Rivaroxaban (Xarelto) for preventing stroke in people with atrial fibrillation This Medicine Update is for people with atrial fibrillation who are taking, or thinking about taking, rivaroxaban. Summary Rivaroxaban is a once-daily tablet that can be used to help prevent strokes in people with a heart condition called atrial fibrillation. People with atrial fibrillation are more likely to develop a blood clot in their heart. If the blood clot then moves through the blood vessels to the brain it can cause a stroke. Rivaroxaban reduces the tendency of blood to clot and, therefore, the risk of having a stroke. It belongs to a group of medicines called anticoagulants. Rivaroxaban is an alternative to warfarin, the most commonly used anticoagulant for people with atrial fibrillation. Rivaroxaban doesn t treat the irregular rapid heartbeat of atrial fibrillation. Your doctor will prescribe other medicines or treatments for this. If you are deciding about rivaroxaban, you ll need to think about the potential harms as well as the possible benefits. As with all anticoagulant medicines, there is a risk of bleeding. Some serious bleeds may be life-threatening, so if you take an anticoagulant you should know how to recognise the signs of bleeding and when to get immediate medical attention. If you do have a serious bleed when taking rivaroxaban, there is currently no specific antidote and it may take longer to treat than if you are taking warfarin. People taking rivaroxaban do not require regular blood tests or dose adjustment as they do with warfarin there are no blood tests to monitor its effects on blood clotting. Because rivaroxaban is a new medicine, the full range of potential side effects is not yet known. Tell your pharmacist, dentist, nurse, specialist, and any other health professionals if you are taking rivaroxaban. Rivaroxaban is currently not subsidised by the PBS when it is prescribed for stroke prevention in atrial fibrillation, but it is available as a private prescription at full cost. www.nps.org.au/medicine-update Date published: December 2012 Independent, not-for-profit and evidence based, NPS enables better decisions about medicines and medical tests. We are funded by the Australian Government Department of Health and Ageing.
Contents section What rivaroxaban is...1 What rivaroxaban is for... 2 What does rivaroxaban do?... 3 Who can take rivaroxaban?... 4 How to take rivaroxaban... 5 Important side effects to consider... 6 What else you should know about rivaroxaban... 7 Other medicines for preventing stroke caused by atrial fibrillation... 8 How to decide between the different anticoagulant medicines... 9 Rivaroxaban availability...10 Other ways to prevent stroke...11 Where to find more information...back page Asking the right questions about new medicines What is Medicine Update? Medicine Update provides independent information about new medicines and new listings on the PBS. It tells you about the possible benefits and harms of new medicines, who can and can't use them, and some of the other treatment options available. How to use Medicine Update Medicine Update is a tool to help you understand your treatment choices and to discuss them with your doctor. Medicine Update doesn t describe all possible side effects, precautions, or interactions with other medicines so you should always read the consumer medicine information (CMI) leaflet (see back page). Who is it for? Medicine Update is for anyone who is starting this medicine or thinking of starting it, and their carers. Where does Medicine Update come from? Medicine Update is written by NPS MedicineWise in consultation with consumers and health professionals. NPS is an independent, non-profit, government-funded organisation. NPS takes reasonable care to ensure this information is accurate and up-to-date at the time of creation. It is for your information only and is not medical advice. NPS does not warrant its completeness and excludes liability where permitted by law. We recommend you seek advice from a health professional about your medical condition. 2
