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英文药名：Bosulif（Bosutinib Hydrate Tablets）
中文药名: 博舒替尼水合物/片剂
生产厂家：辉瑞公司
ボシュリフ錠100mg
药物分类名称
抗肿瘤剂/酪氨酸激酶抑制剂
批准日期：2014年12月
商標名
Bosulif tablets
一般名
ボスチニブ水和物（Bosutinib Hydrate）
化学名
4-［（2,4-Dichloro-5-methoxyphenyl）amino］-6-methoxy-7-［3-（4-methylpiperazin-1-yl）propyloxy］quinoline-3-carbonitrile monohydrate
分子式
C26H29Cl2N5O3・H2O
分子量
548.46
構造式
性状
本品为白色至黄棕色粉末。
本产品溶于二甲基亚砜，微溶于乙醇（99.5），难溶于乙腈，甲醇，难溶于水。
分配系数（log D）
3.1（pH 7.4,1-辛醇/水）
药效药理
1. 抗肿瘤作用
Bostinib体外抑制BCR-ABL融合基因阳性人慢性粒细胞白血病来源的细胞系（KU 812，K 562，Meg-01，Lama 84和KCL 22）的增殖。 此外，通过施用bostinib皮下移植K562细胞系的裸鼠中观察到肿瘤生长抑制作用和存活的延长。
2. 作用机制
Bostinib通过抑制Abl和Src酪氨酸激酶活性来抑制BCR-ABL融合基因阳性肿瘤的增殖。
适应症
慢性粒细胞白血病耐药或不耐受治疗前药物
用法与用量
成人，每天一次，每次口服500mg， 剂量可以根据患者的情况而增加或减少，但是可以每天增加到600mg一次。
包装规格
片剂
100毫克：50片（PTP）
制造和销售（进口）
辉瑞公司
提示：以上中文资料不够完整，使用原处方资料为准。
完整说明书附件：http://www.info.pmda.go.jp/go/pack/4291036F1028_1_07/
Acquired manufacturing and marketing authorization for "Bosliff ® tablet 100mg" for treatment of chronic myelogenous leukemia
~ For chronic myelogenous leukemia, new treatment options
Pfizer Inc.(Headquarters: Shibuya-ku, Tokyo; President: Ichiro Umeda, hereinafter referred to as "Pfizer") announced on September 26(Fri) 2014, "Chronic myelogenous leukemia resistant or intolerable to pre-Manufacture of oral SRC/ABL tyrosine kinase inhibitor "Boschlaf®tablet 100mg"(generic name: Bosutibibu, hereinafter "Boshurif") with the efficacy and effect of the oral SRC /ABL tyrosine kinase inhibitor(hereinafter, "chronic myeloid leukemia"We obtained sales approval.
Treatment with selective BCR-ABL tyrosine kinase imatinib, dasatinib or nilotinib, or allogeneic hematopoietic cell transplantation is currently being performed as the primary treatment option for CML.
However, medical needs in the second and third and subsequent treatments are still high, as patients with sufficient first-line treatment can not obtain a therapeutic effect, or there are patients who need to be discontinued due to side effects.
Boschliff is a candidate for CML patients with imatinib resistant or intolerable (second line) treatment in overseas and domestic clinical trials and also for CML patients with dasatinib or nilotinib resistant or intolerable (after tertiary therapy) Efficacy was recognized for patients, and tolerability was good.
This approval is based on these test results.
In addition, this drug was designated as a drug for rare diseases (Orphan drug) with the same efficacy and was under review as a priority review item.
Overview of Bosliff
product name
Bosliff®tablet 100mg(BOSLIF®Tablets 100mg)
common name
Bosutinib (Bosutinib)
Manufacturing sales
Selling approval acquisition date September 26, 2014
Manufacturing sales
Pfizer Japan Inc
Indication
Chronic myelogenous leukemia resistant or intolerant to pretreatment drugs
Dosage regimen
Usually, adults receive 500 mg once a day as a bostinib orally after meals. Although it may be increased or decreased according to the condition of the patient, it can be increased up to 600mg once a day.
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