Direct Oral Anticoagulants

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1 Direct Oral Anticoagulants Holly Jahn, PharmD, CACP Objectives Identify the FDA approved indications for use, appropriate dosing, and monitoring parameters for each direct oral anticoagulant. Distinguish the key differences among the direct oral anticoagulants. Discuss perioperative management with direct oral anticoagulants. Acknowledge the impact of drug interactions when considering anticoagulation therapy. Review the currently available medication and medications still in clinical trials for the reversal of direct oral anticoagulants. List the newest recommendations related to direct oral anticoagulants from the 10 th edition CHEST guidelines. Direct Acting Oral Anticoagulants Dabigatran Rivaroxaban Apixaban Edoxaban Betrixaban approved June 23,

2 Drug Class Factor Xa inhibitor Rivaroxaban Apixaban Edoxaban Betrixaban Direct thrombin inhibitor Dabigatran Warfarin Warfarin Apixaban Rivaroxaban Edoxaban Betrixaban Dabigatran Indications for VTE Treatment & PPX VTE prophylaxis in the acute setting Betrixaban VTE prophylaxis post-op hip/knee replacement Apixaban Rivaroxaban VTE treatment/secondary prophylaxis Apixaban Rivaroxaban Edoxaban Dabigatran 2

3 Indications for Atrial Fibrillation Only for non-valvular atrial fibrillation Apixaban Rivaroxaban Edoxaban Dabigatran Before we talk renal adjustments Weight, Scr, and Age Apixaban Remember to calculate CrCl using ACTUAL body weight Dabigatran Edoxaban Rivaroxaban Betrixaban Apixaban and Dabigatran Medication Indication Dose Renal adjustment Apixaban Medication Non-Valvular Indication Afib 5 Dose mg PO BID Renal Any 2 adjustment of the following: Age 80 yo, wgt 60 kg, SCr 1.5 mg/dl = 2.5 Apixaban (Eliquis) Non-Valvular Afib DVT/PE 5 mg PO BID 10 mg PO BID x 7 days Any mg 2 PO of the BID* following: Age 80 yo, wgt 60 kg, SCr 1.5 mg/dl = 2.5 No adjustment* mg PO BID* Then 5 mg PO BID x 6 months DVT/PE ~May 10 mg decrease PO BID x to 7 days 2.5 mg PO BID after 6 No adjustment * Post op hip replacement months Then 5 mg of full PO treatment BID x 6 months dosage May decrease to 2.5 mg PO BID after months mg BID of full x 35 treatment days dosage No adjustments, patients with CrCl < 30 ml/min were excluded from Post op hip 10 mg daily x 35 days CrCl < 30 ml/min = Avoid trial Post replacement op knee replacement 2.5 mg BID x 12days Drug interactions: Decrease Post dosage op knee 50% for dosage > mg mg daily PO x BID AND days receiving concomitant clarithromycin, CrCl < 30 ml/min oral = Avoid ketoconazole, itraconazole, or ritonavir (dual replacement strong CYP3A4 and P-gp inhiibtors) ~ AVOID use with above medications if pt is taking 2.5 mg BID or has 2 of following (age, SCR, wt) Drug interactions: For dosage > 2.5 mg PO BID AND receiving concomitant clarithromycin, oral ketoconazole, itraconazole, or ritonavir = decrease dose 50%. ~For dosage of 2.5 mg PO BID and receiving above medicaitons, avoid usage Dabigatran Non- Valvular Afib 150 mg PO BID CrCl ml/min = 75 mg PO BID < 15 ml/min or ESRD = CI DVT/PE 150 mg PO BID after 5-10 days of < 30 ml/min = Avoid Dabigatran (Pradaxa) Non- Valvular Afib 150 mg PO BID CrCl ml/min = 75 mg PO BID parenteral anticoagulant Drug interactions afib: CrCl ml/min and receiving oral ketoconazole or dronedarone = 75 mg < 15 BID. ml/min CrClor ESRD ml/min = CI and receiving concomitant P-gp inhibtor = AVOID Drug interactions DVT/PE: CrCl <50 ml/min and receiving concomitant P-gp inhibitor (amiodarone, clarithromycin, dronedarone, quinidine, verapamil, etc) = AVOID Drug interactions afib and DVT/PE: any P glycoprotein inducer (Rifampin) = AVOID * Patients with SCr > 2.5 mg/dl or CrCl < 25 ml/min were excluded from the trial 3

