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1 Hertfordshire Implementation of NICE TAs 249, 256 and 275 Apixaban, dabigatran and rivaroxaban, novel oral anticoagulants (NOACs) for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation Version 8, 25 April 2013 Contents Page no. 1. Rationale for Hertfordshire recommendations 2 2. Algorithm for the use of warfarin and NOACs 3 3. Choice of appropriate anticoagulant 4 4. Comparison of anticoagulants 7 5. Summary of key NOAC facts Letter template to Primary Care following initiation of dabigatran Letter template to Primary Care following initiation of rivaroxaban Letter template to Primary Care following initiation of apixaban Information for patients Patient agreement 23 The following organisations are acknowledged for sharing their guidelines- NHS Northamptonshire Kent, Surrey and Sussex Health Policy Support Unit West Yorkshire and Humberside Cardiac Network Health Improvement Board, Scotland Version 7 approved by Hertfordshire Medicines Management Committee, 19 th July 2012 Includes changes following the response from cardiac network in October 2012 Version 8 approved by Hertfordshire Medicines Management Committee 25 th April 2013 These guidelines were developed by Pharmacy and Medicines Management Team, NHS Hertfordshire (from 1 April 2013 Pharmacy and Medicines Optimisation team, NHS Central Eastern Commissioning Support Unit) in consultation with the following organisations: Local specialists (haematologists, cardiologists and stroke physicians within local Provider Trusts) Local GPs within Hertfordshire Cardiac Network Advisory Group, Beds, Herts and Milton Keynes Heart and Stroke Network

2 1. Rationale for Hertfordshire Recommendations NICE has issued Technology Appraisals for three novel oral anticoagulants (NOACs): apixaban (Eliquis ), dabigatran (Pradaxa ) and rivaroxaban (Xarelto ) for the prevention of stroke and systemic embolism in non valvular atrial fibrillation (TAs 249, 256 and 275). These guidelines have been produced to help identify those patients who are most likely to benefit from a NOAC and to provide advice on using these new drugs in the safest possible manner. Guidance is provided both for patients newly diagnosed with AF and for existing patients currently taking warfarin. The guidance does not and should not over-ride the NICE Technology Appraisals. Following an informed discussion with a patient about the full risks and benefits of each agent, the clinician can choose an anticoagulant which is in the patient s best clinical interest. Any communication from specialists to GPs must include the full discussion had with the patient. Apixaban, dabigatran and rivaroxaban are orally active antithrombotic agents. Apixaban is a direct, selective inhibitor of factor Xa. Dabigatran is a direct thrombin inhibitor. Rivaroxaban is an oral direct factor Xa inhibitor. Each drug has the potential advantage over warfarin of not requiring INR blood monitoring, but other factors about each of the drugs need to be taken into consideration when deciding on an appropriate drug for an individual patient. These factors include: o Unknown long term safety profile of the new agents. o Lack of reversibility of the new agents. o Consideration of the patient s current INR control on warfarin. o Renal function. o Bleeding risk, especially GI bleeding risk. o Drug interactions. o Compliance. The choice of agent is the decision of the prescriber and there are pros and cons to each agent. In Hertfordshire it is recommended that the novel oral anticoagulants should be initiated in carefully selected patients after an informed discussion with the patient on the risks and benefits of all anticoagulants available, including warfarin. A clear record of reasons for choice, assessment undertaken before initiation and outcomes at each review is recommended to help inform future practice. A patient agreement document is available for use as an option if it is felt that in particular circumstances it may help to highlight to the patient the importance of compliance with treatment. Warfarin remains a suitable first line anticoagulant choice for most patients A MHRA drug safety alert has been issued for dabigatran (March 2013) 15 : Dabigatran (Pradaxa ) is now contraindicated in patients with prosthetic heart valves requiring anti-coagulant treatment related to their valve surgery, regardless of the length of time elapsed since valve replacement took place. The contraindication is based on new clinical trial data in this population, which showed an increased frequency of thromboembolic and bleeding events in the group of patients treated with dabigatran, compared with warfarin. Hertfordshire advise that this alert be observed for all NOACs until further evidence of safety is available. Page 2 of 23

3 2. Algorithm for the use of Warfarin and Novel Oral Anticoagulants (NOACs) for nonvalvular Atrial Fibrillation Algorithm adapted from Health Improvement Board Scotland On balance of risks and benefits, warfarin remains the anticoagulant of choice for moderate or high risk atrial fibrillation patients Is the patient currently taking warfarin? (Existing patient) Yes No No Yes Is the patient complying with their warfarin regimen? (Assess after 3 months of therapy) Make efforts to improve compliance. If non-compliance** is still a concern assess risk and consider stopping. If warfarin is stopped due to intolerable side effects, consider NOAC. New patient Yes Does the patient with nonvalvular atrial fibrillation have a CHADS 2 2? No Review the individual patient and their stroke (CHADS 2 ) and bleeding risk (HAS-BLED). Have risk and benefits of treatments been discussed with patient? Does the patient have good INR control (determined by clinical judgement, no extreme INR variations or time in treatment range [TTR] > 65% [where INR monitoring software is available])? Is warfarin tolerated? Aspirin to be considered for patients with CHADS 2 score of 0-1, unless cardiologist gives rationale for anticoagulation Yes Prescribe in line with patient selection criteria (page 5) Continue on warfarin Yes No Consider prescribing apixaban, dabigatran or rivaroxaban in patients: With poor INR control despite evidence that they are complying to treatment With intolerance to warfarin NB: All anticoagulants increase the risk of bleeding ** Non- compliance: Non-compliance with warfarin is not an indication for initiating therapy with NOACs. Many of the causes of non-compliance with warfarin may also result in non-compliance with NOACs, e.g.alcoholism, chaotic lifestyle, wilful non-compliance. Regular clinical review of patients on NOACs is very important especially as such patients will not be monitored routinely. See prescribing guidance with respect to monitoring BMJ learning modules on anti-coagulation warfarin &page=0 warfarin &page=0 Page 3 of 23

