Prescriber Guide. 20mg. 15mg. Simply Protecting More Patients. Simply Protecting More Patients

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1 Prescriber Guide 20mg Simply Protecting More Patients 15mg Simply Protecting More Patients 1

2 Dear Doctor, This prescriber guide was produced by Bayer Israel in cooperation with the Ministry of Health as part of a risk management plan for all new oral anticoagulants marketed in Israel, in order to provide the most important information to prescribers and healthcare providers. The most important safety information for prescribing physicians At the beginning of this prescriber guide, we would like to draw your attention to several guidelines for the responsible use of Xarelto, in order to maximize the efficiency and the safety during Xarelto treatment: Dosing should be adjusted according to the patient s renal function: Renal function should be evaluated prior to the initiation of Xarelto treatment. In patients with moderate (creatinine clearance ml/min) or severe (15-29 ml/min) renal impairment, dose adjustment should be considered according to the treatment indication, as described in this guide. The use of Xareltois not recommended in patients with creatinine clearance lower than 15 ml/min. There is no recommendation for dose adjustment according to the patient s age or weight. Drugs administered concomitantly with Xarelto must be taken into account: Xarelto should not be used concomitantly with other anticoagulants (such as warfarin, dabigatran, apixaban or heparin) except under the circumstances of switching therapy to or from Xarelto or when heparin is administered at doses necessary to maintain an open central venous or arterial catheter. The use of Xarelto is not recommended in patients receiving concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (e.g. ritonavir). Patients treated with drugs affecting hemostasis, such as NSAIDs, acetylsalicylic acid (such as Aspirin) or platelet aggregation inhibitors are at increased risk for bleeding and should be therefore carefully monitored for signs and symptoms of bleeding complications. For further information regarding Interaction with other drugs, please refer to sections Interaction with other drugs and Populations Potentially at Higher Risk of Bleeding 2

3 Populations Potentially at Higher Risk of Bleeding: Like all anticoagulants, Xarelto may increase the risk of bleeding. Several sub-groups of patients are at increased risk for bleeding and should be carefully monitored for signs and symptoms of bleeding complications. Patients with renal impairment (as specified above) Patients concomitantly receiving other medications (as specified above) Patients with other haemorrhagic risk factors, such as: - Congenital or acquired bleeding disorders - Uncontrolled severe arterial hypertension - Gastrointestinal diseases (not including current or recent gastrointestinal ulceration which is a contra-indication for Xarelto treatment), such as inflammatory bowel disease, oesophagitis, gastritis and gastro-esophageal reflux disease. - Vascular retinopathy - Bronchiectasis or history of pulmonary bleeding Treatment decision in these patients should be done after assessment of treatment benefit against the risk for bleeding. Situations, which require treatment discontinuation: Xarelto administration should be discontinued if severe haemorrhage occurs. Guidance for bleeding management is provided below in this prescriber guide. Premature discontinuation of the treatment increases the risk of thrombotic events. Premature discontinuation of any anticoagulant, including Xarelto, increases the risk of thrombotic events. If the treatment with Xarelto is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant. Indications: Prevention of stroke and systemic embolism in adult patients with non-valvular 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. 3

