NEWER ANTICOAGULANTS: FOCUS ON STROKE PREVENTION IN ATRIAL FIBRILLATION AND DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM
|
|
- Ursula Sutton
- 8 years ago
- Views:
Transcription
1 NEWER ANTICOAGULANTS: FOCUS ON STROKE PREVENTION IN ATRIAL FIBRILLATION AND DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM Carol Lee, Pharm.D., Jessica C. Song, M.A., Pharm.D. INTRODUCTION For many years, warfarin has been the standard of care and the only available oral anticoagulant to prevent thromboembolic complications associated with atrial fibrillation, as well as venous and pulmonary thrombosis. 1 Despite its long-term use and familiarity among many healthcare providers, warfarin is now up against three new oral anticoagulants, dabigatran, rivaroxaban, and apixaban all of which do not require blood monitoring and frequent dose adjustments. 2-5 These newer agents not only provide options for patients who are difficult to manage, but they also enable healthcare providers to choose the most appropriate drug based on patient-specific circumstances. CURRENT STANDARD OF PRACTICE - STROKE PREVENTION IN ATRIAL FIBRILLATION AND DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM Based on the results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) study, dabigatran has been shown to be superior to warfarin in reducing the risk of stroke or systemic embolism. 6 This open-label study included patients with mean CHADS 2 scores of 2.1, and their INRs were in therapeutic range for 64% of the time. Rivaroxaban has been shown to be noninferior to warfarin with regard to preventing stroke and systemic embolism in nonvalvular atrial fibrillation patients. 7 The patients enrolled in the ROCKET-AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism) study were higher-risk patients as shown by a mean CHADS 2 score of 3.5±0.9 ( 3, 87%). In addition, the patients were not well controlled on warfarin therapy, since their INRs were in therapeutic range for 55% of the time. Rivaroxaban has not been compared against apixaban or dabigatran in head-to-head clinical trials of stroke prevention in atrial fibrillation. Apixaban has been shown to be noninferior to warfarin for preventing stroke and systemic embolism. 8 The ARISTOLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) study featured patients with a mean CHADS 2 score of 2.1±1.1 ( 3, 30%) and INRs of warfarin-treated patients were in therapeutic range for 62.2% of the time. The American Heart Association (AHA)/American Stroke Association (ASA) guidelines for the prevention of first and recurrent stroke in patients with non-valvular AF awarded class I recommendations for using warfarin, apixaban, and dabigatran, but gave a class IIa recommendation for rivaroxaban. 9 Because of the high-risk population enrolled in ROCKET-AF, AHA/ASA recommended rivaroxaban as an alternative to warfarin in patients with non-valvular AF who have a prior history of transient ischemic attack, stroke, or systemic embolism or 2 additional risk factors. Apixaban (5 mg twice daily) was deemed to be a viable alternative to warfarin in patients with non-valvular AF who have 1 additional risk factor and do not exhibit more than 1 of the following characteristics: (1) age 80 years; (2) weight 60 kg; or (3) serum creatinine 1.5 mg/dl. AHA/ASA recommended dabigatran as an efficacious alternative to warfarin in patients with non-valvular AF who have 1 additional risk factor and creatinine clearance above 30 ml/minute. Rivaroxaban has been shown to be noninferior to enoxaparin (1 mg/kg subcutaneously twice daily 5 days)/warfarin with regard to preventing recurrence of symptomatic VTE in patients with acute, symptomatic DVT and in patients with an acute symptomatic PE with or without DVT. 10,11 Dabigatran and apixaban have not received FDA (Food and Drug Administration) approval for the indication of treatment of patients with DVT and PE. 3,5 The American College of Chest Physician s Antithrombotic guidelines awarded a grade 1B recommendation for the use of parenteral anticoagulants (IV unfractionated heparin,
2 low-molecular weight heparin, fondaparinux, subcutaneous unfractionated heparin) or rivaroxaban in patients with VTE. 1 However, because of the limited number of publications on the efficacy and tolerability of rivaroxaban for VTE treatment at the time the recommendations were drafted (October 2011), the panel gave a weak recommendation for low molecular weight heparin/warfarin over rivaroxaban. KEY POINTS FOR NEWER ANTICOAGULANTS Dabigatran (Pradaxa ) 3 Since its FDA approval in 2010, dabigatran has been marketed for stroke prevention and systemic embolism in patients with nonvalvular atrial fibrillation. This direct thrombin inhibitor comes as a 75mg or 150mg tablet and is dosed at 150mg twice daily (half-life is approximately hours). A dose adjustment of 75mg twice daily may be necessary for patients with renal impairment (serum creatinine of 15-30mL/min). No consistent change has been noted in dabigatran pharmacodynamics or exposure in patients with moderate hepatic impairment (Child-Pugh Class B). The conversion from warfarin to dabigatran is simple - warfarin is discontinued and dabigatran is started when the International Normalized Ratio (INR) falls below 2. On the other hand, the number of days to convert dabigatran to warfarin depends on the patient s creatinine clearance (CrCl). Dabigatran should be discontinued 3 days after the start of warfarin therapy if a patient has a CrCl of 50 ml/min or higher, 2 days after if the patient has a CrCl ranging from 30 to 50 ml/min, and 1 day after if the patient has a CrCl ranging from ml/min. Patients on dabigatran usually do not require laboratory monitoring with the exception of testing the aptt (Activated Partial Thromboplastin Time) for patients with life-threatening bleeding or need for emergent reversal. In terms of drug interactions, avoid concomitant use of dabigatran with strong p- glycoprotein inhibitors (e.g. ketoconazole, dronedarone) or reduce the dose of dabigatran to 75mg twice daily; avoid