4 3. Choice of appropriate anticoagulant The decision about whether to start treatment with a NOAC should be made after an informed discussion between the clinician and the patient about the risks and benefits of anticoagulants, and in particular NOACs compared with warfarin. For people who are taking warfarin, the potential risks and benefits of switching to a NOAC should be considered in light of their level of international normalised ratio (INR) control. Individual stroke risk and bleeding risk must be assessed using the CHADS 2 and HASBLED CHADS 2 scoring system HAS-BLED bleeding risk score Risk Factor Score if present Risk Factor Score Congestive heart failure (C ) 1 Uncontrolled hypertension (systolic > 160mmHg, unresponsive to antihypertensives) 1 Hypertension (H) 1 Renal disease (dialysis, transplant, Cr>2.3mg/dl or > 200 umol/l) 1 Age 75yrs (A) 1 Liver disease? (cirrhosis; bilirubin >2xnormal in association with AST/ALT/ALP >3x normal) 1 Diabetes mellitus (D) 1 Previous history of stroke 1 Prior stroke or TIA (S 2) 2 Prior major bleeding (anaemia or predisposition to bleeding? 1 Total Score: Age 65 1 Medication usage predisposing to bleeding? (anti-platelets, NSAIDs,etc) 1 1 Alcohol intake (consuming 8 or more alcoholic drinks per week) Labile INRs (refers to unstable INRs/ high INRs or poor time in NB: Where HAS-BLED score is high, prescribers therapeutic range (e.g. TTR<60%). 1 may want to seek guidance from specialists on Total score whether anticoagulation is in the best interest of the patient. A HAS-BLED score of >3 indicates an increased one-year bleed risk on anticoagulation which would be sufficient to justify caution or more frequent evaluation. Where a patient scores 1 point for labile INR, a score of >4 would indicate a need for caution. Interpretation of stroke risk using CHADS 2 score Interpretation of bleeding risk using HAS-BLED score CHADS 2 score Annual stroke rate (%) HAS-BLED score Bleeds/100 patients Page 4 of 23

5 3.1 Patients with non-valvular atrial fibrillation who meet the criteria for anticoagulation but are currently not anticoagulated (i.e. newly diagnosed patients or existing patients in whom an oral anticoagulant is indicated but not currently prescribed). Where the bleeding risk is higher (using HASBLED) than the stroke rate, do not start anticoagulation without first consulting a specialist. WARFARIN REMAINS A SUITABLE FIRST-LINE ORAL ANTICOAGULANT FOR MOST PATIENTS Warfarin is the only option in patients: with CrCl < 15ml/min or other absolute contraindications to NOAC. Note that: Dabigatran is contra-indicated at CrCl <30ml/min Rivaroxaban is contra-indicated at CrCl <15ml/min, AND Rivaroxaban dose should be reduced to 15mg once daily at CrCl 15-49ml/min Apixaban is contra-indicated at CrCl<15ml/min AND Apixaban dose should be reduced in patients with at least two of the following: age 80 years, body weight 60 kg, or serum creatinine 1.5 mg/dl (133 micromol/l). Patients with creatinine clearance ml/min should also receive the lower dose of apixaban 2.5 mg twice daily Warfarin may be the preferred option in patients: with CrCl < 30 ml/min (NB Patients with a baseline CrCl of ml/min are at risk or progressive/acute renal dysfunction and the potential risks of bleeding with NOACs should be weighed on an individual basis) with a history of significant peptic ulcer disease significant ischaemic heart disease in absence of other determining considerations Where a specialist advises a NOAC in these categories a clear rationale will be provided A NOAC may be the preferred initial option in patients: predicted to be difficult to maintain in therapeutic range on warfarin because of the need for recurrent interacting medications e.g. recurrent antibiotics with known excess use of ethanol (NB: patient compliance to treatment must be checked) who require domiciliary testing with a very high risk of stroke e.g. CHADS 2 score of 3 or more where rapid anticoagulation is considered clinically necessary by specialists (except where applies - where warfarin is the only choice; or applies, where warfarin is the preferred choice). NB: Risk versus the benefit must be discussed with patients and clear rationale given to GPs In patients whose relative stroke risk is the same as their bleeding risk (using HASBLED score) dabigatran 110mg bd dosing or apixaban could be considered A NOAC is the preferred option in patients: with a known sensitivity or serious side effect with warfarin which has lead to discontinuation in the past. in whom resistance to warfarin therapy has been shown in the past (inability to get INR into therapeutic range despite high doses of warfarin) which has lead to warfarin discontinuation Warfarin is recommended as the first line treatment in all other patients. The discussion with the patient should include the following factors, to explain why this decision is being made on the grounds of safety as well as cost effectiveness: lack of long term data on NOACs issues concerning reversibility NICE guidance and evidence base for apixaban/dabigatran /rivaroxaban non-compliance in clinical trial setting and its implications for those not in trials principles used in patient selection patient will be converted to NOAC if TTR < 65% after 3 months in presence of compliance higher cost of NOACs Page 5 of 23

