YOUR CABOMETYX HANDBOOK AN OVERVIEW FOR PATIENTS AND CAREGIVERS in the full Prescribing Information.
Table of Contents What s included in this handbook... 3 A kidney cancer overview...4 About CABOMETYX...4 As a first treatment...6 7 For people who have already received treatment... 8 9 Possible side effects... 10 13 Dosing... 14 16 Questions to ask your oncologist...17 How caregivers can help...18 Financial assistance...19 1 What will I find in this handbook? This handbook can help answer many of the questions you may have about your treatment with CABOMETYX. Topics covered in this handbook include: What CABOMETYX is and how it can help How to take CABOMETYX and why your dose may change Financial and support information Please note that italicized words are included in the glossary of terms, which can be found on page 2. If you re looking for more information, please visit: GLOSSARY Advanced: When cancer has spread from the original site in this case, your kidney and moved to other parts of the body. Clinical trial: Research that is designed to test new medical approaches, such as new medicines, and how they work in people. Malignant: Cancerous. These cells can move from their original place (for example, the kidney) to other tissues within the body. Molecule: One or more atoms (tiny particles). Atoms from the same element can join together or atoms from 2 different elements can join together. For example, H 2 O, or water, is a molecule made by the joining of 2 hydrogen atoms and an oxygen atom. Oncologist: A physician who diagnoses and treats cancer. This person is the main contact point for any CABOMETYX-related questions. He or she may also coordinate treatment given by other specialists. Tumor: An abnormal mass of cells that develops because cells are growing and dividing more quickly than they should and don t die when they should. A tumor can be either cancerous or benign (not cancerous). www.cabometyx.com Please talk to your oncology doctor or nurse if you have any questions. They are always your best health resource. 2 in the full Prescribing Information. 3
2 What is kidney cancer? Without cancer Your body is a balance of growing and dying cells. With cancer Cells receive signals to grow and divide without receiving signals to stop or die. When this happens, the cells are malignant, or cancerous. Kidney cancer is diagnosed when these malignant cells grow in the kidney. Cell growth Signals Cell death When someone gets cancer, it s Cell division Kidney 4 How does CABOMETYX work? Different kinds of molecules have been found to send grow and stop signals to kidney cancer cells and normal cells Several of these molecules are known to help kidney cancer cells survive and form tumors When scientists studied CABOMETYX in the laboratory, they found that CABOMETYX attaches to some of these molecules, and blocks them from sending grow signals to cells By blocking these signals, the cancer cells are more likely to stop growing and the tumor is more likely to shrink Signals BLOCK Molecules There are different types of kidney cancer. The most common type is called renal cell carcinoma. Renal cell carcinoma starts in the tubules, or small tubes, of the kidney. Tubules CABOMETYX was proven to help people live longer without their cancer getting worse in two different clinical trials 3 When the cancer spreads from the kidney to other parts of the body, it is advanced. What is CABOMETYX? CABOMETYX (pronounced: ka-boe-met-iks) is: A tablet A prescription medicine used to treat people with advanced kidney cancer (renal cell carcinoma) It is not known if CABOMETYX is safe and effective in children Important Safety Information CABOMETYX may cause serious side effects, including: Severe bleeding (hemorrhage). Tell your healthcare provider right away if you get any signs of bleeding during treatment with CABOMETYX, including: coughing up blood or blood clots vomiting blood or if your vomit looks like coffee-grounds red or black (looks like tar) stools menstrual bleeding that is heavier than normal any unusual or heavy bleeding A tear in your stomach or intestinal wall (perforation) or an abnormal connection between 2 parts of your body (fistula). Tell your healthcare provider right away if you have tenderness or pain in your stomach area (abdomen). 4 in the full Prescribing Information. 5
5 1st line How was CABOMETYX studied as the first treatment given to people with advanced kidney cancer? 6 How did CABOMETYX help?* People taking CABOMETYX had a As the first therapy used to treat advanced kidney cancer, CABOMETYX was compared with sunitinib in a clinical trial of people with advanced kidney cancer. All people in the study had not previously received medicine to treat their advanced kidney cancer. 157 people with advanced kidney cancer lower chance of their cancer getting worse vs sunitinib At 8.6 months, half the people treated with CABOMETYX lived without their tumor getting worse At 5.3 months, half the people treated with sunitinib lived without their tumor getting worse 79 were treated with CABOMETYX 78 were treated with sunitinib* *These data represent an average. CABOMETYX will affect each person differently. Important Safety Information (continued) CABOMETYX may cause serious side effects, including: In the study, people were allowed to stay on treatment until their tumor started to grow again or they had a serious side effect that could not be managed. * Sunitinib is a medication used to treat adults with advanced kidney cancer. Blood clots, stroke, heart attack, and chest pain. Get emergency help right away if you have: swelling or pain in your arms or legs shortness of breath feel lightheaded or faint sweating more than usual numbness or weakness of your face, arm, or leg, especially on one side of your body sudden confusion, trouble speaking or understanding sudden trouble seeing in one or both eyes sudden trouble walking dizziness, loss of balance or coordination a sudden severe headache 6 in the full Prescribing Information. 7