coadministration with drugs that induce p-glycoprotein (e.g. rifampin). Capsules should be used within four months of opening the bottle, assuming appropriate storage conditions (25 0 C in original package). Rivaroxaban (Xarelto ) 4 This oral direct factor Xa inhibitor was developed and first approved by the FDA in 2011 for preventing venous thromboembolism in adults undergoing hip or knee replacement surgery. Shortly after its approval, the FDA accepted its indication for stroke prophylaxis in patients with nonvalvular atrial fibrillation. Finally in 2012, the FDA approved rivaroxaban for the prevention and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), thereby decreasing the recurrence of venous thromboembolism. Rivaroxaban is available in 10mg, 15mg, and 20mg tablets and has a half-life of approximately 5-9 hours. This agent offers the convenience of once daily dosing for 2 indications: (1) 20mg daily for nonvalvular atrial fibrillation; and (2)10mg daily for days for knee replacement, 35 days for hip replacement patients requiring DVT/PE prophylaxis. During the first 3 weeks of treatment, DVT/PE patients should receive rivaroxaban 15mg twice daily with food. After the initial loading phase, patients should receive rivaroxaban 20mg daily for the remaining treatment duration. Rivaroxaban is available in 10mg, 15mg, and 20mg tablets and has a half-life of approximately 5-9 hours. Renally impaired patients may require dose adjustments when considering rivaroxaban - patients with CrCl ranging from 15 to 50 ml/min should receive 15 mg daily. No dose adjustments are needed for the prevention of DVT/PE. However, use of rivaroxaban in patients with CrCl < 15mL/min should be avoided for nonvalvular atrial fibrillation. Similarly, use of rivaroxaban in patients with CrCl < 30 ml/min should be avoided for DVT/PE treatment and prophylaxis. No adjustments are needed for patients with mild hepatic impairment, but should be avoided in patients with moderate to severe hepatic impairment (Child-Pugh classes B and C) and in patients with any hepatic disease associated with coagulopathy. The conversion from warfarin to rivaroxaban begins by stopping warfarin and starting rivaroxaban when the INR falls
3 below 3. Conversely, discontinue rivaroxaban and begin both parenteral anticoagulant and warfarin at the same time of the next dose when rivaroxaban would have been taken. Routine laboratory monitoring for rivaroxaban is not required but the prothrombin time (PT)/INR may be used prior to invasive procedures or for life-threatening bleeding. Avoid concomitant use of drugs that inhibit CYP3A4 and p- glycoprotein (e.g. ketoconazole, itraconazole, ritonavir (alone, or in combination with lopinavir or indinavir), conivaptan) and CYP3A4/p-glycoprotein inducers (e.g. carbamazepine, phenytoin, rifampin, St. John s Wort). Apixaban (Eliquis ) 5 This agent is FDA-approved for use in prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; tablet strengths include 2.5 mg and 5 mg. In patients presenting with 2 or more of the following characteristics: (1) 80 years of age or older; (2) weighing 60kg; (3) presenting with serum creatinine 1.5mg/dL, apixaban should be dosed at 2.5mg twice daily. Otherwise, most patients start at 5mg twice daily. No dose adjustment is needed for mild hepatic impairment, but patients with severe hepatic impairment should avoid taking this drug. The conversion from warfarin to apixaban begins with discontinuing warfarin and starting apixaban when the INR falls below 2. If switching from apixaban to warfarin, stop apixaban and start both parenteral anticoagulant and warfarin when the next dose of apixaban would have been given. Similar to dabigatran and rivaroxaban recipients, apixaban recipients generally do not require laboratory monitoring. However, PT/INR may be analyzed in the event of life-threatening bleeding or if emergent reversal is needed. Patients taking strong dual inhibitors of CYP3A4 and p-glycoprotein should receive apixaban 2.5 mg twice daily. Patients taking drugs that induce CYP3A4 and p-glycoprotein (carbamazepine, phenytoin, rifampin, St. John s Wort) should avoid taking apixaban. BLEEDING RISK In stroke prevention trials that included non-valvular atrial fibrillation patients, major bleeding rates did not differ between dabigatran and rivaroxaban compared with warfarin; lower rates occurred in apixaban recipients relative to warfarin recipients. 6-8 Lower rates of intracranial hemorrhage have been reported in patients with non-valvular atrial fibrillation who received rivaroxaban, apixaban, and dabigatran, relative to warfarin-treated patients. Gastrointestinal bleeding occurred more frequently in dabigatran-treated patients and rivaroxaban-treated patients relative to warfarin, whereas there was no difference between apixaban and warfarin. Rivaroxaban therapy resulted in comparable major bleeding rates compared to enoxaparin/warfarin therapy in a phase 3 acute DVT study 10, whereas major bleeding rates were 50% lower in rivaroxaban recipients compared with the enoxaparin/warfarin treatment group in a phase 3 acute PE clinical trial 11. REVERSAL OF NEWER ANTICOAGULANTS At present, no antidote is available for the newer anticoagulants. However, participants of the Thrombosis and Hemostasis Summit of North America recommended the following measures for reversing the effect of these agents 12 : (1) Supportive Care: Patients treated with apixaban, dabigatran, or rivaroxaban who present with significant bleeding or the need for emergent surgery should receive routine usual supportive care including fluid resuscitation, red blood cell transfusions, maintenance of renal function, identification of bleeding source, and surgical intervention as needed. (2) Discontinuation of drug: Given the relatively short half-lives of the new oral anticoagulants, withholding further doses and supportive care is likely to be sufficient for many patients. In patients with normal renal function, most of the anticoagulant effect of new medications should dissipate within a day or two.