1. What rivaroxaban is The active ingredient of this medicine is rivaroxaban (pronounced riv-ah-rocks-ah-ban). It is also known by the brand name Xarelto. It is a type of medicine called an anticoagulant. Anticoagulants reduce the tendency of blood to form clots (coagulate). The active ingredient is the chemical in the medicine that makes the medicine work. Many medicines are known by their brand names as well as by the name of the active ingredient. Some medicines with the same active ingredient are available under several different brand names. 2. What rivaroxaban is for Rivaroxaban is used to help prevent a stroke in people with atrial fibrillation an irregular, rapid heartbeat that can increase the risk of having a stroke. How does atrial fibrillation contribute to your risk of stroke? The irregular heartbeats of atrial fibrillation can lead to blood clots forming in your heart. If one of these blood clots moves from your heart into your bloodstream, it can block a blood vessel to the brain and cause a stroke. Rivaroxaban can also be used to protect against blood clots after hip or knee replacement surgery. You can read more about taking rivaroxaban after hip or knee surgery at nps.org.au/medicine-update/ rivaroxaban-hip-knee-surgery It s important to note that rivaroxaban doesn t treat the irregular rapid heartbeat of atrial fibrillation. Your doctor will prescribe other medicines or treatments for this. 3. What does rivaroxaban do? Like other anticoagulants, rivaroxaban works by decreasing the tendency of your blood to form a clot, or coagulate. This reduces the chance of clots forming and then blocking the blood vessels to your brain. Anticoagulants are sometimes called blood thinners but they actually work by increasing the time it takes for blood to clot. 3
4. Who can take rivaroxaban? You can be prescribed rivaroxaban to prevent a stroke if: you have atrial fibrillation, and your atrial fibrillation is not due to heart valve disease or heart valve replacement surgery, and your doctor finds that you have one or more of the other risk factors for stroke (see right). Do not take rivaroxaban if you are at high risk of bleeding because you: have or have recently had a serious bleeding episode (e.g. in the stomach or brain) have severely reduced kidney function have a liver problem that affects blood clotting are taking other medicines that can strongly interact with rivaroxaban (see Section 7). Talk with your health professional about all the treatment options for preventing stroke. Other factors that can increase your risk of stroke are: heart failure high blood pressure being over 75 years of age diabetes a previous stroke or systemic embolism. Do not take rivaroxaban if you are pregnant or breastfeeding. Rivaroxaban may not be suitable for you if you have another medical condition that increases your likelihood of bleeding. This includes: uncontrolled high blood pressure recent surgery (particularly brain, spine or eye surgery) any bleeding disorder or history of problems with bleeding (e.g. current or recent stomach ulcers). Your doctor will need to take this into consideration before prescribing rivaroxaban. 5. How to take rivaroxaban If you are taking rivaroxaban to prevent stroke, you will need to take one tablet once a day with food. If you forget to take your rivaroxaban tablet at the usual time, take it as soon as you remember. Do not take more than one tablet in a single day as this will increase your chance of bleeding. For most people, the usual dose is 20 mg. If you have mild to moderate kidney problems, a lower strength 15 mg tablet is recommended. Your doctor will prescribe the most appropriate dose for you. Rivaroxaban tablets can be put into dosette boxes or Webster-paks. How long will I need to take rivaroxaban for? Rivaroxaban for the prevention of stroke is likely to be a long-term treatment. You should not stop taking rivaroxaban unless advised by your doctor. Stopping could put you back at risk of developing a blood clot and having a stroke. 4
6. Important side effects to consider As with other anticoagulant medicines, the most common side effect of rivaroxaban is bleeding (see Serious bleeding is a risk with all anticoagulants in Section 9). Some serious bleeds may be life-threatening. Signs and symptoms of bleeding include: unexplained or severe bruising red or dark brown urine red or black bowel motions dark or blood-stained vomit coughing up blood bleeding from cuts, wounds and scrapes that takes longer than normal to stop nosebleeds that occur more frequently or take longer than normal to stop trouble breathing or swallowing severe or unusual headache unexplained tiredness, pale skin, dizziness or fainting unexplained pain, numbness or swelling in an arm or leg. If you experience any of these signs and symptoms of bleeding, contact your doctor immediately or go to the emergency department at your nearest hospital. Not all types of bleeding are obvious, especially