7 2nd line How was CABOMETYX studied in people who have already received treatment for their advanced kidney cancer? CABOMETYX was studied in a clinical trial of people with advanced kidney cancer. All people in the study had been given at least one other medicine to treat their cancer before taking CABOMETYX. 658 people with advanced kidney cancer 8 How did CABOMETYX help? People who took part in the clinical trial were more likely to benefit from treatment with CABOMETYX than with everolimus. People were more likely to LIVE LONGER People lived nearly without their tumor getting worse More than as many people saw their tumor shrink in size 330 were treated with CABOMETYX 328 were treated with everolimus* In the study, people were allowed to stay on treatment until their tumor started to grow again or they had a serious side effect that could not be managed. * Everolimus is a medication used to treat adults with advanced kidney cancer when certain other medicines have not worked. At 21.4 months, half the people treated with CABOMETYX were still alive At 16.5 months, half the people treated with everolimus were still alive At 7.4 months, half the people treated with CABOMETYX lived without their tumor getting worse At 3.8 months, half the people treated with everolimus lived without their tumor getting worse 17% of people treated with CABOMETYX saw their tumor shrink in size compared with 3% of people treated with everolimus In the clinical trial, the tumor had to shrink by at least 30% and had to be confirmed by a second scan These data represent an average. CABOMETYX will affect each person differently. Important Safety Information (continued) CABOMETYX may cause serious side effects, including: High blood pressure (hypertension). Hypertension is common with CABOMETYX and sometimes can be severe. Your healthcare provider will check your blood pressure before starting CABOMETYX and during treatment with CABOMETYX. If needed, your healthcare provider may prescribe medicine to treat your high blood pressure. 8 in the full Prescribing Information. 9
9 What are the possible side effects of CABOMETYX? CABOMETYX may cause serious side effects, including: Severe bleeding (hemorrhage). Tell your healthcare provider right away if you have any signs of bleeding during treatment with CABOMETYX, including: coughing up blood or blood clots vomiting blood or if your vomit looks like coffee grounds A tear in your stomach or intestinal wall (perforation) or an abnormal connection between 2 parts of your body (fistula). Tell your healthcare provider right away if you have tenderness or pain in your stomach area (abdomen). Blood clots, stroke, heart attack, and chest pain. Get emergency help right away if you have: swelling or pain in your arms or legs shortness of breath feel lightheaded or faint sweating more than usual numbness or weakness of your face, arm, or leg, especially on one side of your body red or black (looks like tar) stools menstrual bleeding that is heavier than normal any unusual or heavy bleeding sudden confusion, trouble speaking or understanding sudden trouble seeing in one or both eyes sudden trouble walking dizziness, loss of balance or coordination a sudden severe headache? High blood pressure (hypertension). Hypertension is common with CABOMETYX and sometimes can be severe. Your healthcare provider will check your blood pressure before starting CABOMETYX and during treatment with CABOMETYX. If needed, your healthcare provider may prescribe medicine to treat your high blood pressure. Diarrhea. Diarrhea is common with CABOMETYX and can be severe. If needed, your healthcare provider may prescribe medicine to treat your diarrhea. Tell your healthcare provider right away if you have frequent loose, watery bowel movements. A skin problem called hand-foot skin reaction. Hand-foot skin reactions are common and can be severe. Tell your healthcare provider right away if you have rashes, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet. Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome can happen during treatment with CABOMETYX. Tell your healthcare provider right away if you have headaches, seizures, confusion, changes in vision, or problems thinking. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with CABOMETYX if you have certain side effects. The most common side effects of CABOMETYX are: tiredness nausea decreased appetite weight loss vomiting altered sense of taste inflamed and sore mouth Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CABOMETYX. For more information, ask your 10 in the full Prescribing Information. healthcare provider or pharmacist. 11
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Before you take CABOMETYX, tell your healthcare provider about all of your medical conditions, including if you: have any unusual bleeding have high blood pressure Plan to have any surgery, including dental surgery. You should stop treatment with CABOMETYX at least 28 days before any scheduled surgery. Have liver problems Are pregnant, or plan to become pregnant. CABOMETYX can harm your unborn baby. If you are able to become pregnant, you should use effective birth control during treatment and for 4 months after your final dose of CABOMETYX. Talk to your healthcare provider about birth control methods that may be right for you. If you become pregnant or think you are pregnant, tell your healthcare provider right away. Are breastfeeding or plan to breastfeed. It is not known if CABOMETYX passes into your breast milk. Do not breastfeed during treatment and for 4 months after your final dose of CABOMETYX. Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. CABOMETYX and certain other medicines may affect each other, causing side effects. 10 Can side effects be managed? Like most medicines, there are side effects that have been seen in people who have taken CABOMETYX. If you are having side effects, your doctor may decide to adjust your dose. It is important to tell your oncology treatment team right away if you experience any side effects. The sooner they know about your side effects, the sooner they can help you manage them if possible. Dose adjustments can be used to manage certain side effects: Diarrhea Mouth sores Nausea (feeling like you re going to throw up) or Vomiting Fatigue (being very tired and/or feeling like you have no energy) Hand-foot syndrome Hypertension (high blood pressure) 12 in the full Prescribing Information. 13