6 3.1.6 When patient is referred from cardiology department with planned cardioversion Dabigatran will be initiated by a cardiologist. There is currently no data on apixaban or rivaroxaban in cardioversion. Clear advice on dose and duration of treatment will be provided to the GP. Anticoagulant service will see within 5 working days to perform counselling, registration etc (as above) Dabigatran should be given for 4 weeks before cardioversion and be continued for 4 weeks after cardioversion. Patients will be reviewed in cardiology outpatient department 4-6 weeks post cardioversion. It is recommended that further anticoagulant choice, if cardioversion fails, is in line with these guidelines. 3.2 Existing patients taking warfarin for non-valvular atrial fibrillation WARFARIN REMAINS A SUITABLE FIRST-LINE ORAL ANTICOAGULANT FOR MOST PATIENTS Conversion to NOAC recommended for patients: intolerant of vitamin K antagonists (VKA) resistant to the effects of warfarin (failure to get into the therapeutic range despite dose escalation) TTR < 65% after > 3 months (despite good compliance with warfarin) Conversion to NOAC may be considered for patients: with history of significant bleed on warfarin (dabigatran 110mg bd or apixaban suggested as options) requiring domiciliary phlebotomy Conversion to dabigatran 150mg bd or apixaban* may be considered in patients with history of stroke or TIA in the last 3 months, whilst taking warfarin despite good compliance, after assessing bleeding risk in relation to stroke risk. * Dabigatran 150mg bd and apixaban have been shown in clinical trials to reduce stroke risk more than warfarin. This additional benefit is dependent upon the degree of INR control in the warfarin group Other patients who are well controlled and tolerant of warfarin are NOT recommended to change Page 6 of 23

7 4. Novel Oral Anticoagulants and Warfarin Comparative evidence and Information for Prescribers Warfarin Dabigatran Rivaroxaban Apixaban How does it work? Warfarin has an effect on several steps of the clotting cascade using compounds made with vitamin K by the liver. Acts as a direct thrombin (factor IIa) inhibitor. It is formulated as dabigatran etexilate, a pro-drug, and converted to dabigatran after administration 2. Acts as a selective direct factor Xa inhibitor. Inhibition of Factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi 10. Acts as a selective direct factor Xa inhibitor which interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting thrombin and the development of thrombi 13 Dose and Administration Variable dose taken once daily, dose adjustment dependent on INR Patients under 80 years - 150mg twice daily 2 Patients >80 years - 110mg twice daily 2 (due to the increased risk of bleeding in this population) Consider 110 mg twice daily when the bleeding risk is high and the thromboembolic risk is low, patients weighing <50kg, patients 75-80yrs, CrCl ml/min and patients taking concomitant verapamil 2. 20mg once daily 10 15mg once daily when CrCl is ml/min 10 5mg twice daily 2.5mg twice daily in patients with at least two of: age 80 years, body weight 60 kg, or serum creatinine 1.5 mg/dl (133 micromole/l) 2.5mg twice daily for patients with creatinine clearance ml/min 13. Monitoring Needs to be adjusted to the individual needs of the patient and therefore requires regular monitoring using blood tests. Available in two strengths which have predictable effects, meaning that the drug does not need the same level of monitoring as warfarin. Available in two strengths which have predictable effects, meaning that the drug does not need the same level of monitoring as warfarin. Annual renal function assessment is Renal function should be recommended to assess appropriate assessed in all patients before starting dabigatran and at least dose is being prescribed. once a year in patients >75 years or those with a suspected decline in renal function 5. A number of cases of serious and fatal haemorrhage have been reported in elderly patients with renal impairment who were receiving dabigatran. Available in two strengths which have predictable effects, so the drug does not need the same level of monitoring as warfarin. Check LFTs before prescribing 13. Annual renal function assessment is recommended to assess appropriate dose is being prescribed.

