What You Need to Know after DVT or PE

Transcription

1 SPIRAL BINDING MARKS What You Need to Know after DVT or PE For your patients prescribed Xarelto J1290_Nurse Patient_Flipbook_AW.indd 1 01/12/ :32

2 A deep vein thrombosis (DVT) is a blood clot, usually occurring in the leg A pulmonary embolism (PE) is a blood clot in the lungs SPIRAL BINDING MARKS Introducing this guide Patients who have been diagnosed with deep vein thrombosis (DVT) and/or pulmonary embolism (PE) need a clear understanding of their condition and its treatment to have the best chance of recovery or avoiding future events. 1 This resource helps you have personalised conversations with patients starting Xarelto (rivaroxaban) to improve their understanding of treatment and to promote adherence. How it helps This guide uses simple language and visuals to: Communicate the seriousness of DVT/PE and the need for anticoagulants Reinforce the need for medication to be taken properly to prevent recurrence Deliver appropriate advice on the prevention and management of bleeding Help patients to manage their therapy over the entire duration of treatment by identifying motivational factors Getting the most out of it Patients who are aware of the essential facts about their condition are more likely to stay motivated during treatment. Personalising the discussion can make this even more effective. 1 This resource is structured to help you provide the appropriate information for each patient: This side is for healthcare professionals only, not to be viewed by the patient. Preparing and starting the conversation Before you start the conversation, it is important to establish the patient s diagnosis (DVT or PE) and whether it was provoked, unprovoked, or recurrent. Provoked DVT/PE is caused by a transient risk factor (e.g. recent surgery or immobilisation) and the patient s risk of recurrence is lower. Unprovoked DVT/PE has no antecedent factors. The patient will usually need longer-term treatment and is at higher risk of recurrence. Patients with recurrent DVT/PE may need lifelong treatment. 2,3 To personalise the conversation, it is important to check the patient s understanding of the immediate and long-term risks of DVT/PE; the role of anticoagulants and how they are taken; and the prevention and management of bleeding. Remember to check how treatment will affect the patient s lifestyle: How have they managed taking medication in the past? What helps them establish and maintain a routine? Make sure that you communicate the key information on each page. Clinics are often busy. Planning is essential. What will you have time to discuss? 3 A Potentially Life-threatening Blood Clot has Formed in Your Body 1 A Potentially Life-threatening Blood Clot has Formed in Your Body Deep Vein Thrombosis (DVT): Pulmonary Embolism (PE): A blood clot in a deep vein in the body (usually in the leg) You may have noticed: Pain, swelling and soreness An intense ache Skin redness DVTs may not cause symptoms and are often only noticed after diagnostic tests. 4 Why did it happen? DVT/PE is a serious condition. It kills more people in Europe in a year than breast and prostate cancer, HIV, and traffic accidents combined. 6 Anyone can have a DVT and/or PE. People are more likely to suffer from blood clots if they have the following: 7,8 >60 years of age First-degree relative with a history of blood clots Severe conditions, such as cancer or heart failure Major surgery Pregnancy 2 Immobility Thrombophilias Obesity (body mass index [BMI] >30 kg/m 2 ) Hormone replacement therapy Varicose veins with inflammation (phlebitis) A blood clot in the lung Caused when part of a DVT clot breaks away and lodges in the lung This prevents blood flowing through the affected part of the lung You may have noticed: Breathlessness Coughing up blood (haemoptysis) A mild fever A fast heart rate (tachycardia) PEs may go unnoticed and cause no obvious symptoms. 5 Check patients know their diagnosis and talk through the relevant information. Was their clot provoked or unprovoked? Highlight the risk factors that apply to them. 4 DVT/PE and Its Treatment Patient motivation and goal setting in DVT/PE Venous thromboembolism is a serious and potentially life-threatening condition. For treatment success with anticoagulants in DVT/PE, adherence is vital. Unlike other health conditions, such as weight loss or smoking cessation, there are no small steps to achieve improved health and wellbeing. In DVT/PE, the only goal for treatment is medication adherence. This may warrant discussing the seriousness of the condition. This resource aims to support you to have these more difficult conversations to help achieve the best outcomes. Prescribing information can be found on final leaf 1 Visual that the patient will see 3 Additional information or topics to cover, as appropriate 2 Priority information for you to discuss 4 Advice on personalising the discussion J1290_Nurse Patient_Flipbook_AW.indd 2 01/12/ :32

