Practical Use of the New Oral Anticoagulants. Learning Objectives. Disclosure 3/30/14

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1 Practical Use of the New Oral Anticoagulants Andrea G. Dooley-Wood, PharmD, BCACP Clinical Pharmacy Specialist Manager, Anticoagulation Program The Heart Group of Lancaster General Health April 11 th, 2014 Learning Objectives Discuss the pharmacokinetics of the new oral anticoagulants (NOAC) Differentiate the clinical use of the new oral anticoagulants (NOAC) Determine appropriate selection of anticoagulation in your patients Disclosure I certify that I do not carry a conflict of interest, financial or material, regarding the information to be discussed today. 1

2 What am I? Advancement in the Realm of Anticoagulation For more than 50 years, warfarin was oral anticoagulant of choice Approx 2 million Americans initiate warfarin annually 1 *2010 estimates Over 30 million prescriptions written each year In the past 3 ½ years three additional agents have come to market Also, 2 new antiplatelets Since Pradaxa s approval in 2010 à 5.5 million prescriptions were dispensed 2 1. RS Epstein, et al. J Am Coll Cardiol. 2010;55(25): Accessed from https://www.pradaxa.com/what-is-pradaxa/pradaxa-vs-warfarin.html on March 23, 2014 Antithrombotic Approval Timeline Antiplatelets 1897 Aspirin 1997 Plavix Dr. Reddy generic briefly to market Generic officially to market 2009 Effient 2011 Brilinta Anticoagulants 1954 Warfarin 2010 Pradaxa à non-valvular AFib 2011 Xarelto à postorthopedic surgery DVT prophylaxis & non-valvular AFib Nov 2012 à treatment of DVT/PE Dec 2012 Eliquis à non-valvular Afib March 2014 post-orthopedic surgery DVT prophylaxis Actions on Coagulation Cascade Onset ~ 2 hours From: J Steffel, E Braunwald. Eur Heart J 2011;32:

3 Why all the excitement over anticoagulation? High risk medications regardless of agent being utilized Warfarin versus new agents versus our standby parenteral agents Novel agents provide additional options for our patients Further individualize anticoagulation Dabigatran (Pradaxa ) 1 st oral direct thrombin inhibitor approved Approved for non-valvular atrial fibrillation (RE-LY trial) Seeking approval status for VTE treatment (RE-COVER trial) Dabigatran etexilate (prodrug) Dosing: 150mg PO bid in AFib 75 mg PO bid if CrCl ml/min Absolute bioavailability: 6.5% 80% renally excreted T ½: hours No therapeutic drug monitoring Could be a good thing or a bad thing Product information for Pradaxa. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT November Dabigatran (Pradaxa ) Cost of 1 month supply: $ Storage: Keep in original bottle Expires 4 months after opened Adjustment based on renal function: > 30 ml/min: no adjustment Pts with CrCl < 30 ml/min were not included in the RE-LY trial ml/min: 75 mg po BID < 15 ml/min or dialysis: Avoid use Caution in: elderly (> 75 yrs), renal impairment, and low body weight à? Increased risk of bleeding 3

4 Dabigatran (Pradaxa ) No specific reversal agent Partially dialyzable* Monitor aptt May utilize additional supportive measures: PCC, FFP Drug-Drug Interactions: Avoid P-glycoprotein inhibitors (dronedarone, ketoconazole, verapamil, quinidine, amiodarone, clarithromycin) especially if CrCl 15 to 30 ml/min No dosage adjustment required Avoid P-glycoprotein inducers (rifampin, carbamazepine, St. John s wort, tenofovir) FDA Drug Safety Communication November 2 nd, 2012 Pradaxa provides an important health benefit when used as directed. Healthcare professionals who prescribe Pradaxa should carefully follow the dosing recommendations in the drug label MedWatch The FDA Safety Information and Adverse Event Reporting Program safetyalertsforhumanmedicalproducts/ucm htm [accessed on 12/2/12] And more further analysis ongoing 4

