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特罗凯(Tarceva)中文说明书

    特罗凯主要针对吸烟的人群设计,可以对非小细胞肺癌起到治疗作用  

相关文章 秘鲁特罗凯怎么样  易瑞沙(IRESSA)中文说明  什么是二代易瑞沙 

  *目前肺癌最新的生物靶向治疗药物
  *临床研究证实能够显著延长肺癌患者生存期的靶向治疗药物
  *目前唯一在美国、加拿大、澳大利亚和欧盟批准上市的表皮生长因子受体酪氨酸激酶抑制剂
  【药品名称】
  商品名:特罗凯
  [1]通用名:盐酸厄洛替尼片
  英文商品名:Tavceva
  英文通用名:Erlotinib HCL Tablets
  份子结构名:盐酸厄洛替尼片
  化学名称:
  N-(3-乙炔苯基)-6,7-双(2-甲氧乙氧基)-4-喹啉胺盐酸盐
  化学结构式:
  分子式:C22H23N3O4·HCl
  分子量:429.90
  【成份】每片内含150mg厄洛替尼(以盐酸厄洛替尼形式存在)
  【性状】圆形、双凸、白色包衣片,一面印有棕色"T"和"150",另一面空白。
  【作用机制】
  Tarceva的抗肿瘤作用机制主要为抑制表皮生长因子(EGFR)酪氨酸激酶胞内磷酸化。
  【药代动力学】
  Tarceva口服后60%吸收,半衰期约36小时,主要由CYP3A4代谢清除。口服Tarceva150mg的生物利用度约60%,4小时后达血浆峰浓度。对591例接受单药Tarceva治疗的药代动力学分析显示,达到稳定血药浓度需7-8 天,患者的年龄、体重、性别与药物的清除速率无显著关系,吸烟可使药物清除率增加24%。
  【适应症】
  Tarceva用于两个或两个以上化疗方案失败的局部晚期或转移的非小细胞肺癌的三线治疗。
  【禁忌症】对本品及成份过敏者禁用。
  【不良反应】
  最常见的不良反应是皮疹和腹泻,3/4度皮疹和腹泻的发生率分别为9%和6%,皮疹的中位出现时间是8天,腹泻中位出现时间为12天。
  发生率大于10%的不良反应有:皮疹、腹泻、食欲减低、疲劳、呼吸困难、咳嗽、恶心、感染、呕吐、口腔炎、瘙痒、皮肤干燥、结膜炎、角膜结膜炎、腹痛。
  肺毒性:
  有较少的报道提示在接受Tarceva治疗的NSCLC患者或其他实体瘤患者中可出现严重的间质性肺病(ILD),甚至导致死亡。在随机对照研究中,ILD的发生率是0.8%,并且这一发生率在Tarceva治疗组和安慰剂组是相同的。报道的ILD包括:肺炎、间质性肺炎、间质性肺病、闭塞性细支气管炎、肺纤维化、急性呼吸应激综合征和肺渗出。症状发生于治疗后5天~超过9个月,中位发生时间为47天。多数患者常有混杂因素导致ILD发生,如:之前有化疗/放疗、原有实质性肺疾病、肺转移或肺部感染。当有新出现的、难以解释的肺部症状,例如:呼吸困难、咳嗽、发热等,需进行检查评价,一旦诊断ILD,应停止继续使用Tarceva,并采取适当治疗。
  肝毒性:
  Tarceva治疗可引起无症状的肝转氨酶升高,因此,治疗期间应定期复查肝功能,包括:转氨酶、胆红素、碱性磷酸酶等,如果肝功能损害严重应减量或停药。肝功能损害常为暂时性的或伴有肝转移。
  较少报道有胃肠道出血,常发生于同时应用华法林的患者,所以,同时服用华法林或其他抗凝剂的患者应监测凝血酶原时间。
  老年患者:
  安全性和药代动力学在年轻人和老年患者中无明显差异,因此,应用于老年患者时不建议调整剂量。
  【肺 毒 性】
  有较少的报道提示在接受Tarceva治疗的NSCLC患者或其他实体瘤患者中可出现严重的间质性肺病(ILD),甚至导致死亡。在随机对照研究中,ILD的发生率是0.8%,并且这一发生率在Tarceva治疗组和安慰剂组是相同的。报道的ILD包括:肺炎、间质性肺炎、间质性肺病、闭塞性细支气管炎、肺纤维化、急性呼吸应激综合征和肺渗出。症状发生于治疗后5天~超过9个月,中位发生时间为47天。多数患者常有混杂因素导致ILD发生,如:之前有化疗/放疗、原有实质性肺疾病、肺转移或肺部感染。当有新出现的、难以解释的肺部症状,例如:呼吸困难、咳嗽、发热等,需进行检查评价,一旦诊断ILD,应停止继续使用Tarceva,并采取适当治疗。
  【肝 毒 性】
  特罗凯Tarceva治疗可引起无症状的肝转氨酶升高,因此,治疗期间应定期复查肝功能,包括:转氨酶、胆红素、碱性磷酸酶等,如果肝功能损害严重应减量或停药。肝功能损害常为暂时性的或伴有肝转移。
  较少报道有胃肠道出血,常发生于同时应用华法林的患者,所以,同时服用华法林或其他抗凝剂的患者应监测凝血酶原时间。
  【老年患者】
  安全性和药代动力学在年轻人和老年患者中无明显差异,因此,应用于老年患者时不建议调整剂量。
  【注意事项】本品必须在有此类药物使用经验的医生指导下使用,并仅在国家肿瘤药物临床试验基地或三级甲等医院使用。
  【用法与用量】本品必须在有此类药物使用经验的医生指导下使用,并仅在国家肿瘤药物临床试验基地或三级甲等医院使用。
  厄洛替尼单药用于非小细胞肺癌的推荐剂量为150mg/日,至少在进食前1小时或进食后2小时服用。持续用药直到疾病进展或出现不能耐受的毒性反应。无证据表明进展后继续治疗能使患者受益。
  【规 格】150mg
  【贮 存】
  25℃保存,15℃~30℃之间也可接受。
  【包 装】PVC泡罩包装;30片/盒。
  【新包】7片/盒
  【有效期】36个月
  【进口药品注册证号】H20060108
  【生产企业】Roche Pharma(Schweiz)Ltd.
  特罗凯的作用机理是什么?
  特罗凯的作用途径与化疗不同,是一种靶向治疗药物,可特异性地针对肿瘤细胞作用,抑制肿瘤的形成和生长。它是一种小分子化合物,可抑制人表皮生长因子受体(EGFR)的信号传导途径;是表皮生长因子(又可称HER1)信号传导通路的关键组分,在多种肿瘤细胞的形成及生长中都扮演了重要的角色。特罗凯的通过抑制酪氨酸激酶的活性的方式来抑制肿瘤生长,酪氨酸激酶是EGFR细胞内的重要组成部分之一。