8 Warfarin Dabigatran Rivaroxaban Apixaban What is the evidence? In a meta-analysis 1 the relative risk reduction (RRR) of stroke with warfarin was highly significant and amounted to 64%, corresponding to an absolute annual risk reduction in all strokes of 2.7%. When only ischaemic strokes were considered, adjusteddose VKA use was associated with a 67% RRR. This reduction was similar for both primary and secondary prevention and for both disabling and non disabling strokes. The RE-LY study 6 enrolled 18,113 patients with AF, who were at increased risk of stroke. 50% of patients were naïve to oral anticoagulants. It was a prospective, open-label, blinded endpoint (PROBE) design. Average CHADS 2 score of 2. Dabigatran 150mg bd reduced the annual absolute risk of stroke or systemic embolism by 0.6% compared with warfarin (35% RRR; NNT = 167; out of a 1000 patients treated with dabigatran 150mg bd instead of warfarin, a further 6 strokes were prevented) and by 0.43% (10% RRR) compared with dabigatran 110mg bd. Both haemorrhagic and ischaemic stroke occurred less often in the dabigatran 150mg bd group than with warfarin. Dabigatran 110mg bd was noninferior to warfarin. Compared with warfarin, dabigatran 110mg bd significantly reduced the incidence of haemorrhagic, but not ischaemic stroke. ROCKET-AF 11 was a double-blind, double dummy randomized trial that enrolled 14,264 patients to either rivaroxaban 20mg od or warfarin with a target INR 2-3. Patients were moderate to high risk of stroke (mean CHADS 2 >3). Patients received r i v a r o x a b a n 20mg od (15mg od if CrCl 30-49mls/min) or warfarin. Rivaroxaban was found to be noninferior to warfarin for the prevention of stroke and systemic embolism in both the per-protocol and intention-to-treat (ITT) analysis. In the ITT analysis 2.1 events were recorded per 100 patientyears in the rivaroxaban group compared to 2.4 events with warfarin (HR 0.88, 95% CI 0.75to 1.03, p<0.001). A superiority test did not reach statistical significance in the ITT population, but did in the safety population. In the ITT population, 30% of outcome events in the rivaroxaban arm occurred after discontinuation of treatment, compared with 22% of events in the warfarin arm. ARISTOTLE 14 was a non inferiority, randomised, double blind, double dummy trial that enrolled 18,201 patients to apixaban or warfarin with a target INR 2-3. Patients had a mean CHADS 2 of 2.1. Apixaban was found to meet the pre-specified endpoint for noninferiority to warfarin, and also demonstrated superiority. After a median follow up of 1.8 years, the annual rates of the composite primary endpoint of stroke or systemic embolism were 1.27% for apixaban and 1.6% for warfarin. Each of the annual rates of intra-cranial bleeding, major or clinically relevant non-major bleeding, and any bleeding were significantly lower with apixaban than warfarin Page 8 of 23

9 Warfarin Dabigatran Rivaroxaban Apixaban Contraindications Safety Hypersensitivity to the active substance or to any of the excipients. Haemorrhagic stroke Clinically significant bleeding Within 72 hours of major surgery with risk of severe bleeding (for information on other surgery see SPC) 1 st and 3 rd trimester of pregnancy and within 48 hours postpartum Long-term safety based on >50 years use in clinical practice. Hypersensitivity to the active substance or to any of the excipients. 2 Severe renal impairment (CrCL < 30 ml/min) Active clinically significant bleeding Organic lesion at risk of bleeding Spontaneous or pharmacological impairment of haemostasis Hepatic impairment or liver disease expected to have any impact on survival Pregnancy and breastfeeding No information available on longterm safety Cannot be used if CrCl <30mls/min. Hypersensitivity to the active substance or to any of the excipients. Clinically significant active bleeding. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C. Pregnancy and breast feeding CrCl <15mls/min 10 No information available on longterm safety. If CrCl 15-49mls/min a reduced dose is recommended 10. Cannot be used if CrCl<15ml/min Hypersensitivity to the active substance or to any of the excipients. Clinically significant active bleeding. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk. Lesion or condition at significant risk of major bleeding. Concomitant treatment with any other anticoagulant agent. CrCl <15ml/min Severe hepatic impairment Pregnancy and breast feeding13 No information available on longterm safety. If CrCl ml/min 13, a reduced dose is recommended. Cannot be used if CrCl<15ml/min Reversibility Effective and well known antidote, should a severe bleed occur whilst being treated No antidotes currently known. Patients with bleeding risk factors were excluded from RE-LY. Haemodialysis will clear dabigatran 9. The serious consequences of the lack of an effective reversal agent should not be underestimated. Prolonged bleeding has increased morbidity and may contribute to deaths 4. No antidote currently known although prothrombin complex concentrate (PCC) has been successful in reversing the effects in a small preliminary trial 12. The serious consequences of the lack of an effective reversal agent should not be underestimated. No antidotes currently known. The serious consequences of the lack of an effective reversal agent should not be underestimated. Prolonged bleeding has increased morbidity and may contribute to deaths Page 9 of 23

10 Bleeding Warfarin Dabigatran Rivaroxaban Apixaban See respective agent for comparison of bleeding risk. RE-LY showed 3 : Major bleeding rates were similar for dabigatran 150mg bd and warfarin, however, major bleeding was lower with dabigatran 110mg BD than with warfarin. The incidence of GI bleeding was significantly higher with dabigatran 150mg bd (p=0.0008), but similar with dabigatran 110mg bd (p=0.52), than in patients treated with warfarin. ROCKET-AF showed 11 : No significant difference in the primary safety endpoint of major or non-major clinically relevant bleeding. GI bleeding was more common with rivaroxaban than warfarin (3.2% vs.2.2%, p=<0.001), as were a decrease in Hb of >2g/dl (4.3% vs. 3.6%, p=0.02), need for transfusion (2.6% vs. 2.1%, p=0.04), epistaxis (10.1% vs. 8.6%, p<0.05), and haematuria (4.2% vs. 3.4%, p<0.05). Intracranial haemorrhage was less Intracranial bleeding was common with rivaroxaban than uncommon but higher with warfarin. Dabigatran 150mg bd warfarin (0.8% vs. 1.2%, p=0.02), reduced the absolute risk of as were critical bleeding (1.3% vs. intracranial bleeding compared 1.9%, p=0.007) and fatal bleeding with warfarin (0.32% vs 0.76% (0.4% vs. 0.8%, p=0.003). respectively) A recent audit of bleeding events with dabigatran highlighted that frail, elderly patients, particularly those with renal impairment and low body weight are at risk of increased bleeds 4. ARISTOTLE showed: Lower risk of major bleeding with apixaban than with warfarin (annual rate 2.13% vs 3.09%). Rates of intracranial haemorrhage (ICH) and all bleeding were also lower with apixaban (ICH annual rate 0.33% vs 0.8%, all bleeding 18.1% vs 25.8%) 14. Page 10 of 23