4 Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Xarelto is also available at a dose of 10 mg, which is indicated for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. This guide refers to Xarelto 15 mg and Xarelto 20 mg only. For treatment guidelines for Xarelto 10 mg, please refer to the full prescribing information. Contraindications: 1. Hypersensitivity to any of the drug components. 2. Active clinically significant bleeding. 3. Lesion or condition, if considered to be a significant risk for major bleeding. This may Xarelto include Prescriber current Guide or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected Patient Alert oesophageal Cardvarices, arteriovenous malformations, vascular aneurysms A patient alert or card intraspinal must be or provided intracerebral to each vascular patient abnormalities. who is prescribed Xarelto 4. Concomitant 15 or 20 mg, and treatment the implications with any of other anticoagulant treatment (such should as warfarin, be dabigatran, explained. Specifically, apixaban the or heparin) need for compliance except under and the signs circumstances of bleeding and of switching therapy when to to seek or medical from rivaroxaban attention should or when be discussed heparin is with given the at patient. doses necessary to maintain an open central venous or arterial catheter. The patient alert card will inform physicians and dentists about the patient s 5. Hepatic disease associated with increased risk for bleeding including cirrhotic anticoagulation treatment and will contain emergency contact information. patients with Child Pugh B and C. The patient should be instructed to carry the patient alert card at all times and 6. Pregnancy and breast feeding. present it to every health care provider. Drug Dosing information: Recommendations Dosing Dosing Recommendations in patients with atrial fibrillation Dosing The recommended recommendations dose for in patients prevention with of stroke atrial fibrillation and systemic embolism in The patients recommended with non-valvular dose for atrial prevention fibrillation of stroke is 20 mg and once systemic daily. embolism in adult patients with non-valvular atrial fibrillation is 20 mg once daily. DOSING SCHEME CONTINUOUS TREATMENT Xarelto 20 mg once daily* TAKE WITH FOOD * In patients with moderate or severe renal impairment the recommended dose is 15 mg once daily. *In patients with moderate or severe renal impairment the recommended dose is 15 mg once daily. 4 Patients with renal impairment: In patients with moderate (creatinine clearance ml/min) or severe

5 Patients with renal impairment In patients with moderate (creatinine clearance ml/min) or severe (15-29 ml/min) renal impairment the recommended dose is 15 mg once daily. Xarelto use is not recommended in patients with creatinine clearance lower than 15 ml/min. Duration of therapy Xarelto should be administered continuously and for long-term, provided that the benefit of stroke prevention therapy outweighs the potential risk of bleeding. Missed dose If a dose is missed the patient should take Xarelto immediately and continue on the following day with the once daily intake as recommended. The dose should not be doubled within the same day to make up for a missed dose**. ** These instructions refer to atrial fibrillation patients. Instructions for a missed dose concerning the indication of deep vein thrombosis (DVT) and pulmonary embolism Xarelto (PE) Prescriber treatment Guide as well as the prevention of DVT and PE recurrence are listed below in this guide. Dosing recommendations for the treatment of deep vein thrombosis (DVT) and Dosing in the treatment of deep vein thrombosis (DVT) and prevention of pulmonary embolism (PE), and prevention of recurrent DVT and PE recurrent DVT and pulmonary embolism (PE) Patients are initially treated with 15 mg twice daily for the first three weeks. This The recommended dose is 15 mg twice daily for the first three weeks. Afterwards initial treatment is followed by 20 mg once daily for continued treatment period. the recommended dose is 20 mg once daily for the continued treatment period. DOSING SCHEME INITIAL TREATMENT CONTINUOUS TREATMENT Xarelto 15 mg twice daily Xarelto 20 mg once daily* FIRST 3 WEEKS BEYOND 3 WEEKS TAKE WITH FOOD * Please see below for recommendations *In patients with moderate for dose or severe adjustment renal impairment in patients the recommended with impaired dose is 15 mg renal once daily. function Patients with renal impairment: Patients In patients with with moderate (creatinine clearance ml/min) or or severe (15-29 ml/min) (15-29 ml/min) renal impairment renal impairment should patients be treated should with be 15 treated mg twice with 15 daily mg for twice the first 3 weeks. daily for Thereafter, the first 3 weeks. a reduction Thereafter, of the the dose recommended from 20 mg dose once is daily 15 mg to once 15 mg daily. once daily Use is should not recommended be considered in patients if the patient s with creatinine assessed clearance risk for < bleeding 15 ml/min. outweighs the Duration of therapy: The duration of therapy should be individualised after assessment of the treatment benefit against the risk for bleeding. 5

