Drug name: RIVAROXABAN (Xarelto ) For the treatment of acute venous thromboembolism in adult patients.

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1 Drug name: RIVAROXABAN (Xarelto ) For the treatment of acute venous thromboembolism in adult patients. DOCUMENT TO BE SCANNED INTO ELECTRONIC RECORDS AS AND FILED IN NOTES Patient Name : Date of Birth: NHS No: Name of Referring Consultant: Contact number: INTRODUCTION Indication and Licensing Rivaroxaban is a novel oral anticoagulant that works through highly selective inhibition of factor Xa. It is already marketed for the prevention of venous thromboembolic events in adults following elective hip or knee replacement surgery. A license extension was recently granted for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults. It has been shown to be as effective as standard anticoagulant therapy comprising a low molecular weight heparin in combination with a vitamin K antagonist (VKA) e.g. warfarin; it has comparable levels of bleeding and a similar adverse effect profile. Due to its selective inhibition of one clotting factor, the anticoagulation effects are more predictable and as such there is no requirement for regular monitoring, unlike warfain. Other potential advantages compared to VKAs include a standard dosing regimen and a lower likelihood of drug interactions. Disadvantages of rivaroxaban are its higher cost (partially offset by the reduced need for INR monitoring) and limited clinical experience of long-term use. For patients treated short term for venous thromboembolism (up to 3 months) rivaroxaban is an attractive and cost effective treatment option. Initiation would be by secondary care only and in accordance with its licensed indication and according to NICE guidelines. Patient selection criteria The following groups of patients will be considered for rivaroxaban: a) Patients in nursing homes; b) Patients currently using long-term low molecular weight heparins; c) Patients for whom it is predicted at the outset that a course of treatment would last no longer than three months; d) Patients whose VTE is provoked by one or other of the clinical factors associated with hypercoagulability; e) Patients for whom the monitoring requirements of warfarin are not achievable or insurmountable; f) Patients for whom it is judged that the use of rivaroxaban would be associated with significantly enhanced patient concordance; g) Patients for whom the use of rivaroxaban can be justified on clinical grounds through patient exceptionality.

2 Checklist for Prescribing of Rivaroxaban (tick to confirm) 1. The patient does not have any of the following: Creatinine clearance less than 15mls/min Recent gastrointestinal or active bleed 2. Dose of rivaroxaban Initial dose 15mg twice a day for the first 3 weeks Thereafter 20mg once a day OR reduced dose of 15mg once a day For patients with CrCl between 15 and 49ml/min or those at higher risk of bleeding 3. The patient is an informed recipient of this treatment The patient has been counselled on the risks and benefits of treatment with rivaroxaban and this has been documented in the medical record. The patient understands the importance of carrying the anticoagulation warning card with them at all times and of compliance with treatment. PATIENT PATHWAY Clinical Speciality Anticoagulation. Prescribing Initiated by Hospital anticoagulation clinic Prescribing Continued by GP after 6 weeks Monitored by Hospital to monitor patient for 3 weeks and then GP subsequently. Duration of treatment Individualised for each patient. Duration advised by anticoagulation clinic. *temporary discontinuation for surgical procedures advised, see below for further details. Patients are to be initiated in the first instance via secondary care. The patient will return to anticoagulation clinic after the initial 3 weeks. If all is well then a further three weeks of treatment will be supplied and the GP to continue supply and monitoring after this time. Duration of treatment will be advised by the anticoagulation clinic. Treatment should be reviewed (at least annually) and an assessment made for new contraindications to ongoing anticoagulation with rivaroxaban (e.g. temporary discontinuation for surgery, marked decline in renal function and increased bleeding risk (see below for further advice on bleeding risk). Where new contraindications are found, treatment is to be reviewed and anticoagulation therapy withdrawn if risks are deemed to outweigh benefits. Ongoing compliance should be reviewed on a regular basis, the duration and method of compliance assessment should be determined by the GP, taking into account individual patient circumstances and factors.

3 NORMAL DOSE AND ADMINISTRATION Rivaroxaban is available in 2 strengths for the treatment of venous thromboembolism. Both are film coated tablets containing 15mg or 20mg. Usual dose: 15mg twice a day for the first 3 weeks, then 20mg once a day; to be swallowed whole with food. *Unless dose reduction indicated as below Dose alterations: Increased risk of bleed: If bleeding risk is assessed as high, patients are to be considered for 15mg tablet once daily and discussed with a haematologist. Clear documentation should be made as to reason for dose reduction. For subjects with gastritis, oesophagitis, or gastroesophageal reflux, a dose of 15mg tablet once daily may be considered due to the increased risk of major gastro-intestinal bleeding. Patients with an increased bleeding risk should be closely monitored clinically (looking for signs of bleeding or anaemia, more details below). Dose adjustment should be decided at the discretion of the physician, following assessment of the potential benefit and risk to an individual patient. If clinically relevant bleeding occurs, treatment should be interrupted and reviewed prior to re initiation. Renal impairment: Renal function should be assessed by calculating creatinine clearance prior to initiation of treatment with rivaroxaban to exclude patients with severe renal impairment (i.e. CrCL < 15 ml/min). CrCL 15-49ml/min; Consider dose reduction to 15mg once a day after the first 3 weeks in patients with creatinine clearance between who are deemed to be at high risk of bleeding. CrCL <15ml/min; Contraindicated Cockroft and Gault formula for calculating CrCl in ml/min in males is: 1.23 x (140 Age) x weight (kg) Serum Creatinine (Micromol/l) For females multiply the above result by 0.85