4 (3) Activated charcoal: If oral drug intake was within a couple hours of presentation, oral activated charcoal offers a low side effect treatment option. (4) Hemodialysis and hemoperfusion: This should be considered for dabigatran recipients, as 2/3 of the drug will be removed in a few hours. Use of dialysis is unlikely to be effective for apixaban or dabigatran, as they are highly protein-bound. (5) The use of factor VIIa in nonhemophiliac patients is associated with an increase in arterial thrombosis. Human rviia decreases the bleeding time in rats that have been given dabigatran or rivaroxaban, however, it does not reverse the anticoagulation effect as measured by most laboratory tests in this model. There have been no human studies to date and it is unclear if this therapy will be useful for emergent anticoagulation reversal. (6) Prothrombin complex concentrate (PCC): The use of either 3-factor or 4-factor PCCs have the potential to increase the risk of thrombosis. One nonactivated 4-factor PCC has been shown to normalize PT in human volunteers that received rivaroxaban, but did not normalize the aptt or thrombin time in dabigatran recipients. There have been no studies evaluating the effect of PCCs on bleeding in humans receiving the new oral anticoagulants. Whether use of PCCs will be effective to stop critical bleeding or reverse the anticoagulant effects of the new agents enough to safely proceed with emergent surgery is not established, but seems, given the current state of information, to be a reasonable approach in dire clinical situations in the opinion of several of the authors. Importantly, however, consensus was not reached regarding PCC, as two authors felt that PCC cannot be recommended at this time due to absence of data. All authors agreed that an equally justifiable approach, based on the current level of information, is to continue supportive care and local measures to arrest bleeding. Of note, the University of Washington Anticoagulation Clinic uses the following guideline for emergent reversal for life-threatening bleeding 13 : Drug Apixaban Dabigatran Rivaroxaban Emergent Reversal for Life-Threatening Bleeding Monitor PT/INR and anti-factor Xa assay to confirm reversal Monitor aptt and/or DTI assay to confirm reversal Monitor PT/INR and anti-factor Xa assay to confirm reversal
5 REFERENCES 1. Ageno WA, Gallus Wittkowsky AS, et al. Oral Anticoagulant Therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9 th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl): e44s-e88s. 2. Phillips KW, Ansell J. The clinical implications of new oral anticoagulants: will the potential advantages be achieved? Thromb Haemost 2010; 103: Dabigatran (Pradaxa ) prescribing information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; December Rivaroxaban (Xarelto ) prescribing information. Titusville, NJ: Janssen Pharmaceuticals; November Apixaban (Eliquis ) prescribing information. Princeton, NJ: Bristol-Myers Squibb Company; December Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: Granger CB, Alexander JH, McMurray JJV, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365: Furie KL, Goldstein LB, Albers GW, et al. Oral anti-thrombotic agents for the prevention of stroke in nonvalvular atrial fibrillation: a Science Advisory for Healthcare Professionals from the American Heart Association/American Stroke Association. Stroke 2012; 43: The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363: The EINSTEIN PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366: Kaatz S, Kouides PA, Garcia DA, et al. Guidance on the emergent reversal of oral thrombin and factor Xa inhibitors. Am J Hematol 2012; 87: S141-S University of Washington Medicine Anticoagulation Services: suggestions for reversal and management of bleeding. Accessed June 21, 2013.
Failure or significant adverse effects to all of the alternatives: Eliquis and Xarelto
This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics
More informationMEDICAL ASSISTANCE HANDBOOK PRIOR AUTHORIZATION OF PHARMACEUTICAL SERVICES. A. Prescriptions That Require Prior Authorization
MEDICAL ASSISTANCE HBOOK PRI AUTHIZATION OF PHARMACEUTICAL SERVICES I. Requirements for Prior Authorization of Anticoagulants A. Prescriptions That Require Prior Authorization Prescriptions for Anticoagulants
More informationFDA Approved Oral Anticoagulants
FDA Approved Oral Anticoagulants Generic (Trade Name) Warfarin (Coumadin, Jantoven ) 1 FDA approved indication Prophylaxis and treatment of venous thromboembolism (VTE) Prophylaxis and treatment of thromboembolic
More informationDVT/PE Management with Rivaroxaban (Xarelto)
DVT/PE Management with Rivaroxaban (Xarelto) Rivaroxaban is FDA approved for the acute treatment of DVT and PE and reduction in risk of recurrence of DVT and PE. FDA approved indications: Non valvular
More informationThe author has no disclosures
Mary Bradbury, PharmD, BCPS Clinical Pharmacy Specialist, Cardiac Surgery September 18, 2012 Mary.bradbury@inova.org This presentation will discuss unlabeled and investigational use of products The author
More informationObjectives. New and Emerging Anticoagulants. Objectives (continued) 2/18/2014. Development of New Anticoagulants
Objectives New and Emerging Anticoagulants Adraine Lyles, PharmD, BCPS Clinical Pharmacy Specialist VCU Medical Center Describe the pharmacology of the novel oral anticoagulants Discuss the clinical evidence
More informationOut with the Old and in with the New? Target Specific Anticoagulants for Atrial Fibrillation
Out with the Old and in with the New? Target Specific Anticoagulants for Atrial Fibrillation Goal Statement Pharmacists and technicians will gain knowledge in the use of target specific oral anticoagulants
More informationMEDICAL ASSISTANCE HANDBOOK PRIOR AUTHORIZATION OF PHARMACEUTICAL SERVICES. A. Prescriptions That Require Prior Authorization
MEDICAL ASSISTANCE HBOOK I. Requirements for Prior Authorization of Anticoagulants A. Prescriptions That Require Prior Authorization Prescriptions for Anticoagulants which meet any of the following conditions
More informationDABIGATRAN ETEXILATE TARGET Vitamin K epoxide reductase WARFARIN RIVAROXABAN APIXABAN
TARGET SPECIFIC ORAL ANTICOAGULANTS (TSOACs) This document is intended as a guideline only and should not replace sound clinical judgment Please refer to UNMH formulary in Lexicomp for approved use(s)
More informationDevang M. Desai, MD, FACC, FSCAI Chief of Interventional Cardiology Director of Cardiac Catheterization Lab St. Mary s Hospital and Regional Medical
Devang M. Desai, MD, FACC, FSCAI Chief of Interventional Cardiology Director of Cardiac Catheterization Lab St. Mary s Hospital and Regional Medical Center A.Fib affects 2.2 million Americans. The lifetime
More informationThe Role of the Newer Anticoagulants
The Role of the Newer Anticoagulants WARFARIN = Coumadin DAGIBATRAN = Pradaxa RIVAROXABAN = Xarelto APIXABAN = Eliquis INDICATION DABIGATRAN (Pradaxa) RIVAROXABAN (Xarelto) APIXABAN (Eliquis) Stroke prevention
More informationTSOAC Initiation Checklist
Task Establish appropriate dose based on anticoagulant selected, indication and patient factors such as renal function. Evaluate for medication interactions that may necessitate TSOAC dose adjustment.