internal bleeding. Get immediate medical attention if you have a serious fall or injury particularly if you hit your head as it may result in internal bleeding that you don t notice. As rivaroxaban is a new medicine not all potential side effects are known Rivaroxaban has been tested in clinical trials, but as it has only been used on a limited number of people for a few years, the full range of potential side effects and who is likely to be affected by them may not yet be known. You should be aware of this and see your doctor straight away if you have any changes in your health or unusual symptoms after starting rivaroxaban. For a more complete list of possible side effects, see the consumer medicine information (CMI) leaflet for Xarelto (rivaroxaban) through our Medicine Finder at nps.org.au/ medicines. If a side effect is described as common this means that in clinical trials between 1% and 10% of people experienced that side effect. Or, out of 100 people, it affected more than one, but fewer than 10, people. A clinical trial is a research study conducted with patients, which compares one treatment with one or more other treatments, to assess its effectiveness and safety. To find out more about clinical trials, see Regulation & trials at nps.org.au/ how-to-be-medicinewise People with questions about side effects can call the NPS Medicines Line on 1300 633 424. To report possible side effects call the NPS Adverse Medicine Events (AME) line on 1300 134 237. Both these services are available Monday to Friday, 9am to 5pm AEST. 5
7. What else you should know about rivaroxaban Do not stop taking rivaroxaban without talking to your doctor. Stopping could put you back at risk of developing a blood clot and having a stroke. Check before taking any other medicine Because of the high risk of bleeding, rivaroxaban should not be taken with certain other medicines including: itraconazole (Sporanox) and ketoconazole tablets (Nizoral) for fungal infections antiviral medicines used for HIV or AIDS. Other medicines can also interact with rivaroxaban. You may not need to avoid these entirely, but the doses may need to be changed or you may need to be monitored regularly. Tell your doctor or pharmacist if you are taking: pain relief or anti-inflammatory medicines like: aspirin (e.g. Aspro Clear, Disprin, Solprin) celecoxib (Celebrex) diclofenac (e.g. Fenac, Voltaren) ibuprofen (e.g. Advil, Nurofen) naproxen (e.g. Naprogesic) Tell your doctor about all the medicines you take before you start rivaroxaban. You should also talk to your doctor or pharmacist before starting or stopping any other medicine while you re being treated with rivaroxaban, including any medicines bought from a pharmacy, supermarket or health food store. An interaction is when another medicine, food or drink (including alcohol) changes how strongly a medicine works, or changes its side effects in some way. The interaction may be with a food or food supplement, another prescription or over-the-counter medicine, or a natural or herbal remedy. other medicines used to reduce blood clotting, such as: apixaban (Eliquis) aspirin (e.g. Cartia, Solprin) clopidogrel (e.g. Iscover, Plavix) dabigatran (Pradaxa) dalteparin (Fragmin) enoxaparin (Clexane) fondaparinux (Arixtra) warfarin (Coumadin, Marevan) medicines used to treat epilepsy, such as: carbamazepine (Tegretol) phenytoin (Dilantin) an antibiotic called rifampin or rifampicin (Rifadin) the herbal remedy St John s wort. Headache, pain or fever can be treated with paracetamol (e.g. Panadol) as this does not interact with rivaroxaban. Rivaroxaban does not appear to interact with foods. Let other health professionals know that you take rivaroxaban Be sure to tell your pharmacist, dentist, nurse, specialist, and any other health professionals that you re taking rivaroxaban. They may need to talk to the doctor who prescribed rivaroxaban for you, particularly if you will be having surgery. 6
