flossing often TIPS Wear thick cotton gloves and/or socks in order to protect your skin Avoid tight footwear and excessive friction Avoid hot water when washing hands, bathing, or showering Your doctor or nurse may give you specific treatments, which may include lotions, moisturizers, or pain medicines Discuss this side effect with your doctor or nurse so he or she can perform a full evaluation 8 Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure.

19 FILLING YOUR SUTENT (sunitinib malate) PRESCRIPTION SUTENT is available through a type of pharmacy called a Specialty Pharmacy Provider. These pharmacies handle medicines that are often not stocked at regular neighborhood pharmacies. Your doctor can help you find a Specialty Pharmacy Provider that works with your insurance. Once your insurance coverage has been verified, the specialty pharmacy provider will contact you to set up delivery of your prescription. Typically, the Specialty Pharmacy Provider will bill your insurance provider for the covered portion of the cost and bill you for the remaining co-pay or co-insurance. Free 8-Day Trial Voucher Eligible newly prescribed patients can start therapy as soon as possible with a free 8-day trial. Ask your doctor for more information on how to get started. Limits, terms, and conditions apply. 9 Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure.

20 Medicare/Government Insured Learning about financial assistance. Together. We re committed to helping you get your prescribed SUTENT (sunitinib malate). Pfizer Oncology Together can help you understand your insurance and identify what financial support may be available for your SUTENT prescription. Help identifying resources for eligible patients with Medicare/Medicare Part D, Medicaid, and other government insurance plans: Assistance with searching for support from independent charitable foundations: These foundations exist independently of Pfizer and have their own eligibility criteria and application processes. Availability of support from the foundations is determined solely by the foundations Financial assistance through Extra Help, a Medicare Part D Low-Income Subsidy (LIS) program Free medicine BIN: 6 GROUP: ID#: EXPIRATION DATE: /3/ Commercially Insured Resources for eligible commercial, private, employer, and state health insurance marketplace patients: Co-pay assistance: Eligible, commercially insured patients may pay as little as $ per month for SUTENT.* There are no income requirements, forms, or faxing to enroll Uninsured Help identifying resources for eligible patients without any form of healthcare coverage: Help finding coverage FOR LIVE, PERSONALIZED SUPPORT Call (Monday Friday 8 am 8 pm ET) LEARN MORE PfizerOncologyTogether.com Free medicine through the Pfizer Patient Assistance Program, or at a savings through the Pfizer Savings Program * Limits, terms, and conditions apply. Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico. Patients may receive up to $5, in savings annually. The offer will be accepted only at participating pharmacies. This offer is not health insurance. No membership fees apply. Pfizer reserves the right to rescind, revoke, or amend this offer without notice. For full Terms and Conditions, please see PfizerOncologyTogether.com/terms. For any questions, please call , visit PfizerOncologyTogether.com/terms or write: Pfizer Oncology Together Co-Pay Savings Program, 5 Perimeter Park Drive, Suite 3, Morrisville, NC 756. Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure. If support through independent charitable foundations or Medicare Extra Help is not available, Pfizer Oncology Together will provide eligible patients with medication for free through the Pfizer Patient Assistance Program. The Pfizer Patient Assistance Program is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation. The Pfizer Patient Assistance Foundation is a separate legal entity from Pfizer Inc. with distinct legal restrictions. The Pfizer Savings Program is not health insurance. For more information, call the toll-free number There are no membership fees to participate in this program. Estimated savings are 5 and depend on such factors as the particular drug purchased, amount purchased, and the pharmacy where purchased.