4 MONITORING STANDARDS FOR RIVAROXABAN Parameter Action required Frequency of monitoring Further action Parameter Haematological tests Action Renal function (Creatinine clearance - CrCl) CrCl 15-49ml/min: Consider dose reduction where patient considered at a high risk of bleeding. 15mg once a day after the first 3 weeks CrCl <15; contraindicated, avoid use Assess renal function prior to treatment to ensure appropriate starting dose then while on treatment renal function should be assessed at least once a year (or more frequently as needed in certain clinical situations when it is suspected that the renal function could decline or deteriorate such as hypovolemia and dehydration). Dose reduction may be required based on initial renal function. If renal function declines rapidly may need to temporarily withhold therapy and review prior to restarting. Minor bleeding (or those at high risk of bleed on treatment) Dose-dependent inhibition of Factor Xa activity was observed in humans. Prothrombin time (PT) is influenced by rivaroxaban in a dose dependent way with a close correlation to plasma concentrations (r value equals 0.98) if Neoplastin is used for the assay, other reagents would provide different results. If clinically indicated rivaroxaban levels can be measured by calibrated quantitative anti-factor Xa tests but liase with haematology prior to requesting. If numerous episodes of minor bleeding are observed or patient at high risk of bleed discuss with haematology. Parameter Compliance Target level 100% Frequency of Prior to initiation, likely compliance should be considered and discussed with monitoring the patient. Following initiation, compliance should be checked and reinforced at a minimum of annually although this is left at the discretion of the physician. Action If compliance likely to be low, consider alternative anticoagulation that can be monitored. KEY ADVERSE EFFECTS & ACTIONS This lists the key adverse drug reactions, for comprehensive information on cautions, contraindications and interactions, please refer to the current British National Formulary and Summary of Product Characteristics. Adverse effects Minor Bleeding Symptoms/signs (specify what would prompt action) Self terminating minor bleeding from scratches, cuts, nose bleeds, gum bleeding etc. may be experienced. If these are frequent or patient / physician concerned - contact local haematology department for advice Actions The degree of bleeding will dictate action. If minor bleeding is infrequent and self terminates, patient can be reassured. If already on lower dose or concerns are raised - liaise with haematology for advice.

5 Clinically significant bleeding Bleeding that does not stop with reasonable intervention should be referred to local A&E, if in doubt contact local haematology department for advice BHR CCGs and BHRuT NHS Trust Shared Care Guidelines The degree of bleeding will dictate the action. If bleeding stops spontaneously and patient taking 20mg once daily, consider omitting a days dose and reducing to 15mg once daily. If already on lower dose or concerns are raised - liaise with haematology for advice. For bleeding that does not stop with intervention, send patient to local A&E. Gastrointestinal Dyspepsia Consider gastro protection in accordance with local guidance. If no further improvement, consider alternatives or referral to specialist. Therefore surgical interventions may require temporary discontinuation of rivaroxaban with or without heparin bridging as per local guidance and protocols for anticoagulation depending on the surgery and thromboembolic risks involved. If an invasive procedure or surgical intervention is required, rivaroxaban should be stopped at least 24 hours before the intervention, if possible and based on clinical judgment of the physician. If surgery cannot be delayed the case should be discussed with haematology for advice on reversal if required. Drug interactions: Rivaroxaban is metabolised via CYP 3A4 and CYP 2J2, for this reason strong CYP 3A4 inducers and inhibitors should be avoided as these can cause significant under and over anticoagulation effect. Inducers such as rifampicin, St. John`s Wort, carbamazepine, or phenytoin, and inhibitors such as ketoconazole and ritonavir are to be avoided. No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with midazolam (substrate of CYP3A4), digoxin (substrate of P-gp), atorvastatin (substrate of CYP3A4 and P-gp) or omeprazole (proton pump inhibitor). Rivaroxaban neither inhibits nor induces any major CYP isoforms like CYP3A4. A full list of interactions can be obtained in the clinical summary of characteristics. PREGNANCY AND BREAST FEEDING The safety of rivaroxaban has not been established in pregnant or lactating women; as such use in these patients is to be avoided. SHARED CARE OF RIVAROXABAN Shared care guideline: is a document which provides information allowing patients to be managed safely by primary care, secondary care and across the interface. It assumes a partnership and an agreement between a hospital specialist, GP and the patient and also sets out responsibilities for each party. The intention to shared care should be explained to the patient and accepted by them. Patients are under regular follow-up and this provides an opportunity to discuss drug therapy. Intrinsic in the shared care agreement is that the prescribing doctor should be appropriately supported by a system of communication and cooperation in the management of patients. The doctor who prescribes the medicine has the clinical responsibility for the drug and the consequence of its use.

