英文药名: Eliquis tablets(Apixaban) 中文药名: 阿哌沙班片 生产厂家: 辉瑞日本公司 药品介绍 口服的FXa抑制剂 上市批准日期：2013年2月 开发商：辉瑞（Pfizer）和百时美施贵宝（Pfizer and Bristol-Myers Squibb） 适应证和用途 ELIQUIS是一种凝血因子Xa的抑制剂抗凝剂适用于在有非瓣膜病房颤患者中减低卒中和全身性栓塞的风险。 剂量和给药方法 （1）推荐剂量是5mg口服每天2次。 （2）在有至少下列特性之二患者：年龄≥80岁，体重≤60 kg，或血清肌酐≥1.5mg/dL，推荐剂量为2.5mg口服每天2次。 剂型和规格 片：2.5mg和5mg 禁忌证 （1）活动性病理性出血 （2）对ELIQUIS (apixaban)严重超敏性 警告和注意事项 （1）ELIQUIS可致严重，潜在致命性出血。及时评估失血的迹象和症状。 （2）人工心脏瓣膜：不建议使用ELIQUIS。 不良反应 最常见不良反应(>1%)是与出血有关。 药物相互作用 （1）强CYP3A4和P-gp的双重抑制剂增加apixaban的血水平：减低ELIQUIS剂量至2.5mg或避免同时使用。 （2）强CYP3A4和P-gp诱导剂的同时使用减低apixaban的血水平：避免同时使用。 特殊人群中使用 （1）哺乳母亲：终止药物或终止哺乳。 （2）妊娠：不建议使用. （3）严重肝受损：不建议使用 包装规格 ELIQUIS片 2.5毫克： 100錠（10錠×10）PTP　140錠（14錠×10）PTP，PTP500粒一瓶 ELIQUIS片 5mg： 100錠（10錠×10）PTP　140錠（14錠×10）PTP　PTP500粒一瓶 完整资料附件：http://www.info.pmda.go.jp/go/pack/3339004F1029_1_11/ The oral anticoagulant FXa inhibitor "Ellicose ® tablets" (generic name: apixaban) Notice on approval of new indications ■ Efficacy and safety were confirmed in patients with acute symptomatic venous thromboembolism in the AMPLIFY test of the oversea phase III trial comparing Ericucus and standard therapy and the AMPLIFY-J test in the domestic Phase III trial It was approved because it was. ■ A wide range of patients, from initial treatment of venous thromboembolism to suppression of recurrence, can be treated with Ericy single agent. Bristol-Myers Co., Ltd. (Headquarters: Tokyo, Shinjuku-ku, President: David Piras, hereinafter "Bristol-Myers") and Pfizer Inc. (Head Office: Shibuya-ku, Tokyo; Representative Director: Ichiro Umeda ") Concerning the oral anticoagulant FXa inhibitor" Ellicose ® tablets 2.5 mg, 5 mg "(common name: apixaban, hereinafter referred to as" Ericci ") developed jointly," venous thromboembolism (deep venous thrombosis We are pleased to announce the approval of a new indication for treatment and repression of recurrence and treatment of pulmonary thromboembolism). The approval of the new indication for treatment and relapse control of venous thromboembolism (VTE) in Japan is based on data such as the AMPLIFY test in oversea Phase III study and the AMPLIFY-J test in domestic Phase III study I am doing. In the AMPLIFY trial for acute symptomatic VTE patients, in the group receiving 10 mg twice daily (BID) for 7 days after oral administration of 5 mg BID for 6 months, overseas standard therapy (2.3% vs. 2.7%, relative risk 0.84, 95% CI: 1.7%) for the group receiving the enoxaparin/warfarin which is the main effectiveness eva luation item for symptomatic VTE recurrence or VTE related death, 0.60 - 1.18 for non - inferiority, P <0.0001 for non - inferiority), the risk of developing major bleeding, a major safety assessment item, was 69% lower than the standard therapy and showed superiority (0.6% vs. 1.8%, relative risk 0.31, 95% CI: 0.17 - 0.55, P <0.0001 for superiority). Also in the AMPLIFY-J trial of Japanese patients with acute symptomatic VTE, the rate of occurrence of major bleeding or clinically significant non-major bleeding events set as the primary endpoint was compared with that of Japanese standard treatment Compared with fractionated heparin/warfarin, Erythrocy showed good results, with similar results to the AMPLIFY study conducted overseas in safety and efficacy in VTE patients. The usages and dosages in this new indication and dose are "Orally administer 5 mg once a day after administering 10 mg twice daily for 7 days as an apixaban to adults for 7 days" . The additional approval of this indication and effect will provide new options for treatment of venous thromboembolism and suppression of recurrence as well as suppression of the onset of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation in Japan . Ericucus is indicated in the European Union (EU) in November 2012 and Canada, Japan, the United States etc. in December 2012 for the indication "Suppressing the development of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation" It is approved. Indications for "treatment of venous thromboembolism (deep vein thrombosis and pulmonary thromboembolism) and suppression of recurrence" are approved in the EU in July 2014 and in the US in August 2014, respectively. Bristol - Myers and Pfizer jointly promote Ericucus and will continue to contribute to improving the quality of life of patients through drug information provision activities aimed at promoting the proper use of pharmaceuticals. Outline of Ericuc® tablets Product name Eriicose ®tablets 2.5mg, 5mg (Eliquis ® tablet 2.5 mg/5mg) Common name Apixaban (Apixaban) Manufacturing marketing approval acquisition date December 25, 2012 Drug price list February 2013 Start selling February 2013 Manufacturer selling agency Bristol-Myers Co., Ltd. Distributor Pfizer Inc. Indication 1. Inhibition of onset of ischemic stroke and systemic embolism in non-valvular atrial fibrillation patients 2. Treatment of venous thromboembolism (deep venous thrombosis and pulmonary thromboembolism) and suppression of recurrence Dosage regimen 1. Inhibition of onset of ischemic stroke and systemic embolism in non-valvular atrial fibrillation patients Usually, adults are orally administered 5 mg once a day as apixaban once a day. In addition, depending on age, weight and renal function, 2.5 mg once a day as apixaban is reduced to twice a day. 2. Treatment of venous thromboembolism (deep venous thrombosis and pulmonary thromboembolism) and suppression of recurrence Usually, adults are orally administered once a day 10 mg as apixaban twice a day for 7 days, then orally administered 5 mg once a day twice a day.