4 Edoxaban, Rivaroxaban, and Betrixaban Medication Indication Dose Renal adjustment Edoxaban Non-Valvular Afib 60 mg daily CrCl > 95 ml/min = AVOID CrCl ml/min = 30 mg daily CrCl < 15 ml/min = AVOID DVT/PE 60 mg PO daily after 5-10 days of parenteral anticoagulation CrCl ml/min = 30 mg daily CrCl < 15 ml/min = AVOID Drug interactions: Concomitant verapamil, quinidine, azithromycin, clarithromycin, erythromycin, itraconazole, or oral ketoconazole= 30 mg daily Weight less than 60 kg = 30 mg daily Rivaroxaban Non-Valvular Afib 20 mg PO daily CrCl ml/min = 15 mg daily CrCl < 15 ml/min or ESRD = CI DVT/PE 15 mg PO BID x 21 days Then 20 mg PO daily with food CrCl < 30 ml/min = AVOID Post op hip replacement 10 mg daily x 35 days CrCl < 30 ml/min = AVOID Post op knee replacement 10 mg daily x days CrCl < 30 ml/min = AVOID Drug interactions: Concomitant vorapaxar, urokinase, St John's Wort, idelalisib, conivaptan, ketoconazole, ritonavir/lopinavir, fluconazole, itraconazole, indinavir, carbamazepine, phenytoin, rifampin= AVOID Drug interactions: Renal dysfunction and concomitant erythromycin, clarithromycin, amiodarone, diltiazem, verapamil, chloramphenicol, cimetidine= CAUTION USE Betrixaban VTE prophylaxis for Initial: 160 mg orally as a single dose, CrCl ml/min = 80 mg X 1 dose, hospitalized patients at followed by 80 mg once daily at the same followed by 40 mg once daily for 35 to 42 risk time each day with food for 35 to 42 days days for VTE Drug interactions: Concomitant use of P-gp inhibitors = Reduce initial dose to 80 mg orally as a single dose, followed by 40 mg once daily for 35 to 42 days What about hepatic impairment? Apixaban Mild impairment Child-Pugh Class A No adjustments Moderate impairment Child-Pugh Class B No adjustments provided use with caution Severe impairment Child-Pugh Class C Use is not recommended Dabigatran No dosage adjustments per manufacturer. In patients with moderate impairment, no changes in exposure or pharmacodynamics were observed in a study. Edoxaban Mild impairment Child-Pugh Class A No adjustments Moderate to severe impairment Child-Pugh Class B and C Use is not recommended Rivaroxaban Mild impairment Child-Pugh Class A No adjustments Moderate impairment Child-Pugh Class B or C Avoid use Betrixaban Use is not recommended Choosing the right medication Indication Patient s lifestyle Compliance Dosing complexity Renal/Hepatic function Age Bleeding Risk Cost 4

5 Apixaban Specific points Duration of therapy orthopedic uses (knee - 12 days, hip - 35 days) VTE dose change at 1 week 10 mg BID X 7 days, then 5 mg BID May crush tablets and place in 60 ml of D5W for immediate delivery down NG tube Can also mix with apple juice, applesauce, D5W, or water and give orally Stable for up to 4 hours Dabigatran Specific points Initiation after 5-10 days of parenteral therapy (VTE) Storage Do not store in pill organizer Must use within 4 months of opening bottle Take with full glass of water With or without food Do not break, crush, chew, or open capsule Side effects Stomach upset, indigestion Edoxaban Specific points Initiation of therapy VTE requires 5-10 days of parenteral therapy Side effects can include rash Take with or without food Should not be used in patients who have a CrCl greater than 95 ml/min due to an increased risk of ischemic stroke 5

6 Rivaroxaban Specific points Duration of therapy orthopedic uses (knee days, hip - 35 days) VTE dose change at 3 weeks Take with food (for doses 15 mg or greater) Crush or chew? May be crushed and mixed in applesauce immediately prior to usage NG tube may be crushed and mixed in 50 ml of water. Administration should be followed by enteral feeding Missed dosage of 15 mg BID Must get 30 mg in a day two 15 mg doses can be given at once Betrixaban Approved on June 23, 2017 Only for use in the acute setting Take at same time each day with food APEX trial Treatment groups Enoxaparin 40 mg daily vs. betrixaban 160 mg X 1, then 80 mg daily for days Primary efficacy endpoint: Composite of: asymptomatic proximal DVT between day Symptomatic proximal or distal DVT Symptomatic non-fatal PE Death from VTE Three cohorts: Patients with elevated D-dimer Patients with elevated D-dimer or age > 75 Entire trial population N Engl J Med 2016; 375:

