英文药名: ZYKADIA Capsules(Ceritinib) 中文药名: 色瑞替尼胶囊 生产厂家: 诺华制药 ジカディアカプセル150mg 治疗类别名称 抗肿瘤药/酪氨酸激酶抑制剂 商標名 ZYKADIA capsules 150mg 構造式   一般名 セリチニブ（Ceritinib） 化学名 5-Chloro-N 2-｛5-methyl-4-（piperidin-4-yl）-2-［（propan-2-yl）oxy］phenyl｝-N 4-［2-（propan-2-ylsulfonyl）phenyl］pyrimidine-2,4-diamine 分子式 C28H36ClN5O3S 分子量 558.14 性状 白色至浅黄色或浅棕色粉末。微溶于甲醇，乙醇，微溶于2-丙醇和乙腈，在极微溶于水。 条件批准 1.建立药品风险管理计划的顶部，要正确实施。 2.由于试验病人在日本是非常有限的，上市后，直至有关一定数量的病例数据集成，通过实现对一切案件的使用，结果调查显示，这使得它能够及早发现这种药物的使用患者的背景资料，数据收集这种药物的安全性和有效性，采取必要的措施，正确使用此药。 3.施用这种药物，肺癌的诊断，熟悉化疗，以便仅在原始药房谁是医生，医疗机构和管理药剂师可充分控制也有关此代理人的风险，等，制造和销售进行在采取必要的措施。 适应病证 切除的晚期或耐药或不耐受的ALK融合基因阳性crizotinib的复发性非小细胞肺癌 用法用量 每天一次750毫克的Serichinibu是内服空腹。应当指出的是，根据该状态的患者使用。 药效药理： 在通过ALK基因的易位/反转表示的ALK融合蛋白，酪氨酸激酶活性异常上升。在ALK融合基因阳性的非小细胞肺癌，ALK融合蛋白参与肿瘤的生长。 1. 抗肿瘤作用 Serichinibu抑制衍生表达ALK融合蛋白的NCI-H2228细胞系人非小细胞肺癌的生长。此外，Serichinibu是，小鼠和大鼠的NCI-H2228细胞系皮下植入，并从小鼠NCI-H2228细胞系的crizotinib抗性肿瘤皮下植入，抑制了肿瘤的生长。 2. 作用机序 Serichinibu是，通过抑制ALK融合蛋白的酪氨酸激酶活性，其抑制肿瘤的生长。 包装规格 胶囊 150毫克：14胶囊（PTP） 制造商 诺华制药有限公司 注：以上中文资料仅供参考，使用以原处方为准：http://www.info.pmda.go.jp/go/pack/4291044M1021_1_02/ Antineoplastic agents "Jikadia ® capsule" ALK inhibitor for non-small cell lung cancer of the ALK fusion gene-positive Novartis Pharma Inc. May 25, non-small as a cell lung cancer therapeutic agent, "Jikadia (R) capsules 150mg" has acquired the manufacturing and marketing approval on March 28 this year (the general name of the ALK fusion gene-positive (ALK +) : started selling Serichinibu). The first cause of death due to cancer of the Japanese in lung cancer, according to national statistics about 70,000 people a year have died of lung cancer. In addition, about 11 million people per year have been newly diagnosed with lung cancer. About 85% of lung cancer were diagnosed with non-small cell lung cancer (NSCLC), since about 2-5% of NSCLC patients have been reported to have a mutation (ALK fusion gene) of ALK gene, in Japan ALK + new number of patients with NSCLC is estimated to be about 2,000 to 5,000 people a year. Exacerbation Currently, the ALK + NSCLC treatment, a plurality of ALK inhibitors have been used, or a intolerance to existing ALK inhibitors, effective or not sufficient, the resistance even once effect is seen case for has been reported to be almost. Also in ALK + NSCLC patients has been suggested to increase the risk of brain metastases, brain metastases is a major concern on the treatment. Response rate 37.1%, also the anti-tumor effects on the brain metastatic lesions Jikadia is a receptor tyrosine kinase inhibits autophosphorylation of ALK, suppresses cancer cell proliferation, potent and selective oral ALK inhibitor.