Non-vitamin K Antagonist Oral Anticoagulant (NOAC) …

1 NOAC GUIDELINES Non-vitamin K Antagonist ORAL Anticoagulant UPDATED JULY 2017 Non-vitamin K Antagonist Oral Anticoagulants (NOAC) Guidelines | Page 2 Clinical Excellence Commission Updated July 2017 The CEC acknowledges the NSW Health Directors of Clinical Governance who commissioned this guideline and the efforts of the members of the Anticoagulant Medicines Working Party who contributed to its development. Clinical Excellence Commission, 2017, Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Guidelines are available at: Clinical Excellence Commission 2017 All rights are reserved. In keeping with the NSW Government's commitment to encouraging the availability, dissemination and exchange of information (and subject to the operation of the Copyright Act 1968), you are welcome to reproduce the information which appears in this publication, as long as the user of the information agrees to.

2 Use the document for information only save or print a single copy for personal use only and not to reproduce any major extract or the entire document except as permitted under Copyright Act 1968 (as amended) without the prior written permission of the State of New South Wales acknowledge the source of any selected passage, table diagram or other extract reproduced not make any charge for providing the Information to another person or organisation without the prior written consent of the State of New South Wales and payment of an agreed copyright fee not modify the Information without the express prior written permission of the State of New South Wales include this copyright notice in any copy made: - Copyright Clinical Excellence Commission for and on behalf of the Crown in right of the State of New South Wales.

3 National Library of Australia Cataloguing-in-Publication entry Title: Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Guidelines, Updated July 2017 SHPN: (CEC) 170449 ISBN: 978-1-76000-703-4 Suggested citation Clinical Excellence Commission, 2017, Non-vitamin K Antagonist Oral Anticoagulant (NOAC) Guidelines, Updated July 2017 Sydney: Clinical Excellence Commission Clinical Excellence Commission Board Chair: Associate Professor Brian McCaughan, AM Chief Executive: Ms. Carrie Marr Any enquiries about or comments on this publication should be directed to: Clinical Excellence Commission Locked Bag 8 Haymarket NSW 1240 Phone: (02) 9269 5500 Email: Non-vitamin K Antagonist Oral Anticoagulants (NOAC) Guidelines | Page 3 Clinical Excellence Commission Updated July 2017 CONTENTS 1.

4 INTRODUCTION .. 5 2. NOAC INDICATIONS AND CONTRAINDICATIONS .. 6 Registered indications and Pharmaceutical Benefits Scheme listings of NOACs .. 7 Contraindications to NOAC therapy .. 8 3. COMMENCING TREATMENT .. 9 Drug interactions .. 11 NOAC dosing .. 13 NOAC administration .. 19 Management of a missed dose .. 19 4. PATIENT FOLLOW-UP AND MONITORING .. 21 Ongoing renal function monitoring .. 21 5 TRANSITIONING BETWEEN ANTICOAGULANTS .. 22 Transitioning from Anticoagulant therapy to a NOAC .. 22 Transitioning from a NOAC to IV UFH or LMWH .. 23 Transitioning from NOAC to warfarin .. 28 6. PERIOPERATIVE MANAGEMENT AND OTHER CONSIDERATIONS.

5 29 Epidural, and spinal anaesthesia and lumbar puncture .. 32 Acute coronary syndrome and stroke admissions .. 33 7. MANAGING BLEEDING .. 34 Reversal agents .. 35 Pro-haemostatic agents .. 36 Use of dialysis in life-threatening bleeding for patients treated with dabigatran .. 36 Blood management guidelines .. 36 8. INFORMATION AND EDUCATION FOR PATIENTS, FAMILIES AND CARERS .. 37 REFERENCES / BIBLIOGRAPHY .. 38 APPENDIX .. 39 1. Abbreviations used .. 39 BOXES 1: Risk factors for stroke and systemic embolism in patients with AF .. 6 2: Contraindications to NOAC therapy .. 8 Non-vitamin K Antagonist Oral Anticoagulants (NOAC) Guidelines | Page 4 Clinical Excellence Commission Updated July 2017 TABLES 1: Registered indications and PBS listings of NOACs.