More informationPrescriber Guide. 20mg. 15mg. Simply Protecting More Patients. Simply Protecting More Patients
Prescriber Guide 20mg Simply Protecting More Patients 15mg Simply Protecting More Patients 1 Dear Doctor, This prescriber guide was produced by Bayer Israel in cooperation with the Ministry of Health as
More informationCommittee Approval Date: September 12, 2014 Next Review Date: September 2015
Medication Policy Manual Policy No: dru361 Topic: Pradaxa, dabigatran Date of Origin: September 12, 2014 Committee Approval Date: September 12, 2014 Next Review Date: September 2015 Effective Date: November
More informationMEDICAL ASSISTANCE BULLETIN
ISSUE DATE June 22, 2015 SUBJECT EFFECTIVE DATE MEDICAL ASSISTANCE BULLETIN NUMBER *See below BY Prior Authorization of Anticoagulants Pharmacy Service Leesa M. Allen, Deputy Secretary Office of Medical
More informationAnalyzing Clinical Trial Findings of the Efficacy and Safety Profiles of Novel Anticoagulants for Stroke Prevention in Atrial Fibrillation
Analyzing Clinical Trial Findings of the Efficacy and Safety Profiles of Novel Anticoagulants for Stroke Prevention in Atrial Fibrillation Drew Baldwin, MD Virginia Mason Seattle, Washington NCVH May 29,
More informationManagement for Deep Vein Thrombosis and New Agents
Management for Deep Vein Thrombosis and New Agents Mark Malesker, Pharm.D., FCCP, FCCP, FASHP, BCPS Professor of Pharmacy Practice and Medicine Creighton University 5 th Annual Creighton Cardiovascular
More informationOral Anticoagulants: What s New?
Oral Anticoagulants: What s New? Sallie Young, Pharm.D., BCPS (AQ-Cardiology) Clinical Pharmacy Specialist, Cardiology Penn State Hershey Medical Center syoung1@hmc.psu.edu August 2012 Oral Anticoagulant
More informationDisclosure/Conflict of Interest
NEW ORAL ANTICOAGULANTS: WHAT EVERY PHARMACIST SHOULD KNOW LORI B. HORNSBY, PHARMD, BCPS ASSOCIATE CLINICAL PROFESSOR AUHSOP CLINICAL PHARMACIST MIDTOWN MEDICAL CENTER OUTPATIENT CLINIC COLUMBUS, GEORGIA
More informationRivaroxaban (Xarelto ) by
Essentia Health Med Moment Short Video Tune-Up A brief overview of a new medication, or important new medication information Rivaroxaban (Xarelto ) by Richard Mullvain RPH BCPS (AQC) Current - August 2011
More informationNovel Anticoagulation Agents DISCLOSURES. Objectives ATRIAL FIBRILLATION TRIALS. NOAC Comparison 6/12/2015
Novel Anticoagulation Agents DISCLOSURES James W. Haynes, MD Department of Family Medicine Univ of TN Health Science Center (Chattanooga) Objectives Understand mechanism of action behind the NOAC agents
More informationHow To Compare The New Oral Anticoagulants
Disclosures The New Oral Anticoagulants: Are they better than Warfarin? Alan P. Agins, Ph.D. does not have any actual or potential conflicts of interest in relation to this CE activity. Alan Agins, Ph.D.
More information5/21/2012. Perioperative Use Issues. On admission: During hospitalization:
Dabigatran and Rivaroxaban: Challenges in the Perioperative Setting Claudia Swenson, Pharm.D., CDE, BC-ADM, FASHP Central Washington Hospital Wenatchee, WA claudia.swenson@cwhs.com Dabigatran and Rivaroxaban:
More informationDabigatran (Pradaxa) Guidelines
Dabigatran (Pradaxa) Guidelines Dabigatran is a new anticoagulant for reducing the risk of stroke in patients with atrial fibrillation. Dabigatran is a direct thrombin inhibitor, similar to warfarin, without
More information4/9/2015. Risk Stratify Our Patients. Stroke Risk in AF: CHADS2 Scoring system JAMA 2001; 285: 2864-71
Anticoagulation in the 21 st Century Adam Karpman, D.O. Saint Francis Medical Center/Oklahoma State University Medical Center Disclosures: None Atrial Fibrillation Most common arrhythmia in clinical practice.
More informationHow To Treat Aneuricaagulation
Speaker Introduction Jessica Wilhoite, PharmD, BCACP Doctor of Pharmacy: Purdue University Postgraduate Residency Training: PGY1 Pharmacy Practice St. Vincent Hospital PGY2 Ambulatory Care St. Vincent
More informationExperience matters: Practical management in your hospital
Experience matters: Practical management in your hospital Dr AGG Turpie McMaster University, Hamilton, ON, Canada Disclosures AGG Turpie has acted as a consultant for Bayer HealthCare, Janssen, Sanofi-Aventis,
More informationThe New Kids on the Block: Oral Anticoagulants
The New Kids on the Block: Oral Anticoagulants Lauren E. Odum, PharmD, BCPS Clinical Assistant Professor UMKC School of Pharmacy at MU April 11, 2014 Objectives Be able to Understand the major trials leading
More informationHERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) RIVAROXABAN RECOMMENDED see specific recommendations for licensed indications below
Name: generic (trade) Rivaroxaban (Xarelto ) HERTFORDSHIRE MEDICINES MANAGEMENT COMMITTEE (HMMC) RIVAROXABAN RECOMMENDED see specific recommendations for licensed indications below What it is Indications
More informationMedication Policy Manual. Topic: Eliquis, apixaban Date of Origin: July 12, 2013. Committee Approval Date: July 11, 2014 Next Review Date: July 2015
Medication Policy Manual Policy No: dru313 Topic: Eliquis, apixaban Date of Origin: July 12, 2013 Committee Approval Date: July 11, 2014 Next Review Date: July 2015 Effective Date: August 1, 2014 IMPORTANT
More informationUSE AND INTERPRETATION OF LABORATORY COAGULATION TESTS IN PATIENTS WHO ARE RECEIVING A NEW ORAL ANTICOAGULANT (DABIGATRAN, RIVAROXABAN, APIXABAN)
USE AND INTERPRETATION OF LABORATORY COAGULATION TESTS IN PATIENTS WHO ARE RECEIVING A NEW ORAL ANTICOAGULANT (DABIGATRAN, RIVAROXABAN, APIXABAN) TARGET AUDIENCE: All Canadian health care professionals:
More informationThe speakers have attested that their presentation will be free of all commercial bias toward a specific company and its products.
