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Xarelto(rivaroxaban,利伐沙班片)

2011-09-26 09:57:44  作者:新特药房  来源:中国新特药网天津分站  浏览次数:1510  文字大小:【】【】【
简介: 制造商:西安杨森治疗 类药物:Xa因子抑制剂。 活性成分(S):利伐沙班10毫克;片。 指示(S):预防的深静脉血栓(DVT),这可能会导致膝关节和髋关节置换手术病人的肺栓塞(PE)的。 药理学:利伐 ...

制造商:
西安杨森治疗

类药物:
Xa因子抑制剂。

活性成分(S):
利伐沙班10毫克;片。

指示(S):
预防的深静脉血栓(DVT),这可能会导致膝关节和髋关节置换手术病人的肺栓塞(PE)的。

药理学:
利伐沙班是口服生物可用的Xa因子抑制剂,选择性块的Xa因子的活性部位,不需要活性的辅助因子(如抗凝血酶III)。 X因子通过激活内在的和外在的途径,以Xa因子,起着核心作用在凝血级联。

临床试验:
三项试验进行评价利伐沙班的安全性和疗效。

两项随机,双盲研究(记录1和2)择期全髋关节置换手术的患者相比,利伐沙班10毫克,每日一次开始与依诺肝素40毫克的伤口封闭后至少有6至8小时,每日一次术前12小时开始。记录1,1513例患者接受利伐沙班; 1473例患者接受依诺肝素。经历静脉血栓栓塞(VTE)的患者占总数的百分比是1.1%,利伐沙班与依诺肝素组为3.9%,相对风险减少(RRR)为71%。在记录2,834例患者接受利伐沙班; 835例患者接受依诺肝素。在这项研究中,研究武器(利伐沙班:33.5 + / - 6.9天;依诺肝素:12.4 + / - 2.9天)治疗的时间长短不同的。经历VTE患者总数的百分比为2%,利伐沙班与依诺肝素组为8.4%,存款准备金率是76%。

择期全膝关节置换手术的患者进行了创纪录的3期试验。患者无论是利伐沙班10毫克,每天一次(813)或依诺肝素40毫克,每天一次(871)。在利伐沙班组,总VTE的比例为9.7%,依诺肝素组有18.8%;存款准备金率是48%。


法律分类:
接收

成人:
手术后6-10小时,一次止血建立。 10毫克,每日一次。臀围:35天的治疗。膝关节:治疗12天。随之而来的P - gp和强CYP3A4诱导剂(如卡马西平,苯妥英钠,利福平,圣约翰草):避免可能会增加食品,如有必要,以20mg每日一次。

儿童:
不推荐。

禁忌(S):
活动严重出血。

警告/注意事项:
在接受椎管内麻醉或抗凝治疗的患者进行脊椎穿刺脊髓/硬膜外血肿的风险增加,神经受损的症状/体征监测。条件与增加出血的危险。严重肾功能不全(肌酐清除率<30mL/min),中度或重度肝功能不全,肝脏疾病与凝血功能障碍相关:避免使用。密切监测血中度肾功能损害的损失;停止急性肾功能衰竭的发展。老人。劳动和交付。怀孕(目录三),使用时需谨慎,与妊娠有关的的出血风险。哺乳母亲:不推荐。

相互作用(S):
见成人剂量。伴随的血小板聚集抑制剂,其他抗栓药物,溶栓治疗,thienopyridines,长期使用非甾体抗炎药出血的风险增加。避免与随之而来的结合P - gp和强CYP3A4抑制剂(如酮康唑,伊曲康唑,洛匹那韦/利托那韦,利托那韦,茚地那韦/利托那韦,conivaptan)。五月potentiated伴肾功能不全,并结合P - gp和弱或中度CYP3A4抑制剂(如红霉素,阿奇霉素,地尔硫卓,维拉帕米,奎尼丁,雷诺嗪,决奈达隆,胺碘酮,非洛地平)。

不良反应(S):
出血,伤口分泌物,下肢肌肉痉挛,昏厥,瘙痒,水疱疼痛。

如何提供:
标签30,100(10X10吸塑卡)