5 AND more Appropriate use and patient selection are key Available at [accessed 8/16/2013] Dabigatran-Black Box Warning Labeling revision April 2013 Increased risk of stroke after drug discontinuation Product information for Pradaxa. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT April New Data-June 2013 RELY-ABLE published in Circulation Multi-center, observational study Patients from RE-LY could enroll 48% of those eligible enrolled Followed for a median of 2.3 years (in addition to RE-LY) Goal was to further compare the two study doses of dabigatran Connolly SJ, et al. Circulation. 2013;128:

6 RELY-ABLE Rates of stroke/systemic embolism: 1.46%/yr dabigatran 150 mg 1.60%/yr dabigatran 110 mg (HR 0.91; 95% CI, ) Major hemorrhage: 3.74%/yr dabigatran 150 mg 2.99%/yr dabigatran 110 mg (HR 1.26; 95% CI, ). Could results change usage of dabigatran in the future? Connolly SJ, et al. Circulation. 2013;128: Rivaroxaban (Xarelto ) Oral direct Xa inhibitor FDA approved July 2011 for VTE prophylaxis following orthopedic surgery (hip or knee) Nov 2011: nonvalvular AFib Nov 2012: VTE treatment (DVT & PE) Jan 2014 FDA response letter denying ACS indication (for the 3 rd time) Oral bioavailability: 10 mg dose= %, 20 mg dose= ~ 60% when fasting (*take w/ food*) Peak plasma concentration: 2-4 hours T1/2: 7-11 hours Renal excretion à Contraindicated if < 30 ml/min* (*based on indication) 1/3 eliminated renally unchanged N Eng J Med 2008;358: Product information for Xarelto. Janssen Pharmaceuticals, Inc. Titusville, NJ November Rivaroxaban (Xarelto ) Cost: $215 for once daily dosing x 1 month In VTE treatment: $380 x 1 month VTE: 15 mg po BID x 21 days, then 20 mg once daily Avoid with CrCl < 30 ml/min DVT prophylaxis post-op ortho: 10 mg po daily Avoid with CrCl < 30 ml/min AFib: 20 mg po qday with evening meal CrCl: ml/min: 15 mg po qday Or largest meal of the day No specific reversal agent Partially dialyzable ~60%? Monitor aptt? May utilize additional supportive measures: PCC, rfviia 6

7 Rivaroxaban (Xarelto ) Drug-Drug Interactions Avoid BOTH P-glycoprotein and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, ritonavir) Strong CYP3A4 inducers may decrease efficacy (e.g., rifampin, carbamazepine, phenytoin, St. John s wort) Product information for Xarelto. Janssen Pharmaceuticals, Inc. Titusville, NJ November Rivaroxaban- Black Box Warning Increased risk of stroke after drug discontinuation (specifically in Afib) ROCKET-AF trial Spinal hematoma following neuraxial anesthesia 1 st Novel Agent Approved for VTE in US [date accessed 11/30/12] 7

8 Apixaban (Eliquis ) Oral factor Xa inhibitor Approved December 28 th, 2012 nonvalvular AFib Dosing: 5mg po BID Reduce to 2.5 mg po BID SCr 1.5 mg/dl Age 80 yrs Weight 60 kg {if meet 2 out of 3 criteria} Approved March 13, 2014 for DVT/PE prophylaxis s/p ortho surgery 2.5 mg po BID Product information for Eliquis. Bristol-Myers Squibb Company. Princeton, NJ March Apixaban (Eliquis ) Oral bioavailability: 50 % Maximal plasma concentration: 3-4 hours T1/2: ~ 12 hours Renal excretion: 27% Contraindicated in CrCl < 15 ml/min and severe hepatic disease Product information for Eliquis. Bristol-Myers Squibb Company. Princeton, NJ March Apixaban (Eliquis ) superior to warfarin in stroke prevention in nonvalvular Afib Cost: $242 for 1 month supply Caution with strong inhibitors of BOTH CYP3A4 and P-glycoprotein à dose reduce to 2.5 mg or do not use Avoid with enzyme inducers Reversal: no antidote, activated charcoal can be useful in overdosage N Engl J Med 2011;365: N Engl J Med 2011;363: Lancet 2010;375: Product information for Eliquis. Bristol-Myers Squibb Company. Princeton, NJ March