8. Other medicines for preventing stroke caused by atrial fibrillation Warfarin has been used to prevent stroke for over 50 years. It is very effective, but when you first start taking warfarin, it may take some time to get the dose right. If you take warfarin, you need to have regular blood tests called INR tests to monitor its effect. Your warfarin dose may need to be adjusted based on your results to keep your INR in the target range. For more information on INR monitoring see nps.org.au/ medicines/warfarin/living-withwarfarin/tests-and-monitoring Your INR is affected by many other medicines as well as certain foods. If you are taking warfarin you can still eat most things, but you do need to be careful not to make big changes to how much you eat of certain foods. Dabigatran (Pradaxa) is another newer anticoagulant medicine that can be used for preventing stroke caused by atrial fibrillation. As it is a new medicine, long-term evidence about the risks and benefits is not available. You can read more about dabigatran for stroke prevention at nps.org.au/ medicine-update/dabigatran-af Aspirin is less effective than warfarin or other anticoagulants such as rivaroxaban. It may be an option for some people with atrial fibrillation, but usually only for those at a low risk of stroke or who can t take warfarin. 9. How to decide between the different anticoagulant medicines Ask your doctor to help you weigh up the potential benefits and harms of warfarin and the newer oral anticoagulant medicines dabigatran (Pradaxa) and rivaroxaban (Xarelto) based on your individual situation and lifestyle. When deciding between the different anticoagulant medicines, keep in mind that doctors are familiar with using warfarin and that the benefits and side effects of this established treatment are well known. Rivaroxaban and dabigatran are new medicines, and less is known about their longer-term effects and how to manage any serious bleeding that may occur when taking them. Dabigatran, rivaroxaban and warfarin are all effective for preventing stroke In clinical trials, rivaroxaban and dabigatran prevented slightly more strokes overall than warfarin. However, because warfarin is very effective, the improvement with the newer oral anticoagulant medicines was small, and not all groups of people benefitted. Serious bleeding is a risk with all anticoagulants In clinical trials comparing dabigatran or rivaroxaban with warfarin, the number of people who had a serious bleed each year was similar between 3 or 4 out of every 100 people (3% to 4%). Serious bleeding needs urgent treatment because it may be life-threatening (see Section 6). For people taking warfarin, vitamin K in a tablet or injection can be given as an antidote to reverse the effect of warfarin if the bleeding won t stop. Continues on next page 7
9. How to decide between the different anticoagulant medicines... continued There is currently no specific antidote for rivaroxaban or dabigatran if serious bleeding occurs This means that if you do have a bleed when you are taking rivaroxaban or dabigatran, it may be more difficult to stop than if you were taking warfarin. But remember, you should only be prescribed dabigatran, rivaroxaban or warfarin if the benefit is thought to outweigh your risk of serious bleeding. Some may find the newer oral anticoagulant medicines more convenient Fewer medicines interact with rivaroxaban or dabigatran than with warfarin. And, unlike warfarin, there are no dietary restrictions with these newer anticoagulant medicines. As warfarin s effect can sometimes vary, it s important to have regular blood tests to make sure that it s working well. There are no tests to check the effect of rivaroxaban or dabigatran on blood clotting, so people taking these medicines do not need to have regular blood tests. Some people find these tests inconvenient. But others like the opportunity to discuss their progress with their health professional and check how the warfarin is working. People managing well on warfarin need not change In clinical trials, people who took their warfarin regularly and had stable blood test (INR) results appeared to gain no advantage from the newer anticoagulant medicines in terms of a reduced risk of stroke. So, if you are doing well on warfarin therapy, then changing medicines may not be the best option. 10. Rivaroxaban availability Rivaroxaban is currently not subsidised through the Pharmaceutical Benefits Scheme (PBS) when it is prescribed for stroke prevention in atrial fibrillation, but it is available for this purpose as a private prescription at full cost. Some doctors are participating in a Product Familiarisation Program where some of their patients have rivaroxaban provided by the pharmaceutical company. This Medicine Update is about using rivaroxaban to prevent a stroke in people with atrial fibrillation. Rivaroxaban is subsidised under the PBS when it is prescribed: after hip or knee replacement surgery to prevent blood clots forming in the legs to treat an existing deep vein thrombosis (DVT), or prevent DVT recurring. You can read more about using rivaroxaban after hip or knee replacement surgery at nps.org.au/ medicine-update/rivaroxaban-hipknee-surgery 8