3 DVT/PE and Its Treatment DVT/PE and Its Treatment J1290_Nurse Patient_Flipbook_AW.indd 3 01/12/ :32

4 This side is for healthcare professionals only, not to be viewed by the patient. A Potentially Life-threatening Blood Clot has Formed in Your Body A Potentially Life-threatening Blood Clot has Formed in Your Body A deep vein thrombosis (DVT) is a blood clot, usually occurring in the leg A pulmonary embolism (PE) is a blood clot in the lungs Deep Vein Thrombosis (DVT): A blood clot in a deep vein in the body (usually in the leg) You may have noticed: Pain, swelling and soreness An intense ache Skin redness DVTs may not cause symptoms and are often only noticed after diagnostic tests. 4 Why did it happen? DVT/PE is a serious condition. It kills more people in Europe in a year than breast and prostate cancer, HIV, and traffic accidents combined. 6 Anyone can have a DVT and/or PE. People are more likely to suffer from blood clots if they have the following: 7,8 >60 years of age Immobility First-degree relative with a history of blood clots Thrombophilias Severe conditions, such as cancer or heart failure Obesity (body mass index [BMI] >30 kg/m 2 ) Major surgery Hormone replacement therapy Pregnancy Varicose veins with inflammation (phlebitis) Pulmonary Embolism (PE): A blood clot in the lung Caused when part of a DVT clot breaks away and lodges in the lung This prevents blood flowing through the affected part of the lung You may have noticed: Breathlessness Coughing up blood (haemoptysis) A mild fever A fast heart rate (tachycardia) PEs may go unnoticed and cause no obvious symptoms. 5 Check patients know their diagnosis and talk through the relevant information. Was their clot provoked or unprovoked? Highlight the risk factors that apply to them. DVT/PE and Its Treatment Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 4 01/12/ :32

5 A Potentially Life-threatening Blood Clot has Formed in Your Body A deep vein thrombosis (DVT) is a blood clot, usually occurring in the leg A pulmonary embolism (PE) is a blood clot in the lungs J1290_Nurse Patient_Flipbook_AW.indd 5 01/12/ :33

6 This side is for healthcare professionals only, not to be viewed by the patient. Your Blood Clot is Being Treated with Anticoagulants 9 Your Blood Clot is Being Treated with Anticoagulants Anticoagulants may also be called blood thinners, however, they do not actually thin your blood. Before treatment After treatment Anticoagulants prevent your clot from growing: Your body has the ability to do this naturally Anticoagulants support your body in dissolving the clot and reducing it in size Anticoagulants work by reducing your body s ability to form clots and prevent new ones from forming It takes time for your original clot to disappear, so you must keep taking your anticoagulant: The importance of compliance Take a moment to check their understanding. As with any medication, it needs to be taken properly to work effectively. Use this opportunity to identify any concerns or worries that might prevent them taking their tablets. What do patients already know about their treatment? Have they been on anticoagulant therapy before? If any symptoms accompanied the clot, these will improve and often eventually disappear Another clot may develop if you stop taking your anticoagulant Patients with DVT Without anticoagulants your blood clot will increase in size and may break off and form a pulmonary embolism. Patients with PE Without anticoagulants, your blood clot will increase in size. If a pulmonary embolism blocks the pulmonary artery (the blood vessel connecting the heart and lungs) it can be fatal. Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 6 01/12/ :33

7 SPIRAL BINDING MARKS Your Blood Clot is Being Treated with Anticoagulants Before treatment J1290_Nurse Patient_Flipbook_AW.indd 7 After treatment 01/12/ :33