6 7 2: Considerations prior to commencing dabigatran (Pradaxa ) .. 9 3: Considerations prior to commencing apixaban (Eliquis ) .. 10 4: Considerations prior to commencing rivaroxaban (Xarelto ) .. 10 5: Dabigatran (Pradaxa ) drug interactions .. 11 6: Apixaban (Eliquis ) and rivaroxaban (Xarelto ) drug interactions .. 12 7: Dabigatran, apixaban and rivaroxaban antithrombotic interactions .. 12 8: Dabigatran (Pradaxa ) dosing for stroke prevention in non-valvular AF .. 13 9: Dabigatran (Pradaxa ) dosing for prevention of VTE in patients undergoing THR or 14 10: Dabigatran (Pradaxa ) dosing for treatment of VTE and prevention of recurrent VTE.

7 14 11: Apixaban (Eliquis ) dosing for stroke prevention in non-valvular AF .. 15 12: Apixaban (Eliquis ) dosing for prevention of VTE in patients undergoing THR or TKR .. 15 13: Apixaban (Eliquis ) dosing for treatment of VTE and prevention of recurrent VTE .. 16 14: Rivaroxaban (Xarelto ) dosing for stroke prevention in non-valvular AF .. 17 15: Rivaroxaban (Xarelto ) dosing for prevention of VTE in patients undergoing THR or TKR .. 17 16: Rivaroxaban (Xarelto ) dosing for treatment of VTE and prevention of recurrent VTE .. 18 17: NOAC administration .. 19 18: Management of a missed dose of dabigatran (Pradaxa ) .. 19 19: Management of a missed dose of apixaban (Eliquis ).

8 20 20: Management of a missed dose of rivaroxaban (Xarelto ) .. 20 21: Effect of NOAC on routinely performed coagulation assays .. 21 22: Transitioning from an Anticoagulant (IV UFH, LMWH or warfarin) to a NOAC .. 22 23: Risk of procedural bleeding (2-Day risk of major bleeding) .. 30 24: Timing for ceasing dabigatran (Pradaxa ) prior to surgery .. 31 25: Timing for ceasing apixaban (Eliquis ) prior to surgery .. 31 26: Timing for ceasing rivaroxaban (Xarelto ) prior to surgery .. 31 27: Recommencing NOAC post-operatively .. 32 28: Timing of VTE prophylactic dose in relation to epidural or spinal anaesthesia in patients without reduced renal function .. 33 FIGURES 1: Transitioning from dabigatran (Pradaxa ) to IV UFH.

9 23 2: Transitioning from dabigatran (Pradaxa ) to LMWH .. 24 3: Transitioning from apixaban (Eliquis ) or rivaroxaban (Xarelto ) to IV 25 4: Transitioning from apixaban (Eliquis ) to LMWH .. 26 5: Transitioning from rivaroxaban (Xarelto ) to LMWH .. 27 6: Management of NOAC associated bleeding .. 34 Non-vitamin K Antagonist Oral Anticoagulants (NOAC) Guidelines | Page 5 Clinical Excellence Commission Updated July 2017 1. INTRODUCTION Non-vitamin K Antagonist oral anticoagulants (NOAC) are now widely used in patients with non-valvular atrial fibrillation (AF) and for the treatment and prevention of venous thromboembolism (VTE) in NSW Health facilities. NOACs include dabigatran, (direct thrombin inhibitor), apixaban and rivaroxaban (Factor Xa inhibitors).

10 The term DOAC , (Direct Oral Anticoagulant ) is also used to describe these medicines. This clinical guideline is intended to assist clinicians with the inpatient and discharge management of patients receiving a NOAC. It addresses NOAC use in adult patients only. This NOAC guideline does not address anticoagulation in: Pregnant or breastfeeding females. All NOACs are contraindicated in pregnancy and breastfeeding(1-3) Paediatric patients less than 18 years of age. NOACs have not been tested in this population (1-3). Information in this guideline should be used in conjunction with Therapeutic Goods Administration (TGA) approved Product Information, local protocols and specialist advice.