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  药店国别: 土耳其药房
产地国家: 土耳其
所属类别: 抗癌药物->治疗肾癌药物
处方药:处方药
包装规格: 400毫克/片 60片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
葛兰素史克
生产厂家英文名:
GLAXOSMITHKLINE
该药品相关信息网址1:
http://www.drugs.com/votrient.html
该药品相关信息网址2:
http://www.rxlist.com/votrient-drug.htm
该药品相关信息网址3:
http://www.medilexicon.com/drugs/votrient.php
原产地英文商品名:
VOTRIENT 400MG/TAB 60TABS/BOX
原产地英文药品名:
PAZOPANIB HYDROCHLORIDE
中文参考商品译名:
VOTRIENT 400毫克/片 60片/盒
中文参考药品译名:
盐酸帕唑帕尼
原产地国家批准上市年份:
2009/10/19
英文适应病症1:
Renal cell carcinoma
临床试验期:
完成
中文适应病症参考翻译1:
肾癌
药品信息:

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 详细处方信息以本药内容附件PDF文件(20123817243021.pdf)的“原文Priscribing Information”为准
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部分中文帕唑帕尼处方资料(仅供参考)

Votrient (pazopanib)
适应症:肾癌
生产商:GlaxoSmithKline
批准日期:2009年10月19日
    葛兰素史克公司的Votrient(帕唑帕尼)用于进展性肾细胞癌的治疗。Votrient是一种口服(每日1次)血管生成抑制剂。不良反应包括:腹泻、高血压、发色改变、恶心、无食欲、呕吐、疲乏、虚弱、腹痛和头疼。Votrient还可引起严重的甚者致死性的肝毒性。故治疗前和治疗期间应监测患者的肝功能。
     一项纳入435例患者、旨在评估无进展生存(PFS)的研究评价了Votrient的安全性和有效性,这是一项III期研究。在该研究中,接受Votrient (帕唑帕尼)治疗的患者总体中位PFS为9.2个月,而接受安慰剂的患者则为4.2个月。初次接受治疗的患者应用Votrient后中位PFS可达11.1个月,而安慰剂组则为2.8个月。此外,曾接受过以细胞因子为基础治疗方案治疗的患者使用Votrient (帕唑帕尼)后中位PFS可达7.4个月,而安慰剂组则为4.2个月。

FDA Approves New Treatment for Advanced Form of Kidney Cancer
FDA批准用于治疗晚期肾癌的新药物
(Oct. 19, 2009)The U.S. Food and Drug Administration today approved Votrient (pazopanib), the sixth drug to be approved for kidney cancer since 2005.
(2009年10月19日)美国食品药品监督管理局(FDA)今日批准Votrient (pazopanib)上市,该药是自2005以来第6个被批准用于治疗肾癌的药物。

Votrient is an oral medication that interferes with angiogenesis, the growth of new blood vessels needed for solid tumors to grow and survive.
Votrient是一种口服药物,可干扰实体肿瘤生长和存活所需的新血管的生成。

Votrient is intended for people with advanced renal cell carcinoma, a type of kidney cancer in which the cancerous cells are found in the lining of very small tubes (tubules) in the kidney. In 2009, approximately 49,000 people were diagnosed with renal cell carcinoma and 11,000 people died from the disease.
Votrient主要用于治疗伴晚期肾细胞癌症的患者,后者是一类在肾小管中发现癌细胞的肾癌类型。在2009年,约49000人被诊断为肾细胞癌,并有11000人死于该病。

“The last five years have seen dramatic improvements in treatment options for patients with kidney cancer. Before 2005, the options available offered only limited effectiveness,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.
FDA药物评估和研究中心的肿瘤药品办公室的Richard Pazdur博士表示,“最近5年来,在针对肾癌患者的治疗药物方面已取得了激动人心的进步,而在2005年之前,可获得的治疗药物仅提供了有限的疗效。”

The five other drugs approved for kidney cancer and their approval dates are: Sorafenib (December 2005), Sunitinib (January 2006), Temsirolimus (May 2007), Everolimus (March 2009), and Bevacizumab (July 2009).
其它5种已被批准用于治疗肾癌的药物及其批准日期:Sorafenib(索拉非尼(多吉美)德国拜耳,2005.12批准),Sunitinib(苏尼替尼(索坦)辉瑞,2006.1批准),Temsirolimus(驮瑞塞尔 惠氏,2007.5批准),Everolimus(依维莫司 诺华,2009.3批准)和贝伐单抗Bevacizumab(贝伐单抗(阿瓦斯汀)罗氏,2009.7批准)。