11. Other ways to prevent stroke Some of the risk factors for stroke, like age, gender and medical conditions (such as atrial fibrillation), are things you can t change. However, there are several lifestyle-related risk factors that you can control. 1. Know your personal risk factors Your doctor can help you monitor and manage medical conditions that increase your risk of having a stroke. These include high blood pressure, diabetes and high blood cholesterol. 2. Stop smoking Smoking is a major risk factor for stroke. If you smoke, get help to stop now. Talk to your doctor or call Quitline on 137 848. Second-hand smoke from other people s cigarettes is also harmful and you should try to avoid it. 3. Be physically active and exercise regularly Keeping fit is important for so many aspects of your health. You don t need to take part in organised sport or exercise classes to do this. Just walking or generally being more active will be of benefit. Remember that if you are taking an anticoagulant medicine you need to be careful to avoid activities that increase your risk of injury. 4. Keep to a healthy diet Fresh rather than processed foods are much better for you. A healthy diet has lots of different vegetables, fruit and whole grains and limits the amount of sugary, salty and fatty foods. 5. Limit alcohol consumption People who drink heavily are three times more likely to have a stroke. Limit your alcohol intake to two drinks a day and have at least two alcohol-free days every week. Learn to recognize the warning signs of a stroke and how to take action The F.A.S.T test is any easy way to remember and recognise the signs of stroke. FAST stands for Face, Arms, Speech and Time to act. Face Check their face. Has their mouth drooped? Arms Can they lift both arms? Speech Is their speech slurred? Do you understand them? Time Is critical. If you see any of these signs call 000 straight away. The signs of stroke may occur alone or in combination and they can last a few seconds or up to 24 hours and then disappear. The National Stroke Foundation (www.strokefoundation.com.au/) has more information about the risk factors for stroke and how it can be prevented. 9
Where to find more information about rivaroxaban You can find more information in the consumer medicine information (CMI). This will tell you: who should not use the medicine which other medicines should be avoided how to take the medicine most of the possible side effects the ingredients. You can get the CMI leaflet for Xarelto (rivaroxaban) from: your doctor or pharmacist the NPS Medicine Finder at nps.org.au/medicines Bayer, the makers of Xarelto (rivaroxaban), on 1800 023 884. Information over the phone NPS works with healthdirect Australia to provide the Medicines Line phone service for consumers. To get more information about any medicine call 1300 MEDICINE (1300 633 424). This service is available from anywhere in Australia, Monday to Friday, 9am to 5pm AEST excluding NSW public holidays, for the cost of a local call (more from mobiles). To report a side effect Call the Adverse Medicine Events (AME) Line on 1300 134 237, Monday to Friday, 9am to 5pm AEST excluding public holidays, for the cost of a local call (more from mobiles). The AME Line is a service where you can report possible side effects of your medicine and contribute to national medicine safety efforts. Information on medicine-related side effects is passed on to the Therapeutic Goods Administration (TGA) for assessment, but your personal details will remain confidential and your privacy maintained. Date published: December 2012 Independent, not-for-profit and evidence based, NPS enables better decisions about medicines and medical tests. We are funded by the Australian Government Department of Health and Ageing. 2012 National Prescribing Service Limited. This work is copyright. You may download, display print and reproduce this work in unaltered form only (retaining this notice) for non-commercial use either personally or within your organisation. Apart from any such use or otherwise as permitted under the Copyright Act 1968, all rights are reserved. Queries concerning reproduction and rights should be sent to copyright@nps.org.au. ABN 61 082 034 393 l Level 7/418A Elizabeth Street Surry Hills NSW 2010 l PO Box 1147 Strawberry Hills NSW 2012 Phone: 02 8217 8700 l Fax: 02 9211 7578 l email: info@nps.org.au l web: www.nps.org.au