Update on New Anticoagulants (Apixaban, Dabigatran and Rivaroxaban) Patient Safety Daniel B. DiCola, MD and Paul Ament,, Pharm.D Excela Heath, Latrobe, PA Disclosures: Paul Ament discloses that he receives
More informationNew Oral Anticoagulants in the Management of Atrial Fibrillation June, 2012 By Deborah K Brokaw, Pharm.D.
New Oral Anticoagulants in the Management of Atrial Fibrillation June, 2012 By Deborah K Brokaw, Pharm.D. Introduction Since the 1950 s, the only orally available anticoagulant has been the vitamin K antagonist
More informationDisclosure: Dr. Smith has no actual or potential conflict of interest associated with this presentation.
Disclosure: Dr. Smith has no actual or potential conflict of interest associated with this presentation. Michael Smith, Pharm. D., BCPS, CACP Pharmacy Clinical Manager William Backus Hospital You were
More informationKevin Saunders MD CCFP Rivergrove Medical Clinic Wellness Institute @ SOGH April 17 2013
Kevin Saunders MD CCFP Rivergrove Medical Clinic Wellness Institute @ SOGH April 17 2013 Family physician with Rivergrove Medical Clinic Practice in the north end since 1985 Medical Director of the Wellness
More informationCOMPARISON OF NEW ORAL ANTICOAGULANTS AND FREQUENTLY- ASKED QUESTIONS FROM PATIENTS. TARGET AUDIENCE: All Canadian health care professionals.
COMPARISON OF NEW ORAL ANTICOAGULANTS AND FREQUENTLY- ASKED QUESTIONS FROM PATIENTS AND PHYSICIANS TARGET AUDIENCE: All Canadian health care professionals. OBJECTIVES: To provide a comparison of the new
More informationSpeaker Disclosure. Outline. Pharmacist Objectives. Patient Case. Outline 9/4/2014
Speaker Disclosure Matthew K. Pitlick, Pharm.D., BCPS St. Louis College of Pharmacy/VA St. Louis HCS mpitlick@stlcop.edu Matthew K. Pitlick, Pharm.D., BCPS declares no conflicts of interest, real or apparent,
More information1/7/2012. Objectives. Epidemiology of Atrial Fibrillation(AF) Stroke in AF. Stroke Risk Stratification in AF
Objectives Atrial Fibrillation and Prevention of Thrombotic Complications: Therapeutic Update Andrea C. Flores Pharm.D Pharmacy Resident at the Miami VA Healthcare System Review the epidemiology, pathophysiology
More informationNew Oral Anticoagulants
New Oral Anticoagulants Tracy Minichiello, MD Associate Professor of Medicine Chief, San FranciscoVA Anticoagulation and Thrombosis Service Ansell, J. Hematology Copyright 2010 American Society of Hematology.
More informationTraditional anticoagulants
TEGH Family Practice Clinic Day April 4, 03 Use of Anticoagulants in 03: What s New (and What Isn t) Bill Geerts, MD, FRCPC Director, Thromboembolism Program, Sunnybrook HSC Professor of Medicine, University
More informationHow To Manage An Anticoagulant
PERI-OPERATIVE MANAGEMENT OF PATIENTS WHO ARE RECEIVING A NEW ORAL ANTICOAGULANT (DABIGATRAN, RIVAROXABAN, APIXABAN) TARGET AUDIENCE: All Canadian health care professionals, including primary care physicians,
More information48 th Annual Meeting. Non-VKA Oral Anticoagulants: Prevention & Treatment of Bleeding. Terminology. Disclosure. Public Health Impact.