7 Results from APEX trial Primary end point, cohort 1 Did not show clinical significance (P = 0.054) Therefore the rest of the analyses were considered exploratory Safety endpoints (betrixaban vs enoxaparin) Major bleeding 0.7% vs 0.6% (P = 0.55) Major or clinically relevant non-major bleeding 3.1% vs 1.6% (P = <0.001) N Engl J Med 2016; 375: Transitioning from warfarin to DOACs Discontinue warfarin, then Dabigatran & Apixaban Initiate when INR is below 2 Rivaroxaban: Initiate when INR is below 3 Edoxaban: Initiate when INR is below 2.5 Betrixaban: No information available Transitioning from Dabigatran to warfarin Adjust the start time of warfarin based on the patient s CrCl: Recommended start of warfarin before discontinuing dabigatran *Because dabigatran can increase INR, the INR will better reflect warfarin s effect only after dabigatran has been stopped for at least 2 days. Dabigatran [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. Accessed September 5,

8 Transitioning from Factor Xa inhibitors to warfarin Discontinue factor Xa inhibitor and initiate a parenteral anticoagulant and warfarin at the time when the next factor Xa dose would have been administered Continue parenteral anticoagulant until INR is therapeutic Includes Rivaroxaban, Apixaban, and Edoxaban Perioperative Management of DOACs 7-11, a Dabigatran >50 ml/min Drugs and CrCl ml/min < 30 ml/min Rivaroxaban, apixaban, or edoxaban >50 ml/min ml/min < 30 ml/min Time of Last Dose Before Minor Procedure 1 day 2 days 4 days 1 day 1 2 days 2 days Time of Last Dose Before Major Surgery 2 days 4 days 5 6 days 2 days 3 4 days 4 days DOAC Dabigatran Rivaroxaban - Apixaban Edoxaban Bleeding risk of invasive procedure LOW HIGH LOW HIGH LOW HIGH Bleeding risk Bleeding risk Bleeding Bleeding risk Bleeding risk Bleeding risk risk GIHP Preoperative CrCl 50 ml/min Last dose Last dose Last Last dose Last dose Last dose (Groupe interruption 24 h before 4 days before dose 3 days before 24 h before 3 days before d Intérêt en No bridging CrCl >30 ml/min Last dose 24 h Hémostase (except 5 days before before Périopératoire) high risk of Very high risk Last dose 5 days before patients with TE) procedure Resumption LOW Bleeding Risk: after Resume minimum 6 h after invasive procedure or invasive HIGH Bleeding Risk: procedure or Prophylactic dose of LMWH, UFH or fondaparinux minimum 6 h after invasive procedure or if venous thromboprophylaxis is indicated Therapeutic dose of DOACs when hemostasis is controlled (24-72 h) For neuraxial anesthesia with indwelling catheter: Resumption with LMWH or UFH until indwelling catheter is out Heidbuchel Preoperative CrCl 80 ml/min 24 h 48 h 24 h 48 h 24 h 48 h et al. interruption CrCl ml/min 36 h 72 h 24 h 48 h 24 h 48 h No bridging CrCl ml/min 48 h 96 h 24 h 48 h 24 h 48 h CrCl ml/min Not Not indicated 36 h 48 h 36 h 48 h indicated CrCl <15 ml/min No official indication for use Resumption LOW Bleeding Risk: after DOACs 6-8 h invasive HIGH Bleeding Risk: procedure or Low TE risk resume DOACs h after procedure High TE risk prophylactic or intermediate dose of LMWH 6-8 h after procedure, resume DOACs when hemostasis is controlled (48-72 h) Spyropoulos Preoperative CrCl >50 ml/min Last dose Last dose Last dose 2 days Last dose 3 days Last dose 2 days before Last dose 3 days before et al. interruption 2 days 3 days before before before No bridging before CrCl ml/min Last dose Last dose 4 Last dose 2 days Last dose 3 days 3 days 5 days before before before before CrCl ml/min Depends on patient Depends on and procedural factors patient and procedural factors Resumption LOW Bleeding Risk: after DOACs 24 h invasive HIGH Bleeding Risk: procedure or Low TE risk resume DOACs h after procedure High TE risk consider a reduced dose of dabigatran (75 mg twice daily), rivaroxaban (10 mg once daily) or apixaban (2,5 mg twice daily) on the evening after and on the following day (first postoperative day) after. Dubois, V et al. Perioperative management of patients on direct oral anticoagulants. Thrombosis Journal 2017; 15:14. 8

