Uncontrolled when printed. Version 1.1. Acute Sector. Lead Author/Co-ordinator: Mr Simon Barker Consultant Orthopaedic Surgeon Julie Fraser

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1 Acute Sector NHS Grampian Staff Local Treatment Protocol For Venous Thromoboembolic Prophylaxis Using Rivaroxaban 10mg Tablets In Adult Patients Undergoing Elective Hip Or Knee Replacement Surgery. Lead Author/Co-ordinator: Mr Simon Barker Consultant Orthopaedic Surgeon Julie Fraser Pharmacist Woodend Hospital Reviewer: Approver: Medicine Guidelines and Policies Group Fiona Doney Pharmacist Identifier: NHSG/Prot/Riv/MGPG357 Review Date: March 2012 Approval Date: March 2010 Uncontrolled when printed Version 1.1

2 This policy is also available in large print and on computer disk. Other formats and languages can be supplied on request. Please call or ext for a copy This controlled document shall not be copied in part or whole without the express permission of the author or the author s representative. Title: Unique Identifier: Replaces: Lead Author/Co-ordinator: Subject (as per document registration categories): Key word(s): Policy, Protocol, Procedure or Process Document: Document application: Purpose/description: Responsibility: Policy statement: NHS Grampian staff local treatment protocol for venous thromoboembolic prophylaxis using rivaroxaban 10mg tablets in adult patients undergoing elective hip or knee replacement surgery. NHSG/Prot/Riv/MGPG357 NA Mr Simon Barker, Consultant Orthopaedic Surgeon Julie Fraser, Pharmacist, Woodend Hospital, Aberdeen Clinical policy/protocol Rivaroxaban, Xarelto, VTE, venous thromboembolism Protocol Elective orthopaedics NHS Grampian Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Responsibility for the effective management of the Acute Sector s policy, protocol, procedure and process documentation ultimately lies with the General Manager for the Acute Sector. Delegation for formulating, disseminating and controlling these documents falls to either a named individual or a working group. It is the responsibility of supervisory staff at all levels to ensure that their staff are working to the most up to date and relevant policies, protocols procedures. By doing so, the quality of the services offered will be maintained, and the chances of staff making erroneous decisions which may affect patient, staff or visitor safety and comfort will be reduced. UNCONTROLLED WHEN PRINTED Review Date: March 2012 Identifier: NHSG/Prot/Riv/MGPG357 - i -

3 Responsibilities for ensuring registration of this document on the NHS Grampian Information/ Document Silo: Medicines Management pharmacist, Pharmacy Medicines Unit Lead Author/Co-ordinator: Physical location of the original of this document: Job title of creator of this document: Job/group title of those who have control over this document: Consultant Orthopaedic Surgeon, Pharmacist Woodend Hospital Pharmacy Medicines Unit Consultant Orthopaedic Surgeon, Pharmacist Woodend Hospital Consultant Orthopaedic Surgeon, Pharmacist Woodend Hospital Responsibilities for disseminating document as per distribution list: Lead Author/Co-ordinator: Consultant Orthopaedic Surgeon, Pharmacist Woodend Hospital Responsibilities for implementation: Organisational: Acute Sector Operational Management Team and Acute Sector General Manager Hospital/Interface services: Assistant General Managers and Group Clinical Directors Operational Management Unit: Unit Operational Managers Departmental: Clinical Leads Area: Line Managers Review: Every two years or earlier if recommendations change Responsibilities for review of this document: Lead Author/Co-ordinator: Consultant Orthopaedic Surgeon, Pharmacist Woodend Hospital Review date: March 2012 Revision History: Revision Previous Date Revision Date 19/05/2010 Unchanged altered before publication Summary of Changes (Descriptive summary of the changes made) Addition of information to see postoperation note for specific time of administration - timing marked as 8-10 hours as per local and Fife practice (previously 6-10 hours) Changes Marked* (Identify page numbers and section heading ) Page 1 administration details ; p4 appendix 1; p5 appendix 2 UNCONTROLLED WHEN PRINTED Review Date: March 2012 Identifier: NHSG/Prot/Riv/MGPG357 - ii -