9 Apixaban- Black Box Warning Increased risk of stroke after drug discontinuation Spinal hematoma following neuraxial anesthesia Dabigatran Rivaroxaban Apixiban Mechanism of Action Reversible direct thrombin inhibitor Reversible direct factor Xa inhibitor Reversible direct factor Xa inhibitor Pharmacokinetics Prodrug Bioavailability Maximum concentration Half-Life Metabolism Dosing (FDA approved dose or as studied) Dose Adjustments (FDA approved dose or as studied) Yes 3-7% 1-2 hours hours Serum esterases and non- CYP hepatic metabolism 150 mg twice daily 75 mg twice daily CrCl ml/min: 75 mg twice daily CrCl < 15 ml/min: not recommended No 80% 2-4 hours 5-9 hours CYP 3A4/5, CYP2J2, hydrolysis 15 mg BID 10, 15, 20 mg daily CrCl 30 49: 15 mg daily (when using for Afib) No 50% 3-4 hours 9-11 hours CYP 3A4/5 (major); other CYP450 enzymes (minor) 2.5-5mg twice daily Patients with 2 of the following: age 80 years, body weight 60 kg, SCr 1.5 mg/dl: 2.5 mg twice daily Monitoring Renal function Renal and hepatic function Renal and hepatic function Reversal/Management of bleeding No direct reversal agent Use blood products, hemodialysis No direct reversal agent Use No direct reversal agent Use blood products blood products FDA approved for Afib/VTE Yes/No Yes/Yes Yes/No* Transition from Warfarin to New Agents Dabigatran (Pradaxa ) Start when INR < 2.0 Rivaroxaban (Xarelto ) Start when INR < 3.0 Apixaban (Eliquis ) Start when INR < 2.0 Available in manufacturer product labeling for dabigatran, rivaroxaban, and apixaban 9

10 Transition from New Agents to Warfarin Dabigatran (Pradaxa ) CrCl 50 ml/min, start warfarin 3 days before discontinuing CrCl ml/min, start warfarin 2 days before discontinuing CrCl ml/min, start warfarin 1 day before discontinuing Rivaroxaban (Xarelto ) Affects INR, consider bridging with LMWH + warfarin Apixaban (Eliquis ) Affects INR, consider bridging with LMWH + warfarin Available in manufacturer product labeling for dabigatran, rivaroxaban, and apixaban Bridging Considerations Practitioners will encounter multiple patients on antithrombotics requiring surgery or other procedures There is a fine balance when deciding to continue antithrombotics through a procedure Risk of bleeding associated with the procedure Risk of thrombotic event if patient is off antithrombotic therapy Risk of Thrombosis Atrial fibrillation Low, Moderate, High Mechanical Valve Recent VTE Recent cardioembolic stroke Recent PCI s/p stent placement (BMS/DES) Risk of Bleeding High Risk GI Procedures Other high risk surgeries Lower Risk: Low risk GI Dental Dermatologic Cataract Bridging Considerations 10

11 Bridging Considerations Low risk surgery Continue antithrombotic therapy Check INR prior to procedure to ensure not supratherapeutic (if on warfarin) High risk surgery & Low thrombotic risk Stop antithrombotics, no bridging required High risk surgery & High/Intermediate thrombotic risk Stop antithrombotics AND bridge Pre-Procedure Management of Novel Oral Anticoagulants No Bridge Agent Required!! Dabigatran (Pradaxa) CrCl > 50 ml/min: Hold 1-2 days CrCl < 50 ml/min: : Hold 2-5 days Hold longer for spinal puncture or epidural. Consider assessing aptt Rivaroxaban (Xarelto) Hold 24 hours Apixaban (Eliquis) Hold 24 hours in low risk surgery Hold 48 hours in high risk surgery Peri-operative management of antithrombotic therapy. CHEST 2012; 1412(2)(Suppl):e326S-50S) ACC/AHA guidelines: Management of Patients with Valvular Heart Disease. JACC 2008;52:e1-e142. Post-Procedure Management of Novel Oral Anticoagulants Do Not restart until cleared for FULL therapeutic anticoagulation If on LMWH, restart oral agent 2 hours prior to next scheduled injection If on UFH infusion, start oral agent when infusion is stopped Peri-operative management of antithrombotic therapy. CHEST 2012; 1412(2)(Suppl):e326S-50S) ACC/AHA guidelines: Management of Patients with Valvular Heart Disease. JACC 2008;52:e1-e