11 How do I take CABOMETYX? CABOMETYX is a tablet you take once a day. 13 Will my CABOMETYX dose change? Your dose may change. How? When? At the same time every day, but If you have certain side effects, your oncology doctor or nurse may pause it for a little while or lower your CABOMETYX dose Swallow whole with 8 oz of water DO NOT CRUSH Do not eat for at least TWO HOURS BEFORE AND ONE HOUR AFTER If you have certain side effects, your oncologist may have you permanently stop taking CABOMETYX 12 Tablet is not actual size. What do I do if I forget to take CABOMETYX? If you forget to take your CABOMETYX and you should be taking your next dose in: Each person who takes CABOMETYX will respond differently. You and your oncologist will figure out what dose is right for you based on how your body responds to CABOMETYX. LESS THAN 12 HOURS Do not try to make up the missed dose Take the next dose when you usually take it 12 OR MORE HOURS Take the missed dose as soon as possible Take the next dose when you usually take it In the clinical trials, many patients paused their treatment or had their dose lowered to manage certain side effects. Most people in the clinical trials had at least one dose reduction. There are 3 different doses for CABOMETYX 60 mg 40 mg 20 mg Call your healthcare provider right away if you take too much CABOMETYX. Tablets are not actual size. Be sure to take your medication as recommended by your oncology doctor. Ask your oncology doctor or nurse about anything you don t understand. This will help you learn more about your treatment, your treatment goals, and what you can do to help with your care. 14 in the full Prescribing Information. 15
14 15 What should I avoid while taking CABOMETYX? Do not drink grapefruit juice, eat grapefruit or supplements that contain grapefruit during treatment with CABOMETYX. Is there anything I can do to help manage side effects? It s important that you keep track of your side effects. Let your oncology doctor or nurse know right away if you feel different or experience a side effect that bothers you or that does not go away. 16 What are examples of some questions to ask your oncologist? It helps to be prepared for your doctor s appointments. Here are some questions you may want to ask your oncologist. This is just a list to help you get started. Feel free to jot down the answers here or make a note of any other questions you d like to ask. If my caregiver or I have questions, and the oncologist isn t available, who should we talk to? Is a nurse or someone else in the office available? There are ways to help manage certain side effects How will I know if my treatment is working? If you d like more information, management tips for certain side effects can be found online at www.cabometyx.com or What types of side effects might be seen with treatment? Is there anything in particular that I should look out for? on the side-effect management tip cards within your patient care kit Are the side effects manageable? You can also talk to your oncology doctor or nurse about his or her recommendations for helping with side effects. 16 in the full Prescribing Information. 17
As a caregiver, what can you do to help? 17 18 You are an essential part of your loved one s treatment circle. There are many things you can do to help. Know what to expect: Find out as much as you can about your loved one s diagnosis and treatment You ll have a better idea of what to expect during your loved one s journey Understand the dosing schedule and potential side effects of CABOMETYX You can help your loved one keep an eye on both especially side effects, since some can be managed Go along to doctor s appointments: Go to checkups with your loved one He or she will have a second pair of ears listening to the doctor and nurse Come prepared with questions to ask the doctor or nurse Make sure you get all the answers you re looking for Take notes and speak up! Don t be afraid to ask questions if you don t understand something Get organized: Try to be as organized as possible There s a lot of paperwork in healthcare to keep track of Make sure you have a place to store important documents so you can find them easily And don t forget to take care of yourself too! Is there financial assistance available? To learn more about how EASE can help you, contact us: 1-844-900-EASE (1-844-900-3273) Monday to Friday, 8:00 am to 8:00 pm ET Access. Assistance. Along the journey. EASE is your resource for questions and needs related to coverage, financial assistance, and treatment support for CABOMETYX (cabozantinib). PERSONALIZED SUPPORT FOR YOU Trained professionals are available by phone to help you: Understand if your health insurance covers CABOMETYX and what your out-of-pocket costs associated with CABOMETYX will be Learn about your financial support options If you are commercially insured EASE Co-pay Program Eligible commercially insured patients pay no more than $10 per month for CABOMETYX. The program covers the remaining out-of-pocket drug costs, up to a $25,000 yearly limit. Patients with government insurance are excluded. Additional restrictions and eligibility rules apply. If you are uninsured, or insured but still cannot afford your medicine EASE Patient Assistance Program May provide you with CABOMETYX free of charge if you qualify. Additional restrictions and eligibility rules apply. This description of the Exelixis Access Services program is for informational purposes only. Exelixis makes no representation or guarantee concerning reimbursement or coverage for any service or item. Information provided through the Exelixis Access Services program does not constitute medical or legal advice and is not intended to be a substitute for a consultation with a licensed healthcare provider, legal counsel, or applicable third-party payer(s). Exelixis reserves the right to modify the program at any time without notice. 18 in the full Prescribing Information. 19
FIND OUT MORE AT WWW.CABOMETYX.COM in the full Prescribing Information. 2018 Exelixis, Inc. Printed in USA 4/18 CA-0838