11 Warfarin Dabigatran Rivaroxaban Apixaban Nonhaematological side effects Other side effects can include hair loss Dyspepsia occurred at a higher rate with both doses of dabigatran, compared with warfarin. These events may be due in part to the acidic core of the dabigatran etexilate capsule formulation (the tartaric acid core lowers ph and enhances dabigatran etexilate a bsorption). These GI adverse events frequently led to drug discontinuation (7%, 6.5% and 3.9% in the dabigatran 150mg, 110mg and warfarin groups respectively) 3. There was a non-significant increase in the number of myocardial infarctions (MI) in patients taking dabigatran compared to warfarin (0.82% for 110mg and 0.81% for 150mg vs. There were no significant differences in the incidence of any other adverse event other than bleeding in ROCKET-AF 10 (81% with rivaroxaban vs. 82% of warfarin patients). The most frequently reported non-haematological adverse events in the rivaroxaban group were peripheral oedema (6.1%) and dizziness (6.1%), and in the warfarin group were nasopharyngitis (6.4%) and dizziness (6.3%). The rate of MI was numerically, but not statistically significantly lower in the rivaroxaban arm compared with the warfarin group 11. There were no significant differences in the incidence of any other adverse event other than bleeding in ARISTOTLE 14 (81% with apixaban vs. 83% of warfarin patients). The only serious adverse events reported in >1% of patients in either group were atrial fibrillation in 3.3% apixaban and 3.2% warfarin patients, and pneumonia in 2.2% of apixaban and 2.6% of warfarin patients. 0.64% p=0.12) 3,6,7. A meta-analysis 8 combining 7 studies showed dabigatran was significantly associated with a higher risk of MI or ACS than that seen with agents used in the control group. The control group varied and included enoxaparin, warfarin and placebo 8. Page 11 of 23

12 Interactions Warfarin Dabigatran Rivaroxaban Apixaban Drug-food interactions Drug-food interactions 2 Cranberry juice and Currently there are no known alcohol interact with food interactions. warfarin. Some foods Drug-drug interactions 2 interact with warfarin (e.g. Not recommended to foods containing high concomitantly administer with amounts of vitamin K). other drugs which increase Drug-drug bleeding risk, e.g. antiplatelets, interactions heparin, other anticoagulants. Many interactions requiring additional INR monitoring. Chronic NSAID use and SSRIs increase risk of bleeding in combination with dabigatran. No effect on cytochrome P450, so the potential for cytochrome P450 drug interactions is low. There is a potential for P-gp interactions. Concomitant treatment with systemic ketoconazole, cyclosporin, itraconazole, dronedarone and tacrolimus is contraindicated. Caution with amiodarone, quinidine, clarithromycin and verapamil (reduce dose to 110mg bd with verapamil). Concomitant administration of a P-gp inducers such as rifampicin, St. John s wort, carbamazepine, phenytoin or protease inhibitors such as ritonavir should be avoided. Consult the SPC for full details. Drug-food interactions 10 Currently there are no known food interactions. It is recommended that the 15mg and 20mg tablets are taken with food to increase absorption. Drug-drug interactions 10 Not recommended with concomitant systemic treatment with azole-antimycotics e.g. ketoconazole, itraconazole, voriconazole, posaconazole, HIV protease inhibitors e.g. ritonavir and dronedarone. These active substances are strong inhibitors of both CYP3A4 and P-gp. 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 and should be coadministered with caution Rivaroxaban itself has no inhibiting or inducing effect on any major CYP isoforms like CYP3A4. Due to the increased bleeding risk, care should be taken if treating concomitantly with any other anticoagulant, antiplatelet or NSAID. Consult the SPC for full details. Drug-food interactions 13 Currently there are no known food interactions. Drug-drug interactions 13 Not recommended to concomitantly administer with other drugs which increase bleeding risk, e.g. antiplatelets, heparin, other anticoagulants. Caution is recommended with concomittant use of NSAIDs. Not recommended in patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp, such as azoleantimycotics (e.g., ketoconazole, itraconazole, voriconazole and posaconazole) and HIV protease inhibitors (e.g., ritonavir). Caution recommended for concomitant use with strong CYP3A4 and P-gp inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital or St. John's Wort). Consult the SPC for full details Page 12 of 23

