Date of preparation: September 2014 L.GB.12.2013.4666d This medicine is subject to additional monitoring. This will allow quick identification of new safety information. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
FOREWORD It is human nature to have questions when we come across or try something new. When something new is related to our health, it s even more important that we have access to the information we need to enable us to feel comfortable. If you are preparing for treatment with Xarelto (rivaroxaban) for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery Working in collaboration with a key patient organisation, Bayer HealthCare have developed Xarelto Xpert, to help you understand and better manage your condition. By following our five step plan this leaflet will help you become an expert by: ploring your condition roviding you with information on Xarelto and how it works xplaining how to take Xarelto evealing answers to frequently asked questions aking you to other useful sources of information We hope this leaflet helps you to feel confident about taking the next step in your treatment journey with Xarelto. Please read the Patient Information Leaflet that is in your pack of Xarelto tablets. 1
WHAT IS VENOUS THROMBOEMBOLISM? VTE is composed of deep vein thrombosis (DVT) and pulmonary embolism (PE) A DVT is a blood clot that forms in the veins deep in your leg, usually in the calf or thigh, but can sometimes occur in other veins in your body. The blood clot blocks the flow of blood in the affected vein either partially or completely. A PE is usually the result of an underlying blood clot in the leg known as a DVT. The clot breaks away and travels through the body, via the heart to reach the lungs. When the clot reaches the lungs, it travels through the vessels of the lung until it reaches smaller vessels where it becomes wedged. The clot may then prevent any further blood from travelling to that section of the lung. A PE is a serious, potentially life-threatening condition which requires immediate treatment. Hospital acquired VTE is a major health risk. It has been estimated that more than 25,000 preventable deaths are associated with hospital acquired VTE each year in the UK. 1 The diagram on page 4 helps illustrate a PE. 2
More than 25,000 preventable deaths are associated with hospital acquired VTE each year in the UK. 1 3
A DVT is a blood clot that forms in the veins deep in your leg, usually in the calf or thigh The diagram above explains how a DVT and PE can occur. 4 Why does blood clot? Blood clots occur as a vital protection system in our body. When we injure or cut ourselves, a clot is formed outside of our veins to protect us from the loss of blood. This is a natural process known as the clotting cascade. However, there are times when the clotting cascade goes wrong and blood clots form inside our veins, causing a DVT. What are the causes and symptoms of a DVT? Certain people are more likely to develop a DVT than others. Risk factors include: age older people are more likely to have a DVT than younger people immobility caused by long travel journeys, illnesses or injuries having a recent operation pregnancy having severe pre-existing medical illnesses such as cancer, heart problems or respiratory disease previous experience of a DVT taking hormone-based treatment, such as the contraceptive pill and hormone replacement therapy obesity smoking.
A clot which has travelled up from the leg to lodge within the lung is known as a PE Some people with a DVT may have no symptoms, but common symptoms of a DVT are: tenderness in the leg redness swelling and a feeling of tightness, the skin may feel stretched pain. Some people may only realise they have a DVT when a PE develops as a result of the clot travelling to the lungs. Symptoms of a PE include: chest pain that is sharp and is worse when taking a deep breath shortness of breath sweating. What can I do to reduce the chance of having a DVT? It is important to listen to the medical team looking after you once you ve had an operation and move around when you are asked to. If you can t move easily after the operation you may be asked to do leg exercises. You may also be offered elastic compression stockings or a mechanical foot pump in order to help blood flow in your leg. Drink plenty of fluids if you are able to and if you experience any leg or chest symptoms, tell your doctor or a nurse immediately. 5
A STEP- BY- STEP GUIDE TO XARELTO What is Xarelto? Xarelto is an anticoagulant, which is a type of medication that slows down your body s ability to clot, therefore reducing the likelihood of dangerous blood clots forming. How does Xarelto work? The formation of a blood clot is a natural process (called the clotting cascade) within your body. For example, when you cut yourself, you will see a clot form to stop the bleeding. Xarelto belongs to a group of medicines called antithrombotic agents. It works by blocking a specific protein in the blood Factor Xa ( ten A ) which is known to play a key role in starting the blood clotting cascade process. Blocking Factor Xa prevents the formation of subsequent proteins that are also involved in the clotting cascade, so reducing the tendency for blood clots to form. How is Xarelto taken? Xarelto is taken by mouth (orally) and the usual dose for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery is one 10mg table once a day. If you have had a hip operation you will usually take Xarelto for 5 weeks. If you have had a knee operation you will usually take Xarelto for 2 weeks. 6 The tablet should be swallowed whole, preferably with water, and can be taken with or without food. Try to take it at the same time each day to help you remember it.
