您好,欢迎光临世界标品! 登录 注册(订药物标准品请用邮件联系我们)

中国医药研发对照标品提供商
Non-clinical Research-used
Medicine Sample Provider

当前本网站药物产品种数共 8473 处方药 8099 非处方药 268 保健品/医疗用具 106

世界标品医药目录搜索(中英文):
世界各国官方药品目录搜索(英文):
世界标品医药知识搜索(中英文):

联系方式
国内客服电话:
国际免费电话:


QQ客服1:1793093587
QQ客服2:1586083059
QQ客服3:2786706041
QQ客服6:2992753224
QQ客服7:2394834588

咨询邮箱:
scimed.shanghai@shijiebiaopin.com
info@shijiebiaopin.com
pharmacy.shijiebiaopin1@gmail.com
pharmacy.shijiebiaopin2@gmail.com

  药店国别: 美国药房
产地国家: 美国
所属类别: 抗癌药物->治疗细胞瘤药物
处方药:处方药
包装规格: 150毫克/胶囊 30胶囊/盒
计价单位:
   
生产厂家英文名:
GENENTECH
该药品相关信息网址1:
http://www.erivedge.com/
原产地英文商品名:
Erivedge 150mg 30 capsules
原产地英文药品名:
VISMODEGIB
中文参考商品译名:
Erivedge 150毫克/胶囊 30胶囊/盒
中文参考药品译名:
VISMODEGIB
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Metastatic basal cell carcinoma
临床试验期:
完成
中文适应病症参考翻译1:
转移性基底细胞癌
药品信息:
基底细胞癌新药-Erivedge(vismodegib)胶囊 制造商: Genentech公司 类药物: Hedgehog信号通路抑制剂。 活性成分(S): vismodegib 150毫克;帽。 指示(S): 治疗成人转移性基底细胞癌,基底细胞癌晚期,已复发,手术后或不适合手术的候选人,谁是没有辐射的候选人。 药理作用: vismodegib是Hedgehog信号通路抑制剂。 vismodegib结合并抑制理顺,参与hedgehog信号转导跨膜蛋白。 临床试验: 一个单臂,开放标签,2世代的审判进行了104例患者中,无论是转移性基底细胞癌(服C)(N = 33)或局部晚期基底细胞癌(laBCC)(N = 71)。 laBCC患者需要放疗后复发的病灶,除非放疗禁忌或不适当的,病变或者不能手术切除或手术切除会导致大量的畸形。患者接受每天150毫克vismodegib直至疾病进展或不可接受的毒性。 主要疗效测量结果是客观反应率(ORR),作为一个独立的审查教师评估。在服C队列,肿瘤的反应进行了评估,根据实体瘤疗效评价标准(RECIST标准)1.0版。肿瘤反应评估在laBCC队列,包括外部课税肿瘤的测量(包括SCAR)在照片和溃疡的评估,靶病变的影像学评估(如适用),肿瘤活检。在laBCC的ORR至少需要以下条件和没有任何疾病进展的标准之一:从基线靶病变的影像学评估;≥30%≥30%,减少病灶大小[最长的直径总和(SLD)]民主左翼联盟从基线减少外部可见维靶病变或溃疡在所有目标病灶的彻底解决。没有剩余BCC肿瘤活检取样的ORR(定义)被定义为完全缓解。病情恶化被定义为下列任何一项:≥20%的增长目标病变从低谷中SLD(通过照相或由外部可见的尺寸);新的目标,坚持没有证据表明,至少2周的愈合病变溃疡;新病变的影像学评估或体检;或RECIST标准由非靶病变的进展。 这项研究表明,Erivedge萎缩病变(客观反应率,或ORR)43%(27/63)与晚期基底细胞癌患者和30%的独立审查评估,转移性基底细胞癌患者(10/33)。的响应时间平均为7.6个月。 法律分类: RX 成人: 吞下。 150毫克,每天一次,直至疾病进展或不可接受的毒性。 儿童: 不成立的。 警告/注意事项: 胚胎胎儿死亡和严重的出生缺陷,孕妇的风险。验证怀孕状态之前开始治疗。律师病人(男性和女性)在治疗期间和之后的避孕需要。提醒患者,不捐,同时对治疗和至少7个月后的最后一剂的血液或血制品。怀孕(Cat.D)。哺乳母亲:不推荐。 互动(补): 可能可以由P-糖蛋白抑制剂(如红霉素,克拉霉素,阿奇霉素)。可拮抗药物,影响胃的pH值(例如,质子泵抑制剂,H2受体拮抗剂,制酸剂)。 不良反应(S): 肌肉痉挛,味觉障碍,脱发,消瘦,乏力,胃肠不适,食欲减退,便秘,关节痛,ageusia。 注释: 报告立即暴露在怀孕期间Erivedge由基因泰克不良事件线(888)835-2555联系。 ERIVEDGE Manufacturer: Genentech, Inc. Pharmacological Class: Hedgehog pathway inhibitor. Active Ingredient(s): Vismodegib 150mg; caps. Indication(s): Treatment of adults with metastatic basal cell carcinoma, or locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. Pharmacology: Vismodegib is an inhibitor of the Hedgehog pathway. Vismodegib binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction. Clinical Trials: A single-arm, open-label, 2-cohort trial was conducted in 104 patients with either metastatic basal cell carcinoma (mBCC) (n=33) or locally advanced basal cell carcinoma (laBCC) (n=71). Patients with laBCC were required to have lesions that had recurred after radiotherapy, unless radiotherapy was contraindicated or inappropriate, and where the lesions were either unresectable or surgical resection would result in substantial deformity. Patients were to receive 150mg vismodegib per day until