6 risk for recurrent DVT and PE. The use of Xarelto is not recommended in patients with creatinine clearance < 15 ml/min. Duration of therapy The duration of therapy should be individualized after assessment of the treatment benefit against the risk for bleeding. Missed dose Twice daily treatment period (15 mg b.i.d. for the first three weeks): If a dose is missed, the patient should take Xarelto immediately to ensure intake of 30 mg Xarelto per day. Continue with the regular 15 mg twice daily intake on the following day. Once daily treatment period (beyond three weeks): If a dose is missed, the patient should take Xarelto immediately and continue on the following day with the once daily intake as recommended. The dose should not be doubled within the same day to make up for a missed dose. Premature discontinuation of the treatment increases the risk of thrombotic events Premature discontinuation of any anticoagulant, including Xarelto, increases the risk of thrombotic events. If the treatment with Xarelto is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant. Intake with food Xarelto 15 mg and 20 mg must be taken with food. The intake of these doses with food at the same time supports the required absorption of the drug, thus ensuring high oral bioavailability. * Note: Xarelto is also available at a 10 mg dose for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. This dose can be taken with or without food. Instructions prior to surgery or invasive treatment If an invasive procedure or surgical intervention is required, Xarelto 15/20 mg should be discontinued, if possible, at least 24 hours before the intervention and based on the clinical judgment of the physician. If the procedure cannot be delayed, the increased risk of bleeding should be assessed against the urgency of the intervention. Xarelto should be restarted after the invasive procedure or surgical intervention as 6

7 Xarelto Prescriber Guide soon as possible provided the clinical situation allows and adequate hemostasis has been Oral established. Intake Xarelto 15 mg and 20 mg must be taken with food. The intake of these doses In with patients food at undergoing the same time procedures support the with required a low absorption risk of bleeding of the (e.g. drug, dental thus Interventions ensuring a high or oral cataract bioavailability. surgery) Note: interruption Xarelto of is Xarelto also available treatment a 10 may mg not dose be required. for the prevention Avoid performing of venous thromboembolism elective procedures (VTE) at peak in adult rivaroxaban patients undergoing activity (i.e. within elective 4 hip hours or knee after replacement tablet intake). surgery. This dose can be taken without food. Neuraxial Perioperative anesthesia Management (Spinal/epidural) or spinal puncture - When neuraxial anaesthesia If invasive (spinal/epidural) procedure or surgical or spinal intervention puncture is required, is employed, Xarelto patients should be treated with anticoagulant stopped at least are 24 at hours increased before the risk intervention, of developing if possible an epidural and based or spinal on the haematoma. Please clinical refer judgement to the of full the prescribing physician. If information the procedure for cannot detailed be delayed guidance the on increased this topic. risk of bleeding should be assessed against the urgency of the intervention. Converting from Vitamin K Antagonists (VKA) to Xarelto For Xarelto patients should treated be restarted for prevention after the invasive of stroke procedure and systemic or surgical embolism, intervention treatment with as soon VKA as should possible be provided stopped the and clinical Xarelto situation therapy allows should and adequate be initiated when the INR is haemostasis 3.0 or lower. has been established. Converting from VKA to Xarelto For patients treated for DVT, PE and prevention of recurrent DVT and PE, For patients treated for prevention of stroke and systemic embolism, treatment with VKA should be stopped and Xarelto therapy should be initiated treatment with VKA should be stopped and Xarelto when the INR is 2.5 or lower. therapy should be initiated when the INR is 3.0. INR For measurement patients treated is for not DVT appropriate and prevention to measure of recurrent the anticoagulant DVT and PE, activity of Xarelto, treatment and with therefore VKA should should be stopped not be and used Xarelto for this therapy purpose. should Treatment be initiated with Xarelto when the only INR does is 2.5. not require routine coagulation monitoring. Stop VKA CONVERTING FROM VKA TO XARELTO VKA Xarelto * PREVENTION OF STROKE AND SYSTEMIC EMBOLISM: Initiate Xarelto once INR 3.0 INR testing (duration according to individual decrease of VKA plasma levels) DVT AND PREVENTION OF RECURRENT DVT AND PE: Initiate Xarelto once INR 2.5 DAYS * Please see dosing recommendations for required daily dose *See dosing recommendations for required daily dose INR measurement is not appropriate to measure the anticoagulant activity of Xarelto, and therefore should not be used for this purpose. Treatment with Xarelto only does not require routine coagulation monitoring. 7

