来那度胺胶囊Lenalidomide(Revlimid Capsules 40x5mg)

产地国家:日本

处方药:是

所属类别: 5毫克/胶囊 40胶囊/盒

包装规格: 5毫克/胶囊 40胶囊/盒

计价单位:盒

生产厂家英文名:Cell Gene Co.Ltd

原产地英文商品名:Revlimid(レブラミドカプセル)5mg/Capsules 40capsules

原产地英文药品名:Lenalidomide Hydrate

中文参考商品译名:Revlimid(レブラミドカプセル)5毫克/胶囊 40胶囊/盒

中文参考药品译名:来那度胺水合物

简介:

部份中文盐酸来那度胺处方资料(仅供参考)英文名:Lenalidomide Hydrate商品名:Revlimid Capsules中文名:来那度胺胶囊生产商:细胞基因公司レブラミドカプセル2.5mg/レブラミドカプセル5mg药物类别名称抗血肿恶性肿瘤剂批准日期:2015年11月商標名Revlimid Capsules一般名レナリドミド水和物 Lenalidomide Hydrate(JAN)、lenalidomide(INN)化学名(3RS)-3-(4-amino-1-oxo-1, 3-dihydro-2H-isoindol-2-yl)piperidine-2, 6-dione hemihydrate分子式C13H13N3O3・1/2H2O分子量268.27化学構造式性状它是黄白色到浅黄色的粉末。 水、乙醇(95)或很难溶于2-丙醇,几乎不溶于乙酰乙酸酯或甲醇。熔点265 到 270分布系数P=0.46 (1-辛醇/wed)处理注意事项药品管理必须严格遵循适当的管理程序,并彻底。存放在阳光直射下,开封后避免高温高湿。批准条件在制造、管理和使用这种药物时,应严格遵守”再石斑鱼适当管理程序”。 此外,卫生、劳动和福利部必须事先征得卫生、劳动和福利部的同意,才能修改这一程序。制定药品风险管理计划并适当实施。在具有充分知识和经验的医生的指导下,在医疗设施中,在具有充分知识和经验的医生的指导下,对这种药物进行管理,只有在认为适当的情况下,对患者或其家属的疗效和危险,才用文件加以说明, 采取严格和适当的措施,以确保只有在获得书面同意后才能实施。复发性或折射性多发性骨髓瘤,骨髓增生综合征,染色体5长臂缺失由于日本的临床试验病例数量极为有限,在生产和销售后,通过对所有病例进行使用性能调查,以及掌握使用这种药物的患者的背景信息,在积累与一定数量的病例相关的数据之前, 我们会在早期收集有关该药物的安全及效力的数据,并采取必要措施,以正确使用该药物。

药用药理学:药理作用体外测试对各种人类多发性骨髓瘤衍生细胞系表现出生长抑制作用,与地塞米松结合增强。TNF-α在人外周血单核细胞IL-1+中,抑制炎性细胞因子的产生,如IL-6和IL-12,促进抗炎细胞因子IL-10的产生。 此外,还促进了IL-2生产和在人类T细胞中的IFN-+生产。它抑制血管内皮细胞微血管细胞的迁移和形成,抑制血管生成。抑制缺失5号染色体长臂的造血肿瘤细胞的生长。 同时,在CD34阳性造血干细胞分化诱导过程中,促进胎儿血红蛋白的表达。它显示生长抑制作用对人成人T细胞白血病淋巴瘤衍生细胞系(HuT102)。体内测试在严重复杂的免疫缺陷小鼠移植人类多发性骨髓瘤衍生细胞系(NCI-H929)中,表现出剂量依赖性肿瘤生长抑制作用。在严重复合免疫缺陷小鼠移植的人类成人T细胞白血病淋巴瘤衍生细胞系(HuT102)中,表现出剂量依赖性肿瘤生长抑制作用。

作用机制:利纳利多米德,细胞因子生产调节,生长抑制作用于造血肿瘤细胞,被认为具有血管生成抑制作用。 然而,具体的行动机制尚未阐明。

适应症:多发性骨髓瘤骨髓增生异常综合征与染色体5长臂缺失复发性或难治性成人T细胞白血病淋巴瘤

用法用量:多发性骨髓瘤与地塞米松结合,通常,每天口服21天,每天一次,作为成人的利利多米德,并暂停7天。这是重复管理作为一个周期。另外,根据病人的情况,它适当地减轻了体重。骨髓增生综合征与染色体5长臂删除通常,每天口服21天,每天10毫克,成人为利利多米德,并暂停7天。 这是重复管理作为一个周期。另外,根据病人的情况,它适当地减轻了体重。复发性或折射性成人T细胞白血病淋巴瘤通常,成人口服每天25毫克一次,每天一次作为利利多米德。另外,根据病人的情况,它适当地减轻了体重。

包装:2.5毫克:10胶囊(10胶囊x1);5毫克:10胶囊(10胶囊x1)40粒(10粒x4)

英文版说明书

Revlimid Capsules(Lenalidomide Hydrate)Lenalidomide is a structural analog of thalidomide with similar but more potent biological activity. It has a good therapeutic effect on multiple myeloma, which can significantly prolong the life of these cancer patients and improve their quality of life. It is by far the best drug for multiple myeloma. It also has a good therapeutic effect on myelodysplastic syndrome with 5q chromosome deletion.Product recommendation basis and reasonMultiple myeloma is a malignant plasma cell proliferative blood tumor. Plasma cells have the function of secreting immunoglobulins, but most of the proliferating plasma cells of patients with multiple myeloma produce only one kind of immunoglobulin, which is called paraprotein or M protein, which is not beneficial to the body, normal plasma cells and Other white blood cells are replaced by malignant plasma cells, resulting in reduced synthesis and secretion of normal immunoglobulins. Multiple myeloma cells also invade other tissues of the body, such as bone tissue, and cause tumorigenesis.Multiple myeloma is the second largest blood tumor, with approximately 1% of all cancer patients and 2% of all cancer deaths. There are approximately 200,000 patients worldwide. It is estimated that there will be about 74,000 new cases worldwide in 2004, and the number of deaths in 2005 will reach 60,000.Lenalidomide is a new immunomodulatory, non-chemotherapy anticancer drug with a chemical composition similar to thalidomide, but it is more effective in experimental applications and does not appear to take sali Some side effects often produced by sulphate.Revlimid has an effect on a variety of biological pathways in the cell. At present, celgene is still eva luating the hematology and oncology of this product, including multiple myeloma, myelodysplastic syndrome, chronic lymphocytic leukemia and solid tumors. Myelodysplastic syndrome is a malignant blood disease with approximately 300,000 patients worldwide. Myelodysplastic syndromes occur when blood cells in the bone marrow are always at an immature stage and fail to perform their necessary functions.The bone marrow is filled with these immature cells, inhibiting the development of normal cells. Patients with myelodysplastic syndrome must often rely on blood transfusions to resist symptoms such as anemia and fatigue until they develop into life-threatening iron overload or iron poisoning. The treatment of this disease urgently requires a cure for the disease rather than just controlling the symptoms. More than half of patients with myelodysplastic syndrome have been diagnosed with cellular chromosomal variations, including partial or complete deletions of more than one chromosome. The most common cell chromosomal abnormalities in myelodysplastic syndrome occur in the absence of q on chromosomes 5, 7, and 20. Another more common variant is the extra copy of chromosome 8. The proportion of 5q chromosome deletion in patients with myelodysplastic syndrome can reach 20% to 30%.https://www.kegg.jp/medicus-bin/japic_med?japic_code=00065995

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