12 Considerations in periprocedural management of Novel Agents No reversal agent/antidote Unlike warfarin à Vitamin K Unable to monitor level of anticoagulation with lab testing pre-procedure Unlike warfarin à INR We have lots of new drugs A variety of indications How do you choose? ACC/AHA Nov 2011 CHEST Feb 2012 CHADS = 0 à ASA mg CHADS = 1à ASA mg or warfarin CHADS= 2 à warfarin 1A: warfarin as anticoagulant of choice for those at high risk 1B: Dabigatran is a useful alternative if no valve disease, no renal impairment (<15 ml/min), no advanced hepatic disease CHADS 1 à oral anticoagulation over aspirin (Grade 1B) Dabigatran over warfarin if no valve disease, stable CAD, or stent placement (Grade 2B) ACC/AHA versus ACCP-CHEST Atrial Fibrilliation Anderson et al. JACC 2013; 61(18) : CHEST 2012; 141(2)(Suppl):e531S e575s 12

13 CHADS-VASc Recommended by European Society of Cardiology Score 1 = ASA or anticoagulant GY Lip, et al. CHEST. 2010;137(2): ! AHA March 2011 CHEST Ileofemoral-DVT: warfarin targeted to INR 2-3 (1A) Dabigatran appears to be as effective as warfarin in acute DVT, but no specifics on ileofemoral DVT *And NOT FDA approved for this indication* DVT of the leg and no cancer à VKA therapy over LMWH for long-term therapy (Grade 2C) Patients with DVT and no cancer who are not treated with VKA therapy, suggest LMWH over dabigatran or rivaroxaban for long-term therapy (Grade 2C). AHA versus ACCP-CHEST Venous Thromboembolism Jaff MR, et al. Circulation. 2011;123: CHEST 2012; 141(2)(Suppl):e419S e494s Cost Comparison Old Agents (cost/tablet) Warfarin: $0.05 PT/INR by venipuncture performed in house: ~$1.86/ test (includes lab labor, direct and indirect expenses) PT/INR by point of care method: ~$2.46 direct & indirect expense and partial labor Lovenox: $14.00/inj New Agents (cost/tablet) Pradaxa: $4.21 $8.42 /day Xarelto: $7.58 Eliquis: $4.21 $8.42 /day Clopidogrel: $ 0.20 Effient: $7.36 Brilinta: $3.90 Amerisource Bergen [accessed on Mar 2014] 13

14 Recommended Monitoring Dabigatran (Pradaxa ) Per PI: assess renal function prior to starting & periodically assess as clinically indicated Rivaroxaban (Xarelto ) Per PI: periodically assess renal function as clinically indicated Apixaban (Eliquis ) No mention in PI, but a SCr is necessary for initial dose choice Recommended Monitoring European Heart Rhythm Association For all new oral anticoagulants: Medication adherence monitored at every visit Annually: Hgb, renal function, liver function If baseline renal function is reduced, recommend monitoring every 3-6 months H. Heidbuchel, et al. Europace 2013; 15: Rivaroxaban Patient education resources and coaching Live telephone help with care coordinators Phone and refill reminders Including reminder to switch to qday dosing at day 22 for VTE treatment Savings Card: out-of-pocket costs for up to 12 months, 12 uses, or $1,200 maximum benefit Can potentially drop a pt s copayment to $10/month Federal & state insurance excluded [accessed on 3/23/14] 14