21 RESOURCES & SUPPORT Finding resources for your day-to-day. Together. Managing day-to-day life after diagnosis can be overwhelming, but you don t have to do it alone. With Pfizer Oncology Together, you ll have a dedicated Care Champion who has social work experience. Your Care Champion will talk with you one-on-one in order to provide you with resources to help with some of the day-to-day challenges you may be facing.* Emotional Support Find resources for emotional support and other daily challenges. These resources include support groups, an independent organization s helpline, and a free app designed to help you connect with loved ones. FOR LIVE, PERSONALIZED SUPPORT Call (Monday Friday 8 am 8 pm ET) Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure. LEARN MORE PfizerOncologyTogether.com

22 Transportation and Lodging Connect to an independent organization that helps eligible patients find rides and lodging for treatment-related appointments. Ongoing Education Get guidance on living with your condition, including nutritional information, communication tips, and toolkits specific to your prescribed medicine. Financial Support Workplace Guidance Receive information to help you prepare for leaving or returning to work after being diagnosed. Get help identifying financial assistance resources regardless of your insurance coverage. FOR LIVE, PERSONALIZED SUPPORT Call (Monday Friday 8 am 8 pm ET) LEARN MORE PfizerOncologyTogether.com Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure. * Some services are provided through third-party organizations that operate independently and are not controlled by Pfizer. Availability of services and eligibility requirements are determined solely by these organizations.

23 GLOSSARY QUESTIONS TO ASK YOUR HEALTHCARE TEAM Adjuvant Therapy An additional cancer treatment taken after your primary treatment, such as surgery. The goal of adjuvant therapy is to help reduce the risk of, or delay, recurrence. Metastatic Metastatic cancer is a cancer that has spread from the part of the body where it started (the primary site) to other parts of the body. Oncologist A doctor qualified to diagnose and treat cancers. Recurrence When cancer comes back after a period of time when it could not be detected, it is called a cancer recurrence. Renal Cell Carcinoma (RCC) A kidney cancer in which malignant (cancer) cells form in small tubes within the kidney. Urologist A doctor who specializes in the study or treatment of the urinary system. Whether you re about to start SUTENT (sunitinib malate), or are considering it, learning more about your treatment options can help you make informed decisions. SUTENT is a prescription medicine used to treat adults with kidney cancer that has not spread (localized) and who are at high risk of RCC coming back again after having kidney surgery. Below are a few questions to help guide the conversation: What type of kidney cancer do I have? How often should I have scans? What is the stage of my cancer? What is my risk of recurrence? Are there any other specialists who should be involved in my cancer treatment? How quickly after surgery should I start taking SUTENT? How long should I take SUTENT? What side effects can I expect during treatment and are there ways to help manage them? If you have any other questions, please be sure to ask your healthcare team. 3 Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure.

24 Talk to your doctor about SUTENT (sunitinib malate) and visit SELECTED SAFETY INFORMATION SUTENT can cause severe liver problems that can lead to death. Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems during treatment with SUTENT: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area. Your healthcare provider should do blood tests to check your liver function before you start taking and during treatment with SUTENT. Your healthcare provider may tell you to temporarily or permanently stop taking SUTENT if you develop liver problems. Please see Important Safety Information on pages 7-. Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems, following this brochure. PP-SUT-USA Pfizer Inc. All rights reserved. Printed in USA/February 9

