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尼罗替尼(Tasigna)中文说明书

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【商品名】尼罗替尼
【通用名】Tasigna
【英文名】nilotinib

【作用机制】
Tarceva的抗肿瘤作用机制主要为抑制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用于至少一种化疗方案失败的局部晚期或转移性NSCLC。

日前,白血病治疗新药Tasigna(尼洛替尼)在瑞士获得了世界范围内首个上市批准。该药是一种新型的靶向肿瘤治疗药物,对那些产生格列卫耐药的慢性粒细胞白血病患者疗效显著。
  慢性粒细胞白血病是四种最常见的白血病之一,在所有白血病病例中占15%。格列卫已经在包括美国、欧盟和日本在内的90多个国家被批准用于治疗各期慢性粒细胞白血病。
对产生格列卫®耐药的患者疗效显著
  这种新型抗肿瘤药物获得了世界范围内首个上市批准,它更加有效、优先地针对慢性粒细胞白血病的病因
  数据显示,在那些对格列卫产生了耐药或者不耐受的患者使用后,Tasigna显示了良好的耐受性、高有效率和便于管理的安全性
  美国和欧盟的管理机构有望在2007年做出注册批准,同时日本也于2007年第二季度提交了上市申请
  Tasigna的快速研发再次证明诺华履行了自己的承诺--不断研发创新药品,以满足患者尚未被满足的需求
  日前,Tasigna®(尼洛替尼)在瑞士获得了世界范围内首个上市批准。    
Tasigna是一种新型的靶向肿瘤治疗药物,它对那些产生格列卫®(伊马替尼)耐药或者不能耐受的慢性粒细胞白血病(CML)患者疗效显著。格列卫*是另外一种由诺华公司开发的用于治疗CML的优选药物。
  基于一项关键的II期临床试验所产生的积极结果,瑞士卫生管理机构在加快审评后批准了Tasigna。结果显示,病人使用Tasigna后有效率高、耐受性好、安全性可管理。
  每天服用两次,Tasigna可以通过靶向性地作用于Bcr-Abl蛋白,来抑制含有异常染色体的癌细胞的产生。Bcr-Abl蛋白是由含有异常的费城染色体的细胞产生的,在患有CML的患者中,这种蛋白质被认为是致癌白细胞过度增殖的一个重要因素。
  在临床试验中,使用Tasigna治疗后,42%的对格列卫耐药的慢性期费城染色体阳性(Ph+)CML患者会出现异常染色体减少或者消失的情况;而在处于加速期的患者中,也有31%的患者能够获得同样的效果。

==== 汉译英 ====

【Product Name】 Nilotinib
【Common name】 Tasigna
【English name】 nilotinib
【Mechanism】
The anti-tumor mechanism of Tarceva mainly inhibit intracellular EGFR tyrosine kinase 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 at least one chemotherapy regimen for the failure of locally advanced or metastatic NSCLC.

Recently, the leukemia drug Tasigna (nilotinib) in Switzerland won the first world-wide market approval. The drug is a new targeted cancer therapies, for those who produce Gleevec-resistant chronic myeloid leukemia patients with significant effect.
Chronic myeloid leukemia is one of the four most common leukemia in all leukemia cases accounted for 15%. Gleevec has been in the United States, the European Union and Japan, including more than 90 countries have been approved for the treatment phases of chronic myeloid leukemia.
That produce Gleevec ®-resistant patients with significant effect
The new anticancer drug first gained world-wide market approval, it is more effective, giving priority to the cause of chronic myeloid leukemia
Data show that, among those who had a right Gleevec-resistant or intolerant patients after use, Tasigna showed good tolerability, high-efficient and manageable security
U.S. and EU regulatory agencies are expected to make a registered and approved in 2007, while Japan is also in the second quarter of 2007, filed to go public
Tasigna once again proves the rapid development of Novartis to fulfill its own commitments - continued development of innovative medicines to meet unmet needs of patients
Recently, Tasigna ® (nilotinib) in Switzerland won the first world-wide market approval.
Tasigna is a new type of targeted cancer therapy, it those arising from Gleevec ® (imatinib mesylate)-resistant or intolerant chronic myeloid leukemia (CML) patients with significant effect. Gleevec * is another developed by Novartis and the preferred drug for the treatment of CML.
Based on a key phase II clinical trial produced positive results, the Swiss health authority to review and approved by accelerating the Tasigna. The results showed that patients after the use of Tasigna high efficiency, good tolerance, security, manageability.
Take twice daily, Tasigna targeted manner by acting on the Bcr-Abl protein, to inhibit cancer cells containing abnormal chromosome generation. Bcr-Abl protein containing the abnormal Philadelphia chromosome by the cells, in patients with CML, this protein is considered cancer-causing excessive proliferation of white blood cells is an important factor.
In clinical trials, the use of Tasigna treatment, 42% of the pairs of Gleevec-resistant chronic phase Philadelphia chromosome-positive (Ph +) CML patients with abnormal chromosomes will be reduced or disappear situation; while in patients in accelerated phase, there are 31% of patients can get the same effect.

Tags: 尼罗替尼(Tasigna)中文说明书

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更新日期: 2010-02-11 04:26
作者: : mcyclub
修订: 1.0

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