13 When should it be avoided? Warfarin Dabigatran Rivaroxaban Apixaban Intolerance to warfarin including allergy, rash, side effects likely to result in discontinuation of therapy (other than bleeding complications) e.g. severe alopecia (although acenocoumarol may be a suitable alternative in these patients). Unmanageable warfarin control due to long term interacting drug therapy (INR persistently and significantly above or below range that does not respond to dose titration), and/or impossibility of accessing monitoring services AVOID dabigatran in patients with a history of poor medication adherence. Dabigatran is not stable in compliance aids such as blister packs. Dabigatran cannot be pushed out from its packaging. The seal has to be carefully peeled off to access the tablet. AVOID in patients with severe renal impairment and patients with severe hepatic impairment. Dabigatran is not a suitable alternative to warfarin in patients with contraindications to warfarin therapy due to a high bleeding risk or trivial side effects related to warfarin. AVOID rivaroxaban in patients with a history of poor medication adherence. AVOID in patients with severe renal impairment and patients with severe hepatic impairment. Rivaroxaban is not a suitable alternative to warfarin in patients with bleeding complications associated with warfarin treatment, contraindications to warfarin therapy due to a high bleeding risk or trivial side effects related to warfarin. AVOID apixaban in patients with a history of poor medication adherence. AVOID in patients with severe renal impairment and patients with severe hepatic impairment. Apixaban is not a suitable alternative to warfarin in patients with contraindications to warfarin therapy due to a high bleeding risk or trivial side effects related to warfarin. 1. Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007;146: SPC Pradaxa. Accessed march Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361: Harper P, Young L, Merriman E. Bleeding Risk with Dabigatran in the Frail Elderly. N Engl J Med 2012; 366: Connolly SJ, et al. Newly identified events in the RE-LY trial. N Engl J Med 2010;363: Hohnloser SH, Oldgren J, Yang S, et al. Myocardial ischemic events in patients with atrial fibrillation treated with dabigatran or warfarin in the RE-LY trial. Circulation 2012; DOI: /?CIRCULATIONAHA Available at: 8. Uchino K, Hernandez AV. Dabigatran association with higher risk of acute coronary events: meta-analysis of noninferiority randomized controlled trials. Arch Intern Med 2012; DOI: /archinternmed Available at: 9. Stangier J, Rathgen K, Stähle H, Mazur D. Influence of renal impairment on the pharmacokinetics and pharmacodynamics of oral dabigatran etexilate: an open-label, parallel-group, single- centre study. Clin Pharmacokinet Apr;49(4): SPC Xarelto 20mg. Accessed march Patel MR, Mahaffey KW, Garg J et al. Rivaroxaban versus warfarin in Nonvalvular Atrial Fibrillation. N Engl J Med 2011;365: Eerenberg ES et al. Reversal of Rivaroxaban and Dabigatran by Prothrombin Complex Concentrate. Circulation 2011; 124: SPC Eliquis, accessed March Granger et al, Apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation. N Engl J Med 2011;365: MHRA Drug Safety Update, March 2013 (Volume 6, Issue 8) Page 13 of 23

14 Summary of key NOAC facts The following factors need to be considered in selecting a NOAC for non-valvular AF (Note that the trials compared different levels of INR control) Efficacy in stroke prevention compared to warfarin Reduced risk of bleeding compared to warfarin Dabigatran Rivaroxaban Apixaban Overall no difference Superior (150mg bd dose) Non-inferior (110mg bd dose) Evidence for reduced bleeding risk at lower dose. NB Increased risk of GI bleed compared to warfarin at higher dose which is the usual dose. Overall reduced intra cranial Overall no difference Non inferior (ITT analysis) Equivalent to warfarin (except reduced ICH) haemorrhage (ICH) Reversibility Uncertain. Uncertain (possible data supports use of prothrombin complex concentrate which may reverse the laboratory abnormalities of clotting but this may not translate into stopping the actual bleeding event) Dialysable Yes, but will need to be carried out for at least 6 hours in order to ensure adequate drug clearance Superior Evidence for reduced bleeding risk. Uncertain. Currently no experience with the use of recombinant factor VIIa in individuals receiving apixaban Dosing bd od bd Drug interactions P- glycoprotein inducers and inhibitors Simultaneous PGP & CYP- 3A4 inducers/inhibitors Simultaneous PGP & CYP- 3A4 inducers/inhibitors Drug cautions (increased bleeding risk) Antiplatelet agents, NSAIDs, SSRIs or SNRIs Antiplatelet agents, NSAIDs Antiplatelet agents, NSAIDs Use in patients with swallowing difficulties Suitability for storage in monitored dosage system NHS cost /patient/ year (Costs may vary in different settings because of negotiated procurement discounts) Possibility of using in other conditions treatment. Disclaimer: This summary in itself is not enough to educate prescribers on the comparative information on these new anticoagulants. Pages 7-13 gives more comprehensive, referenced information and should be used in conjunction with the summary. For full prescribing information refer to Summaries of Product Characteristics (SPCs) available at No Cannot be crushed May be crushed and put May be crushed and put through NG tube through NG tube Not suitable Suitable Suitable 804 (cost is significantly reduced in Herts due to primary care rebate scheme) NICE approved for orthopaedic prophylaxis. Phase III data shows efficacy in DVT but no NICE appraisal currently planned 767 (cost is significantly reduced in Herts due to primary care rebate scheme) NICE approved for orthopaedic prophylaxis, treatment of DVT and the prevention of recurrent VTE. Licensed and NICE recommended for prevention of DVT associated with hip and knee surgery, treatment of DVT, and the prevention of recurrent DVT and PE following an acute DVT in adults. Licensed for PE No 804 (no rebate scheme offered by the company) Licensed and NICE recommended for orthopaedic prophylaxis. Page 14 of 23

