ASH Clinical News June 2015 | Page 23

The #1 prescribed novel oral anticoagulant in the US*1 The patients they studied are the ones I see. AMONG NOVEL ORAL ANTICOAGULANTS: Most real-world experience: more than 2 million patients prescribed in the US.2 Most safety data generated in clinical trials in patients studied with high risk of thrombotic events.†3-16 Most affordable: the lowest average out-of-pocket cost.17 Not intended to be a comparison of safety or efficacy outcomes. *Among Factor Xa inhibitors and direct thrombin inhibitors. † Based on the following: CHADS2 scores 3-6 in ROCKET AF (N=12,402), ARISTOTLE (N=5502), ENGAGE-AF (N=~11,200), and RE-LY (N=5882); risk factors of DVT, PE, DVT/PE, cancer, elderly, previous VTE, provoked VTE, unprovoked VTE, and recent trauma or surgery in EINSTEIN pooled analysis (N=8281), AMPLIFY (N=5395), Hokusai-VTE (N=8240), and RE-COVER I and II (N=5107). IMPORTANT SAFETY INFORMATION WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO® INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA A. PREMATURE DISCONTINUATION OF XARELTO® INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including XARELTO®, increases the risk of thrombotic events. If anticoagulation with XARELTO® is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant. B. SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas have occurred in patients treated with XARELTO® who 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 non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants, see Drug Interactions A history of traumatic or repeated epidural or spinal punctures A history of spinal deformity or spinal surgery Optimal timing between the administration of XARELTO® and neuraxial procedures is not known 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. CHADS2 = congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack; DVT = deep vein thrombosis; PE = pulmonary embolism; VTE = venous thromboembolism. Please see Important Safety Information on following pages. Please see Brief Summary of full Prescribing Information, including Boxed WARNINGS, on following pages. LEARN WHY Model depiction of healthcare professional. XARELTO® is leading the new generation visit www.XARELTOhcp.com