8 This side is for healthcare professionals only, not to be viewed by the patient. You Must Keep Taking Your Treatment to Prevent New Blood Clots from Forming (Recurrence) You Must Keep Taking Your Treatment to Prevent New Blood Clots from Forming (Recurrence) After your first clot you are at risk of having another one: 10,11 You are at the highest risk during the first month 12 Your risk of recurrence reduces but it does not go away 1 in 3 people will have another clot within the next 10 years 11,13,14 At the start of therapy you are at the highest risk, so it is vital that you take your medication Staying motivated Find out how their DVT/PE has been affecting their daily lives. Remind them that taking their medication will help their symptoms improve and reduce the chances of new blood clots from forming. Use these statistics appropriately. Highlighting the risk of recurrence may not be appropriate for all patients. However, they may be useful to promote adherence to therapy. It is essential that you take your medication as advised to reduce your risk of another blood clot from forming. Provoked blood clots: 2,3 Your treatment is usually for 3 months You are at low risk of recurrence ( 3% annual risk) after completing treatment Unprovoked blood clots: 2,3 Your treatment is usually for more than 3 months You are at moderate risk of recurrence (3 9% annual risk) after completing treatment Recurrent unprovoked blood clots: 2,3 Your treatment is usually long term and may be lifelong The benefits of longer-term treatment outweigh the risks of bleeding (>9% annual risk of recurrence after stopping treatment) Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 8 01/12/ :33

9 You Must Keep Taking Your Treatment to Prevent New Blood Clots from Forming (Recurrence) At the start of therapy you are at the highest risk, so it is vital that you take your medication J1290_Nurse Patient_Flipbook_AW.indd 9 01/12/ :33

10 This side is for healthcare professionals only, not to be viewed by the patient. Taking Xarelto Taking Xarelto Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 10 01/12/ :34

11 Taking Xarelto Taking Xarelto J1290_Nurse Patient_Flipbook_AW.indd 11 01/12/ :34

12 This side is for healthcare professionals only, not to be viewed by the patient. You are Taking Xarelto to Treat Your Blood Clot DAYS 1 TO 21 AM PM AM or PM DAY 22 ONWARDS Counting down to once daily: From day 22 the dose of Xarelto is 20 mg once a day Counting down to once daily Getting to 21 days of therapy and the end of the twice-a-day dosing regimen is an important milestone. This achievement should be celebrated. Encourage patients to recognise its importance. Side effects As with all anticoagulants, there is a risk of bleeding Xarelto has only minor influence on the ability to drive or use machines. However, if patients experience syncope (fainting; uncommon) or dizziness (common), they should not drive or use machinery Patients should report all side effects to their healthcare team. They might not all be due to Xarelto. You are Taking Xarelto to Treat Your Blood Clot 15 Anticoagulation therapy with Xarelto Xarelto is a fast-acting anticoagulant It may also be called by its scientific name of rivaroxaban With Xarelto you can eat and drink what you like in moderation Days 1 to 21: You must take two tablets every day with food: One 15 mg tablet in the morning with breakfast One 15 mg tablet in the evening with dinner While you are at the highest risk, this initial high dose helps to treat your clot and protect you from new clots appearing Day 22 onwards: You will need to take just one 20 mg tablet a day, either with breakfast or your evening meal This 20 mg Xarelto tablet continues to help treat your blood clot as well as helping to prevent any new clots from forming You must continue to take Xarelto until your healthcare team tells you otherwise If you have kidney (renal) problems: Your doctor may decide to reduce the dose for the treatment after 3 weeks, to one 15 mg tablet once a day, if your risk for bleeding is higher than your risk for having another blood clot. Your doctor will discuss this with you Taking Xarelto Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 12 01/12/ :34

13 You are Taking Xarelto to Treat Your Blood Clot DAYS 1 TO 21 DAY 22 ONWARDS AM PM AM or PM Counting down to once daily: From day 22 the dose of Xarelto is 20 mg once a day J1290_Nurse Patient_Flipbook_AW.indd 13 01/12/ :34

14 This side is for healthcare professionals only, not to be viewed by the patient. If You Miss a Dose of Xarelto, Take it Immediately after You Remember on that Day DAYS 1 TO 21 AM PM AM or PM DAY 22 ONWARDS Take your next dose at the usual time Setting reminders Ask patients what helps them to set and stick to a routine. Suggest ways to help them remember to take their medication at home. If You Miss a Dose of Xarelto, Take it Immediately after You Remember on that Day 15 Missed doses of Xarelto For the first 21 days: Take Xarelto immediately to ensure you take 30 mg Xarelto per day If you forgot your morning dose and remember in the evening, you can take two 15 mg tablets at once You should continue with the regular 15 mg twice-daily dose on the following day Day 22 onwards: You should take Xarelto immediately You should continue on the following day with the once-daily dose Do not double the dose within the same day to make up for a missed dose Using a treatment tracker In the Xarelto patient booklet (Getting off to the Right Start), there is a tablet tracker that patients can use to help them remember what they have taken and what dose they are on. Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 14 01/12/ :34