The safety and effectiveness of Votrient was evaluated in a 435-patient study that examined a patient’s progression-free survival – the length of time, following enrollment in the study, before the tumor began growing again or before the patient died. Progression-free survival averaged 9.2 months for patients receiving Votrient compared to 4.2 months for patients who did not receive the drug.
Votrient的安全性和有效性在一项纳入了435名患者的研究中已被评估,该研究对这些患者的无进展性存活的时间长度(从被纳入研究后至肿瘤再次开始生长或患者死亡前)进行了检查。接受Votrient治疗的患者的无进展性存活平均为9.2个月,而未接受该药的患者则为4.2个月。

Adverse reactions included diarrhea, high blood pressure, hair color changes, nausea, loss of appetite, vomiting, fatigue, weakness, abdominal pain and headache. Votrient can also cause severe and fatal liver toxicity. Health care professionals should order blood tests to monitor liver function before and during treatment with the drug. Since Votrient can harm a fetus, it should not be used during pregnancy.
不良反应包括腹泻、高血压、头发颜色改变、恶心、食欲降低、呕吐、疲劳、无力、腹痛和头痛。Votrient还可引起严重和致命性肝毒性。医护人员在开始使用该药之前和治疗期间应进行用于监测肝功能的血液检验。由于Votrient可伤害胎儿,故不应用于妊娠期。

The drug has also been associated with heart rhythm irregularities. Patients receiving Votrient should be monitored with periodic electrocardiograms, which measure heart rhythm, and blood tests to monitor electrolytes since an electrolyte imbalance can lead to an irregular heart rhythm.
另外,该药还可能引起心律不齐。接受Votrient的患者应进行定期的心电图监测,以测量心律,并且由于电解质失衡可导致心律不齐,故同时需要进行血液检验以监测电解质。

Votrient is manufactured by London-based GlaxoSmithKline.
Votrient由位于伦敦的葛兰素史克公司生产。

Votrient (pazopanib)
Company: GlaxoSmithKline
Approval Status: Approved October of 2009
Treatment for: renal cell carcinoma
Areas: Urology & Kidneys; Cancer & Oncology

General Information
Votrient (pazopanib) is a vascular epidermal growth factor receptor (VEGFR) tyrosine kinase inhibitor which acts at all three isoforms: VEGFR-1, VEGFR-2 and VEGFR-3. VEGF is a chemical signal produced by cells that stimulates the growth of new blood vessels. It is part of the system that restores the oxygen supply to tissues when blood circulation is inadequate. When VEGF is overexpressed, it can contribute to disease. Solid cancers need an adequete blood supply or they will not be able to grow. Hence, cancer that can express VEGF are able to grow and metastasize.

Votrient is specifically indicated for the treatment of patients with advanced renal cell carcinoma.

Votrient is supplied as a tablet designed for oral administration. The recommended initial dose is 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). The dose of Votrient should not exceed 800 mg.

Clinical Results
FDA Approval
The FDA approval of Votrient was based on the results of a randomized, double-blind, placebo-controlled, multicenter study in 435 subjects with locally advanced and/or metastatic RCC who had received either no prior therapy or one prior cytokine-based systemic therapy. The subjects were randomized to receive Votrient 800 mg once daily or placebo once daily. The primary objective progression-free survival (PFS); the secondary endpoints included overall survival (OS), overall response rate (RR), and duration of response. The median progression free survival for the overall population was 9.2 months in the Votrient arm versus 4.2 months in the placebo group (P<0.001). The median progression free survival for the treatment-naïve subgroup was 11.1 months versus 2.8 months and in the Cytokine pre-treated subgroup 7.4 months versus 4.2 months. In the Votrient arm, there was a 30% response rate (complete response + partial response) versus 3% in the placebo arm. The median duration of response was 58.7 weeks in the Votrient arm.

Side Effects
Adverse events associated with the use of Votrient may include, but are not limited to, the following:
Diarrhea
Hypertension
Hair color change
Nausea
Fatigue
Anorexia
Vomiting

Mechanism of Action
Votrient (pazopanib) is a vascular epidermal growth factor receptor (VEGFR) tyrosine kinase inhibitor which acts at all three isoforms: VEGFR-1, VEGFR-2 and VEGFR-3. VEGF is a chemical signal produced by cells that stimulates the growth of new blood vessels. It is part of the system that restores the oxygen supply to tissues when blood circulation is inadequate. When VEGF is overexpressed, it can contribute to disease. Solid cancers need an adequete blood supply or they will not be able to grow. Hence, cancer that can express VEGF are able to grow and metastasize.

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 详细处方信息以本药内容附件PDF文件(20123817243021.pdf)的“原文Priscribing Information”为准
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更新日期: 2012-7-13
附件:




20123817243021.PDF    

 
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