48 th Annual Meeting Terminology Non-VKA Oral Anticoagulants: Prevention & Treatment of Bleeding Stacy A. Voils, PharmD, MS, BCPS Navigating the Oceans of Opportunity Target-specific oral anticoagulants
More informationAHA/ASA Scientific Statement Oral Antithrombotic Agents for the Prevention of Stroke in Atrial Fibrillation
AHA/ASA Scientific Statement Oral Antithrombotic Agents for the Prevention of Stroke in Atrial Fibrillation A Statement for Healthcare Professionals from the American Heart Association/American Stroke
More informationComparison between New Oral Anticoagulants and Warfarin
Comparison between New Oral Anticoagulants and Warfarin Warfarin was the mainstay of oral anticoagulant therapy until the recent discovery of more precise targets for therapy. In recent years, several
More informationNnEeWw DdEeVvEeLlOoPpMmEeNnTtSs IiıNn OoRrAaLl AaNnTtIiıCcOoAaGgUuLlAaTtIiıOoNn AaNnDd RrEeVvEeRrSsAaLl
NnEeWw DdEeVvEeLlOoPpMmEeNnTtSs IiıNn OoRrAaLl AaNnTtIiıCcOoAaGgUuLlAaTtIiıOoNn AaNnDd RrEeVvEeRrSsAaLl Mikele Wissing, RN June 2014 Introduction until recently, was the unrivaled medication for treatment
More informationBreadth of indications matters One drug for multiple indications
Breadth of indications matters One drug for multiple indications Sylvia Haas, MD, PhD Formerly of the Technical University of Munich Munich, Germany Disclosures: Sylvia Haas 1 Novel oral anticoagulants:
More informationQUICK REFERENCE. Mary Cushman 1 Wendy Lim 2 Neil A Zakai 1. University of Vermont 2. McMaster University
QUICK REFERENCE Clinical Practice Guide on Antithrombotic Drug Dosing and Management of Antithrombotic Drug- Associated Bleeding Complications in Adults February 2014* Mary Cushman 1 Wendy Lim 2 Neil A
More informationStop the Bleeding: Management of Drug-induced Coagulopathy. Stacy A. Voils, PharmD, BCPS Critical Care Specialist, Neurosurgery
Stop the Bleeding: Management of Drug-induced Coagulopathy Stacy A. Voils, PharmD, BCPS Critical Care Specialist, Neurosurgery Objectives Discuss contemporary management of warfarin reversal in patients
More informationPrior Authorization Guideline
Guideline Guideline Name Formulary Xarelto (rivaroxaban) UnitedHealthcare Community & State Approval Date 0/0/203 Revision Date 8//204 Technician Note: CPS Approval Date: /5/20; CPS Revision Date: 8/20/204
More informationEfficacy in Hip Arthroplasty. Efficacy in Knee Arthroplasty. Adverse Effects. Drug Interactions
Objectives Just for the RECORD: Rivaroxaban joins the US Anticoagulation Arsenal Anne P. Spencer, PharmD, FCCP, BCPS (AQ Cardiology) Cardiovascular Care Pharmacy Specialist Roper Saint Francis Healthcare
More informationOral Anticoagulation in Older Persons The Next Generation
Oral Anticoagulation in Older Persons The Next Generation Luis Viana B.Sc. Phm., Pharm D (candidate), M.Ed., ACPR, CGP Clinical Consultant Pharmacist, Medical Pharmacies Group Limited Adjunct Clinical
More informationMore information for patients and caregivers can be accessed at http://www.xarelto-us.com/.
Janssen Research & Development Submits Application to U.S. FDA for XARELTO (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome RARITAN, DECEMBER 29, 2011 -
More informationCardiovascular Disease
Cardiovascular Disease 1 Cardiovascular Disease 1. More target specific oral anticoagulants (TSOAC) 2. Vorapaxar (Zonivity) 3. Continued noise about a polypill 4. WATCHMAN 3 1 2 3 4 Left Atrial Appendage
More informationEliquis. Policy. covered: Eliquis is. indicated to. reduce the. therapy. Eliquis is. superior to. of 32 to. Eliquis is AMPLIFY. nonfatal. physicians.
Eliquis (apixaban) Policy Number: 5.01.573 Origination: 06/2014 Last Review: 07/2015 Next Review: 07/2016 Policy BCBSKC will provide coverage for Eliquis when it is determined to be medically necessary
More informationThree new/novel oral anticoagulants (NOAC) have been licensed in Ireland since 2008:
Key Points to consider when prescribing NOACs Introduction Three new/novel oral anticoagulants (NOAC) have been licensed in Ireland since 2008: Dabigatran Etexilate (Pradaxa ) 75mg, 110mg, 150mg. Rivaroxaban
More information9/28/15. Dabigatran. Rivaroxaban. Apixaban. Edoxaban. From the AC Forum Centers of Excellence website: Dabigatran, Rivaroxaban, & Apixaban
Identify the FDA approved direct oral anticoagulants (DOACs) Linda Kelly, PharmD, PhC, CACP Presbyterian Healthcare Services Distinguish the differences in the dosing of DOACs for various indications Describe
More informationNovel Oral Anticoagulants (NOACs) Prescriber Update 2013
Novel Oral Anticoagulants (NOACs) Prescriber Update 2013 Indications/Contraindications Indications Orthopedic VTE Prophylaxis VTE Treatment Stroke Prevention for non-valvular AF Contraindications 150 mg
More informationNew Oral Anticoagulant (Rivaroxaban [Xarelto])
TABLE OF CONTENTS New Oral Anticoagulant (Rivaroxaban [Xarelto]) 1-2 New Antiplatelet (Ticagrelor [Brilinta]) 2-3 Update on Dabigatran (Pradaxa) Safety and Use at UIMCC 3-4 What Methods are Available for
More informationCardiology Update 2014
Cardiology Update 2014 Update on the Novel Oral Anticoagulants (NOACS) Raymond Kawasaki, MD AMG Cardiology December 6, 2014 Disclosures I have no disclosures relevant to this presentation Contents I. The
More informationTeddie Gould, Pharm. D, BCPS
Teddie Gould, Pharm. D, BCPS Associate Professor of Pharmacy Practice College of Pharmacy, Idaho State University Clinical Pharmacist, Pocatello Cardiology Financial Disclosure Statement I have no relevant
More informationThrombosis management: A time for change practical management with NOACs Dr Wala Elizabeth Medical Director, Bayer Healthcare
Thrombosis management: A time for change practical management with NOACs Dr Wala Elizabeth Medical Director, Bayer Healthcare Kenya Association of Physicians Conference 10 th May 2013 New anticoagulants:
More informationTA 256: Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation
Service Notification in response to DHSSPS endorsed NICE Technology Appraisals TA 256: Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation 1 Name of Commissioning
More information2/17/2015 ANTICOAGULATION UPDATE OBJECTIVES BRIEF REVIEW: CLASSES OF ORAL ANTICOAGULANTS
ANTICOAGULATION UPDATE C AR R I E P AL M E R, D N P, RN, AN P - BC OBJECTIVES At the end of the presentation, the NP will be able to: Identify new indications for target-specific oral anticoagulants (TSOACs),
More informationNew Oral Anticoagulants. How safe are they outside the trials?