disease progression or unacceptable toxicity. The major efficacy outcome measure was objective response rate (ORR) as assessed by an independent review faculty. In the mBCC cohort, tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. In the laBCC cohort, tumor response evaluation included measurement of externally assessable tumor (including scar) and assessment for ulceration in photographs, radiographic assessment of target lesions (if appropriate), and tumor biopsy. An ORR in laBCC required at least one of the following criteria and absence of any criterion for disease progression: ≥30% reduction in lesion size [sum of the longest diameter (SLD)] from baseline in target lesions by radiographic assessment; ≥30% reduction in SLD from baseline in externally visible dimension of target lesions; or complete resolution of ulceration in all target lesions. Complete response was defined as ORR (as defined previously) with no residual BCC on sampling tumor biopsy. Disease progression was defined as any of the following: ≥20% increase in the SLD from nadir in target lesions (either by radiography or by externally visible dimension); new ulceration of target lesions persisting without evidence of healing for at least 2 weeks; new lesions by radiographic assessment or physical examination; or progression of non-target lesions by RECIST. The study demonstrated that Erivedge shrank lesions (objective response rate, or ORR) in 43% (27/63) of patients with locally advanced BCC and 30% of patients (10/33) with metastatic BCC, as assessed by independent review. The median duration of response was 7.6 months. Legal Classification: Rx Adults: Swallow whole. 150mg once daily, until disease progression or unacceptable toxicity. Children: Not established. Warnings/Precautions: Risk of embryo-fetal death and severe birth defects in pregnant women. Verify pregnancy status prior to initiation of therapy. Counsel patients (males and females) on the need for contraception during and after treatment. Advise patients not to donate blood or blood products while on therapy and for at least 7 months after last dose. Pregnancy (Cat.D). Nursing mothers: not recommended. Interaction(s): May be potentiated by P-gp inhibitors (eg, clarithromycin, erythromycin, azithromycin). May be antagonized by drugs that affect gastric pH (eg, proton pump inhibitors, H2-receptor antagonists, antacids). Adverse Reaction(s): Muscle spasms, alopecia, dysgeusia, weight loss, fatigue, GI upset, decreased appetite, constipation, arthralgias, ageusia. Notes: Report immediately exposure to Erivedge during pregnancy by contacting the Genentech Adverse Event Line at (888) 835-2555.
更新日期: 2014-06-23
附件:
20147819135220.pdf    

 
调控比例: 100%
订购表单下载
Copyrights © 2010,2011,2012 www.ShiJieBiaoPin.com, Inc., All rights Reserved www.ShiJieBiaoPin.com, Inc.
客服工作时间:太平洋时间18:00-24:00
国内客服电话:     国际免费电话:
友情提示:以上电话为免费电话,无需您承担任何费用,世界标品提供中文客服,请您放心拨打!
电子邮箱:info.shijiebiaopin.com@gmail.com, info@shijiebiaopin.com