产地国家：日本 处方药：是 所属类别： 15毫克/片 20片/盒 包装规格： 15毫克/片 20片/盒 计价单位：盒 生产厂家英文名：Otsuka Pharmaceutical Co.Ltd 原产地英文商品名：ICLUSIG tablets(アイクルシグ錠)15mg/tab 20tabs/box 原产地英文药品名：Ponatinib Hydrochloride 中文参考商品译名：ICLUSIG(アイクルシグ錠)15毫克/片 20片/盒 中文参考药品译名：盐酸普纳替尼

简介：

部分中文盐酸普纳替尼处方资料(仅供参考) 英文名：Ponatinib Hydrochloride 商标名：ICLUSIG tablets 15mg 中文名：盐酸普纳替尼片 日文名：アイクルシグ錠15mg 生产商：大冢制药 药物分类名称：抗肿瘤药/酪氨酸激酶抑制剂 批准日期：2016年11月 化学名：3-[2-(Imidazo[1,2-b]pyridazin-3-yl)ethynyl]-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl｝benzamide monohydrochloride 分子式：C29H27F3N6O・HCl 分子量：569.02 性　状：含粉白色物质为黄色。微溶于二甲亚砜，乙醇和微溶于水。处理注意事项1.※PTP包装产品，打开铝枕头之后被存储在黑暗中以避免水分。2.※塑料瓶包装制品，因为容易受到湿度，牢固地拧紧帽每次使用。此外，封闭的干燥剂是你把所有的时间。条件批准1.对药品风险管理计划的发展，要正确实施。2.由于审判案件在日本是非常有限的，上市后，直到一定数量的情况下的数据集成，通过实现对一切案件的使用效果调查，把握这种药物的背景信息使用患者数据采集初期这种药物的安全性和有效性，采取措施以获得正确使用药物。 药用药理学：1.行动机制Ponatinib在体外抑制ABL的酪氨酸激酶活性，包括突变体如T315I。2.抗肿瘤作用(1)体外试验Ponatinib是来源于表达BCR-ABL的人pro-B细胞的Ba / F3细胞系的增殖，所述BCR-ABL具有来自表达BCR-ABL和T315I的人慢性髓性白血病的K562，KY01和LAMA细胞系等突变。它被抑制。(2)体内试验Ponatinib在用表达具有T515I突变的BCR-ABL和K562细胞系的B5 / F3细胞系皮下移植的小鼠中显示出肿瘤生长抑制作用。 适应症：(1)性粒细胞白血病耐药或不耐受预处理药物。(2)发性或难治性费城染色体阳性急性淋巴细胞白血病。 用法与用量：每天一次口服45mg普纳替尼。 此外，根据患者的状况进行减重。 包装：片剂15毫克：[PTP] 20片(10片x 2) 14粒

英文版说明书：

ICLUSIG Tablets 15mg Approved in Japan for Patients with Chronic Myeloid Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic LeukemiaICLUSIG, an oral tyrosine kinase inhibitor (TKI) discovered by ARIAD Pharmaceuticals, Inc. and indicated for chronic myeloid leukemia (CML) and Philadelphia　Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), has been approved in Japan.ICLUSIG is already used in the U.S. and Europe for CML and Ph+ ALL patients who demonstrate resistance or intolerance to an existing TKI treatment and is awaited by patients in Asia.Otsuka plans to market ICLUSIG in Japan, and if approved, in nine other Asian countries and regions.Otsuka Pharmaceutical Co.Ltd. has received regulatory approval in Japan for manufacture and sales of ICLUSIG® Tablets 15 mg (ponatinib hydrochloride), a tyrosine kinase inhibitor (TKI) indicated to treat patients with chronic myeloid leukemia (CML) who are resistant or intolerant to previous treatments and patients with recurrent or refractory Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).Although TKIs are used as a first-line treatment for CML and Ph+ ALL, mutation of BCR-ABL genes can develop during the treatment period and indicates resistance to the currently used TKI.In addition, intolerance to the side effects of existing TKI treatments can lead to a discontinuation of treatment.ICLUSIG, discovered in the U.S. by ARIAD Pharmaceuticals, Inc., is a TKI that targets BCR-ABL expressed in CML and Ph+ ALL. This drug is a new chemically synthesized oral TKI, and is specifically designed to inhibit mutated TK caused by a T315I mutation which induces resistance to the currently used TKI. ICLUSIG demonstrates efficacy in CML patients with resistance to or with intolerance to currently available TKIs. ICLUSIG was approved in the U.S. in 2012, in Europe in 2013, and in 2014 Otsuka obtained the rights to commercialize and develop ICLUSIG in ten Asian countries and regions.ICLUSIG was designated as an orphan drug in Japan and a new drug application (NDA) was submitted in January 2016. NDAs have been submitted in Korea and Taiwan as well.Early access program until reimbursement is in placeDue to the limited existing treatment options for patients in Japan, Otsuka will provide access to ICLUSIG free of charge as soon as procedures are in place from an ethical standpoint. This program will be offered at medical institutions where clinical trials of ICLUSIG were performed and which are amenable to accepting the drug access program until the product is listed on the Japan National Health Insurance (NHI) price list. Otsuka will conduct this program in accordance with the Fair Competition Code of the Ethical Drug Manufacturing Industry.*1 Japan, Indonesia, Malaysia, China (including Hong Kong), Philippines, Singapore, Korea, Taiwan, Thailand, Vietnam*2 Chromosome abnormality seen in CML and Ph+ ALL. Due to translocation of Chromosome 22 and Chromosome 9, genes c-ABL and BCR bind together to form an abnormal protein which causes indefinite proliferation of hematopoietic stem cells and leads to leukemia.