阿扎胞苷 ,阿扎胞苷 Vidaza Injection 100mg(ビダーザ注射用 Azacitidine)

药店国别:

产地国家:日本

处方药:

所属类别: 100毫克/瓶

包装规格: 100毫克/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:nippon-shinyaku

原产地英文商品名:VIDAZA(ビダーザ) 100mg/Vial

原产地英文药品名:AZACITIDINE

中文参考商品译名:维达扎(ビダーザ) 100毫克/瓶

中文参考药品译名:阿扎胞苷

曾用名:阿扎胞苷、5-氮杂胞苷、5-氮杂胞嘧啶核苷、氮胞苷、氮杂胞苷、Ladakamycin

简介

英文药名: Vidaza(Azacitidine Injection)

中文药名: 维达扎(阿扎胞苷注射液)

开发与上市厂商:5-azacitidine由Pharmion公司开发,于 2004年7月在美国首次上市。

药品英文名:Azacitidine

药品别名:氮杂胞苷、5-氮杂胞嘧啶核苷、5-Azacytidine、AzGR、Mylosar

药物剂型粉针剂:每支50mg、100mg。用前水溶解为本品浓度5mg/ml和含甘露醇5mg/ml注射液。pH在6.0~7.5之间,在滴注前可进一步在乳酸盐林格注射液中稀释。

药理作用

抗肿瘤药,本品在体内先转变成氮杂胞苷酸(AZCRP),可掺入肿瘤细胞RNA和DNA中;能抑制DNA合成,阻碍RNA及蛋白质合成;主要杀伤S期细胞,也可抑制乳酸脱羧酶,使嘧啶的新合成受影响。

药动学

静脉给药后血浆生物半衰期为3.5h,85%的放射性在48h内排出。适应证主要用于治疗髓细胞白血病。注意事项肾功能不全患者慎用。

不良反应

有报告2例应用本品治疗发生预料不到的酸碱电解质异常,并有2例死亡。给药200mg/kg,5~7天,多发生多尿、糖尿或暂时的血液中碳酸氢盐或磷酸盐的改变,提示肾小管功能不全。

用法用量

静脉滴注:每天50~200mg/kg,连用5天。临床研究22例接受2个疗程以上的治疗,其中7例难治性急性粒细胞白血病完全缓解(32%),3例部分缓解(14%)。

英文版说明

VIDAZA is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).IMPORTANT SAFETY INFORMATION•VIDAZA is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol and in patients with advanced malignant hepatic tumors.•In Studies 1 and 2, the most commonly occurring adverse reactions by SC route were nausea (70.5%), anemia (69.5%), thrombocytopenia (65.5%), vomiting (54.1%), pyrexia (51.8%), leukopenia (48.2%), diarrhea (36.4%), injection site erythema (35.0%), constipation (33.6%), neutropenia (32.3%), and ecchymosis (30.5%). Other adverse reactions included dizziness (18.6%), chest pain (16.4%), febrile neutropenia (16.4%), myalgia (15.9%), injection site reaction (13.6%), and malaise (10.9%). In Study 3, the most common adverse reactions by IV route also included petechiae (45.8%), weakness (35.4%), rigors (35.4%), and hypokalemia (31.3%).•In Study 4, the most commonly occurring adverse reactions were thrombocytopenia (69.7%), neutropenia (65.7%), anemia (51.4%), constipation (50.3%), nausea (48.0%), injection site erythema (42.9%), and pyrexia (30.3%). The most commonly occurring Grade 3/4 adverse reactions were neutropenia (61.1%), thrombocytopenia (58.3%), leukopenia (14.9%), anemia (13.7%) and febrile neutropenia (12.6%).•Because treatment with VIDAZA is associated with anemia, neutropenia and thrombocytopenia, complete blood counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each dosing cycle.•Because azacitidine is potentially hepatotoxic in patients with severe preexisting hepatic impairment, caution is needed in patients with liver disease. In addition, azacitidine and its metabolites are substantially excreted by the kidneys and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.•VIDAZA may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be apprised of the potential hazard to the fetus. Men should be advised not to father a child while receiving VIDAZA.•Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.Please see full Prescribing Information.

 

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