8 Converting from Xarelto to VKA It is important to ensure adequate anticoagulation while minimizing the risk of bleeding during conversion of therapy. Xarelto Prescriber Guide When converting to VKA, Xarelto and VKA should be given overlapping until the INR is 2.0. For the first two days of the conversion period, standard initial dosing of VKA should be used followed by VKA dosing guided by INR testing. Converting from Xarelto to VKA It is important to ensure adequate anticoagulation while minimizing the risk of INR measurement bleeding during is not conversion appropriate of therapy. to measure the anticoagulant activity of Xarelto. While patients are on both Xarelto and VKA the INR should not be tested earlier When than 24 converting hours after to VKA, the previous Xarelto and dose VKA but should prior to be the given next overlapping dose of Xarelto. until the Once Xarelto INR is 2.0. is discontinued, For the first two INR days values of the can conversion be reliably period, obtained standard at least initial 24 dosing hours after the of VKA last dose should of be Xarelto. used followed by VKA dosing guided by INR testing. CONVERTING FROM XARELTO TO VKA Xarelto * Standard VKA dose INR testing before Xarelto administration INR adapted VKA dose Xarelto can be stopped once INR 2.0 DAYS * Please see dosing recommendations for required daily dose *See dosing recommendations for required daily dose INR measurement is not appropriate to measure the anticoagulant activity Converting from Parenteral Anticoagulants to Xarelto of Xarelto Patients with. While patients are on both Xarelto continuously administered intravenous and VKA the INR should not heprin- Xarelto should be be tested earlier than 24 hours after the previous dose but prior to the started at the time of discontinuation. next dose of Xarelto Patients treated with Low. Once Xarelto Molecular Weight is discontinued INR testing may be done Heparin Xarelto should be started reliably at least 24 hours after the last dose. 0 to 2 hours before the time of the next scheduled administration of the parenteral Converting drug. from Parenteral Anticoagulants to Xarelto 8 Converting Patients from with Xarelto continuously to Parenteral administered Anticoagulants parenteral drug such as The first dose intravenous of the parenteral unfractionated anticoagulant heparin: Xarelto should should be given be started instead at of the the next Xarelto dose time at of the discontinuation. same time. Patients with parenteral drug on a fixed dosing scheme such as LMWH: Xarelto should be started 0 to 2 hours before the time of the next scheduled administration of the parenteral drug. Converting from Xarelto to Parenteral Anticoagulants

9 Interaction with other drugs The concomitant use of rivaroxaban with other strong CYP3A4 inducers (e.g. phenytoin, carbamazepine, phenobarbital or St. John s Wort) may lead to reduced rivaroxaban plasma concentrations. Therefore, concomitant administration of strong CYP3A4 inducers should be avoided unless the patient is closely observed for signs and symptoms of thrombosis. For additional interactions please see information below in the section Populations Potentially at Higher Risk of Bleeding Populations Potentially at Higher Risk of Bleeding Like all anticoagulants, Xarelto may increase the risk of bleeding; therefore a bleeding source should be searched in any case of unexplained decrease in hemoglobin levels or blood pressure. Careful attention should be given to the contraindications listed above. Several sub-groups of patients are at increased risk for bleeding and should be carefully monitored for signs and symptoms of bleeding complications. Treatment decision in these patients should be taken after assessment of treatment benefit against the risk for bleeding. Patients with renal impairment - please see above recommendations for dose adjustments for patients with moderate (creatinine clearance ml/min) or severe (15-29 ml/min) renal impairment. The use of Xarelto is not recommended in patients with creatinine clearance lower than 15 ml/min. Patients concomitantly receiving other drugs Systemic azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (e.g. ritonavir): use of Xarelto is not recommended. Drugs affecting hemostasis such as NSAIDs, acetylsalicylic acid (such as Aspirin), or platelet aggregation inhibitors Dronedarone - given the limited clinical data available with dronedarone, coadministration with rivaroxaban should be avoided. 9

