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 27 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 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 XARELTO (rivaroxaban) XARELTO works by blocking Factor Xa ( 10a ), an enzyme needed for blood clots to form. Warfarin (eg, Coumadin )* Warfarin works by interfering with vitamin K, and at least 6 blood-clotting factors. Blood Monitoring Dietary Restrictions Drug Interactions 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 and other medications. Please talk to your 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 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. 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. 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 3. It may block proper blood flow, and cause a stroke. Select Important Safety Information 3 2 Do not stop taking XARELTO without talking to your doctor. Stopping XARELTO increases your risk of having a stroke. 1 6 7 XARELTO FOR AFIB AFib is an irregular heartbeat that keeps the upper and lower chambers of the heart from working together. Why do you need a blood thinner?
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 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 27 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. XARELTO is taken once daily after the first 21 days. The starting dose is one 15-mg tablet, taken twice a day with food for the first 21 days On the 22nd day, the dose is changed by your doctor to one 20-mg tablet once a day with 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. 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 free 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. Signing up is easy. Go to: The Janssen CarePath program includes: janssencarepath.com/xarelto Janssen CarePath Savings Card See how you can be eligible for a $0 co-pay every month (1-888-927-3586) or call 1-888-XARELTO for detailed information Janssen CarePath Trial Offer You may be eligible to receive a 30-day free trial supply of XARELTO 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 14 SAVINGS AND SUPPORT Care4Today Mobile Health Manager a two-way messaging app for all your treatment needs and questions 15
Frequently Asked Questions It is normal to have questions when it comes to your treatment options. You want to make sure you are taking all the steps you can when it comes to protecting your health. FAQs about XARELTO (rivaroxaban) for people with atrial fibrillation (AFib), deep vein thrombosis (DVT), or pulmonary embolism (PE). Q. What makes XARELTO different? A. Similarly to warfarin, XARELTO is proven to reduce stroke risk in people with AFib, as well as treat and help prevent DVT and PE. Warfarin interferes with vitamin K and at least six bloodclotting factors. XARELTO works selectively, targeting one critical factor of your body s natural clotting function. And with XARELTO you don t have to plan your schedule around a blood monitoring routine or change the way you eat. Q. How does XARELTO safety compare with warfarin/coumadin? A. In AFib clinical studies of more than 14,000 patients, XARELTO showed similar bleeding rates vs warfarin, with much less bleeding in the brain (fatal bleeding) and higher GI bleeding. Q. Can I afford XARELTO, a branded medication? A. With the Janssen CarePath Savings Card, you can be eligible for a $0 co-pay every month. Additionally, with the Janssen CarePath Trial Offer, you may be eligible to receive a 30-day free trial supply of XARELTO. 16 Q. What is the most important side effect I should be aware of with XARELTO? A. If you have AFib, or a prior DVT or PE, you may need a blood thinner to reduce your risk of a DVT/PE blood clot or stroke. Like all blood thinners, XARELTO can cause bleeding, which can be serious, and rarely may lead to death. Be sure to take XARELTO exactly as prescribed and do not stop taking XARELTO without talking with your doctor first. Stopping XARELTO may increase your risk of having a stroke or blood clots. You should discuss all potential benefits and risks with your doctor. Q. Are there any foods or medicines I should avoid when taking XARELTO? A. Unlike warfarin, XARELTO has no known dietary restrictions. You can eat leafy greens without affecting how XARELTO works. Like all blood thinners, you have a higher risk of bleeding if you take XARELTO with other medicines, such as: aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, heparin, clopidogrel (Plavix ), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), or other medicines to prevent or treat blood clots. Be sure to tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. 17 FAQs
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 for the $0 co-pay, or the Medicare lowest branded co-pay offered with XARELTO? 18 Use the space below for any additional questions: GET TO KNOW MORE ABOUT XARELTO BY TALKING TO YOUR DOCTOR TODAY. 19 DISCUSSION GUIDE
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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 and pulmonary embolism, and to help reduce the risk of these conditions occurring again. 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 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 that 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 (anticoagulant) 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 patients with artificial heart valves. WHO SHOULD NOT TAKE XARELTO? 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. 24 Are allergic to rivaroxaban or any of the ingredients of XARELTO. WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO? Before taking XARELTO, tell your doctor if you: Have ever had bleeding problems Have liver or kidney problems Have any other medical condition 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 while taking XARELTO. If you take XARELTO during pregnancy, tell your doctor right away if you have bleeding or symptoms of blood loss. Are breastfeeding or plan to breastfeed. It is not known if XARELTO passes 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 nonprescription 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? Please see full Prescribing Information, including Boxed Warnings, and Medication Guide, 25
IMPORTANT SAFETY INFORMATION (Cont d) Especially tell your doctor if you take: Ketoconazole (Nizoral ) Itraconazole (Onmel, Sporanox ) Ritonavir (Norvir ) Lopinavir/ritonavir (Kaletra ) Indinavir (Crixivan ) Carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol -XR, Teril, Epitol ) Phenytoin (Dilantin-125, Dilantin ) Phenobarbital (Solfoton ) Rifampin (Rifater, Rifamate, Rimactane, Rifadin ) St. John s wort (Hypericum perforatum) Ask your doctor if you are not sure if your medicine is one listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. 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 will tell you how much XARELTO to take and when to take it. 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 once or twice a day as prescribed by your doctor. Take XARELTO with food at the same time each day. If you miss a dose of XARELTO : and take XARELTO 2 times a 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. and 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. 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 tablet whole, talk to your doctor about other ways to take XARELTO. Your doctor will decide how long you should take XARELTO. Do not stop taking XARELTO without talking to your doctor first. 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. Please see full Prescribing Information, including Boxed Warnings, and Medication Guide, 26 27
Moisten and seal here. IMPORTANT SAFETY INFORMATION (Cont d) I d like to sign up for Janssen CarePath Ongoing Support. I am a: Patient Caregiver I prefer to receive communications by: 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? Please see What is the most important information I should know about XARELTO? Tell your doctor if you have any side effect that bothers you or that does not go away. 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). 052839-160508 Detach, seal, and mail today Warfarin The information you provide will only be used by (eg, Janssen Coumadin Pharmaceuticals, )* Inc., our affiliates, and our service providers for your registration and Warfarin participation works in by the interfering CarePath Support with vitamin Program K, and and at to least contact 6 blood-clotting you. You may factors. ask to withdraw from the program by calling 1-888-XARELTO Requires blood tests. (1-888-927-3586). Our Privacy Policy, which may Blood tests are required at the start and be found at www.xarelto-us.com/privacy-policy, throughout your treatment. governs the use of the information you provide. Dietary By providing restrictions the information, exist. signing, and Spinach, submitting cabbage, this form, broccoli, you indicate and other that foods 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 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 Moisten and seal here. Please see full Prescribing Information, including Boxed Warnings, and Medication Guide, Trademarks are those of their respective owners. Suite/Apt Number To receive information, you must sign and return this card. Support Program for Patients & Caregivers City State ZIP *Coumadin is a registered trademark of Bristol-Myers Squibb. 3780 Janssen Pharmaceuticals, Inc. 2017 February 2017 053256-170201 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.
Get XARELTO at $0 co-pay every month.* See page 14 Visit XARELTO.com Download the XARELTO app Call 1-888-XARELTO (1-888-927-3586) For the commercially insured. * 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 February 2017 053256-170201 Janssen Pharmaceuticals, Inc.