药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(20212719594526.pdf,20212719593621.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文依度沙班处方资料(仅供参考)
【英文名称】SAVAYSA
【适用证】
SAVAYSA是因子Xa抑制剂表示:
降低非瓣膜性心房颤动(NVAF)患者中风和全身性栓塞(SE)的风险(1.1)
NVAF的使用限制
SAVAYSA不应用于肌酐清除率(CrCL)> 95 mL / min的患者,因为与研究的最高剂量华法林相比,缺血性卒中的风险增加(60 mg)(1.1) SAVAYSA适用于 用肠外抗凝剂初始治疗5到10天后治疗深静脉血栓形成(DVT)和肺栓塞(PE)(1.2)
【用法用量】
治疗NVAF:
在开始治疗前评估CrCL(2.1)
对于CrCL> 50至≤95mL / min的患者,推荐剂量为每日一次60 mg。 不要在CrCL> 95 mL / min(2.1)的患者中使用SAVAYSA
肌酐清除率为15至50 mL / min的患者每日一次减量至30 mg(2.1)
治疗DVT和PE:
推荐剂量为每日一次60毫克(2.2)
对于CrCL 15至50 mL / min或体重小于或等于60 kg或使用某些P-gp抑制剂(2.2)的患者,推荐剂量为每日30 mg
【注意事项】
出血:严重且可能致命的出血。 及时评估失血的体征和症状(5.2)
机械心脏瓣膜或中度至重度二尖瓣狭窄:不推荐使用(5.5)
【INDICATIONS AND USAGE】
SAVAYSA is a factor Xa inhibitor indicated:
To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1)
Limitation of Use for NVAF
SAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1) SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant (1.2)
【DOSAGE AND ADMINISTRATION】
Treatment of NVAF:
Assess CrCL before initiating therapy (2.1)
The recommended dose is 60 mg once daily in patients with CrCL >50 to ≤ 95 mL/min. Do not use SAVAYSA in patients with CrCL > 95 mL/min (2.1)
Reduce dose to 30 mg once daily in patients with creatinine clearance 15 to 50 mL/min (2.1)
Treatment of DVT and PE:
The recommended dose is 60 mg once daily (2.2)
The recommended dose is 30 mg once daily for patients with CrCL 15 to 50 mL/min or body weight less than or equal to 60 kg or who use certain P-gp inhibitors (2.2)
【WARNINGS AND PRECAUTIONS】
Bleeding: Serious and potentially fatal bleeding. Promptly evaluate signs and symptoms of blood loss (5.2)
Mechanical heart valves or moderate to severe mitralstenosis: Use is not recommended (5.5)
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(20212719594526.pdf,20212719593621.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- |