9 Drug Interactions Rivaroxaban, Apixaban, and Edoxaban Metabolized by CYP3A4 Substrate for P-glycoprotein Dabigatran Substrate for P-glycoprotein Management of DOAC-related bleeding Idarucizumab Approved in 2015 under accelerated approval Humanized monoclonal antibody fragment Neutralizes the anticoagulant effect of dabigatran by binding to dabigatran and its acylglucuronide metabolites Indicated for life threatening bleeding or need for emergent 5 g (administered via 2 vials) IV Dabigatran can be reinitiated 24 hours after administration Not compatible with other medications RE-VERSE AD trial The anticoagulant effect of dabigatran was fully reversed in 88-98% of patients at 4 hours following administration of idarucizumabthrombotic events occurred in 5 patients (n = 90) Management of DOAC-related bleeding Andexanet alpha Binds factor Xa inhibitors ANNEXA A and ANNEXA R trials Phase 3, Studied the reversal effects on apixaban and rivaroxaban in healthy volunteers Anti factor Xa activity was reduced by 94% and 92% respectively with andexanet vs. 21% and 18% with placebo No major thrombotic adverse events reported ANNEXA-4 Ongoing Trial Phase 3 Evaluating efficacy in patients with an acute major bleed Estimated primary completion date November 2022 A study of the PK/PD, safety, and tolerability in healthy subjects Ongoing trial Estimated primary completion date September

10 Management of DOAC-related bleeding Ciraparantag Binds to edoxaban, rivaroxaban, apixaban, dabigatran, and LMWH/UFH Phase I trial Evaluation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of a Double-Blind, Single Dose of Ciraparantag Administered Alone, and Following a Single Dose of Edoxaban 80 healthy participants In patients receiving a single intravenous dose of PER977 (100 to 300 mg) 3 hours after the administration of edoxaban, the whole-blood clotting time decreased to within 10% above the baseline value in 10 minutes or less, whereas in patients receiving placebo, the time to reach that level was much longer (approximately 12 to 15 hours) Ongoing Study Phase 2 Placebo-Controlled, Single-Site, Single-Blind Study of Rivaroxaban Reversal by Ciraparantag as Measured by whole blood clotting time Estimated study completion date- December CHEST guidelines 10 th edition Summary: Risk reduction for recurrent VTE with all of the DOACs appears to be similar to the risk reduction with VKA Risk reduction for recurrent VTE among the different DOACs appears to be similar Risk of bleeding with the DOACs, and particularly intracranial bleeding, is less than with VKA therapy based on patients with atrial fibrillation GI bleeding may be higher with dabigatran, rivaroxaban, and edoxaban than with VKA therapy, although this has not been seen in patients with VTE Risk of bleeding may be lower with apixaban than with the other DOACs Risk that a major bleed will be fatal appears to be no higher for DOACs than for VKA therapy Suggest that a DOAC is used in preference to VKA for the initial and long-term treatment of VTE in patients without cancer Questions 10

11 References 1. Apixaban. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; November Accessed March 24 th, Dabigatran. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; October Accessed March 24 th, Edoxaban. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; February Accessed March 24 th, Rivaroxaban. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; July Accessed March 24 th, Cohen, A et al. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med 2016; 375: Dubois, V et al. Perioperative management of patients on direct oral anticoagulants. Thrombosis Journal 2017; 15: Nutescu EA, Dager WE, Kalus JS et al. Management of bleeding and reversal strategies for oral anticoagulants: clinical practice considerations. Am J Health-Syst Pharm. 2013; 70: Boehringer Ingelheim Pharmaceuticals. Pradaxa (dabigatran etexilate mesylate)prescribing information. (accessed 2016 Jan 7). 9. Bristol-Myers Squibb. Eliquis(apixaban) prescribing information. (accessed 2015 Jul 30). 10. Daiichi Sankyo. Savaysa (edoxaban)prescribing information. (accessed 2015Jul 30). 11. Janssen Pharmaceuticals. Xarelto (rivaroxaban) prescribinginformation. (accessed 2015 Jul30). 12. Gulseth M. Overview of direct oral anticoagulant therapy reversal. Am J Health-Syst Pharm. 2016; 73(suppl 2):S Product Information: PRAXBIND(R) intravenous injection, idarucizumab intravenous injection. Boehringer Ingelheim Pharmaceuticals (per FDA), Ridgefield, CT, Pollack C. Idarucizumab for Dabigatran Reversal. N Engl J Med 2015; 373: Siegal D. Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity. N Engl J Med 2015; 373: Connolly S. Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors. N Engl J Med 2016;375: Ansell J. Use of PER977 to Reverse the Anticoagulant Effect of Edoxaban. N Eng J Med 2014; 371: Martin K, et al. Use of the direct oral anticoagulants in obese patients: guidance from the SSC of the ISTH. J Thromb Haemost 2016; 14(6):

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