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1 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

2 Name of Drug, Description, and Mechanism of Action Name of Drug: Rivaroxaban (Xarelto ) Description: Oral Anticoagulant (Blood-Thinner) Factor Xa Inhibitor Mechanism of Action: Rivaroxaban selectively inhibits factor Xa without the need of cofactor (eg, anti-thrombin III) for activity

3 New Anticoagulants ORAL PARENTERAL TTP889 TF/VIIa TFPI (tifacogin) X IX Rivaroxaban Apixaban LY YM150 DU-176b Betrixaban TAK 442 IXa VIIIa Va Xa II AT APC (drotrecogin alfa) stm (ART-123) Fondaparinux Idraparinux DX-9065a Dabigatran IIa Fibrinogen Fibrin Adapted from Weitz & Bates, J Thromb Haemost 2007

4 Direct Factor Xa inhibition XIIa XIa IXa Xa Factor II (prothrombin) VIIa Rivaroxaban Apixaban YM150 DU-176b LY Betrixaban TAK 442 Tissue factor Fibrinogen Fibrin clot

5 FDA Approved Indication Rivaroxaban (Xarelto ) On July 1, 2011, FDA approved Xarelto (Rivaroxaban, Janssen Pharmaceuticals, Inc.) The first oral factor Xa inhibitor approved for deep vein thrombosis (DVT) prophylaxis in the U.S. Xarelto is indicated for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) after elective total hip or knee replacement surgery

6 Knee or Hip Replacement

7 Rivaroxaban (Xarelto ) Approval for DVT prophylaxis after hip and knee replacement was based on 3 studies in almost 10,000 patients The comparator was enoxaparin 40 mg once daily Not Approved for Atrial Fibrillation (Yet)! Scheduled to go before the FDA Advisory Committee on September 8, 2011 for A-Fib indication Comparator for A-Fib is Warfarin

8 Rivaroxaban (Xarelto) vs Dabigatran (Pradaxa) No Head to Head Data Available! Pradaxa, a Direct Thrombin Inhibitor, approved first for A-Fib, and trying to get approval for DVT prophylaxis and treatment Xarelto, a factor Xa Inhibitor, approved first for DVT prophylaxis, and trying to get approval for A-Fib and DVT Treatment

9 Dabi vs. Roxa RE-LY vs. ROCKET-AF Indication: Atrial Fibrillation Dabi Approved by FDA October 2010 Roxi Submit for FDA approval January 2011

10 Dabi vs. Roxa Open Label 18,130 patients 71.5 years old avg Indication: Atrial Fibrillation RE-LY vs. ROCKET-AF Double Blinded 14,000 patients 73 years old Lower Risk Patients? CHADS2 Score 2.1 Less HF & Stroke Patients 32% & 20% INR s Therapeutic 64% Drop Out Rate 20% Higer Risk Patients? CHADS2 Score 3.5 More HF & Stroke Patients 63% % 55% INR s Therapeutic 58% Drop Out Rate 25% Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, et al. Dabigatran versus Warfarin K Mahaffey in (Duke Clinical Research Institute, Durham, NC) American Heart Patients with Atrial Fibrillation. N Engl J Med. 2009; 361: (RE-LY) Association 2010 Scientific Sessions (ROCKET-AF)

11 Dosing information Rivaroxaban (Xarelto ) Xarelto is only available as a 10 mg tablet Fixed dose = 10 mg once daily Start 6 10 hours post-op, after hemostasis has been established Treatment duration 12 days after knee replacement 35 days after hip replacement

12 Rivaroxaban (Xarelto ): Kidney or Liver? Not recommended for patients with CrCl <30 ml/min. Should be used with caution in patients with CrCl 30 ml/min. to 49 ml/min. Discontinue rivaroxaban in the event of acute renal failure! Avoid use in moderate or severe liver disease

13 Kinetics Rivaroxaban (Xarelto ) Absorption Tmax, Oral: 2 to 4 hours Bioavailability, Oral: 80% to 100% Effects of food: no effect Distribution Vd: 50 L Protein binding, Albumin: 92% to 95% Metabolism Liver: major site Excretion Fecal: 28%, 7% unchanged Renal: 66%, 36% unchanged Dialyzable: No (hemodialysis) Total body clearance: 10 L/hr Elimination Half Life 5 to 9 hours (Age years old) 11 to 19 hours (Elderly)

