To significantly reduce stroke risk from AFib and to treat and help prevent DVT and PE blood clots DO YOU HAVE AFIB OR DVT/PE BLOOD CLOTS? GET TO KNOW HOW THIS LATEST-GENERATION BLOOD THINNER HELPS PROTECT YOU FROM A STROKE OR BLOOD CLOTS. Once I got the facts, my doctor and I chose XARELTO Do not stop taking XARELTO without talking to your doctor. Stopping XARELTO increases your risk of having a stroke. Please see accompanying full Prescribing Information for XARELTO, including Boxed Warnings, and Medication Guide, and Important Safety Information.
There s more to know about XARELTO XARELTO (rivaroxaban) is a prescription medication, proven to: Significantly lower the risk of stroke in people with atrial fibrillation (AFib) not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO and warfarin compare in reducing the risk of stroke Treat and help prevent blood clots in deep veins (such as in the legs) and in the lungs Reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery Learn how XARELTO may help you XARELTO, a latest-generation blood thinner, is selective. But what does that mean? Warfarin interferes with vitamin K and at least six blood-clotting factors. XARELTO targets one critical factor of your body s natural clotting process. KNOW XARELTO WITH MORE THAN 35 MILLION US PRESCRIPTIONS. 2 With XARELTO, you don t have to spend time visiting blood clinics to see if it s working, or make frequent adjustments to your dosage. Additionally, there are no known dietary restrictions. This means you can eat what you want without worrying which foods on your plate are high in vitamin K. Select Important Safety Information XARELTO can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO is a blood thinner medicine (anticoagulant) that reduces blood clotting. While you take XARELTO you are likely to bruise more easily, and it may take longer for bleeding to stop. Call your doctor or get medical help right away if you develop any signs or symptoms of bleeding. 3
See how XARELTO compares to warfarin How Medication Works Blood Monitoring Dietary Restrictions XARELTO (rivaroxaban) XARELTO works by blocking Factor Xa ( 10a ), an enzyme needed for blood clots to form. No regular blood tests. Regular blood tests are not needed with XARELTO. No known dietary restrictions. With XARELTO you can continue to eat the healthy food you enjoy. There are limited known interactions between XARELTO Drug and other medications. Please talk to your Interactions doctor about a list of medications that may interact with XARELTO. *Coumadin is a registered trademark of Bristol-Myers Squibb. WITH XARELTO, FOODS YOU LOVE are back on the menu Select Important Safety Information Do not take XARELTO if you: Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO if you currently have unusual bleeding. Are allergic to rivaroxaban or any of the ingredients of XARELTO. 4 Detach, seal, and mail today Warfarin (eg, Coumadin )* Warfarin works by interfering with vitamin K, and at least 6 blood-clotting factors. Requires blood tests. Blood tests are required at the start and throughout your treatment. Dietary restrictions exist. Spinach, cabbage, broccoli, and other foods high in vitamin K can affect how well warfarin works. There is a broad range of medications that interact with warfarin. Please talk to your doctor about a list of medications that may interact with warfarin. Why don t I need blood monitoring when taking XARELTO? XARELTO has been shown to deliver a predictable blood-thinning (anticoagulant) effect. In clinical studies, involving more than 55,000 people, regular blood monitoring was not required. With warfarin (eg, Coumadin ), another medicine that helps reduce the risk of DVT and PE blood clots and strokes, blood-thinning levels (eg, INR) can change based on age, race, weight, gender, and what you may eat. These are just a few of the reasons why regular blood monitoring is necessary with warfarin. The predictable effect of XARELTO means that regular blood tests aren t needed to see if it s working, check your levels, or change your medication dose. So you don t have to plan your schedule around a blood monitoring routine when you take XARELTO. 5
Learn how AFib can lead to a stroke Atrial fibrillation (AFib) can be a difficult condition to understand. The better informed you are, the better able you are to help protect yourself from stroke risk. AFib is an irregular heartbeat that keeps the upper and lower chambers of the heart from working together. 1. Blood can pool in the upper chambers and form a clot. 2. If part of the clot breaks free, it can travel to your brain. 3. It may block proper blood flow, and cause a stroke. Why do you need a blood thinner? Adding a blood thinner is important because risk of stroke is 5 times higher in a patient with AFib. You re still at risk of a stroke, even if you don t have any symptoms. People with AFib are 5 TIMES MORE LIKELY to have a stroke XARELTO FOR AFIB 3 2 Select Important Safety Information Do not stop taking XARELTO without talking to your doctor. Stopping XARELTO increases your risk of having a stroke. 1 6 7
