乐伐替尼胶囊Lenvima 10mg carton(Lenvatinib Mesilate)

药店国别:

产地国家:日本

处方药:是

所属类别: 10毫克/胶囊 20胶囊/盒

包装规格: 10毫克/胶囊 20胶囊/盒

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Eisai

原产地英文商品名:Lenvima(レンビマカプセル)10mg/carton 20carton/box

原产地英文药品名:Lenvatinib Mesilate

中文参考商品译名:Lenvima(レンビマカプセル)10毫克/胶囊 20胶囊/盒

中文参考药品译名:乐伐替尼

曾用名:

简介:

近日,新药LENVIMA(lenvatinib mesylate)在日本获批,用于不可切除的肝细胞癌治疗。值得一提的是,这是LENVIMA在全世界获得的首个针对肝细胞癌的批准,也是日本10年来首个能用于前线治疗的肝癌创新系统疗法。在全球,肝癌是第二大癌症死因,每年造成了75万个死亡案例。此外据估计,全球每年还会迎来78万个新发肝癌病例,其中80%集中在亚洲,而中国和日本更是肝癌大国。在肝癌中,肝细胞癌占了85%-90%,但用于不可切除性肝细胞癌的疗法却非常有限。在日本获批上市的LENVIMA有望为患者们带来治疗的希望。作为一款口服的多重RTK抑制剂,它能以全新的机制,选择性地抑制多种VEGF受体、多种FGF受体、以及其他RTK。药物分类名称抗肿瘤药批准日期:2015年2月商標名LENVIMA一般名:レンバチニブメシル酸塩(Lenvatinib Mesilate)化学名:4-{3-Chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy}-7-methoxyquinoline-6-carboxamide monomethanesulfonate分子式:C21H19ClN4O4・CH4O3S分子量;522.96構造式性 状Lenbatynib甲磺酸盐是一种白色至薄带红黄色粉末。该产品几乎不溶于水,甲醇或N-甲基吡咯烷酮,几乎不溶于乙醇(99.5)。熔点221至224℃(分解)分配系数log P = 3.30(1-辛醇/水系统)批准条件制定药品风险管理计划并适当实施。<治愈性不可切除的甲状腺癌>由于日本的临床试验数量非常有限,通过对所有病例进行使用结果调查,直到制造和销售后累积一定数量的病例数据为止, 除了掌握所用患者的背景信息外,尽快收集该药的安全性和有效性数据,并采取必要措施正确使用该药。

药用药理学

1.作用机制Lenvatinib参与肿瘤血管生成和肿瘤生长等等,血管内皮生长因子(VEGF)受体(VEGFR1-3),成纤维细胞生长因子(FGF)受体(FGFR1-4),血小板衍生的生长因子受体体(PDGFR)α,干细胞因子受体(KIT),抑制了重排期间转染原癌基因(RET)受体酪氨酸激酶,例如。此外,libbatinib抑制由VEGF和FGF诱导的血管腔内血管腔结构的形成。

2.抗肿瘤作用Lenvatinib是人甲状腺乳头状癌来源的细胞系(K1),人甲状腺滤泡癌衍生的细胞系(RO82-W-1),人甲状腺髓样癌的细胞系(TT),人甲状腺未分化癌衍生的细胞系( 8305C),人甲状腺原点鳞状细胞癌的细胞系(SW579),人肝细胞癌来源的细胞系(喉癌3B2.1-7,LIXC-012和PLC / PRF / 5)和肝细胞癌的患者的肿瘤组织片(LI0050和LI0334)移植的小鼠显示出肿瘤生长抑制作用。

适应症

根治性无法治愈的甲状腺癌不可切除的肝细胞癌

用法与用量

胶囊:4毫克和10毫克根治性无法治愈的甲状腺癌成人每天口服一次,每次为24mg。另外;根据患者的状况进行减重。胶囊4毫克不可切除的肝细胞癌成人,如果体重根据体重为60kg或更多体重为12mg,当体重低于60kg时体重为8mg,则每天口服给药一次。另外,根据患者的状况进行减重。

包装

胶囊4毫克:20粒(PTP 10 C×2)10毫克:20粒(PTP 10 C×2)

乐伐替尼英文版说明书

announced on 26th March that it will introduce new anti-cancer agent “Rembima® capsule 4 mg (generic name: renbatinib mesylate) Announced that it has obtained additional approval for the efficacy and effect of hepatocellular carcinoma.”Lenvima capsule 4 mg” has already been approved for the indication of “radical cure-free thyroid cancer” and Eisai Co., Ltd. concluded with Merck (MSD) in March It became the first approval after the joint development and co-promotion alliance agreement of “Rembima®”.For primary therapy of hepatocellular carcinoma, approved systemic chemotherapy is limited and it is one of the high diseases of Unmet · Medical · Needs (treatment field in which effective treatment is not established).”Sorafenib (product name · Nexavar)” listed in the drug price list in April 2008 was the only insurance approval drug that has been approved for hepatocellular carcinoma (HCC) which can not progression/unresectable, In 2017 “Legolafenib (product name · Stiberga ◇ 2013 colon cancer)” was added insurance approval, it became two drugs. (However, eva luation of stibarga may cause severe hepatic dysfunction, and available patients are limited)For that reason, the appearance of new secondary therapeutic drugs has been long awaited for patients who have progressed or exacerbated (swollen) after administration of sorafenib (or regolafenib) or when drug resistance develops.Since hepatocellular carcinoma is a typical polycythemic tumor in which tumor vascular network has developed, VEGF (Vascular endothelial growth factor = vascular endothelial growth factor) and FGF (fibroblast growth factors) inducibility It is thought that angiogenesis in plays an important role.In addition, hepatocellular carcinoma expresses FGFR1 ~ 4, suggesting that enhancement of FGFR (Fibroblast Growth Factor Receptor) signal is related to cancer cell malignancy and poor prognosis.”Rembima® capsule 4 mg” has a selective inhibitory activity against receptor tyrosine kinase such as VEGFR (vascular endothelial growth factor · receptor) 1 to 3 and FGFR 1 to 4, and it has tumor angiogenesis and malignant , It is expected to have a therapeutic effect on unresectable hepatocellular carcinoma.This drug is a drug researched and developed by Eisai Co., Ltd. and Tsukuba Research Laboratories, has been approved for thyroid cancer so far and has been approved in more than 50 countries including the United States, Japan and Europe.For the addition of indications and indications on unresectable hepatocellular carcinoma, we applied for approval in June 2017, after undergoing prompt examination, approved in Japan on March 23, 2018 ahead of the world.

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