25 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SUTENT safely and effectively. See full prescribing information for SUTENT. SUTENT (sunitinib malate) capsules, for oral use Initial U.S. Approval: 6 WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity has been observed in clinical trials and postmarketing experience. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions (5.)] INDICATIONS AND USAGE SUTENT is a kinase inhibitor indicated for: the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (.) the treatment of advanced renal cell carcinoma (RCC). (.) the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (.3) the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pnet) in patients with unresectable locally advanced or metastatic disease. (.4) DOSAGE AND ADMINISTRATION GIST and Advanced RCC: 5 mg orally once daily, with or without food, 4 weeks on treatment followed by weeks off. (.) Adjuvant RCC: 5 mg orally once daily, with or without food, 4 weeks on treatment followed by weeks off for nine 6-week cycles. (.) pnet: 37.5 mg orally once daily, with or without food, continuously without a scheduled off-treatment period. (.3) Dose Modification: Dose interruptions and/or dose adjustments of.5 mg recommended based on individual safety and tolerability. (.4) DOSAGE FORMS AND STRENGTHS Capsules:.5 mg, 5 mg, 37.5 mg, 5 mg (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Hepatotoxicity, including fatal liver failure, has been observed. Monitor liver function tests before initiation of treatment, during each cycle of treatment, and as clinically indicated. Interrupt SUTENT for Grade 3 or 4 drug-related hepatic adverse reactions and discontinue if there is no resolution. Do not restart SUTENT if patients experience severe changes in liver function tests or have signs and symptoms of liver failure. (5.) Cardiovascular events including myocardial ischemia, myocardial infarction, left ventricular ejection fraction declines to below the lower limit of normal and cardiac failure including death have occurred. Monitor patients for signs and symptoms of congestive heart failure. Discontinue SUTENT for clinical manifestations of congestive heart failure. (5.) Prolonged QT intervals and Torsade de Pointes have been observed. Monitor patients at higher risk for developing QT interval prolongation. Consider monitoring of electrocardiograms and electrolytes. (5.3) Hypertension may occur. Monitor blood pressure and treat as needed. (5.4) Hemorrhagic events, including tumor-related hemorrhage, and viscus perforation (both with fatal events) have occurred. Perform serial complete blood counts and physical examinations. (5.5) Cases of Tumor Lysis Syndrome (TLS) (some fatal) have been reported primarily in patients with RCC and GIST with high tumor burden. Monitor these patients closely and treat as clinically indicated. (5.6) Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, sometimes leading to renal failure or a fatal outcome, has been reported. Discontinue SUTENT in patients developing TMA. (5.7) Proteinuria, including renal failure or a fatal outcome, has occurred. Monitor urine protein. Interrupt treatment for 4-hour urine protein 3 grams. Discontinue for repeat episodes of protein 3 grams despite dose reductions or nephrotic syndrome. (5.8) Necrotizing fasciitis, erythema multiforme, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) (some fatal) have occurred. Discontinue SUTENT if these events occur. (5.9) Thyroid dysfunction may occur. Patients with signs and/or symptoms suggestive of hypothyroidism or hyperthyroidism should have laboratory monitoring of thyroid function performed and be treated as per standard medical practice. (5.) Hypoglycemia may occur. Check blood glucose levels regularly and assess if antidiabetic drug dose modifications are required. (5.) Osteonecrosis of the jaw has been reported. Consider preventive dentistry prior to treatment with SUTENT. If possible, avoid invasive dental procedures, particularly in patients receiving intravenous bisphosphonate therapy. (5.) Wound Healing: Impaired wound healing has occurred with SUTENT. Temporary interruption of therapy with SUTENT is recommended in patients undergoing major surgical procedures. (5.3) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. (5.4, 8., 8.3) ADVERSE REACTIONS The most common adverse reactions ( 5) are fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia/altered taste, dyspepsia, and thrombocytopenia. (6) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at or FDA at -8-FDA-88 or DRUG INTERACTIONS CYP3A4 Inhibitors: Consider dose reduction of SUTENT when administered with strong CYP3A4 inhibitors. (7.) CYP3A4 Inducers: Consider dose increase of SUTENT when administered with CYP3A4 inducers. (7.) USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed. (8.) See 7 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: /8 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: HEPATOTOXICITY INDICATIONS AND USAGE. Gastrointestinal Stromal Tumor (GIST). Advanced Renal Cell Carcinoma (RCC).3 Adjuvant Treatment of Renal Cell Carcinoma (RCC).4 Advanced Pancreatic Neuroendocrine Tumors (pnet) DOSAGE AND ADMINISTRATION. Recommended Dose for GIST and RCC. Recommended Dose for Adjuvant Treatment of RCC.3 Recommended Dose for pnet.4 Dose Modification 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5. Hepatotoxicity 5. Cardiovascular Events 5.3 QT Interval Prolongation and Torsade de Pointes 5.4 Hypertension 5.5 Hemorrhagic Events and Viscus Perforation