When the lining of the blood vessel becomes damaged, platelets are activated at the site to help prevent further injury The clotting cascade is activated to form a blood clot Activates Activates Becomes Activates Activates Pt Pt Pt Pt Pt Pt Pt Proteins Xarelto works by blocking Factor Xa Prothrombin Thrombin Fibrinogen Fibrin - glue that binds platelets together to form a Factor Xa, blood clot so reducing Xarelto the ability for blood clots to form The illustration above will help you better understand how Xarelto works. Why have I been prescribed Xarelto? You have been prescribed Xarelto because you have recently undergone hip or knee replacement surgery. After surgery, you are at an increased risk of developing blood clots in your veins. Xarelto can help reduce the chances of these blood clots forming. Xarelto has been prescribed for you personally and should not be passed on to others. It is also important that you read the patient information leaflet that comes in your Xarelto pack. Xarelto is used to treat different patients for different reasons. Another person prescribed Xarelto may take a different dose from you. Always take Xarelto exactly as your doctor has told you and check with your doctor or pharmacist if you are unsure of your correct dose. 7
YOUR XARELTO QUESTIONS ANSWERED How do I take Xarelto? Always take Xarelto exactly as your doctor or nurse has told you to. If you are not certain, make sure you check with your medical team or pharmacist. The usual dose is one 10 mg tablet once a day. Swallow the tablet, preferably with water. Xarelto can be taken with or without food. Take the first tablet 6 to 10 hours after your operation. Then take a tablet every day until your doctor or nurse tells you to stop. Try to take the tablet at the same time every day to help you to remember it. If you have had a hip operation you will usually take Xarelto for 5 weeks. If you have had a knee operation you will usually take Xarelto for 2 weeks. It is important to take Xarelto for the recommended length of time because you may still be at risk of developing a blood clot even after you leave hospital. How should I store Xarelto? This medicine does not require any special storage conditions and can be stored in a dosing box. Keep it out of the reach and sight of children. Do not use Xarelto after the expiry date (this is stated on the pack). What if I take more Xarelto than I should have? Contact your doctor immediately if you have taken too many Xarelto tablets. Taking too much Xarelto increases the risk of bleeding. What should I know before taking Xarelto? Tell your doctor, nurse or pharmacist if you are taking, or have recently taken any other medicines, including St John s Wort and any other medicines obtained without a prescription. Xarelto contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Xarelto. 10
What are the most common side effects of Xarelto? Like all medicines, Xarelto can cause side effects. As we are all different these will vary from one person to another. As Xarelto is an anticoagulant medicine that slows down your body s ability to clot, a common side effect is an increased risk of bleeding either external, visible blood loss or internal bleeding inside the body. Symptoms of bleeding include: unexplained dizziness or weakness swelling and discomfort sudden, severe headache unusual bruising, nosebleeds, bleeding of gums, cuts that take a long time to stop bleeding menstrual flow or vaginal bleeding that is heavier than normal pink or brown urine, red or black stools coughing up blood, or vomiting blood or material that looks like coffee grounds. If you have any symptoms of bleeding, tell your doctor or visit your nearest A&E department immediately so that you can be monitored and have your treatment assessed. For a full list of possible side effects, please refer to the Patient Information Leaflet provided with your Xarelto tablets. If you think you are experiencing side effects from Xarelto at any time, contact your doctor or pharmacist immediately for advice. Please remember to take Xarelto every day missing a dose will increase your risk of having a DVT. 11
YOUR XARELTO QUESTIONS ANSWERED Can I take Xarelto if I am intolerant to some sugars? Xarelto contains lactose and you should speak to your doctor if you have a known intolerance to some sugars before taking it. Can I drive or operate machinery whilst taking Xarelto? Xarelto may cause fainting or dizziness. If you experience these symptoms you should not drive or use machinery. Can I take Xarelto if I am pregnant or breastfeeding? It is important that you discuss this with your doctor as you must not take Xarelto if you are pregnant or breastfeeding. If there is a chance that you could become pregnant, it is essential that you use a reliable contraceptive while you are taking Xarelto. If you become pregnant while you are using Xarelto, inform your doctor immediately, who will discuss your treatment options moving forwards. When should I not take Xarelto? You must not take Xarelto: if you are allergic (hypersensitive) to Xarelto or any of the other ingredients of Xarelto if you are bleeding excessively if you have a liver disease which leads to an increased risk of bleeding if you are pregnant or breastfeeding. Speak to your doctor if any of these apply to you. If you still have questions about the use of Xarelto please ask your doctor who will be able to answer these and provide you with more information as appropriate. Date of preparation: February 201 L.GB.02.2013.1681 12
HOW TO USE YOUR XARELTO PATIENT ALERT CARD Patient Alert Card Xarelto 10 mg s Keep this card with you at all times s Present this card to every physician or dentist prior to treatment This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the patient information leaflet for how to report side effects. In the unlikely event of an emergency, a doctor treating you will need to be made aware of the existing medications you are on so that you can be cared for appropriately. The attached alert card has been designed to make the doctor aware that you are receiving treatment with Xarelto. Please carry this with you at all times. In addition, please show your card in advance of any dental treatment/operations to ensure you are treated appropriately. 13
USEFUL SOURCES OF INFORMATION To find out more about managing your DVT please visit the following independent websites and organisations: AntiCoagulation Europe (ACE) Tel 020 8289 6875 Email admin@anticoagulationeurope.org Website www.anticoagulationeurope.org Circulation Foundation Tel 020 7304 4779 Email info@circulationfoundation.org.uk Website www.circulationfoundation.org.uk Lifeblood: The Thrombosis Charity Tel 01558 650222 Email lifeblood.charity@googlemail.com Website www.thrombosis-charity.org.uk 14
MY NOTES
REFERENCES 1. House of Commons Health Committee. The Prevention of Venous Thromboembolism in Hospitalised Patients, Second Report of Session 2004-05. Available at http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/99/99.pdf Last Accessed February 2013.