6 Consultant 1. Ensure that the patient/carer is an informed recipient of rivaroxaban. 2. Ensure that patients understand rivaroxaban treatment and monitoring (e.g. renal function) or follow up that is required (using advocacy if appropriate). 3. Ensure baseline investigations are normal before commencing treatment. Give the patient a patient held anticoagulant card. 4. Initiate treatment and prescribe until the GP formally agrees to shared care (after 4 to 6 weeks). 5. Send a letter to the GP requesting shared care for this patient having completed the checklist on page Send a letter/results notification to the GP after the clinic meeting confirming the current dose and most recent blood results. 7. Evaluation of any reported adverse effects by GP or patient. 8. Advise GP on review, duration or discontinuation of treatment where necessary. 9. Ensure that backup advice is available at all times. General Practitioner 1. Reinforce the patient understands the nature, effect and potential side effects of rivaroxaban before prescribing it as part of the shared care programme and contact the specialist for clarification where appropriate. 2. Monitor patient s overall health and well-being. 3. Report any adverse events to the consultant, where appropriate. 4. Report any adverse events to the CSM, where appropriate. 5. Help in monitoring the progression of disease 6. Prescribe the drug treatment as described. PCT 1. To provide feedback to trusts via Trust Medicines Committee. 2. To support GPs to make the decision whether or not to accept clinical responsibility for prescribing. 3. To support trusts in resolving issues that may arise as a result of shared care. Patient/ Carer 1. Report any adverse effects to their GP and/or specialist 2. Ensure they have a clear understanding of their treatment (rivaroxaban). 3. Carry an anticoagulation card with them at all times 4. Report any changes in disease symptoms to GP and/or specialist 5. Alert GP and/or specialist of any changes of circumstance which could affect management of disease 6. Take/ administer rivaroxaban as prescribed

7 Costs Drug Product Rivaroxaban tablets [15mg and 20mg] (28) BHR CCGs and BHRuT NHS Trust Shared Care Guidelines Cost in primary care 840 / year excluding any rebates RESOURCES AVAILABLE See references Barking, Havering & Redbridge University Hospitals Trust Consultants Haematologists, via switchboard: Dr Khalid Saja Dr Jane Stevens (On call haematologist out of hours emergencies) Telephone Queens Hospital switchboard: and request by name. Fax to Anticoagulation Clinic Registrar on-call during working hours Clinical Nurse Specialist: DECT 6837 via switchboard DECT 6116 (Brenda Thompson) NHS BHR CCGs Medicines Management Team /76 References 1. NICE (2102) Technology Appraisal Guidance 261 Rivaroxaban for the treatment of deep vein thrombosis and the prevention of recurrent deep vein thrombosis and pulmonary embolism. 2. Scottish Intercollegiate Guidelines Network (SIGN) (2012) No. 129 Antithrombotics, indications and management. 3 UKMI (2012) New Drug Evaluation 114 Rivaroxaban for the treatment and prevention of DVT 4. Rivaroxaban, Summary of Product Characteristics (SPC) Refer to the relevant BHR CCG website to obtain the latest version of this guideline

8 Appendix 1 BHR CCGs and BHRuT NHS Trust Shared Care Guidelines SHARED CARE AGREEMENT LETTER RIVAROXABAN for treatment of acute venous thromoboembolism in adult patients Name of GP Practice Address Hospital specialist name Hospital Address Dr Jane Stevens Dr Khalid Saja (Delete as appropriate) The Haematology Dept Queens Hospital, Rom Valley Way, Romford. RM7 OAG Dear Colleague, Re: Patient s name.. Date of birth Hospital number NHS number Proposed dose mg/15mg (delete as appropriate) once a day I have commenced this patient on oral rivaroxaban therapy for the treatment of acute venous thromboembolism. I hope that you will agree to share the care of this patient with the hospital. Please find enclosed a copy of the shared care guidelines for rivaroxaban to be retained in the patient s notes. If you agree to shared care, could you kindly sign below and fax/return this letter to the hospital specialist at the address given above. You will be sent a letter with more information about the treatment plan and relevant clinical and haematological findings. Thank you in anticipation Yours Sincerely, Consultant Haematologist I accept shared care for this patient I do not accept shared care for this patient (please give your reason in the space below)... Signature..... Name Date...

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