CardioSource WorldNews August 2013 | Page 28
Brief Summary of Prescribing Information for XARELTO® (rivaroxaban) XARELTO® (rivaroxaban) tablets, for oral use See package insert for full Prescribing Information WARNING: (A) DISCONTINUING XARELTO IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION INCREASES RISK OF STROKE, (B) SPINAL/EPIDURAL HEMATOMA A. DISCONTINUING XARELTO IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION Discontinuing XARELTO places patients at an increased risk of thrombotic events. An increased rate of stroke was observed following XARELTO discontinuation in clinical trials in atrial fibrillation patients. If anticoagulation with XARELTO must be discontinued for a reason other than pathological bleeding, consider administering another anticoagulant [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Clinical Studies (14.1) in full Prescribing Information]. 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 resu [???]\?H? \?X[?[? \?[ \?\????Y\? \?H ?\??? ?[? ??Y [[?? ]Y[? ??? ?[?[ ???Y \?\??X??? ]?[?[??X\?H H ?\???]?[?[??\Y \?[? ?[?[[X]?X\?[? \?H ]Y[? ?[?? YN?8?(?H \?H?[? ?[[??\Y \?[?]]\??8?(?H????Z][? \?H??\? ?Y?? ]Y??X?[[??\?\? ?X?\???\?\??Y[[?KZ[??[[X]?H ?Y??
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