地西他滨冻干粉注射剂Dacogen 50mg powder solution infusion

地西他滨冻干粉注射剂Dacogen 50mg powder solution infusion

药店国别:

产地国家:比利时

处方药:

所属类别: 50毫克/瓶

包装规格: 50毫克/瓶

计价单位:瓶

生产厂家中文参考译名:

生产厂家英文名:Janssen-Cilag Ltd

原产地英文商品名:Dacogen powder solution infusion 50mg/Vial

原产地英文药品名:Decitabine

中文参考商品译名:Dacogen冻干粉注射剂 50毫克/瓶

中文参考药品译名:地西他滨

曾用名:

简介:英文药名: Dacogen(Decitabine Injection)中文药名: 达珂(地西他滨注射剂)生产厂家: Johnson &
Johnson
Inc药品简介Dacogen-地西他滨是通过磷酸化后直接掺入DNA,抑制DNA甲基化转移酶,引起DNA低甲基化和细胞分化或凋亡来发挥抗肿瘤作用。体外试验显示地西他滨抑制DNA甲基化,在产生该作用的浓度下不会明显抑制DNA的合成。地西他滨诱导肿瘤细胞的低甲基化,从而恢复控制细胞分化增殖基因的正常功能。在快速分裂的细胞中,掺入DNA的地西他滨可与DNA甲基转移酶共价结合从而产生细胞毒性作用。而非增殖期细胞则对地西他滨相对不敏感。

适应症:

Dacogen适用于IPSS评分系统中中危-2和高危的初治、复治骨髓增生异常综合征(MDS)患者,包括原发性和继发性的MDS,按照FAB分型所有的亚型:难治性贫血,难治性贫血伴环形铁粒幼细胞增多,难治性贫血伴原始细胞过多,难治性贫血伴有原始细胞增多-转变型,慢性粒-单核细胞白血病。

首次给药周期:

Dacogen推荐剂量为15mg/m2,连续静脉输注3小时以上,每8小时1次,连续3天。患者可预先使用常规止吐药。每6周重复一个周期。推荐至少重复4个周期。然而,获得完全缓解或部分缓解的患者可以治疗4个周期以上。如果患者能继续获益可以持续用药。依据血液学实验室检查值进行的剂量调整或延迟给药:如果经过前一个周期的治疗,血液学恢复(ANC≥1000/uL,血小板≥50000/uL)需要超过6周,则下一周期的治疗应延迟,且剂量应按以下原则进行暂时性的调整:如果出现以下任一非血液学毒性,暂停Dacogen治疗直至毒性恢复:血清肌酐≥2mg/dL;SGPT、总胆红素≥2倍ULN;活动性或未控制的感染。恢复时间超过6周,但少于8周-Dacogen给药应延迟2周,且重新开始治疗剂量减少到11mg/m2,每8小时1次,(33mg/m2/天,99mg/m2/周期);恢复时间超过8周,但少于10周-患者应进行疾病进展的评估(通过骨髓穿刺评估),如未出现进展,达珂给药应延迟2周以上,重新开始时剂量减少到11mg/m2,每8小时1次(33mg/m2/天,99mg/m2/周期),然后在接下来的周期中,根据临床情况维持或增加剂量。在欧洲进行了另两项开放、单臂、多中心研究,评价了本药治疗FAB分类中所有亚型的MDS患者的安全性和有效性。本药每8小时静脉输注15mg/m24小时以上,第一周的第1,2,3天给药,6周为一周期。II期试验的结果与III期结果一致,总缓解率分别为26%(N=66)和24%(N=98)。临床使用说明剂量和用法:第一治疗周期的推荐剂量为静脉注射地西他滨15mg/m23小时,间隔8小时重复一次,连续三天。患者须提前服用止吐剂。此疗程每六周重复一次。患者最少应经过四个疗程,直到病情得到控制与好转。第一和第二治疗周期中,骨髓抑制和中性粒细胞减少症较常见。较严重的中性粒细胞减少症发生率为87%,血小板减少症为85%,热性的中性粒细胞减少症为23%,白细胞减少为22%。骨髓抑制是减少剂量或中断治疗的主要原因。在整个治疗的过程中须密切关注血小板数量,随时调整剂量或暂停治疗。

地西他滨冻干粉注射剂英文版说明书:

DACOGEN is a prescription medicine for patients with myelodysplastic syndrome (MDS), including previously treated and untreated MDS and de novo (cause unknown) and secondary (treatment-related) MDS of all French-American- British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups.This site will provide you with information about DACOGEN, how DACOGEN may affect MDS, and what you can expect from treatment with DACOGEN, along with helpful resources.INDICATION:DACOGEN is a prescription medicine indicated for treatment of patients with myelodysplastic syndromes (MDS), including:Previously treated and untreated MDSDe novo (cause unknown) and secondary (treatment-related) MDS: ◦All French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia)◦Intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groupsIMPORTANT SAFETY INFORMATION:Treatment with DACOGEN is associated with serious, sometimes fatal, blood disorders including: ◦fewer white blood cells (neutropenia and leukopenia), platelets (thrombocytopenia), and/or red blood cells (anemia)◦fever associated with low white blood cell counts (febrile neutropenia)◦bone marrow suppression◦infectionsYour doctor will test and monitor your blood cells before and during treatment with DACOGEN. Your doctor may prescribe medicine to help manage your blood cell counts and/or medicines to prevent or treat infections. Your doctor may need to delay your treatment and/or reduce your dose if you experience certain side effects. Patients should monitor and report any symptoms or fever to their doctor as soon as possibleHarm to a fetus when administered to a pregnant woman: Women of childbearing potential and men with female partners of childbearing potential should use effective contraception and avoid pregnancy while taking DACOGEN。

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