索拉非尼Nexavar tablets 200mg(Sorafenib Tosilate)

药店国别:

产地国家:美国

处方药:

所属类别: 200毫克/片 56片(28片×2)/盒

包装规格: 200毫克/片 56片(28片×2)/盒

计价单位:盒

生产厂家中文参考译名:

生产厂家英文名:Bayer Yakuhin Co.Ltd

原产地英文商品名:Nexavar(ネクサバール錠)200mg/Tablet 56tablets(28tablets×2)/box

原产地英文药品名:Sorafenib Tosilate

中文参考商品译名:Nexavar片(ネクサバール錠)200毫克/片 56片(28片×2)/盒

中文参考药品译名:索拉非尼

曾用名

简介

部分中文甲苯磺酸索拉非尼处方资料(仅供参考商品名:Nexavar英文名:Sorafenib tosylate中文名:甲苯磺酸索拉非尼片生产商:拜耳药品ネクサバール錠200mg药用类别名称抗恶性肿瘤蛋白酶抑制剂批准日期:2008年4月商標名Nexavar 200mg構造式一般名ソラフェニブトシル酸塩(Sorafenib Tosilate)JAN(Sorafenib)INN化学名4-{4-[3-(4-Chloro-3-trifluoromethylphenyl)ureido]phenoxy}-N2-methylpyridine-2-carboxamide mono(4-methylbenzenesulfonate)分子式C21H16ClF3N4O3・C7H8O3S分子量637.03融点223〜231℃性状本产品为白色带黄色白色或带棕色白色粉末。本品易溶于二甲基亚硫酸或N、n-二甲基甲酰胺, 几乎不溶于甲醇或乙醇(99.5), 且几乎不溶于水。分布系数由于该产品很难溶于辛醇水和辛醇/磷酸盐缓冲液, 因此无法测量其分布系数。

操作注意事项

铝袋打开后, 由于吸湿, 配方的溶解度可能会降低, 从而通过避免水分来保持。批准条件制定药品风险管理计划并适当实施。治疗性甲状腺癌。由于日本的临床试验病例极为有限, 使用这种药物的患者的背景资料是通过对所有病例进行使用结果调查来掌握的, 直到生产和销售后积累了与一定数量病例有关的数据, 我们将在早期阶段收集有关该制剂安全性和有效性的数据, 并采取必要措施正确使用该制剂。

药用药理学

1. 抗肿瘤作用该制剂抑制肾细胞癌细胞系(RENCA, 78-o)和肝细胞癌细胞系(PLC/PRF5)移植的小鼠的肿瘤生长。此外, 肿瘤生长被抑制的结瘤小鼠有过度表达生长因子受体, 如EGFR和其他人类衍生肿瘤与k-ras或B-RAF突变。

2. 作用机制在体外研究中, 该制剂抑制受体酪氨酸激酶活性, 如C-Raf、正常和突变b-raf激酶活性, 以及FLT-3和c-KIT, 参与肿瘤的进展。此外, 该制剂抑制酪氨酸激酶活性, 如血管内皮生长因子(VEGF)受体和血小板衍生生长因子(PDGF)受体参与肿瘤血管生成。在体内研究中, 该药物抑制了使用肾细胞癌和肝癌细胞系的癌小鼠肿瘤组织中的血管生成。 此外, 利用肝细胞癌细胞抑制肿瘤细胞 erk 磷酸化, 诱导荷癌小鼠凋亡。

适应症

非治疗性或转移性肾细胞癌、不可切除的肝细胞癌、非治疗性甲状腺癌。

用法与用量

通常情况下, 成人每天口服两次400毫克的索拉非尼。此外, 有必要根据病人的病情用药。包装錠剤 PTP包装 56錠(28錠×2)

制造和销售来源

拜耳股份有限公司

索拉非尼英文版说明书

(Nexavar) new indications for thyroid cancer approved by Japan June 20, 2014, anticancer drug DOGMI (Nexavar, general name: Sola, sorafenib) was approved by the Japanese Ministry of Labour, Health and Welfare (MHLW) for the treatment of non-resected differentiated thyroid carcinoma (DCT).Earlier, MHLW had granted Nexavar the status of an orphan drug in the treatment of thyroid cancer in September 2013. The approval of the new Nexavar indications is based on data from phase III DECISION clinical trials, which showed that Nexavar significantly prolonged the patient’s disease-free survival (PFS) compared to the placebo) (10.8 months vs 5.8 months,P<0.0001), reaching the main endpoint of the study.The approval was the third indication of Nexavar in Japan, which had previously been approved for the treatment of hepatocellular carcinoma and advanced renal cell carcinoma.The FDA and the European Union approved Nexavar for the treatment of locally advanced or metastatic radioactive iodine (RAI) refractory differentiated thyroid carcinoma (DCT) in November 2013 and June 2014, respectively, and were the first in the United States and the European Union to be approved for radioactive iodine refractory differentiated thyroid cancer.About Dogmi (Nexavar): Nexavar is an oral anticancer drug that has been approved by more than 100 countries around the world for the treatment of liver and advanced renal cancer.In Europe, Nexavar was approved for the treatment of hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC) that had failed treatment with alpha interferon or interleukin 2(IL-2) or were not considered applicable to such therapies.In preclinical studies, Nexavar has been shown to inhibit a wide range of kinases involved in cell proliferation and angiogenesis, including RAF kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.At present, Bayer and Onyx Pharmaceuticals, international research groups, government agencies and individual researchers are also investigating the efficacy of Nexavar in other cancers.

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