==== 汉译英 ====

* At present, the latest bio-targeted therapy of lung cancer drug
* Clinical study confirmed that patients with lung cancer can significantly extend the survival of the targeted therapy drugs
* Currently only in the United States, Canada, Australia and the European Union approved the listing of epidermal growth factor receptor tyrosine kinase inhibitors
【Drug name】
Product Name: Tarceva
[1] Common name: Erlotinib hydrochloride tablets
English trade name: Tavceva
English Common Name: Erlotinib HCL Tablets
Elements of the structure name: Erlotinib hydrochloride tablets
Chemical Name:
N-(3 - acetylene phenyl) -6,7 - bis (2 - methoxy-ethoxy) -4 - quinoline hydrochloride
Chemical Structure:
Molecular formula: C22H23N3O4 · HCl
MW: 429.90
【Ingredients】 contains 150mg per tablet Erlotinib (in the form of Erlotinib hydrochloride)
【Properties】 circular, double-convex, white coated tablets, one side printed with brown "T" and "150" on one side and a blank.
【Mechanism】
The anti-tumor mechanism of Tarceva mainly inhibit epidermal growth factor (EGFR) tyrosine kinase intracellular phosphorylation.
Pharmacokinetics】
Tarceva, after oral administration of 60% absorption, half-life of about 36 hours, mainly by the CYP3A4 metabolic clearance. Tarceva150mg oral bioavailability of about 60%, 4 hours after the peak concentration reached in plasma. Of 591 cases receiving single-agent Tarceva therapy pharmacokinetics analysis showed that plasma concentration required to reach a steady 7-8 days, the patient's age, weight, sex and drug clearance rate was no significant relationship between drug clearance rate of smoking can increase of 24%.
【Indications】
Tarceva for two or more chemotherapy failure of locally advanced or metastatic non-small cell lung cancer third-line therapy.
】 【Contraindication for this product and the ingredients were banned allergies.
Adverse reactions 【】
The most common adverse reactions are skin rash and diarrhea, 3 / 4 degree of skin rash and diarrhea rates were 9% and 6%, skin rash occurs, the median time is 8 days, diarrhea occurred a median time of 12 days.
The incidence of greater than 10% of the adverse reactions include: skin rash, diarrhea, reduced appetite, fatigue, difficulty breathing, cough, nausea, infection, vomiting, stomatitis, pruritus, dry skin, conjunctivitis, corneal conjunctivitis, abdominal pain.
Pulmonary toxicity:
There are fewer reports of prompt treatment of NSCLC receiving Tarceva patients or patients with other solid tumors can be severe interstitial lung disease (ILD), and even lead to death. In the randomized controlled studies, ILD incidence is 0.8%, and the incidence rate in the Tarceva treatment group and placebo group are the same. ILD reported include: pneumonia, interstitial pneumonia, interstitial lung disease, bronchiolitis obliterans, pulmonary fibrosis, acute respiratory stress syndrome and pulmonary effusion. Occurred in the treatment of symptoms after 5 days to more than 9 months, with a median time of occurrence of 47 days. Most patients are often confounding factors have led to ILD occurred, such as: preceded by chemotherapy / radiotherapy, the original parenchymal lung disease, lung metastases or lung infection. When a new, difficult to explain pulmonary symptoms, such as: difficulty breathing, coughing, fever and so on, need to check evaluation, once the diagnosis of ILD, should stop the continued use of Tarceva, and to take appropriate treatment.
Hepatotoxicity:
Tarceva treatment can cause asymptomatic elevated liver transaminase, therefore, should be regularly reviewed during the treatment of liver function, including: transaminase, bilirubin, alkaline phosphatase, etc., if severe liver dysfunction should be reduction or withdrawal. Liver dysfunction often is accompanied by temporary or liver metastases.