Get to know XARELTO for atrial fibrillation With one tablet a day, XARELTO (rivaroxaban) helps protect you from stroke risk around-the-clock. In fact, a clinical study of more than 14,000 people has proven that XARELTO significantly lowers your chance of having a stroke due to AFib not caused by a heart valve problem. It has similar effectiveness to warfarin, and it may be a good fit for you. ONCE A DAY with the evening meal Select Important Safety Information XARELTO can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO is a blood thinner medicine (anticoagulant) that reduces blood clotting. While you take XARELTO you are likely to bruise more easily, and it may take longer for bleeding to stop. 8 9
Staying informed is important for your health Understanding DVT/PE. Learning you have deep vein thrombosis (DVT) or pulmonary embolism (PE) can be unsettling news. But managing it doesn t have to be. The better informed you are, the better able you are to make choices that can help protect your health. DVT is a blood clot that forms in a vein deep inside your body, such as in the legs. DVT is a serious condition and can lead to pulmonary embolism. DVT and PE blood clots are serious. DVT and PE cause more deaths in the US than breast cancer, traffic accidents, and HIV combined. If you ve already had a DVT or PE, you have an increased risk of developing another blood clot, and your risk increases over time. MORE PEOPLE DIE OF DVT/PE EACH YEAR than breast cancer, traffic accidents and HIV combined PE occurs when a blood clot formed elsewhere in your body travels through the bloodstream and becomes lodged in your lungs. A PE can block blood flow and is potentially life threatening. XARELTO FOR DVT/PE Select Important Safety Information Do not take XARELTO if you: Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO if you currently have unusual bleeding. Are allergic to rivaroxaban or any of the ingredients of XARELTO. 10 11
Get to know XARELTO for DVT/PE Proven in large clinical studies. XARELTO has already been prescribed more than 35 million times in the US, and it is proven to work. In the largest clinical study of DVT and PE ever conducted, XARELTO was proven effective at treating DVT and PE, and reducing the risk of these blood clots happening again. For most patients who are prescribed XARELTO for deep vein thrombosis (DVT) or pulmonary embolism (PE), the dosing schedule is: INITIAL TREATMENT OF AT LEAST 6 MONTHS First 21 days Start with: One 15-mg tablet twice a day with food AM PM On day 22 Switch to: One 20-mg tablet once a day with food TREATMENT TO REDUCE THE RISK OF ANOTHER DVT OR PE After at least 6 months Switch to: One 10-mg tablet once a day with or without food Take XARELTO as your doctor prescribes To benefit from XARELTO, you should take it exactly as your doctor prescribes. Your doctor will decide how long you should take XARELTO. Do not stop taking XARELTO without talking with your doctor first. Stopping XARELTO may increase your risk of stroke or DVT/PE blood clots. If you miss a dose of XARELTO, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Tell all your doctors, including dentists, that you are taking XARELTO. They should talk to the doctor who prescribed XARELTO before any surgical, medical, or dental procedure. Your doctor may stop your XARELTO for a short time and tell you when to start taking XARELTO again after your surgery or procedure. Tablets shown not actual size. Remember to talk to your doctor about: The date you may need to switch your dose What dose is right for you To help prevent another DVT or PE: Take your medicines exactly as your doctor prescribed to treat or help prevent blood clots Contact 1-888-XARELTO (1-888-927-3586) for additional questions Follow up with your doctor for tests and treatment Wear compression stockings, if your doctor recommends them, to prevent leg swelling Ask your doctor about leg exercises that can help prevent blood clots on long trips 12 13
The benefits of the Janssen CarePath Patient Support Program With XARELTO (rivaroxaban) you don t have to go it alone. The Janssen CarePath Patient Support Program offers you valuable information and tools to help you better understand your condition, stay with the treatment plan your doctor prescribes, and save on your XARELTO prescription costs. The Janssen CarePath program includes: Janssen CarePath Savings Card See your healthcare provider to learn about how you may be eligible to save on your next XARELTO prescription Free Medication Tracker Keep a record of your medications and a reminder of when to take them Ongoing Support Valuable information to learn more about treating your condition or changing your dose, if necessary Helpful Reminders Reminders on when to refill your prescription Care4Today Connect A helpful medication, appointment, and healthy habits reminder tool Dedicated Care Coordinator A live Care Coordinator can review your insurance coverage for XARELTO and help identify options to help you pay for XARELTO BIN: 610020 ID: GROUP: XARELTO01 Savings Program Please read the accompanying full Prescribing Information, including Boxed Warnings, and Medication Guide for XARELTO, and discuss any questions you have with your doctor. SEE BELOW. RESTRICTIONS APPLY. Signing up is easy. Go to: XARELTO.com or call 1-888-XARELTO (1-888-927-3586) for detailed information SAVINGS AND SUPPORT 14 15