15 If You Miss a Dose of Xarelto, Take it Immediately after You Remember on that Day DAYS 1 TO 21 DAY 22 ONWARDS AM PM AM or PM Take your next dose at the usual time J1290_Nurse Patient_Flipbook_AW.indd 15 01/12/ :34

16 This side is for healthcare professionals only, not to be viewed by the patient. Managing Therapy Managing Therapy Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 16 01/12/ :34

17 Managing Therapy Managing Therapy J1290_Nurse Patient_Flipbook_AW.indd 17 01/12/ :34

18 This side is for healthcare professionals only, not to be viewed by the patient. Preparation Will Help You get the Most from Your Therapy Preparation Will Help You get the Most from Your Therapy Be aware of your condition The way you re feeling today is a completely normal response to any major health emergency The best way to deal with your feelings is to learn more about your condition Be aware of your condition Be alert to possible risks Be ready for the months ahead Be alert to possible risks Your clot will respond to treatment and your symptoms should improve You should soon feel well enough to take some gentle exercise perhaps a walk in the garden or a trip to the shops Nevertheless, you may be at very high risk of your clot returning 12 You must continue taking your anticoagulant medication Managing Therapy Tailor the information based on how long patients will be taking their medication for. If they are taking lifelong medication, there may be activities that they will no longer be able to do. Be ready for the months ahead Every day, your medication is reducing your risk of another clot After a while you should be able to do all the things you once enjoyed whether it s spending quality time with loved ones or your leisure activities. Only you can make this happen If you have symptoms after your treatment has finished, contact your healthcare team. Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 18 01/12/ :34

19 SPIRAL BINDING MARKS Preparation Will Help You get the Most from Your Therapy Be aware of your condition J1290_Nurse Patient_Flipbook_AW.indd 19 Be alert to possible risks Be ready for the months ahead 01/12/ :34

20 This side is for healthcare professionals only, not to be viewed by the patient. Stay Safe by Taking Precautions to Avoid Injuring Yourself While on Anticoagulants Anticoagulants make you bruise and bleed more easily than usual Tips to reduce patients risk of injury 16 To wear protective clothes e.g. gloves when using sharp items To use an electric razor especially if they regularly cut themselves To avoid scratches e.g. they should not expose bare skin when walking in the countryside or gardening To use a softer toothbrush and waxed dental floss to clean their teeth To blow their nose gently they should take care not to cause a nosebleed To not strain on the toilet recommend they have plenty of fibre in their diet to keep their bowel movements regular Stay Safe by Taking Precautions to Avoid Injuring Yourself While on Anticoagulants Risk of bleeding Anticoagulants make it harder for your blood to clot If you hurt yourself you will bleed more easily and for longer You may also bruise more easily You should report any spontaneous bruising (without injury), or unusual bleeding (e.g. from your nose or gums) to your healthcare team Preventing bleeding Take additional care to avoid injuring yourself while you are taking anticoagulants You should take precautions to reduce your risk of injury (see Box) Advice for women: If your menstrual periods are heavier and last longer than usual, please contact your healthcare team You should not take Xarelto when you are pregnant. Avoid becoming pregnant while taking Xarelto Do not breastfeed while taking Xarelto Select the precautions that are the most relevant and discuss them with your patients. Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 20 01/12/ :34

21 Stay Safe by Taking Precautions to Avoid Injuring Yourself While on Anticoagulants Anticoagulants make you bruise and bleed more easily than usual J1290_Nurse Patient_Flipbook_AW.indd 21 01/12/ :35