15 Dabigatran PradaxaLink support program Education regarding Afib Live Operator support hotline Medication Reminders ( , phone, mail) Pradaxa Savings Card Patient-Doctor tip guide Savings Card: insured patient, could pay no more than $10 with a maximum benefit of $150 per monthly prescription over a 12-month period. government-funded insurance or are cash paying, eligible for one free 30-day supply one time in 12 months [accessed on 3/23/14] Apixaban 360 Support Program: Receive Afib related information Access to live agent Savings Card: Free 30-day trial offer on 1 st Rx Once per lifetime Eligible patients can pay no more than $10/ month for up to 24 months. Maximum annual benefit of $3,400 Excludes state and federal programs [accessed on 3/23/14] Which therapy is right for your patient? Is warfarin still King in anticoagulation management? Take into account à What indication are you treating? Ex: Pradaxa not approved for VTE Is your patient already on warfarin and well controlled? Are you concerned about adherence? Is cost going to be an issue for your patient? 15

16 General Comparison in Patient Selection: Non-valvular AFib Age Wt (yrs) (kg) CrCl CHADS TTR # pts f/u GI Bleed Intra cranial Bleed Pradaxa Dosing: BID Xarelto Dosing: qday Eliquis Dosing: BID excluded < 30 ml/ min 73? Mean 67 ml/min Excluded < 25 ml/ min 83% > 50ml/min ,076 2 yrs 1.51% 0.30% , yrs 2.2% * 0.5% *only classified if major , yrs 0.76% 0.33% Additional Uses of Novel Agents: CV Ablation: data supporting dabigatran s use VTE Treatment Both dabigatran and apixaban Dabigatran submitted application in EU Apixaban submitted to FDA except comment in August ACS to prevent stent thrombosis Rivaroxaban approved in EU? Use as bridge therapy pre/post-procedure Being done off-label in US On the horizon more Me-too Direct oral factor Xa inhibitors Darexaban (YM150) Betrixaban Edoxaban NDA submitted to FDA January 2014 Non-valvular AF and VTE treatment 16

17 Additional Provider Resources: Your pharmacist J Pharmaceutical company websites/local pharmaceutical representatives American College of Cardiology IPad app Patient Cases 1. I m sick of these injections 2. Is there a better option than testing my INR each week? 3. I have insurance coverage, is there another option for me? I m sick of these injections 56 yo m w/ recurrent Afib s/p DCCV 5/18 Ht: 76 in, Wt: 138 kg Meds: ASA 81mg daily Carbamazepine 200 mg BID Glimepiride 2 mg daily Metformin 500 mg BID Metoprolol succinate 50 mg daily Enoxaparin 120 mg sc q 12 hours Warfarin 5 mg as directed 17

18 Labs: Date 19-May 22-May 26-May 30-May 1-Jun 5-Jun 6-Jun 8-Jun 12-Jun INR Lovenox stopped ~ 3 weeks of Lovenox use! Would one of the novel oral agents be an option for this patient to avoid 3 weeks of Lovenox injections? Is there another option than testing my INR weekly? 46 yo female utilizes a home INR monitor for testing PMH: Afib, CVA, mechanical AVR, hypothyroidism, asthma Medications: Atenolol 50 mg daily Warfarin 2 mg tabs as directed INR range: , last INR 2.7 Albuterol inh prn Advair 250/50 1 p BID Levothyroxine 125 mcg daily Ht: 69 in Wt: 58.9 kg Scr: 0.8 mg/dl 18

19 Can this patient safely utilize a novel oral anticoagulant? I have prescription coverage, would one of these new medications work for me? 62 yo female PMH: AFib, TIA, CAD, hyperlipidemia Meds: ASA 81 mg daily, bisoprolol 5 mg daily, lisinopril 20 mg daily, furosemide 40 mg daily, pravastatin 20 mg at bedtime, ezetimibe 10 mg daily, zolpidem CR 12.5 mg at bedtime warfarin 5 mg as directed INR range: , last INR 2.7 (60% time in range) Ht: 66 in, Wt: kg, SCr: 0.7 mg/dl Can this patient utilize a novel agent? Any contraindications based on indication for anticoagulation? Any contraindications based on possible drug-drug interactions? Is patient s renal function stable? 19

20 Conclusions Many new options recently approved in the anticoagulation/antiplatelet arena There are multiple factors to take into account & individualize the choice for your patients Cost is always a factor to consider and may determine your patient s ability to continue with recommended treatment Questions? Thank you! Practical Use of New Oral Anticoagulants Andrea G. Dooley-Wood, PharmD, BCACP April 11 th,

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