10 Patients with other haemorrhagic risk factors Congenital or acquired bleeding disorders Uncontrolled severe arterial hypertension Gastrointestinal disease (not including current or recent gastrointestinal ulceration which is a contra-indication for Xarelto treatment) such as inflammatory bowel disease, oesophagitis, gastritis and gastroesophageal reflux disease. Vascular retinopathy Bronchiectasis or history of pulmonary bleeding Overdose Due to limited absorption, a ceiling effect with no further increase in average plasma exposure is expected at supratherapeutic doses of 50 mg Xarelto and above. The use of activated charcoal to reduce absorption in case of overdose may be considered. Should a bleeding complication arise in a patient receiving Xarelto The next Xarelto administration should be delayed or treatment should be discontinued as appropriate. Individualized bleeding management may include: Symptomatic treatment, such as mechanical compression, surgical intervention, fluid replacement Hemodynamic support - blood product or blood component transfusion For life-threatening bleeding that cannot be controlled with the above measures, administration of a specific procoagulant agent should be considered, such as prothrombin complex concentrate (PCC), activated prothrombin complex concentrate (APCC) or recombinant factor VIIa (r-fviia). However, there is currently very limited clinical experience with the use of these products in individuals receiving Xarelto Due to the high plasma protein binding Xarelto is not expected to be dialyzable. Coagulation Testing Xarelto does not require routine coagulation monitoring. However, measuring Xarelto levels may be useful in exceptional situations where knowledge of Xarelto exposure may help to take clinical decisions, e.g., overdose and emergency surgery. Anti-FXa assays with Xarelto -(rivaroxaban) specific calibrators to measure rivaroxaban levels are now commercially available. 10

11 If clinically indicated, hemostatic status can also be assessed by PT using Neoplastin as described in the full prescribing information. The following coagulation tests might be increased: Prothrombin time (PT), activated partial thromboplastin time (aptt) and calculated PT international normalized ratio (INR). Since the INR was developed to assess the effects of VKAs on the PT, it is therefore not appropriate to use the INR to measure activity of Xarelto. Dosing or treatment decisions should not be based on results of INR except when converting from Xarelto to VKA as described above. Patient Safety Information Card Please provide a Patient card to each patient who is prescribed with Xarelto 15 or 20 mg. Explain to the patient the implications of anticoagulant treatment, including the need for compliance. Please also explain the signs of bleeding and when to seek medical attention. The patient card will inform physicians and dentists about the patient s anticoagulation treatment and will contain emergency contact information. The patient should be instructed to carry the patient card at all times and present it to every health care provider, who is treating him/her. Additional information This prescriber guide is aimed to provide the most important information to the prescribing physician and to healthcare providers. For additional information, please refer to the full prescribing information. For additional information please contact Bayer Israel: 36 Hacharash St., Hod Hasharon, IL Telephone number: Fax number: Reporting adverse events Adverse events can be reported to the Ministry of Health using the online form for adverse event reporting which can be found on the Ministry of Health website: or by using the following link: https://forms.gov.il/globaldata/getsequence/getsequence. Adverse events can be also reported to the Bayer Israel, according to following contact details: Fax:

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16 20mg Simply Protecting More Patients 15mg Simply Protecting More Patients : פקס, : טלפון, , השרון - הוד,36 החרש : באייר ישראל בע מ

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