New Oral Anticoagulants How safe are they outside the trials? Objectives The need for anticoagulant therapy Indications for anticoagulation Traditional anticoagulant therapies Properties of new oral anticoagulants
More informationDisclosure. Warfarin
Disclosure No conflicts of interest to disclose Reversal Strategies for Novel Oral Anticoagulants Noelle de Leon, PharmD, BCPS Critical Care Pharmacist, Department of Pharmaceutical Services Assistant
More informationEast Kent Prescribing Group
East Kent Prescribing Group Rivaroxaban (Xarelto ) Safety Information Approved by the East Kent Prescribing Group. Approved by: East Kent Prescribing Group (Representing Ashford CCG, Canterbury and Coastal
More informationSTROKE PREVENTION IN ATRIAL FIBRILLATION
STROKE PREVENTION IN ATRIAL FIBRILLATION OBJECTIVE: To guide clinicians in the selection of antithrombotic therapy for the secondary prevention of ischemic stroke and arterial thromboembolism in patients
More informationSTARTING, SWITCHING OR STOPPING NEW ORAL ANTICOAGULANTS: A Practical Approach
STARTING, SWITCHING OR STOPPING NEW ORAL ANTICOAGULANTS: A Practical Approach Jeffrey I Weitz, MD, FRCP(C), FACP Professor of Medicine and Biochemistry McMaster University Canada Research Chair in Thrombosis
More informationThe New Anticoagulants are Here! Do you know how to use them? Arrhythmia Winter School February 11 th, 2012. Jeff Healey
The New Anticoagulants are Here! Do you know how to use them? Arrhythmia Winter School February 11 th, 2012 Jeff Healey RELY: A New Era in AF Connolly SJ et al. N Engl J Med 2009;361:1139-1151 ROCKET-AF:
More informationCardiovascular Subcommittee of PTAC Meeting held 27 February 2014. (minutes for web publishing)
Cardiovascular Subcommittee of PTAC Meeting held 27 February 2014 (minutes for web publishing) Cardiovascular Subcommittee minutes are published in accordance with the Terms of Reference for the Pharmacology
More informationNew Treatments for Stroke Prevention in Atrial Fibrillation. John C. Andrefsky, MD, FAHA NEOMED Internal Medicine Review course May 5 th, 2013
New Treatments for Stroke Prevention in Atrial Fibrillation John C. Andrefsky, MD, FAHA NEOMED Internal Medicine Review course May 5 th, 2013 Classification Paroxysmal atrial fibrillation (AF) Last < 7
More informationDOACs. What s in a name? or TSOACs. Blood Clot. Darra Cover, Pharm D. Clot Formation DOACs work here. Direct Oral AntiCoagulant
DOACs NOACs or TSOACs Generic Name DOACs Brand Name Mechanism of Action Direct Xa Inhibitor Direct Thrombin Inhibitor Dabigatran Pradaxa X Rivaroxaban Xarelto X Darra Cover, Pharm D Apixaban Eliquis X
More informationNHS FORTH VALLEY Rivaroxaban for Stroke Prevention in Atrial Fibrillation
NHS FORTH VALLEY Rivaroxaban for Stroke Prevention in Atrial Fibrillation Date of First Issue 06/06/2012 Approved 06/06/2012 Current Issue Date 29/10/2014 Review Date 29/10/2016 Version 1.4 EQIA Yes 01/06/2012
More informationOral anticoagulants new and old: bleeding risk and management strategies. Logan Tinsen Pharm.D. Benefis Hospitals
Oral anticoagulants new and old: bleeding risk and management strategies Logan Tinsen Pharm.D. Benefis Hospitals Disclaimer! I am not receiving any compensation from any drug company! Any opinions I may
More informationNew Anticoagulation Options for Stroke Prevention in Atrial Fibrillation. Joy Wahawisan, Pharm.D., BCPS April 25, 2012
New Anticoagulation Options for Stroke Prevention in Atrial Fibrillation Joy Wahawisan, Pharm.D., BCPS April 25, 2012 Stroke in Atrial Fibrillation % Stroke 1991;22:983. Age Range (years) CHADS 2 Risk
More informationNHS FORTH VALLEY RIVAROXABAN AS TREATMENT FOR DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM IN ADULTS
NHS FORTH VALLEY RIVAROXABAN AS TREATMENT FOR DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM IN ADULTS Date of First Issue 01/12/ 2012 Approved 15/11/2012 Current Issue Date 29/10/2014 Review Date 29/10/2016
More informationVenous Thromboembolism: Long Term Anticoagulation. Dan Johnson, Pharm.D.
