savaysa(edoxaban)使用使用说明书201509版本.doc

批准时间：2015-01-08 Savaysa (edoxaban) 药品使用说明书 用于预防心房颤动（房颤）患者发生 中风和全身性栓塞（SE） HAOEYOU ( 好医友 ) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SAVAYSA? safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA (edoxaban) tablets for oral use Initial U.S. Approval: 2015 WARNING (A) REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLA- TION PATIENTS WITH CREATININE CLEARANCE (CRCL) > 95 ML/MIN (B) PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS (C) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning. (A) REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CRCL > 95 ML/MIN: SAVAYSA should not be used in patients with CrCL > 95 mL/min. In the ENGAGE AF-TIMI 48 study, nonval- vular atrial fibrillation patients with CrCL > 95 mL/min had an increased rate of ischemic stroke with SAVAYSA 60 mg once daily compared to patients treated with warfarin. In these patients another anticoagulant should be used (5.1). (B) PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS: Premature discontinuation of any oral anticoagu- lant in the absence of adequate alternative anticoagulation increases the risk of ischemic events. If SAVAYSA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant as described in the transition guid- ance (2.4, 5.2, 14). (C) SPINAL/EPIDURAL HEMATOMA: Epidural or spinal hematomas may occur in patients treated with SAVAYSA who are receiving neuraxial anes- thesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures (5.4). ______________________ INDICATIONS AND USAGE ____________________ SAVAYSA is a factor Xa inhibitor indicated: To reduce the risk of stroke and systemic embolism (SE) in patients with non- valv