Personalized Discussion Guide Have you spoken to your doctor about your treatment options? You should always feel comfortable approaching your doctor to get informed and ask questions about your treatment options. Take a minute to think about your experience with your current medication. You may have questions like the ones below. Select the questions that are right for you and ask your doctor today about XARELTO (rivaroxaban). How does XARELTO help protect me from a stroke? What are the benefits and side effects of XARELTO compared to warfarin? How can I reduce my AFib-related stroke risk or DVT/PE blood clots? Is XARELTO a latest-generation blood thinner I should consider? Would I need to change my XARELTO dose if my diet changes? Are there any foods I need to avoid while taking XARELTO? Do any of the medications I take affect the way XARELTO works? If there are no regular blood tests or dietary restrictions, how do I know XARELTO is working? Am I eligible to save on XARELTO through the Janssen CarePath Savings Program? 18 Use the space below for any additional questions: GET TO KNOW MORE ABOUT XARELTO BY TALKING TO YOUR DOCTOR TODAY. 19 DISCUSSION GUIDE
Notes 20 21
WHAT IS XARELTO (rivaroxaban)? XARELTO is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO and warfarin compare in reducing the risk of stroke. XARELTO is also a prescription medicine used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months. XARELTO is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery. IMPORTANT SAFETY INFORMATION WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO? For people taking XARELTO for atrial fibrillation: People with atrial fibrillation (an irregular heart beat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO, you may have increased risk of forming a clot in your blood. Do not stop taking XARELTO without talking to the doctor who prescribes it for you. Stopping XARELTO increases your risk of having a stroke. If you have to stop taking XARELTO, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming. Please see full Prescribing Information, including Boxed Warnings, and Medication Guide, 22 XARELTO can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO is a blood thinner medicine (anticoagulant) that reduces blood clotting. While you take XARELTO you are likely to bruise more easily, and it may take longer for bleeding to stop. You may have a higher risk of bleeding if you take XARELTO and take other medicines that increase your risk of bleeding, including: Aspirin or aspirin-containing products Non-steroidal anti-inflammatory drugs (NSAIDs) Warfarin sodium (Coumadin, Jantoven ) Any medicine that contains heparin Clopidogrel (Plavix ) Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) Other medicines to prevent or treat blood clots Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding: Unexpected bleeding or bleeding that lasts a long time, such as: Nosebleeds that happen often Unusual bleeding from gums Menstrual bleeding that is heavier than normal, or vaginal bleeding Bleeding that is severe or you cannot control Red, pink, or brown urine Bright red or black stools (looks like tar) Cough up blood or blood clots 23 IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION (cont d) Vomit blood or your vomit looks like coffee grounds Headaches, feeling dizzy or weak Pain, swelling, or new drainage at wound sites Spinal or epidural blood clots (hematoma): People who take a blood thinner medicine like XARELTO, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if: A thin tube called an epidural catheter is placed in your back to give you certain medicine You take NSAIDs or a medicine to prevent blood from clotting You have a history of difficult or repeated epidural or spinal punctures You have a history of problems with your spine or have had surgery on your spine If you take XARELTO and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence). XARELTO is not for people with artificial heart valves. Do not take XARELTO if you: Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO if you currently have unusual bleeding. Are allergic to rivaroxaban or any of the ingredients of XARELTO. Before taking XARELTO, tell your doctor about all your medical conditions, including if you: Have ever had bleeding problems Have liver or kidney problems Are pregnant or plan to become pregnant. It is not known if XARELTO will harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with XARELTO. Taking XARELTO while you are pregnant may increase the risk of bleeding in you or in your unborn baby. If you take XARELTO during pregnancy, tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. See What is the most important information I should know about XARELTO? for signs and symptoms of bleeding. Are breastfeeding or plan to breastfeed. XARELTO may pass into your breast milk. You and your doctor should decide if you will take XARELTO or breastfeed. Tell all of your doctors and dentists that you are taking XARELTO. They should talk to the doctor who prescribed XARELTO for you before you have any surgery, medical or dental procedure. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO works. Certain medicines may increase your risk of bleeding. See What is the most important information I should know about XARELTO? 24 Please see full Prescribing Information, including Boxed Warnings, and Medication Guide, 25