22 This side is for healthcare professionals only, not to be viewed by the patient. Apply Pressure, Elevate, and Bandage Cuts to Help Them Close Immediately contact your healthcare team if you have long or excessive bleeding, or blood in your stools or urine What daily activities might increase their risk of bleeding or bruising? Ask patients about their daily lives to assess for risk of bleeding. There may be activities that they should avoid or additional precautions that they should take. How to manage a nose bleed 1. Pinch the nose below the bone on the fleshy part covering the nostrils 2. Apply ice to the bridge of the nose 3. Lean forward to avoid swallowing blood which might make you feel nauseous 4. If the bleeding has not stopped after 15 minutes seek medical help Apply Pressure, Elevate, and Bandage Cuts to Help Them Close How to manage a bleed from an injury Apply pressure to the cut with a pad (e.g. a clean cloth) or fingers 2. Elevate and support the injured limb 3. Bandage the pad firmly to control bleeding (not so tight that it stops blood going to fingers or toes) 4. Do not remove the pad if blood comes through. Bandage another one over the original and seek medical help immediately 5. It is important to seek medical help urgently if the bleeding doesn t stop Signs of severe bleeding Immediately seek medical advice if you have any of the following symptoms: Long or excessive bleeding Bloody stools or urine Bleeding in the eye Head injury with or without bleeding Headache Dizziness Weakness Paleness Coughing/vomiting blood Make sure your family are aware of the dangers of bleeding and what to do should you need help Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 22 01/12/ :35

23 Apply Pressure, Elevate, and Bandage Cuts to Help Them Close Immediately contact your healthcare team if you have long or excessive bleeding, or blood in your stools or urine J1290_Nurse Patient_Flipbook_AW.indd 23 01/12/ :36

24 This side is for healthcare professionals only, not to be viewed by the patient. Be Vigilant for any Signs of Another Blood Clot Be Vigilant for any Signs of Another Blood Clot You must look out for signs that you have another clot: Remember to be alert for signs even after you have completed treatment Contact your healthcare team if you notice any signs or symptoms of blood clots Signs of DVT are: Leg pain Tenderness and aching Swelling and redness If you notice any of these signs, you should contact your healthcare team. Signs of PE are: Chest pain Shortness of breath Coughing Feeling faint or dizzy Passing out If you have signs of PE, you should call [Insert Emergency No.] or go to your local emergency department. Remembering the signs and symptoms A list of some of the symptoms of DVT/PE is in the Xarelto patient booklet (Getting off to the Right Start). Did they have a DVT or PE previously? Which symptoms did they notice? Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 24 01/12/ :36

25 Be Vigilant for any Signs of Another Blood Clot Contact your healthcare team if you notice any signs or symptoms of blood clots J1290_Nurse Patient_Flipbook_AW.indd 25 01/12/ :36

26 This side is for healthcare professionals only, not to be viewed by the patient. Your Goals Your Goals Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 26 01/12/ :36

27 Your Goals Your Goals J1290_Nurse Patient_Flipbook_AW.indd 27 01/12/ :36

28 This side is for healthcare professionals only, not to be viewed by the patient. What Questions do You Have? What Have You Remembered? Your Goals What Questions do You Have? What Have You Remembered? Xarelto patient booklet The patient booklet (Getting off to the Right Start) contains further information on treatment with Xarelto and includes information on: DVT and PE How anticoagulants work Treatment with Xarelto Preventing and managing bleeding Patient experiences Tablet tracker Checking their understanding It is essential that patients take their medication as prescribed. Use these prompts to ensure that they have understood what you have discussed: Do you have any questions? Is there anything that you do not understand? Is there anything that will stop you taking your tablets every day? Learning by repetition If there is time, get patients to repeat back key information to you to help them to memorise it: Have patients understood their condition and its treatment? Do they know what to do in the case of minor or major bleeding? Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 28 01/12/ :36

29 What Questions do You Have? What Have You Remembered? J1290_Nurse Patient_Flipbook_AW.indd 29 01/12/ :36

30 This side is for healthcare professionals only, not to be viewed by the patient. What Will Motivate You to Keep Taking Your Treatment? What Will Motivate You to Keep Taking Your Treatment? Keeping patients motivated Having an aim will help you to focus on a healthier future and stay motivated Make suggestions based on the patients lifestyle and motivation: Decide on one or two things that will keep you focused during therapy. Ask your friends or family to help I will keep taking my medication so I can start playing golf again My clot shrinks I can start swimming again I don t get another clot I can go travelling Make the pledge public: Telling people what you want to achieve will help you stick to it Get help from family and friends who will you get to support you? Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 30 01/12/ :36

31 What Will Motivate You to Keep Taking Your Treatment? Decide on one or two things that will keep you focused during therapy. Ask your friends or family to help J1290_Nurse Patient_Flipbook_AW.indd 31 01/12/ :36