15 Template letter to Primary Care from Specialist following initiation of dabigatran for stroke prevention in AF Dear Dr Your patient has today been started on dabigatran to prevent stroke associated with non-valvular atrial fibrillation. The decision to do so instead of using warfarin has been made on the basis of: predicted to be difficult to maintain the therapeutic range on warfarin because of the need for variable interacting medications e.g. recurrent antibiotics with known excess use of ethanol (but patient is judged as likely to comply with treatment) domicillary testing would be required with warfarin a very high stroke risk e.g. CHADS 2 score > 3, and rapid anticoagulation is considered clinically necessary, and with no absolute or relative contraindication to dabigatran A previous hypersensitivity or serious side effect to warfarin which has lead to discontinuation in the past Previous demonstrated resistance to warfarin TTR <65% after >3months taking warfarin, despite good compliance History of significant bleeding on warfarin (evidence supports use of dabigatran 110mg bd for this group of patients) History of stroke or TIA within last 3 months, despite good compliance with warfarin (dabigatran 150mg) Short term use for patient undergoing cardioversion. Cardioversion is planned for prescribe dabigatran until review following cardioversion on.. Please CHADS 2 = % annual stroke risk HASBLED = % annual bleed risk CrCl Hb Platelets Your patient has been prescribed: dabigatran 150mg bd dabigatran 110mg bd Your patient has been counselled about the safe use of dabigatran been supplied with the attached frequently asked questions sheet signed the attached patient agreement (discretionary document) Yes / No been issued with an alert card (produced by the manufacturer) The following monitoring is recommended for patients on dabigatran: FBC 12 monthly, to check for signs of bleeding For patients with CrCl >60 ml/min: check renal function 12 monthly For patients with CrCl 30-59ml/min: check renal function 6 monthly More frequent checks on renal function may be necessary in patients >75years old or in those where a decline in renal function is suspected. Annual review History of any stroke / TIA or bleeding in last year Review blood tests and recheck HASBLED If at any point the CrCl drops below 30 ml/min, stop dabigatran and recheck HASBLED score. Change to aspirin if the risks of anticoagulation are considered to outweigh the benefits. If anticoagulation is still indicated, swap to warfarin, or consider rivaroxaban/apixaban (if CrCl >15 ml/min) and/or refer to specialist. If HASBLED rises, or bleeding events or a fall in Hb occur, consider whether anticoagulation is still indicated and if so reduce the dose to 110 mg bd, and/or seek specialist assessment. Page 15 of 23

16 DABIGATRAN KEY POINTS for clinicians It does not require blood tests to monitor anticoagulant effect (INR monitoring) Regular blood tests are needed to monitor kidney function and to look for signs of bleeding It must be stopped if kidney function declines so that the CrCl <30ml/min At standard dose (150mg bd), it has the same overall risk of major bleeding as warfarin with a higher risk of gastrointestinal bleeding but a lower risk of intracranial bleeding. Dabigatran levels drop by half in only hours, in presence of normal kidney function. Taking the tablets on a regular basis twice a day is therefore very important; as protection from stroke will be lost if only one dose is missed (the effect of warfarin lasts longer). In the event of surgery or procedures, dabigatran doses may need to be missed, details are provided in the summary of product characteristics: Dabigatran interacts with P glycoprotein substrates and cannot be used with the following medications: Ketoconazole, dronedarone, ciclosporin, tacrolimus, itraconazole, posaconazole, rifampicin, St John s Wort, carbamazepine, phenytoin and protease inhibitors. It should be used with caution with other p glycoprotein substrates (e.g. verapamil, quinidine, amiodarone and clarithromycin). For patients taking verapamil, a lower dose of dabigatran, 110mg bd should be prescribed. Use with ticagrelor may increase exposure to dabigatran and may increase risk of bleeding. It causes prolongation of the clotting tests APTT and TT but these are not measures of the degree of anticoagulation. A normal thrombin time will rule out the presence of any significant anticoagulant effect from dabigatran. There is no established method to reverse the effect of dabigatran. In the event of suspected overdose, activated charcoal should be administered within 2 hours of ingestion. For further information or advice please contact able to answer any further questions you may have., the local Trust contact who will be Signature of specialist Page 16 of 23

17 Template letter to Primary Care from Specialist following initiation of rivaroxaban for stroke prevention in AF Dear Dr Your patient has today been started on rivaroxaban to prevent stroke associated with non-valvular atrial fibrillation. The decision to do so instead of using warfarin has been made on the basis of: predicted to be difficult to maintain the therapeutic range on warfarin because of the need for variable interacting medications e.g. recurrent antibiotics with known excess use of ethanol (but patient is judged as likely to comply with treatment) domicillary testing would be required with warfarin a very high stroke risk e.g. CHADS 2 score > 3, and rapid anticoagulation is considered clinically necessary, and with no absolute or relative contraindication to rivaroxaban. A previous hypersensitivity or serious side effect to warfarin which has lead to discontinuation in the past Previous demonstrated resistance to warfarin TTR <65% after >3months taking warfarin, despite good compliance History of stroke or TIA whilst taking warfarin despite good compliance CHADS 2 = % annual stroke risk HASBLED = % annual bleed risk CrCl Hb Platelets Your patient has been prescribed: Rivaroxaban 20mg od Rivaroxaban 15mg od Your patient has: Been counselled about the safe use of rivaroxaban Been supplied with the attached frequently asked questions sheet Signed the attached patient agreement (discretionary document) Yes / No Been supplied with an alert card (produced by the manufacturer) The following monitoring is recommended for patients on rivaroxaban Renal function 12 monthly check, more frequently if unstable FBC 12 monthly, to check for signs of bleeding Annual review History of any stroke/ TIA or bleeding in the last year Recheck HASBLED and review renal function & FBC If at any point the CrCl drops below 15ml/min, stop rivaroxaban and recheck HASBLED score. Change to aspirin if the risks of anticoagulation are considered to outweigh the benefits. If anticoagulation is still indicated, swap to warfarin and/or refer to specialist. If HASBLED rises, or bleeding events or a fall in Hb occur, consider whether anticoagulation is still indicated and/or consider referral to a specialist. Page 17 of 23