Venous Thromboembolism: Long Term Anticoagulation Dan Johnson, Pharm.D. Disclosures No financial relationships with products discussed Off-label use of drug therapy always discussed Objectives Review clinical
More informationEINSTEIN DVT/PE IMPORTANT SAFETY INFORMATION
EINSTEIN DVT/PE % INDICATIONS is indicated for the treatment of deep vein thrombosis (DVT). is indicated for the treatment of pulmonary embolism (PE). is indicated for the reduction in the risk of recurrence
More informationTime of Offset of Action The Trial
New Antithrombotic Agents DISCLOSURE Relevant Financial Relationship(s) Speaker Bureau - None Consultant Amgen Tom DeLoughery, MD FACP FAWM Oregon Health and Sciences University What I am Talking About
More informationNewer Anticoagulants and Newer Diabetic Drug Classes. Nicole N. Nguyen, PharmD Senior Clinical Pharmacist Health Care Services August 21, 2013
Newer Anticoagulants and Newer Diabetic Drug Classes Nicole N. Nguyen, PharmD Senior Clinical Pharmacist Health Care Services August 21, 2013 Apixaban Newer Anticoagulants Dabigatran etexilate Rivaroxaban
More information3/3/2015. Patrick Cobb, MD, FACP March 2015
Patrick Cobb, MD, FACP March 2015 I, Patrick Cobb, MD, DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict
More informationHow To Understand The History Of Analgesic Drugs
New Developments in Oral Anticoagulants: Treating and Preventing Embolic Events in the 21 st Century David Stewart, PharmD, BCPS Associate Professor of Pharmacy Practice East Tennessee State University
More informationAssessing Oral Anticoagulants: A Review for the Pharmacist
INDIANA PHARMACISTS ALLIANCE (IPA) CONTINUING PHARMACY EDUCATION (CPE) 2013 Article Assessing Oral Anticoagulants: A Review for the Pharmacist Authors: Kendra Feltz, Pharm.D., BCPS Clinical Pharmacist
More informationHow To Treat A Stroke With Warfarin
Financial Disclosure Statement I have no relevant financial interests with respect to this subject. Teddie Gould, Pharm. D, BCPS Associate Professor of Pharmacy Practice College of Pharmacy, Idaho State
More informationNHS FORTH VALLEY Rivaroxaban for Stroke Prevention in Atrial Fibrillation
NHS FORTH VALLEY Rivaroxaban for Stroke Prevention in Atrial Fibrillation Date of First Issue 06/06/2012 Approved 06/06/2012 Current Issue Date 06/06/2012 Review Date 06/06/2014 Version 1.1 EQIA Yes /
More informationhttp://www.medscape.org/viewarticle/808338_print
Page 1 of 18 From Medscape Education Cardiology Pharmacokinetics of Anticoagulants: Why It Matters Matthew A. Cavender, MD, MPH; Robert P. Giugliano, MD, SM CME Released: 07/31/2013 ; Valid for credit
More informationReversing the New Anticoagulants
Reversing the New Anticoagulants Disclosure Susan C. Lambe, MD Assistant Clinical Professor Department of Emergency Medicine University of California, San Francisco Roadmap for today 1 Roadmap for today
More informationNew Anticoagulation Agents and Their Reversal Agents. Objectives. Background 12/21/2015
New Anticoagulation Agents and Their Reversal Agents Jay Hazelcorn, Pharm.D. PGY-1 Pharmacy Resident Broward Health Medical Center Objectives Review the pharmacology, indications, and place in therapy
More informationNews Release. Media contacts: Ernie Knewitz Tel: 908.927.2953 Mobile: 917.697.2318 eknewitz@its.jnj.com
News Release Media contacts: Ernie Knewitz Tel: 908.927.2953 Mobile: 917.697.2318 eknewitz@its.jnj.com Shaun Mickus Phone: 908.927.2416 Mobile: 973.476.7144 smickus@its.jnj.com Investor contacts: Stan
More informationCardiac Diseases and Therapies ATRIAL FIBRILLATION RIVAROXABAN CLINICIAN SUMMARY
Mechanism of Action: Direct Factor Xa inhibitor BACKGROUND Rivaroxaban is a direct Factor Xa inhibitor that is administered orally. Rivaroxaban is currently indicated for: - prevention of venous thromboembolic
More informationGuideline for the Prescribing of Novel Oral Anticoagulants (NOACs): Dabigatran (Pradaxa ), Rivaroxaban (Xarelto ), Apixaban (Eliquis )
Guideline for the Prescribing of Novel Oral Anticoagulants (NOACs): Dabigatran (Pradaxa ), Rivaroxaban (Xarelto ), Apixaban (Eliquis ) The contents of this CPG are to be used as a guide. Healthcare professionals
More informationABOUT XARELTO CLINICAL STUDIES
ABOUT XARELTO CLINICAL STUDIES FAST FACTS Xarelto (rivaroxaban) is a novel, oral direct Factor Xa inhibitor. On September 30, 2008, the European Commission granted marketing approval for Xarelto for the
More informationGuideline for managing patients on a factor Xa inhibitor Apixaban (Eliquis ) or Rivaroxaban (Xarelto )
Guideline [Optional heading here. Change font size to suit] Document Number # QH-GDL-950:2014-2 Guideline for managing patients on a factor Xa inhibitor Apixaban (Eliquis ) or Rivaroxaban (Xarelto ) 1.
More informationDabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism ERRATUM
Dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism ERRATUM This report was commissioned by the NIHR HTA Programme as project number 12/78
More informationRecommendations on Use of Dabigatran in Atrial Fibrillation
Recommendations on Use of Dabigatran in Atrial Fibrillation Developed by participants from the Section of Hematology/Oncology and Section of Cardiology, and Faculty of Pharmacy, University of Manitoba
More informationThe 50-year Quest to Replace Warfarin: Novel Anticoagulants Define a New Era. CCRN State of the Heart 2012 June 2, 2012
The 50-year Quest to Replace Warfarin: Novel Anticoagulants Define a New Era CCRN State of the Heart 2012 June 2, 2012 Disclosures I have I have been involved in trials of new anticoagulants and have received
More informationxaban) Policy covered: Coverage of following criteria: the following those who meet the or Hip Xarelto is For those impacted by this policy.
Xarelto (rivarox xaban) Policy Number: 5.01.575 Origination: 06/2014 Last Review: 07/2015 Next Review: 07/2016 Policy BCBSKC will provide coverage for Xarelto when it is determined to be medically necessary
More informationNew Oral Anticoagulants Increase Risk for Gastrointestinal Bleeding - A Systematic Review and Meta-Analysis
New Oral Anticoagulants Increase Risk for Gastrointestinal Bleeding - A Systematic Review and Meta-Analysis Holster IL, Valkhoff VE, Kuipers EJ, Tjwa ET Departments of Gastroenterology and Hepatology,
More informationRivaroxaban (Xarelto) in the management of stroke and DVT
Rivaroxaban (Xarelto) in the management of stroke and DVT Steve Chaplin MSc, MRPharmS, Victoria Haunton BM, DGM, MRCP, Thompson Robinson BMedSci, MD, FRCP and Catherine Bagot MD, FRCPath KEY POINTS is
More information