IMPORTANT SAFETY INFORMATION (cont d) HOW SHOULD I TAKE XARELTO? Take XARELTO exactly as prescribed by your doctor. Do not change your dose or stop taking XARELTO unless your doctor tells you to. Your doctor may change your dose if needed. If you take XARELTO for: Atrial Fibrillation: Take XARELTO 1 time a day with your evening meal. If you miss a dose of XARELTO, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Blood clots in the veins of your legs or lungs: Take XARELTO 1 or 2 times a day as prescribed by your doctor. For the 15-mg and 20-mg doses, XARELTO should be taken with food. For the 10-mg dose, XARELTO may be taken with or without food. Take your XARELTO dose(s) at the same time each day. If you miss a dose: If you take the 15-mg dose of XARELTO 2 times a day (a total of 30 mg of XARELTO in 1 day): Take XARELTO as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time. If you take XARELTO 1 time a day: Take XARELTO as soon as you remember on the same day. Take your next dose at your regularly scheduled time. Please see full Prescribing Information, including Boxed Warnings, and Medication Guide, 26 Hip or knee replacement surgery: Take XARELTO 1 time a day with or without food. If you miss a dose of XARELTO, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time. If you have difficulty swallowing the XARELTO tablet whole, talk to your doctor about other ways to take XARELTO. Your doctor will decide how long you should take XARELTO. Your doctor may stop XARELTO for a short time before any surgery, medical or dental procedure. Your doctor will tell you when to start taking XARELTO again after your surgery or procedure. Do not run out of XARELTO. Refill your prescription for XARELTO before you run out. When leaving the hospital following a hip or knee replacement, be sure that you have XARELTO available to avoid missing any doses. If you take too much XARELTO, go to the nearest hospital emergency room or call your doctor right away. WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO? See What is the most important information I should know about XARELTO? Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/ medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736). Please see full Prescribing Information, including Boxed Warnings, and Medication Guide, Trademarks are those of their respective owners. 27 083075-171026
Moisten and seal here. Notes I d like to sign up for Janssen CarePath Ongoing Support. I am a: Patient Caregiver I prefer to receive communications by: Detach, seal, and mail today Warfarin The information you provide will only be used (eg, by Janssen Coumadin Pharmaceuticals, )* Inc., our affiliates, and our service providers for your registration Warfarin and participation works by in interfering the Janssen with CarePath vitamin Patient K, and Support at least Program 6 blood-clotting and to contact factors. you. You may ask to withdraw from the program by calling Requires blood tests. 1-888-XARELTO (1-888-927-3586). Our Privacy Blood tests are required at the start and Policy, which may be found at www.xarelto-us.com/ throughout your treatment. privacy-policy, governs the use of the information Dietary you provide. restrictions By providing exist. the information, signing, Spinach, and submitting cabbage, this broccoli, form, you and indicate other foods that you have high read, in understand, vitamin K can and affect agree how to these well terms. warfarin works. There is a broad range of medications that First interact Name with warfarin. Last Please Name talk to your doctor about a list of medications that may interact with warfarin. E-mail Street Address Suite/Apt Number E-mail Postal Mail E-mail and Postal Mail Patient information Gender: Male Female Age Group: Under 18 years of age 18 44 45 64 65 74 75+ Health Condition: AFib DVT and/or PE Been prescribed XARELTO for your condition: Yes No I am currently treating my condition with: Warfarin (eg, Coumadin )* Another prescription drug Aspirin Not treating at all Signature To receive information, you must sign and return this card. Moisten and seal here. City State ZIP *Coumadin is a registered trademark of Bristol-Myers Squibb. 3780 Janssen Pharmaceuticals, Inc. 2017 December 2017 053256-171117 Janssen Pharmaceuticals, Inc. 28 Moisten and seal here.
BUSINESS REPLY MAIL FIRST-CLASS MAIL PERMIT NO. 9 COLMAR PA POSTAGE WILL BE PAID BY ADDRESSEE JANSSEN PHARMACEUTICALS INC PO BOX 3002 COLMAR PA 18915-9803 NO POSTAGE NECESSARY IF MAILED IN THE UNITED STATES Please see full Prescribing Information for XARELTO (rivaroxaban), including Boxed Warnings, and Medication Guide, and Important Safety Information inside. Please read and discuss any questions you may have with your doctor. Janssen Pharmaceuticals, Inc.
Xarelto.com 1-888-XARELTO (1-888-927-3586) Monday Friday, 8:00 AM 8:00 PM, ET Please see accompanying full Prescribing Information for XARELTO, including Boxed Warnings, and Medication Guide, and Important Safety Information. XARELTO is licensed from Bayer HealthCare AG, 51368 Leverkusen, Germany Janssen Pharmaceuticals, Inc. 2017 December 2017 053256-171117 Janssen Pharmaceuticals, Inc.