East Kent Prescribing Group

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1 East Kent Prescribing Group Rivaroxaban (Xarelto ) Safety Information Approved by the East Kent Prescribing Group. Approved by: East Kent Prescribing Group (Representing Ashford CCG, Canterbury and Coastal CCG, South Kent Coast CCG and Thanet CCG) Date: July 2015 Address: c/o Canterbury and Coastal CCG, Ground Floor, Council Offices, Military Road, Canterbury, Kent,CT1 1YW Contact: T: E: Page 1 of 8

2 Rivaroxaban (Xarelto ) Safety Information Rivaroxaban is an oral anticoagulant acting as a factor Xa inhibitor. It has licenses for thromboprophylaxis in some elective orthopaedic patients, the treatment of deep vein thrombosis, secondary prevention of deep vein thrombosis and pulmonary embolus, pulmonary embolism and for stroke prevention in atrial fibrillation. Use in the local NHS must be consistent with the relevant NICE Technical Appraisals and local agreed practice (see formulary) that apply at any given time. Dose will depend upon indication. Be careful as different dose pills are marketed for the differing indications. It does not require routine laboratory monitoring. Experience with another new oral anticoagulant, dabigatran showed that 25% of serious bleeding events were associated with prescribers not adhering strictly to the summary of product characteristics. You should adhere strictly therefore to the latest advice relevant to the indication it is used for. It should be avoided in patients taking azole antimycotics and HIV protease inhibitors. It should be used with caution in patients receiving CYP3A4 inducers such as phenytoin, carbamazepine and St Johns Wort all of which may reduce the anticoagulant effect. It should not be co-administered with other anticoagulants (including prophylactic LMWH, apixaban, dabigatran, edoxaban and warfarin, ) except at times of transition, with transition being managed as per the summary of product characteristics. Co-administration with antiplatelet agents. This has some definite indications but is not recommended without an informed individualised risk assessment, with detailed knowledge of the latest guidelines adopted by the Trust (ie ESC 2014 see summary below). Low dose aspirin appears relatively safe and there is emerging evidence with clopidogrel. A combination of the two antiplatelets and an anticoagulant would for example be absolutely indicated in the rare patient within 3 months of PCI and who had a VTE event. Doses of rivaroxaban would usually be reduced to lowest licensed dose. In the absence of evidence with other antiplatelet agents rather than aspirin and clopidogrel it is necessary to change to these. PCI and acute myocardial infarction within the last year almost always will require continuation of antiplatelet agent(s) and consideration of the safest anticoagulant as warfarin has the best evidence base in combination with antiplatelet agents. Trials in acute coronary syndrome have defined that bleeding risk with rivaroxaban is unacceptable above 2.5 mg bd which is insufficient for full anticoagulation action, as is desired in atrial fibrillation and after VTE. Dual antiplatelet therapy, as might be required after a coronary stent and an absolute indication to newly anticoagulate will require a decision that must be informed by the latest evidence base and individual patient factors. Where new anticoagulation is necessary contact urgently the cardiologist who did the PCI or failing that the cardiologist on call to define the appropriate antiplatelet regime or anticoagulant choice, recognising and explaining to the patient if appropriate, that rapid review might be appropriate if information to make the safest longer term decision is not immediately available. The management plan agreed must be communicated to primary care.

3 It is excreted by the kidneys and therefore renal function is important in dosing. The following is a summary of the local agreed cardiology guidelines: In patients with a firm indication for oral anticoagulation (e.g. atrial fibrillation with CHA2DS2- thromboembolism, LV thrombus, or mechanical valve prosthesis), oral anticoagulation is recommended in addition to antiplatelet therapy. In patients with SCAD and atrial fibrillation with CHA2DS2-VASc score 2 at low bleeding risk (HAS-BLED 2), initial triple therapy of (N)OAC and ASA ( mg/day) and clopidogrel 75 mg/day should be considered for a duration of at least one month after BMS or new-generation DES followed by dual therapy with (N)OAC and aspirin mg/day or clopidogrel (75 mg/day) continued up to 12 months. DAPT should be considered as alternative to initial triple therapy for patients with SCAD and atrial fibrillation with a CHA2DS2-VASc score 1. In patients with ACS and atrial fibrillation at low bleeding risk (HAS-BLED 2), initial triple therapy of (N)OAC and ASA ( mg/day) and clopidogrel 75 mg/day should be considered for a duration of 6 months irrespective of stent type followed by (N)OAC and aspirin mg/day or clopidogrel (75 mg/day) continued up to 12 months. C In patients requiring oral anticoagulation at high bleeding risk (HAS BLED 3), triple therapy of (N)OAC and ASA ( mg/day) and clopidogrel 75 mg/day should be considered for a duration of one month followed by (N)OAC and aspirin mg/day or clopidogrel (75 mg/day) irrespective of clinical setting (SCAD or ACS) and stent type (BMS or new-generation DES). Dual therapy of (N)OAC and clopidogrel 75 mg/day may be considered as an alternative to initial triple therapy in selected patients. The use of ticagrelor and prasugrel as part of initial triple therapy is not recommended Dosage & Indications DVT, prevention recurrent VTE and Pulmonary Embolism Treatment : Although the manufacturer SPC allows use of drug down to creatinine clearance of 15ml/min the East Kent pathway of care has chosen egfr cut off of 30 for consistency with other new oral anticoagulants Renal function Acute treatment of DVT egfr >30 (creatinine clearance >30ml/minute) After 3 weeks and for long term prevention of recurrence egfr > 50 (creatinine clearance > 50ml/minute) Dosage 15mg twice daily for first 3 weeks 20mg once daily After 3 weeks and for long term prevention of recurrence egfr (creatinine clearance ml/minute) The recommended dose is 20 mg once daily. A reduction of the dose from

