RIVAROXABAN. Consumer Information

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1 RIVAROXABAN Consumer Information Rivaroxaban is a medicine that is used to increase the time it takes for blood to clot. It belongs to a class of medicines called anticoagulants, which are sometimes also called anti- clotting medicines. These medicines help to prevent unwanted blood clots in the brain (which may cause a stroke), lungs or legs. Rivaroxaban is also sometimes referred to as a Novel Oral Anticoagulant or NOAC. In Australia there is only one brand of rivaroxaban, called XARELTO. Rivaroxaban is available in Australia for people with the following conditions: An irregular heartbeat called atrial fibrillation. This condition increases the risk of a blood clot forming in the heart. If part of this blood clot breaks off and travels through the bloodstream to the brain, then a stroke may occur. Taking rivaroxaban significantly reduces the risk of this occurring. Recent hip or knee replacement surgery. Lying in bed for a long period of time, particularly for people who have recently had surgery, increases the risk of blood clots developing in the veins in the legs. Taking rivaroxaban for a period of time after the operation helps to prevent these blood clots. Deep vein thrombosis (DVT). A blood clot in a deep vein; most commonly affecting the veins in the leg. Pulmonary embolism (PE). A blockage in one of the blood vessels of the lungs, usually due to a blood clot that has travelled through the bloodstream and become stuck. How does rivaroxaban work? Rivaroxaban is known as a factor Xa inhibitor (pronounced factor ten A inhibitor ). It interferes with the body s normal pathway for producing a blood clot, therefore increasing the amount of time it takes for a clot to form. This is useful for people who have an increased chance of clots forming within their bloodstream; or for people who already have a clot, to stop it getting bigger and allow it to be broken down over time. How do I take rivaroxaban? Take rivaroxaban exactly as prescribed by your doctor. If you forget to take your rivaroxaban, take the missed dose as soon as you remember. Take your next dose at the usual time the following day. Do not take a double dose if you miss a dose this will increase your risk of bleeding. Page 1 of 7

2 Take rivaroxaban with food for the best effect. It is very important that you take it at about the same time every day; use a calendar or your smartphone to keep a record and to mark off each day after taking a dose. The usual directions are listed below but your doctor may suggest different directions for you: Reason for taking rivaroxaban Usual directions Additional instructions Prevention of blood clot after hip or knee replacement Prevention of stroke in atrial fibrillation (AF) Treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) ONE 10mg tablet ONCE DAILY ONE 20mg tablet ONCE DAILY People with kidney problems may be advised to take ONE 15mg tablet ONCE DAILY ONE 15mg tablet TWICE DAILY for 3 weeks, then ONE 20mg tablet ONCE DAILY The usual length of treatment is for 14 days after a knee replacement and 35 days after a hip replacement. The 10mg tablets may be taken without food if desired. Long- term treatment may be required During the first 3 weeks, take doses as close to 12 hours apart as possible People with severe liver disease should avoid taking rivaroxaban. If you are unsure whether this applies to you, check with your doctor. Starting and stopping rivaroxaban Rivaroxaban starts working within 2 to 4 hours of taking a dose, so there is no need to cross over with other anticoagulant medicines for several days, as is the case with warfarin. Take rivaroxaban for as long as your doctor advises you to take it. This will depend on why you re taking it. If you are unsure, ask your doctor for advice. Some people will swap from other anticoagulant medicines to rivaroxaban, or from rivaroxaban to other anticoagulant medicines. The most common medicine that people are likely to swap from, or to, is warfarin. From rivaroxaban to warfarin: It is suggested to keep taking rivaroxaban with warfarin until the INR result is greater than 2. From warfarin to rivaroxaban: In people with atrial fibrillation, it is suggested to stop warfarin and start taking rivaroxaban when the INR result is less than 3. In people undergoing treatment of a deep vein thrombosis, it is suggested to stop warfarin and start rivaroxaban when the INR result is less than 2.5. Page 2 of 7

3 These are general recommendations and your doctor may make a different suggestion for you. If you are swapping from one medication to another, and are not sure of when to stop one and start the other, check with your doctor as soon as possible. Side effects of rivaroxaban As with all anticoagulant medicines, the most common side effect of rivaroxaban is bleeding. Even when rivaroxaban is working properly, you may see a little bleeding, like bruises on your body, or slight gum bleeding when you brush your teeth. Signs of slight bleeding that you may notice from time to time: Gum bleeding while brushing teeth. Occasional nose bleeds. Easy bruising. Bleeding after a minor cut that stops within a few minutes. Menstrual bleeding that is a little heavier than normal. Nose bleeds, gum bleeding and bleeding from minor cuts should all stop within a few minutes. If bleeding persists or you are at all concerned, contact your doctor as soon as possible. Signs and symptoms of more serious bleeding to watch for include: Severe bruising that gets worse. Any bleeding that take a long time to stop. Unexplained bleeding or bruising. Menstrual bleeding that is much heavier than usual. Red or dark urine. Red or black bowel motions. Coughing up blood, or anything red. Bloody or dark stained vomit. Severe headache or dizziness. Weakness or lethargy. Unusual pain or swelling. If any of the above symptoms occur you should contact your doctor immediately. If your doctor is unavailable, go to your nearest hospital emergency department. Other side effects of rivaroxaban include swollen ankles, itch, skin blisters and muscle spasm. If you are concerned about any of these side effects, talk to your doctor as soon as possible. Rivaroxaban and other medications A small range of medicines may increase the levels of rivaroxaban in the bloodstream and increase its effectiveness these medicines can significantly increase the risk of bleeding with rivaroxaban. Page 3 of 7