4 NHS Grampian Staff Local Treatment Protocol for Venous Thromoboembolic Prophylaxis using Rivaroxaban 10mg tablets in adult patients undergoing elective hip or knee replacement surgery. New medicine name: Rivaroxaban 10mg film-coated tablets (Xarelto ). Mode of action: Rivaroxaban is an oral, once-daily direct Factor Xa inhibitor. Licensed indication(s): [1] Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Scottish Medicines Consortium advice: [2] Rivaroxaban is accepted for use in the above indications and in three large phase III trials was superior to low molecular weight heparins (LMWH) in reducing VTE and all cause mortality whilst having a similar incidence of bleeding events. Grampian Formulary Group advice: Hospital use only for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Context: [3] Without specific anticoagulant prophylaxis, there is a high incidence of asymptomatic DVT (50% detected by routine venography 7-14 days after surgery) at the site of surgery (femoral vein at hip replacement, popliteal vein at knee replacement) and a significant incidence of non-fatal, clinical DVT and PE (up to 5% in hip replacement; up to 14% in knee replacement). The overall risk of fatal pulmonary embolism is about 0.4% (95% CI %). These risks of clinical and fatal VTE are similar to those in major general or gynaecological surgery, despite the higher incidence of asymptomatic DVT in major orthopaedic surgery (total DVT 50%; proximal DVT 16%). Prescriber details: Hospital Use Only Elective Orthopaedics Only. Note: - The full course will be supplied by the hospital pharmacy prior to discharge. Criteria for patient selection: First-line in adult patients undergoing elective hip or knee replacement surgery. Administration details: The dose of rivaroxaban is 10mg orally once daily starting 6 to 10 hours after surgery, provided that haemostasis has been established [1]. Local practice is to give the initial dose 8 to 10 hours after surgery, see post-op instructions on operation note for specific time of administration. UNCONTROLLED WHEN PRINTED Review Date: March 2012 Identifier: NHSG/Prot/Riv/MGPG

5 Duration of therapy: Knee Surgery patients 14 days. [2] Hip Surgery patients 35 days. [2] Patients on anti-platelet therapy: Stop prior to admission as per Consultant Orthopaedic Surgeon s instructions. Antiplatelet therapy should be stopped one week prior to admission. These should routinely be re-started the day after the rivaroxaban has been stopped. The patient and GP should be informed of this through pre-admission clinics and immediate discharge letters respectively. Patients on combination anti-platelet therapy and/or at very high risk of cardiovascular events, (e.g. recent coronary intervention or angioplasty) should be assessed prior to admission by a consultant anaesthetist and an individual VTE management plan formed and documented in consultation with a cardiologist if required. Patients already on warfarin should not be given rivaroxaban but should be treated as per their Consultant Orthopaedic Surgeon s/anaesthetist s instructions and an individual management plan formed and documented. Contra-indications: [1] Hepatic disease associated with coagulopathy and clinically relevant bleeding risk. Clinically significant active bleeding. Renal impairment Creatinine Clearance <15mL/min. Side-effects/cautions: [1] Common (>1/100) adverse events include bleeding, anaemia, nausea and increased liver transaminases and GGT. Due to the mode of action the most pertinent side-effect to be monitored is occult or overt bleeding. Any such new bleeding must urgently be assessed by medical personnel. Patients with liver or renal impairment should be closely monitored for signs of bleeding. As with other anti-coagulants caution should be exercised with patients at increased bleeding risk from other causes. Spinal/Epidural Anaesthesia or Puncture: [1] Such patients should be monitored frequently for signs of neurological impairment as would be the case with other anti-coagulants. Usual postoperative observations in patients with epidural or spinal anaesthesia apply. Removal of peripheral nerve or epidural catheters: [1] Peripheral nerve catheters or epidural catheters are not to be removed earlier than 18 hours after the last administration of rivaroxaban. After catheter removal the next rivaroxaban dose must not be administered until at least 6 hours have elapsed. As rivaroxaban is a black triangle new drug then any adverse events should be reported to the MHRA via the yellow card reporting system. UNCONTROLLED WHEN PRINTED Review Date: March 2012 Identifier: NHSG/Prot/Riv/MGPG