32 This side is for healthcare professionals only, not to be viewed by the patient. Contact Information Contact Information Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 32 01/12/ :36

33 Contact Information Contact Information J1290_Nurse Patient_Flipbook_AW.indd 33 01/12/ :36

34 Contact Information This side is for healthcare professionals only, not to be viewed by the patient. Contact Information Contact Information You will have received a contact card for the thrombosis clinic so that you have all the details you need in one place You must inform other doctors, surgeons, nurses or dentists about your anticoagulation therapy if they are discussing any treatments or procedures with you. Your tablets may need to be adjusted Keep the contact details of your healthcare team on you at all times Alerting people that you are on anticoagulant therapy If you have been prescribed lifelong anticoagulant therapy, consider wearing an information bracelet Xarelto patient card You should also have a patient card, which you should carry with you everywhere and present to all your healthcare providers This card will inform physicians and dentists about your Xarelto treatment and will contain emergency contact information Xarelto patient booklet A booklet to help you start your treatment with confidence (Getting off to the Right Start) Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 34 01/12/ :36

35 Contact Information Keep the contact details of your healthcare team on you at all times J1290_Nurse Patient_Flipbook_AW.indd 35 01/12/ :36

36 This side is for healthcare professionals only, not to be viewed by the patient. Prescribing information can be found on final leaf J1290_Nurse Patient_Flipbook_AW.indd 36 01/12/ :36

37 Xarelto 10 mg / 15 mg / 20 mg film-coated tablets (Refer to full SmPC before prescribing.) This medicinal product is subject to additional monitoring Composition: Active ingredient: 10 mg / 15 mg / 20 mg rivaroxaban. Excipients: Microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, sodium laurilsulfate, magnesium stearate, macrogol 3350, titanium dioxide (E171), iron oxide red (E172). Indications: 10 mg: Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. 15 mg / 20 mg: Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Contraindications: Hypersensitivity to the active substance or any of the excipients; active clinically significant bleeding; lesion or condition if considered a significant risk for major bleeding; concomitant treatment with any other anticoagulants except under the circumstances of switching therapy to or from rivaroxaban or when unfractionated heparin is given at doses necessary to maintain an open central venous or arterial catheter; hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C; pregnancy and breast feeding. Warnings and Precautions: Clinical surveillance in line with anticoagulation practice is recommended throughout treatment. Xarelto should be discontinued if severe haemorrhage occurs. Increasing age may increase haemorrhagic risk. Not recommended: in patients with severe renal impairment (creatinine clearance <15 ml/min); in patients receiving concomitant systemic treatment with strong concurrent CYP3A4- and P-gp-inhibitors, i.e. azole-antimycotics or HIV protease inhibitors; in patients with increased bleeding risk; in patients receiving concomitant treatment with strong CYP3A4 inducers unless the patient is closely observed for signs and symptoms of thrombosis; not recommended due to lack of data: in patients below 18 years of age, in patients concomitantly treated with dronedarone. 15 mg / 20 mg add*: in patients with prosthetic heart valves, in patients with PE who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. Use with caution: in conditions with increased risk of haemorrhage; in patients with severe renal impairment (creatinine clearance ml/min) or with renal impairment concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations; in patients treated concomitantly with medicinal products affecting haemostasis. 10 mg add*: when neuraxial anaesthesia or spinal/ epidural puncture is employed; 15 mg / 20 mg add*: specific dose recommendations apply for patients with moderate to severe renal impairment and in case of DVT/ PE-patients only if the patient s assessed risk for bleeding outweighs the risk for recurrent DVT/PE. In patients at risk of ulcerative gastrointestinal disease prophylactic treatment may be considered. Although treatment with rivaroxaban does not require routine monitoring of exposure, rivaroxaban levels measured with a calibrated quantitative anti-factor Xa assay may be useful in exceptional situations. Xarelto contains lactose. Undesirable effects: Common: anaemia, dizziness, headache, eye haemorrhage, hypotension, haematoma, epistaxis, haemoptysis, gingival bleeding, gastrointestinal tract haemorrhage, gastrointestinal and abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting, pruritus, rash, ecchymosis, cutaneous and subcutaneous haemorrhage, pain in extremity, urogenital tract haemorrhage (menorrhagia very common in women < 55 years treated for DVT, PE or prevention of recurrence), renal impairment, fever, peripheral oedema, decreased general strength and energy, increase in transaminases, post-procedural haemorrhage, contusion, wound secretion. Uncommon: thrombocythemia, allergic reaction, dermatitis allergic, cerebral and intracranial haemorrhage, syncope, tachycardia, dry mouth, hepatic function abnormal, urticaria, haemarthrosis, feeling unwell, increases in: bilirubin, blood alkaline phosphatase, LDH, lipase, amylase, GGT. Rare: jaundice, muscle haemorrhage, localised oedema, bilirubin conjugated increased, vascular pseudoaneurysm. Frequency not known: compartment syndrome or (acute) renal failure secondary to a bleeding, angioedema and allergic oedema (uncommon in pooled phase III trials). Classification for supply: Medicinal product subject to medical prescription. Marketing Authorisation Holder: Bayer Pharma AG, D Berlin, Germany Further information available from: xarelto.medinfo@bayer.com Version: EU/3 * add = additional precautions to be followed for individual dosages J1290_Nurse Patient_Flipbook_AW.indd 37 01/12/ :36