14 Rivaroxaban (Xarelto ) FDA Boxed Warning: WARNING: SURGICAL SETINGS--SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients who are anticoagulated and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants a history of traumatic or repeated epidural or spinal punctures a history of spinal deformity or spinal surgery. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis

15 Rivaroxaban (Xarelto ) SPINAL/EPIDURAL HEMATOMA Epidural catheter withdrawal should not be attempted within 18 hours of the last rivaroxaban dose The first/next rivaroxaban dose should be held for at least six hours Withhold rivaroxaban for 24 hours after traumatic epidural or spinal puncture

16 Contraindications & Precautions Rivaroxaban (Xarelto ) Contraindicated in patients hypersensitive to rivaroxaban, and patients with active major bleeding Avoid in significant renal or hepatic impairment Dosing in pregnancy has not been studied

17 Rivaroxaban (Xarelto ) Drug Interactions Use rivaroxaban with caution in patients with increased bleeding risk. This includes concomitant use of medications that affect hemostasis NSAIDs Other antiplatelet drugs Other anticoagulants Fibrinolytics Avoid concomitant use of clopidogrel (Plavix) unless the benefit outweighs the increased bleeding risk Bleeding time was approximately twice the maximum increase seen with either Plavix or Xarelto alone There was no change in the pharmacokinetics of either drug

18 Drug Interactions with Rivaroxaban (Xarelto ) CYP3A4 inhibitors increase rivaroxaban concentrations ketoconazole, itraconazole, ritonavir, conivaptan Patients with renal impairment taking p-glycoprotein inhibitors that are also weak or moderate CYP3A4 inhibitors may be at increased bleeding risk Examples include: amiodarone, diltiazem, dronedarone, felodipine, macrolides, quinidine, ranolazine, and verapamil Drugs that are both p-glycoprotein inducers and strong CYP3A4 inducers may decrease rivaroxaban concentrations. Examples include: carbamazepine, phenytoin, rifampin, St. John s wort

19 Common Side Effects Rivaroxaban (Xarelto ) Bleeding is the most common adverse effect In clinical trials, the risk of bleeding was similar to that of enoxaparin (Lovenox) 40 mg once daily Major bleeding occurred in less than 1% of patients Less common: Muscle pain or spasm Syncope Pruritis or Blister Hepatobiliary disorders: jaundice, cholestasis, cytolytic hepatitis

20 Rivaroxaban (Xarelto ) : Overdose or Bleeding? There is no antidote! Interventions appropriate to the specific situation Hold Rivaroxaban (half-life 5 to 13 hours) Consider Blood transfusion & Compression Recombinant factor VIIa, prothrombin complex concentrate, or activated prothrombin complex concentrate can be considered, but have not been studied for reversing the effects of rivaroxaban Protamine and vitamin K would not be expected to help Due to the high plasma protein binding, rivaroxaban is not expected to be dialyzable

21 Final Comments Rivaroxaban (Xarelto ) Xarelto will cost about $8 per day vs around $25 to $50 for enoxaparin once-daily Can be taken with or without food May improve adherence over low-molecular weight heparin? Avoids the concern of heparin-induced thrombocytopenia and thrombosis (HITT), and it does not require laboratory monitoring

22 Rivaroxaban (Xarelto ) Links for more information on this drug: _PR/evidencexpert/CS/D37768/ND_AppProduct/evidencexpert/DUPLICATI ONSHIELDSYNC/03791E/ND_PG/evidencexpert/ND_B/evidencexpert/ND_ P/evidencexpert/PFActionId/evidencexpert.IntermediateToFullDocumentLin k/docid/929924/contentsetid/100/title/rivaroxaban/servicestitle/rivaroxaba n 1&cs=CEPDA&s=PL&pt=6&fpt=20&dd=270806&pb=PL

More information for patients and caregivers can be accessed at http://www.xarelto-us.com/.

More 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 -

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