4 Medicines that should be avoided when taking rivaroxaban include: certain antifungal medicines when taken by mouth or intravenously (itraconazole, ketoconazole, posaconazole and voriconazole), and HIV- protease inhibitors (e.g. ritonavir, saquinavir). Other medicines that should be taken with caution include: certain medicines for irregular heart rhythms (amiodarone and quinidine), anti- rejection medicines (cyclosporine and tacrolimus), antibiotics (clarithromycin and erythromycin), calcium channel blockers (diltiazem and verapamil), the antifungal medicine fluconazole and grapefruit juice. Other medicines increase the risk of bleeding via other mechanisms and should be taken with caution. These include: aspirin, anti- inflammatory medicines (or NSAIDs ), antiplatelet medicines (clopidogrel, prasugrel and ticagrelor), fish oils and antidepressant medicines (selective serotonin reuptake inhibitors [SSRIs] or serotonin- noradrenaline reuptake inhibitors [SNRIs]). Finally, there are several medicines that may decrease the effectiveness of rivaroxaban, including: carbamazepine, phenobarbitone, phenytoin, rifampicin and St John s wort. Check with your doctor if you are taking any of these medicines to ensure that this combination of medicines is right for you. Living safely with rivaroxaban Remember that because you are taking rivaroxaban you have an increased chance of bleeding. There are several things that you can do to reduce your risk of experiencing bleeding problems. Check with your doctor before beginning any activity (e.g. sporting activities) with a high risk of injury. Avoid contact sports. Make sure that you use protective gear, such as a helmet and gloves, if necessary. Think about your day- to- day activities. How can you reduce your chances of hurting yourself? There are a number of things that you can do to help lessen your risk of bleeding while taking rivaroxaban: Talk to your healthcare professional about your therapy, tell them how you are going, what problems you're having, and about anything that's concerning you. You should notify your healthcare professional of any changes in factors which may alter the way your anticoagulant medicine works (other medications you may have started, smoking- either if you start or plan to quit, illnesses, or any plans you have to travel). Avoid contact sports and other physical activities that may cause injury or bleeding. Report any falls, blows or injuries to your doctor. You might not always see visible signs of bruising. Taking anticoagulant medicines doesn't mean that you cannot do the things you enjoy, but when you're doing them you need to think about how you can protect yourself from injury. Around the home, minimise your risk of bleeding by: Always wearing shoes outdoors. Wearing shoes or non- skid slippers indoors. Using a non- slip bath mat. Page 4 of 7

5 Using a soft bristle toothbrush. Using an electric shaver. Wearing gloves while gardening. Being careful around pets. Taking care with sharp objects such as kitchen knives. Complete a first aid course so that you know how to manage cuts and other injuries if they occur. Ask a family member or friend to join you that way they ll be able to look after you if you can t! Report to your doctor any falls, blows to the head or body, car accidents or other major injuries. You may not always see visible signs of bleeding from an internal injury. Other useful ways of keeping yourself safe while taking rivaroxaban include: Wearing a MedicAlert bracelet identifying that you take rivaroxaban (for more information, ask your pharmacist, call , or visit Registering for an ehealth record is also a good idea. More information about ehealth records is available at Alcohol Consuming large amounts of alcohol, especially binge drinking, can increase the risk of bleeding, whether you have been prescribed rivaroxaban or not. It is best to drink only in moderation, and limit your daily intake to no more than 1 or 2 standard drinks a day, with at least 2 alcohol free days a week. Some people may have other medical reasons for avoiding alcohol completely. Discuss with your doctor or pharmacist the alcohol intake that is safe for you. Pregnancy and breastfeeding Because rivaroxaban is quite new, there is not yet enough information to show that it is safe in pregnancy and breastfeeding. Therefore, rivaroxaban should not be taken during pregnancy or breastfeeding. If you wish to become pregnant and are taking rivaroxaban, there are other anticoagulant medicines that are safe in pregnancy and breastfeeding. Discuss your options with your doctor. Should you become pregnant while taking rivaroxaban, you should notify your doctor as soon as possible. Storage Rivaroxaban should be stored in a cool, dry place below 30 C. Page 5 of 7

6 Where can I find more information? For further information on rivaroxaban, please contact your doctor, pharmacist or other healthcare professional. Other useful sources of information are shown below. Rivaroxaban (Xarelto) Consumer Medicine Information blood- and- blood- vessels/anti- clotting- medicines/for- individuals/anticoagulant- medicines/for- individuals/active- ingredients/rivaroxaban/for- individuals/brands/xarelto- tablets Poisons Information line For information on overdoses or poisoning: HealthDirect For health advice from experienced nurses: Page 6 of 7

7 Authorship & acknowledgements This material has been downloaded from This information leaflet was developed by Dr Leanne Chalmers, Professor Gregory Peterson and Associate Professor Luke Bereznicki, who are based at Pharmacy, School of Medicine, University of Tasmania. The authors would like to thank the Royal Hobart Hospital Research Foundation, Rotary Tasmania and the Pharmaceutical Society of Australia (Tasmanian Branch) for supporting the development of this material. This material was developed with the financial support of the Tasmanian Community Fund. Page 7 of 7

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