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英文药名：Vidaza for Injection（Azacitidine）
中文药名：阿扎胞苷冻干粉注射剂
生产厂家：日本新薬
ビダーザ注射用100mg
药物分类名称
骨髓增生异常综合征药物
批准日期：2011年3月
商標名
Vidaza for Injection 100mg
一般名
アザシチジン（Azacitidine）（JAN）
化学名
4-Amino-1-β-D-ribofuranosyl-1,3,5-triazin-2(1H)-one
分子式
C8H12N4O5
分子量
244.20
化学構造式
性状
白色至细灰色固体。
该产品易溶于二甲基亚砜，易溶于水或N-甲基吡咯烷酮，几乎不溶于乙醇（99.5）。
熔点
约227°C（分解）
批准条件
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情况调查，直到制作销售后累积了一定数量的病例， 除了掌握使用患者的背景资料外，尽快收集有关该药物安全性和有效性的资料，并采取必要措施，妥善使用该药。
药效药理
1. 作用机序
由于该产品被纳入DNA和RNA，因此主要抑制蛋白质合成并显示出细胞杀伤作用。在MDS中，已经报道了肿瘤抑制基因启动子区域中DNA的高甲基化和抑制癌症抑制基因的表达，并且掺入DNA中的氮杂胞苷抑制DNA甲基化 并且还报道了表现出细胞抑制作用的可能性。
2. 薬理作用
(1) Azacytidine在体外试验中显示从MDS转移到急性骨髓性白血病患者的SKM-1细胞系的生长抑制作用。
(2) 阿扎胞苷对皮下注射SKM-1细胞株的NOD/SCID小鼠显示肿瘤生长抑制作用。
适应症
骨髓增生异常综合征
用法与用量
成人；每天一次皮下接受7天的75mg/m2（体表面积）或静脉滴注10分钟，然后停药3周。 这被定义为一个周期，并且重复管理。 另外，根据患者的状况进行体重减轻。
包装规格
注射液
100毫克：1瓶
制造厂商
日本新薬株式会社
提示：以上中文处方资料不够完整，使用者以原处方为准。
完整说明书附件：http://www.info.pmda.go.jp/go/pack/4291419D1026_1_05/
Notice of new release of "Vidaza ® 100 mg for injection" for myelodysplastic syndrome
Nippon Shinyaku Co., Ltd. announces that it has started selling today "Vidaza ® 100 mg for injection" for myelodysplastic syndrome treatment.
"Bidaza® 100 mg for injection" (generic name: azacytidine) is a nucleic acid analog introduced as a treatment for myelodysplastic syndrome (MDS), based on a license agreement with Celgene (Headquarters: New Jersey, USA) It is a lyophilized preparation for injection mainly containing azacitidine in the body.
MDS is a refractory disease with a poor prognosis with a high rate of transition to leukemia, has been designated intractable disease in Japan, and the number of patients is estimated at about 9,000 people, but a useful treatment method is established The development of new drugs has been long awaited, as it has not been done. Major symptoms are general malaise due to anemia, easily infectious by leukopenia, bleeding tendency due to thrombocytopenia, and complications include iron overload due to frequent transfusion and multiple organ dysfunction.
This product has been marketed in more than 30 countries including the United States and Europe, and has been designated as a drug for rare diseases on November 17, 2008 in Japan.
The characteristics of this drug are as follows.
·In overseas clinical trials in high-risk MDS patients, the median survival was 15.0 months in the conventional treatment group, whereas in the azacytidine group, a significant extension was confirmed, a significant extension was confirmed, and the 2-year survival rate Has doubled.
It has also been reported that it is taken up into RNA or DNA after being phosphorylated in the cell, inhibits protein synthesis and exhibits a cytocidal effect and inhibits abnormal DNA methylation which is frequently found in MDS cells It is.
·In the United States, it is used as the first-line treatment of MDS treatment.
By delivering this drug to the medical institution, we will be able to become a gospel of patients and their families suffering from MDS because there are no useful treatments so far, and for MDS therapy I hope that I can contribute to everyone involved in medical care.
product name :
Vidaza ® for injections 100 mg
Manufacturing selling agency:
Nippon Shinyaku
Composition/Property:
Sales name
Vidaza®for injections 100mg
Ingredients·Content: 100mg of azacytidine in 1 vial
Additive: 100 mg of D-mannitol
Dosage form: lyophilized injection
Properties: White cake-like mass or powder
a) Liquid obtained by uniformly suspending 1 vial of this drug in 4mL of water for injection
b) A solution prepared by dissolving 1 vial of this drug in 10mL of water for injection
common name:
Azacitidine (JAN)
Indications/effects:
Myelodysplastic syndrome
Dosage/administration:
Normally, adults receive 75mg/m2(body surface area) as azacitidine subcutaneously once a day for 7 days or intravenously dropwise over 10 minutes, followed by withdrawal for 3 weeks. This is defined as one cycle and administration is repeated. Incidentally, weight reduction is made according to the condition of the patient.
Manufacture and sale approval day:
January 21, 2011
Drug price criteria Listed date:
March 11, 2011
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