38 References 1. Skinner N. and Moran P. Guidelines from the Case Management Society of America for improving patient adherence to DVT medication therapies, August 2008: 2. Konstantinides S.V., Torbicki A., Agnelli G. et al ESC Guidelines on the diagnosis and management of acute pulmonary embolism: The Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC) Endorsed by the European Respiratory Society (ERS). Eur Heart J. 2014;pii:ehu Keeling D., Baglin T., Tait C. et al. Guidelines on oral anticoagulation with warfarin - fourth edition. Br J Haematol. 2011;154(3): Anderson F.A. and Audet A.M. (1998). Best Practices. Preventing Deep Vein Thrombosis and Pulmonary Embolism: A Practical Guide to Evolution and Improvement. [PDF]. Massachusetts: Centre for Outcomes Research, University of Massachusetts Medical Centre., pp Available at [Accessed 30 Oct 2014]. 5. Moser K.M., Fedullo P.F., LitteJohn J.K. et al. Frequent asymptomatic pulmonary embolism in patients with deep venous thrombosis. JAMA. 1994;271(3): Cohen A.T., Agnelli G., Anderson F.A. et al. Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007;98(4): Cushman M. Epidemiology and Risk Factors for Venous Thrombosis. Semin Hematol. 2007;44(2): Lowe GD. Common risk factors for both arterial and venous thrombosis. Br J Haematol. 2008;140(5): Waldron B. and Moll S. Cardiology patient page. A patient s guide to recovery after deep vein thrombosis or pulmonary embolism. Circulation 2014;129(17):e Palareti G. Recurrent venous thromboembolism: what is the risk and how to prevent it. Scientifica (Cairo) 2012;2012: Heit J.A., Silverstein M.D., Mohr D.N. et al. The epidemiology of venous thromboembolism in the community. Thromb Haemost. 2001;86(1): Limone B.L, Hernandez A.V., Michalak D. et al. Timing of recurrent venous thromboembolism early after the index event: a meta-analysis of randomized controlled trials. Thromb Res. 2013;132(4): Prandoni P., Noventa F., Ghirarduzzi A. et al. The risk of recurrent venous thromboembolism after discontinuing anticoagulation in patients with acute proximal deep vein thrombosis or pulmonary embolism. A prospective cohort study in 1,626 patients. Haematologica 2007;92(2): Schulman S., Lindmarker P., Holmstrom M. et al. Post-thrombotic syndrome, recurrence, and death 10 years after the first episode of venous thromboembolism treated with warfarin for 6 weeks or 6 months. J Thromb Haemost. 2006;4(4): Xarelto (rivaroxaban) Summary of Product Characteristics as approved by the European Commission. 16. Fiumara K. and Goldhaber S.Z. Cardiology patient pages. A patient s guide to taking coumadin/warfarin. Circulation 2009;119(8):e St John Ambulance. Bleeding: J1290_Nurse Patient_Flipbook_AW.indd 38 01/12/ :36

39 Bayer Healthcare Pharmaceuticals November 2014 G.GM.XA J1290_Nurse Patient_Flipbook_AW.indd 39 01/12/ :36

40 J1290_Nurse Patient_Flipbook_AW.indd 40 01/12/ :36