New oral anticoagulants (NOAC) WATAG guidelines
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The document summarizes guidelines for new oral anticoagulants (NOACs) such as dabigatran, rivaroxaban, and apixaban. It outlines their development as alternatives to traditional anticoagulants which have limitations including a narrow therapeutic window and need for monitoring. The NOACs have faster onset, shorter half-lives, and less drug interactions than traditional options. The document reviews indications, dosing, switching between anticoagulants, management of bleeding, and prescribing considerations for the new oral anticoagulants.
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New oral anticoagulants (NOAC) WATAG guidelines
- 2. What’s wrong with traditional anticoagulants???
- 3. Development Traditional anticoagulants have 2 major limitations: - Narrow therapeutic window of adequate anticoagulation without bleeding - Highly variable dose-response, requiring monitoring by lab testing These limitations have provided impetus for development of other antithrombotic agents. 3 new oral anticoagulants (NOAC) dagibatran, rivaroxaban, apixaban listed on PBS.
- 4. Mechanism Dagibatran – direct thrombin inhibitor Rivaroxaban – factor Xa inhibitor Apixaban – factor Xa inhibitor
- 5. Indications 1. Prevention of venous thromboembolism in a patient undergoing total hip or knee replacement 2. Prevention of stroke or systemic embolism in patients who have non-valvular atrial fibrillation and has one or more risk factors for developing stroke or systemic embolism 3. Rivaroxaban for the prevention of recurrent venous thromboembolism and for the treatment of deep vein thrombosis and pulmonary embolism.
- 6. Contraindications Known hypersensitivity to ingredients of NOAC Clinically significant active bleeding Renal impairment <30ml/min Hepatic disease (child pugh – C) Recent high risk bleeding lesion (eg. ICH < 6 months) Pregnancy or breast feeding Recent stroke, surgery, GI bleed or ulcer Recent fibronolytic therapy <10days Concomitant warfarin therapy
- 7. Features of NOAC Features to consider - Faster onset - Shorter ½ life - Less drug-drug interactions - No need for monitoring with NOACs - No antidotes
- 8. Dosing – Total hip / knee replacement (VTE prophylaxis) Dagibatran Rivaroxaban Crcl > 50ml / min 220mg once daily 10mg once daily Crcl 30–50ml / min 150mg once daily 10mg once daily Crcl 15-30ml / min contraindicated contraindicated Apixaban 2.5mg once daily
- 9. Dosing – Non-valvular Atrial Fibrillation Dagibatran Rivaroxaban Crcl > 50ml / min 150mg twice daily 20mg once daily Crcl 30-50ml / min 110mg twice daily 15mg once daily Crcl 15-30ml / min Contraindicated Special populations Older than 75 Not applicable years old 110mg twice daily Apixaban 5mg twice daily Contraindicated At least two of following: -older than 80 yo -Weight less than 60kg -Scr > 133micromol/L -2.5mg twice daily
- 10. Dosing – treatment of DVT / PE Rivaroxaban Crcl > 30ml / min 15mg twice daily for three weeks, followed by 20mg daily
- 11. Switching anticoagulants Switching from Switching to Instructions LMW Heparin NOACs When next dose of LMW Heparin is due Heparin NOACs Immediately when heparin ceased Warfarin NOACs Start once INR < 2 Dagibatran LMW heparin / UFH No bolus required. Start 12 hrs after last dose Rivaroxaban / Apixaban LMW heparin / UFH No bolus required. Start 24 hrs after last dose NOACs Warfarin Continue NOAC and give warfarin ≤ 5 mg Stop NOAC once INR ≥ 2 on 2 consecutive days
- 12. What do we do when patients bleed?
- 13. Management of bleeding (Initial Ix) Seek early haematology advice Dagibatran: Measure: FBC, U&E, LFT, coagulation profile, Haemoclot and dabigatran level normal TT excludes dabigatran activity normal aPTT suggests bleeding not due to dabigatran
- 14. Management of bleeding (Initial Ix) Rivaroxaban / Apixaban: Measure: FBC, U&E, LFT, coagulation profile, anti-Xa and rivaroxaban level normal PT suggests rivaroxaban level not high aPTT cannot predict anticoagulant effect tests are currently inconclusive for apixaban
- 15. Management of bleeding (mild) Mild bleeding - - local haemostatic measures - delay or discontinue NOAC as required
- 16. Management of bleeding (clinically significant) reduction in Hb >20 g/L or requiring RBC transfusion > 2 units Stop NOAC therapy Give oral charcoal if NOAC ingested < 2 hours ago Maintain adequate hydration to aid drug clearance Local haemostatic measures: mechanical compression Transfusion support: RBC transfusion as per Hb level Consider platelet transfusion if on antiplatelet therapy or if platelets < 50 x 109/L Consider radiological and surgical interventions to identify and treat source of bleeding
- 17. Management of life threatening bleeding bleeding in critical area or organ, loss of Hb > 50 g/L, hypotension not responding to resuscitation Get advice of haematologist!!! T/f to SCGH or RPH a)FEIBA (factor eight inhibitor bypass activity) 25 -100 International Units/kg, repeat at 12 hours (probably beneficial) b)rVIIa 90 microgram/kg every 2-3 hours (possibly beneficial) c)prothrombinex – VF 25-50 International Units/kg (if not administered earlier) d)tranexamic acid 15-30 mg/kg IV for mucosal bleeds
- 18. Prescribing a new oral anticoagulant 1. Lab tests – FBC, EUC, LFTs Contraindications: -Poor renal function (CrCl ≤ 30 mL/ min, apixaban: ≤ 15 mL/min) -Liver disease (e.g. ALT > 3x upper limit of normal) -Hb ≤ 100 g/L (assess risk vs. benefit)
- 19. Prescribing a new oral anticoagulant 2. Detailed History EXCLUSION Criteria: -Known hypersensitivity to NOAC preparation -Pregnant or breastfeeding -Stable warfarin therapy -Prosthetic heart valve -Recent stroke
- 20. Prescribing a new oral anticoagulant 3. Assess bleeding risk -Disorder of haemostasis -Recent surgery (≤ 1 month ago) -GI bleed ≤ 12 months ago -Ulcer ≤ 30 days ago -Fibrinolytic treatment last 10 days -Dual antiplatelet therapy
- 21. Prescribing a new oral anticoagulant 4. Consider contaminant medications Rivaroxaban / apixaban -Systemic azole antifungals (except fluconazole) -HIV-protease inhibitors Dabigatran -Systemic azole antifungals (except fluconazole) -dronedarone -Simultaneous initiation with verapamil -cyclosporin and tacrolimus
- 22. Prescribing a new oral anticoagulant Is patient on warfarin? Stop warfarin Start NOAC once INR < 2
- 23. Western Australia Therapeutic Advisory Group Guidelines Please visit http://www.watag.org.au/watag/publications.cfm#guidelines