6 Monitoring - response to treatment: [1] There is no monitoring required during treatment. INR measurements have no value in assessing efficacy of treatment or potency of effect. Monitoring - treatment safety: [1] Patients will require monitoring for signs and symptoms of bleeding throughout the duration of treatment and for 48 hours post treatment as with other anti-coagulants. Patients should be counselled on the symptoms and signs of bleeding prior to discharge and an information leaflet supplied. This is particularly important for the at risk patient groups highlighted above. Overdose: [1] Maximum plasma concentration is 2-4 hours post dose. Half life is 7-11 hours (drug eliminated after 5 half lives hours). There is no specific antidote. Bleeding should be managed in a supportive manner, severe bleeding would warrant urgent haematology referral. Drug Interactions: [1] Rivaroxaban use is contra-indicated with azole-antimycotics (ketoconazole, itraconazole, voriconazole and posiconazole) as well as HIV protease inhibitors (for example ritonavir). These drugs may increase rivaroxaban plasma concentrations to a clinically significant level and lead to an increased bleeding risk. Interaction with fluconazole or macrolide antibiotics however is not deemed clinically significant. They can be co-administered with caution but they may increase the anticoagulant effect of rivaroxaban. Co-administration of strong CYP3A4 inducers such as rifampicin, carbamazepine, phenytoin, phenobarbital or St John s Wort can significantly reduce plasma concentrations of rivaroxaban therefore caution should be exercised as the anticoagulant effect will be reduced. Due to increased risk of bleeding caution should be exercised in the combined use of rivaroxaban with NSAIDS, anti-platelet agents or other anti-coagulants. REFERENCES 1. Summary of Product Characteristics Xarelto. Bayer plc. Accessed via on 10/12/2009 [last updated May 2009]. 2. Scottish Medicines Consortium, NHS Scotland, Rivaroxaban (Xarelto ), No. (519/08), 07 Nov Accessed via on 10/12/ SIGN 62, Prophylaxis of Venous Thromboembolism, CONSULTATION GROUP Mr James Bidwell Mr Timothy Dougall Dr Henry Watson Janette McDonald Joyce Gauld Consultant Orthopaedic Surgeon Unit Clinical Director for Orthopaedics Consultant Orthopaedic Surgeon Consultant Haematologist Principal Pharmacist Pharmacist DISTRIBUTION LIST Elective orthopaedics NHS Grampian. UNCONTROLLED WHEN PRINTED Review Date: March 2012 Identifier: NHSG/Prot/Riv/MGPG

7 Appendix 1: Summary of Procedure Patient listed for surgery (TKR/THR) Surgeon completes VTE prophylaxis plan Check Protocol: contra-indication? drug interaction? YES High risk patients = individual plan NO Stop antiplatelet therapy - 7 days prior to admission Surgery Total Knee Replacement Total Hip Replacement Give Tranexamic acid 500mg IV at wound closure Give 10mg Rivaroxaban orally at STRICTLY 8-10* hours post-op and daily there after Give 10mg Rivaroxaban orally at STRICTLY 8-10* hours post-op and daily there after Continue for 14 days post-op Continue for 35 days post-op Restart antiplatelet therapy day after completed course (where appropriate) * See post-op instructions on operation note for specific time of administration UNCONTROLLED WHEN PRINTED Review Date: March 2012 Identifier: NHSG/Prot/Riv/MGPG

8 Appendix 2: NHSG Orthopaedic Surgery - VTE prophylaxis planning sheet Affix in medical notes with clinic letter Name Address CHI: (or affix label) Additional risk factors: Consultant: Procedure: TKR THR Other Date of plan: Overall VTE risk assessed to be: LOW MODERATE HIGH Planned prophylaxis: Early mobilisation INITIAL TKR Rivaroxaban - as per protocol: mg tranexamic acid IV at closure 2. 10mg Rivaroxaban daily from 8-10 * hours post-op for 14 days THR Rivaroxaban - as per protocol: 10mg Rivaroxaban daily from 8-10 * hours post-op for 35 days Calf/foot pumps Aspirin (150mg orally x 35 days) Warfarin - titrate to target INR of LMWH (specify) Graduated elastic compression stockings Other (specify) Signature: Name: Date: Changes: (sign and date) /continue overleaf if required * See post-op instructions on operation note for specific time of administration. UNCONTROLLED WHEN PRINTED Review Date: March 2012 Identifier: NHSG/Prot/Riv/MGPG

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