最后更新:
2011年7月28日

FDA:Xarelto减轻膝髋关节置换术病人血凝风险

2011年7月1日,美国食品药物监管局(FDA)批准Xarelto (利伐沙班)用于减轻膝关节或髋关节替换手术后血栓、深静脉血栓(DVT)以及肺栓塞(PE)的形成。Xarelto每日服用一片。膝关节替换术后的病人应服用12天,髋关节置换术病人服用35天。
Xarelto的安全性和有效性在膝髋关节置换术病人中得到评估。临床试验通过使用Xarelto和依诺肝素(防止DVT和血液凝结药物)对比治疗确认治疗中患者发生静脉栓塞(VTE)、DVT、PE或者死亡事件。
“Xarelto代表了一种新的口服治疗方案,以防止膝髋关节置换术后患者的血液凝结”Richard Pazdur(医学博士、美国FDA抗肿瘤药物评价和研究中心主任)说。
超过6000的接受膝髋关节置换的病人使用了Xarelto。在接受膝关节置换术的病人中,服用Xarelto的病人中出现VTE的概率为9.7%,而服用依诺肝素的为18.8%。在一项髋关节置换术研究中,服用Xarelto的病人出现VTE的概率为1.1%,而服用依诺肝素的为3.9%。在另一项研究中,Xarelto的概率为2.0%,依诺肝素的为8.4%。
Xarelto治疗中最常见的副作用是出血。

其他FDA批准的防止血液凝固的药物包括只用于髋关节置换术的Lovenox(依诺肝素),依诺肝素的仿制药,Arixtra(fondaparinux),Fragmin(达肝素钠)。Coumadin(华法林)和肝素。
在美国市场,Xarelto由杨森制药公司销售。

XARELTO

Manufacturer:

Janssen Therapeutics

Pharmacological Class:

Factor Xa inhibitor.

Active Ingredient(s):

Rivaroxaban 10mg; tablets.

Indication(s):

Prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing knee and hip replacement surgery.

Pharmacology:

Rivaroxaban is an orally bioavailable factor Xa inhibitor that selectively blocks the active site of factor Xa and does not require a cofactor (such as Antithrombin III) for activity. Activation of factor X to factor Xa via the intrinsic and extrinsic pathways plays a central role in the cascade of blood coagulation.

Clinical Trials:

Three trials were conducted to ­evaluate the safety and efficacy of rivaroxaban.

Two randomized, double-blind, studies (RECORD 1 and 2) involving patients undergoing elective total hip replacement surgery compared rivaroxaban 10mg once daily starting at least 6 to 8 hours after wound closure versus enoxaparin 40mg once daily started 12 hours preoperatively. In RECORD 1, 1513 patients received rivaroxaban; 1473 patients received enoxaparin. The total percentage of patients experiencing venous thromboembolism (VTE) was 1.1% for the rivaroxaban group versus 3.9% for the enoxaparin group; relative risk reduction (RRR) was 71%. In RECORD 2, 834 patients received rivaroxaban; 835 patients received enoxaparin. In this study the treatment duration differed between study arms (rivaroxaban: 33.5 +/- 6.9 days; enoxaparin: 12.4 +/- 2.9 days). The total percentage of patients experiencing VTE was 2% for the rivaroxaban group versus 8.4% for the enoxaparin group; RRR was 76%.

The RECORD 3 trial was conducted in patients undergoing elective total knee replacement surgery. Patients were given either rivaroxaban 10mg once daily (813) or enoxaparin 40mg once daily (871). In the rivaroxaban group, the percentage of total VTE was 9.7%; the enoxaparin group had 18.8%; RRR was 48%.

Legal Classification:

Rx

Adults:

Take 6–10 hours after surgery once hemostasis established. 10mg once daily. Hip: treat for 35 days. Knee: treat for 12 days. Con­comitant P-gp and strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin, St. John’s wort): avoid; may increase to 20mg once daily with food if necessary.

Children:

Not recommended.

Contraindication(s):

Active major bleeding.

Warnings/Precautions:

Increased risk of spinal/epidural hematoma in anticoagulated patients receiving neuraxial anesthesia or undergoing spinal puncture; monitor for signs/symptoms of neurological impairment. Conditions with increased risk of hemorrhage. Severe renal impairment (CrCl<30mL/min), moderate or severe hepatic impairment, hepatic disease associated with coagulopathy: avoid. Monitor closely for blood loss with moderate renal impairment; discontinue if acute renal failure develops. Elderly. Labor & delivery. Pregnancy (Cat. C); use with caution, risk of pregnancy-related hemorrhage. Nursing mothers: not recommended.

Interaction(s):

See Adult dose. Increased risk of bleeding with concomitant platelet aggregation inhibitors, other antithrombotic agents, fibrinolytic therapy, thienopyridines, chronic use of NSAIDs. Avoid with concomitant combined P-gp and strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, lopinavir/ritonavir, rito­navir, indinavir/ritonavir, conivaptan). May be potentiated with concomitant renal impairment and combined P-gp and weak or moderate CYP3A4 inhibitors (eg, erythromycin, azithromycin, diltiazem, verapamil, quinidine, ranolazine, dronedarone, amiodarone, felodipine).

Adverse Reaction(s):

Bleeding, wound secretion, pain in extremity, muscle spasm, syncope, pruritus, blister.

How Supplied:

Tabs—30, 100 (10x10 blister cards)

责任编辑:admin


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