18 RIVAROXABAN KEY POINTS for clinicians It does not require blood tests to monitor anticoagulant effect (INR monitoring) Regular blood tests are needed to monitor kidney function and look for signs of bleeding It must be stopped if kidney function declines so that the CrCl <15ml/min In patients with liver disease associated with clotting problems and clinically significant bleeding risk, including those with cirrhosis, rivaroxaban should not be prescribed Rivaroxaban levels drop by half in 5-9 hours in young patients and hours in elderly patients. Taking the tablets on a regular basis is therefore very important, and protection from stroke will be lost if only one dose is missed (the effect of warfarin lasts longer). In the event of surgery or procedures, rivaroxaban should be stopped 24 hours prior to the intervention. See product SPC for details: Rivaroxaban should not be used with the following drugs because of interactions: Systemic azole antifungals: ketoconazole, voriconazole, itraconazole, posaconazole, HIV protease inhibitors, rifampicin, phenytoin, carbamazepine, Phenobarbital, St. John s wort and dronedarone. Rivaroxaban causes an increase principally in prothrombin, but this is not a measure of degree of anticoagulation There is no established method to reverse the effect of rivaroxaban. For further information or advice please contact able to answer any further questions you may have., the local Trust contact who will be Signature of specialist Page 18 of 23

19 Template letter to Primary Care from Specialist following initiation of apixaban for stroke prevention in AF Dear Dr Your patient has today been started on apixaban to prevent stroke associated with non-valvular atrial fibrillation. The decision to do so instead of using warfarin has been made on the basis of: predicted to be difficult to maintain the therapeutic range on warfarin because of the need for variable interacting medications e.g. recurrent antibiotics with known excess use of ethanol (but patient is judged as likely to comply with treatment) domicillary testing would be required with warfarin a very high stroke risk e.g. CHADS 2 score > 3, and rapid anticoagulation is considered clinically necessary, and with no absolute or relative contraindication to apixaban. A previous hypersensitivity or serious side effect to warfarin which has lead to discontinuation in the past Previous demonstrated resistance to warfarin TTR <65% after >3months taking warfarin, despite good compliance History of stroke or TIA whilst taking warfarin despite good compliance History of significant bleeding on warfarin (evidence supports use of apixaban for this group of patients) CHADS 2 = % annual stroke risk HASBLED = % annual bleed risk CrCl Hb Platelets Your patient has been prescribed: Apixaban 5mg bd Apixaban 2.5mg bd Your patient has: Been counselled about the safe use of apixaban Been supplied with the attached frequently asked questions sheet Signed the attached patient agreement (discretionary document) Yes / No Been supplied with an alert card (produced by the manufacturer) The following monitoring is recommended for patients on apixaban For patients with CrCl >50 ml/min: check renal function 12 monthly For patients with CrCl 30-49ml/min: check renal function 6 monthly More frequent checks on renal function may be necessary in patients >80years old, weight <60kg or in those where a decline in renal function is suspected. FBC 12 monthly, to check for signs of bleeding Annual review History of any stroke/ TIA or bleeding in the last year Recheck HASBLED and review renal function and FBC If at any point the CrCl drops below 15ml/min, stop apixaban and recheck HASBLED score. Change to aspirin if the risks of anticoagulation are considered to outweigh the benefits. If anticoagulation is still indicated, swap to warfarin and/or refer to specialist. If HASBLED rises, or bleeding events or a fall in Hb occur, consider whether anticoagulation is still indicated and/or consider referral to a specialist. Page 19 of 23

20 APIXABAN KEY POINTS for clinicians It does not require blood tests to monitor anticoagulant effect (INR monitoring) Regular blood tests are needed to monitor kidney function and look for signs of bleeding It must be stopped if kidney function declines so that the CrCl <15ml/min In patients with severe liver disease associated with clotting problems and clinically significant bleeding risk, including those with cirrhosis, apixaban should not be prescribed Apixaban levels drop by half in approximately 12 hours. Taking the tablets on a regular basis is therefore very important, and protection from stroke will be lost if only one dose is missed (the effect of warfarin lasts longer). In the event of surgery or procedures, apixaban should be stopped hours prior to the intervention depending on the bleeding risk of the procedure. See product SPC for details: Apixaban should not be used with the following drugs because of interactions: Ketoconazole, itraconazole, voriconazole and posaconazole and HIV protease inhibitors (e.g., ritonavir). Caution recommended for concomitant use with strong CYP3A4 rifampicin, phenytoin, carbamazepine, phenobarbital or St. John's Wort). Apixaban prolongs clotting tests such as prothrombin time (PT), INR and activated partial thromboplastin time (aptt) but these are not a measure of degree of anticoagulation There is no established method to reverse the effect of apixaban. In the event of suspected overdose, activated charcoal should be administered within 2 hours of ingestion. For further information or advice please contact able to answer any further questions you may have., the local Trust contact who will be Signature of specialist Page 20 of 23

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