药品信息:
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DACOGEN® (decitabine) for Injection is a therapy approved to treat myelodysplastic syndromes (MDS). It can help treat the disease and improve your MDS symptoms. Even if you have already received other treatment for MDS, you can still be treated with DACOGEN.
DACOGEN.com is your resource for MDS information and the treatment with DACOGEN. Learn how DACOGEN helps relieve MDS symptoms and works to change the course of the disease.
DACOGEN is indicated for treatment of patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo, and secondary MDS of all FAB subtypes (RA, RARS, RAEB, RAEB-t, CMML) and Intermediate-1, Intermediate-2, and High-Risk IPSS groups.
DACOGEN may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while using DACOGEN. Men should be advised not to father a child while receiving treatment with DACOGEN, and for 2 months afterwards. The most commonly occurring adverse reactions include neutropenia, thrombocytopenia, anemia, fatigue, pyrexia, nausea, cough, petechiae, constipation, diarrhea, and hyperglycemia.
DACOGEN is available by prescription only. Please see the important product information for DACOGEN for more information. This site does not contain everything that is known about DACOGEN. If you would like to know more, talk to your healthcare professional.
Decitabine (商品名为Dacogen)本是用于治疗骨髓增生异常综合征(MDS)的罕见病药物.而2003年上半年,SuperGen公司又获得美国FDA批准进行将其用于治疗镰状细胞性贫血的II期临床试验,而且本品还有望用于治疗难治性慢性髓性白血病(CML)和实体瘤. MGI制药和SuperGen公司宣布,美国FDA批准了Dacogen(decitabine,地西他滨)注射液的上市申请,获批用于治疗骨髓异常综合征(MDS),包括所有法、美、英型(FAB型)的已接受治疗和未接受治疗的,新发病的和继发性的MDS患者,以及按IPSS系统分为高危险、中度2级危险、中度1级危险的MDS患者。 MGI制药计划于今年第二季度上市该产品。Dacogen是一类低甲基化试剂,具有独特的治疗机制。2004年3月,SuperGen公司完成了Dacogen治疗MDS患者的Ⅲ期临床试验,向FDA报批。 MGI制药SuperGen公司达成协议,拥有该产品在全世界的独占开发、生产和经销权。两公司目前正计划将该药运用到更多的血液肿瘤疾病中脱氧氮杂胞苷
[中文别名] 5-氮杂胞嘧啶脱氧胞苷,5-氮杂-2’-脱氧胞苷。 [外 文 名] 5-Aza-2'-deoxycytidine,Decitabine. [药理作用] 本品为目前已知最强的DNA甲基化特异性抑制剂,阻断DNA甲基化可致基因激活与诱导细胞分化。其对L1210的细胞毒作用可为胸苷所加强,是因胸苷可使本品掺入DNA的量增加,从而增加本品对DNA甲基化的抑制作用。本品为S期细胞周期特异性药物。 [体内过程] 本品静脉注射给药后,迅速从血中消除,半衰期为10~35分钟。可透过血-脑屏障,在脑脊液中可达细胞毒浓度。本品在肝脏中被腺苷脱氨酶代谢为无细胞毒性的5-氮杂脱氧尿苷,未代谢物从尿中排出。 [临床应用] 对急性非淋巴细胞白血病及慢性粒细胞白血病急变有一疗效;诱导分化治疗可用于急性粒细胞白血病及骨髓增生不良综合征。 [用法用量] 静脉滴注:每日500mg/m2,静脉滴注24小时,连用3日。 [不良反应] (1)主要为白细胞、血小板减少,轻中度恶心、呕吐。 (2)大剂量可引起神经毒性,表现为嗜睡、失语、偏瘫等,但停药后可恢复正常。
2-8摄氏度保存
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