There are fewer reports of gastrointestinal bleeding, often occurs at the same time in patients with warfarin, therefore, while taking warfarin or other anticoagulants should be monitored in patients with prothrombin time.
Elderly Patients:
Safety and pharmacokinetics in young and elderly patients was no significant difference, therefore, when used in elderly patients is not recommended to adjust dosage.
【Pulmonary toxicity】
There are fewer reports of prompt treatment of NSCLC receiving Tarceva patients or patients with other solid tumors can be severe interstitial lung disease (ILD), and even lead to death. In the randomized controlled studies, ILD incidence is 0.8%, and the incidence rate in the Tarceva treatment group and placebo group are the same. ILD reported include: pneumonia, interstitial pneumonia, interstitial lung disease, bronchiolitis obliterans, pulmonary fibrosis, acute respiratory stress syndrome and pulmonary effusion. Occurred in the treatment of symptoms after 5 days to more than 9 months, with a median time of occurrence of 47 days. Most patients are often confounding factors have led to ILD occurred, such as: preceded by chemotherapy / radiotherapy, the original parenchymal lung disease, lung metastases or lung infection. When a new, difficult to explain pulmonary symptoms, such as: difficulty breathing, coughing, fever and so on, need to check evaluation, once the diagnosis of ILD, should stop the continued use of Tarceva, and to take appropriate treatment.
【Liver toxicity】
Tarceva Tarceva treatment can cause asymptomatic elevated liver transaminase, therefore, should be regularly reviewed during the treatment of liver function, including: transaminase, bilirubin, alkaline phosphatase, etc., if severe liver dysfunction should be reduction or stop medicine. Liver dysfunction often is accompanied by temporary or liver metastases.
There are fewer reports of gastrointestinal bleeding, often occurs at the same time in patients with warfarin, therefore, while taking warfarin or other anticoagulants should be monitored in patients with prothrombin time.
【Elderly patients】
Safety and pharmacokinetics in young and elderly patients was no significant difference, therefore, when used in elderly patients is not recommended to adjust dosage.
【Note】 The product must be of such drug use under the guidance of experienced doctors to use, and only at the national cancer clinical trials of drug base or three A-level hospitals.
【Usage and Dosage】 This product must be of such drug use under the guidance of experienced doctors to use, and only at the national cancer clinical trials of drug base or three A-level hospitals.
Erlotinib monotherapy for non-small cell lung cancer The recommended dose of 150mg / day, at least 1 hour before eating or 2 hours after eating take. Continuing medication until disease progression or toxicity occurred can not be tolerated. There is no evidence that progress will continue after treatment can benefit patients.
【Specification】 150mg
【Storage】
25 ℃ to save, 15 ℃ ~ 30 ℃ between acceptable.
【Packing】 PVC blister packaging; 30 / box.
【7】 new package / box
【Valid Period】 36 months
【Imported drug registration证号】 H20060108
【Manufacturer】 Roche Pharma (Schweiz) Ltd.
Tarceva Mechanism of that?
The role of Tarceva with chemotherapy in different ways, is a targeted therapy can be specifically targeting tumor cells, inhibit tumor formation and growth. It is a small molecule compounds, inhibit the human epidermal growth factor receptor (EGFR) signal transduction pathway; the epidermal growth factor (can also called HER1) signaling pathway key components in a variety of tumor cell formation and Growth has played an important role. Tarceva by inhibiting the tyrosine kinase activity of the ways to inhibit tumor growth of EGFR-tyrosine kinase is an important component of the cell is one.
 
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更新日期: 2014-06-27 09:10
作者: : mcyclub
修订: 1.11

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