4 egfr <30 (creatinine clearance <30ml/min) egfr <15 (creatinine clearance <15ml/min) 20 mg once daily to 15 mg once daily should be considered if the patient s assessed risk for bleeding outweighs the risk for recurrent DVT and PE. Not recommended Contraindicated Atrial fibrillation rivaroxaban for prevention of stroke in atrial fibrillation is covered in clinical guidelines for all oral anticoagulants used in this indication. The decision to initiate therapy is supported by patient information as in this FAQ. If a patient is already on rivaroxban for a NICE approved indication it can be continued if elective cardioversion is planned. Renal function creatinine clearance > 50ml /min (egfr > 50) egfr (creatinine clearance ml/ min) egfr <30 (creatinine clearance <30ml/min) egfr <15 (creatinine clearance <15ml/min) Dose 20mg once daily 15mg once daily Not recommended Contraindicated Prevention of venous thromboembolism in adults undergoing elective hip or knee replacement therapy 10mg once a day for up to 5 weeks after hip surgery and 2 weeks after knee surgery Do not use when egfr <15 (creatinine clearance <15ml/min) Prevention of atherothrombotic events in adult patients after acute coronary syndrome (ACS) This indication is strictly according to NICE TA335 but for safe repeat prescribing requires separate detailed safety documentation and patient information process yet to be agreed locally. Treatment has to be regularly evaluated in the individual patient weighing the risk for ischaemic events against the bleeding risks. The dose is 2.5mg bd (co-administered with only as antiplatelet agents aspirin/clopidogrel) and treatment will only have been initiated by a cardiologist. Patients with ECr < 30 should not take the drug in this indication. One of the reasons why use is likely to be rare is that in the patient group with most likely benefit in East Kent is routinely treated with an alternative antiplatelet agent to clopidogrel.

5 Elective Surgery There is no treatment routinely available to immediately reverse Rivaroxaban therefore pre-operative planning is essential Check renal function (egfr). Discontinue Rivaroxaban as follows: egfr Timing of discontinuation of Rivaroxaban before surgery Standard bleeding risk High bleeding risk > hours 48 hours > 30 but < hours 4 days < days > 5 days For minor procedures Rivaroxaban may not need to be discontinued Consider bridging therapy with Low Molecular Weight Heparin if patient is at high risk of thrombosis Urgent Surgery Stop Rivaroxaban immediately If possible, delay surgery until Rivaroxaban has cleared (24 hours from last dose). Patients with reduced egfr may have ongoing anticoagulation effect for significantly longer Check full blood count, renal function and coagulation screen (PT, aptt) indicating time of last dose of Rivaroxaban when requesting. PT may be prolonged with Rivaroxaban administration but does not correlate well with anticoagulant effect If clotting screen is normal, surgery may proceed For urgent life-saving surgery which cannot be delayed, discuss with Consultant Haematologist. Vitamin K/Fresh frozen plasma will not reverse the effects of Rivaroxaban. Prothrombin complex concentrate has reversed anticoagulation in healthy volunteers but no experience has been reported in preventing bleeding. Restarting Rivaroxaban after surgery Day 0 If no excess bleeding, restart rivaroxaban 6-8 hours post surgery. Day +1 onwards Continue usual dose of Rivaroxaban if no excess bleeding High bleeding risk Short-term use of prophylactic dose Enoxaparin may be appropriate if the risk of post-operative bleeding is high. Restart Rivaroxaban on Day+2 post surgery if no excess bleeding Spinal/epidural anaesthesia or lumbar/epidural puncture

6 Not to be given for 48 hours before a procedure. Emergency lumbar/epidural puncture should only be done after specific discussion with haematologist If traumatic puncture occurs must not be given for 24 hours after procedure Rivaroxaban must otherwise not be given earlier than 6 hours after epidural or spinal puncture or removial of an epidural catheter.

7 Management of Bleeding Patients on Rivaroxaban Stop Rivaroxaban immediately Check FBC, coagulation screen (PT, aptt, TT and fibrinogen) and renal function Patient with bleeding on Rivaroxaban therapy Mild bleed Moderate-Severe bleed Life-threatening bleed Discontinue Rivaroxaban or delay next dose as appropriate Local measures to control bleeding Mechanical compression Surgical intervention Fluid replacement and haemodynamic support Blood product transfusion Oral charcoal (if Rivaroxaban ingestion <2 hours before) Consider in discussion with haematologist prothrombin complex concentrates (PCC) beriplex or octaplex Mechanical compression Surgical intervention Fluid replacement and haemodynamic support Blood product transfusion Oral charcoal (if Rivaroxaban ingestion <2 hours before) Rivaroxaban is not expected to be dialyzable Monitoring. Renal function must be assessed in all patients before commencing the drug. Other monitoring guidance at this time results from experience with other renally excreted oral anticoagulants and may change with experience.

8 Patients newly started on other drugs that may adversely affect renal function should have renal function checked at that time. In patients over 75 yearly renal function should be checked. Authors Dr K Elliott Dr G Evans Dr M L Jenkinson References SPC Rivaroxaban May ESC/EACTS guideline on myocardial revascularization NICE TA335 March 2015 V 2.9 Issued July 2012 V 3.0 Updated August 2012 V 3.1 Updated April 2013 V 3.2 Updated August 2013 V 3.3 Updated September 2013 V 3.4 Updated October 2014 V 3.5 Updated November 2014 V 3.6 Updated February 2015 V 3.7 Updated July 2015 Endorsement Version 3.7 of this safety information was endorsed by the East Kent Prescibing Group on 15 th July 2015

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