维达扎,维达扎Vidaza(Azacitidine Injection)

药店国别:

产地国家:美国

处方药:

所属类别: 100毫克/瓶 10瓶/盒

包装规格: 100毫克/瓶 10瓶/盒

计价单位:

生产厂家中文参考译名:

生产厂家英文名:CELGENE

原产地英文商品名:VIDAZA 100mg/Vial 10Vials/box

原产地英文药品名:AZACITIDINE

中文参考商品译名:维达扎 100毫克/瓶 10瓶/盒

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)药品介绍阿扎胞苷(Azacitidine)

英文名称:Azacitidine

英文别名:5-Azacytidine、Ladakamycin

其他名:5aza-C,拉达卡霉素(Ladakamycin),5-氮杂胞苷、5-氮杂胞嘧啶核苷、氮胞苷、氮杂胞苷。

作用机制:

嘧啶类抗代谢药,干扰核苷酸的合成,以假嘧啶形式掺入DNA和RNA中,并与之结合。

适应症:

急性非淋巴细胞性白血病。用于乳腺癌、肠癌、黑色素瘤等有一定疗效。

常用剂量:100mg/m2,静脉推注,每8小时一次,连用5天,200mg/(m2·d)静脉持续滴注,连用5天。

注意事项:

由于药物的稳定性差,因此应该在用药前配药,配药后立即使用,配药后8小时未用则应丢弃。静脉滴注应该用新鲜林格液配制,每8小时配制一次。

毒性反应:

(1)骨髓抑制和其他血液学反应:所有的病人都会出现严重的骨髓抑制和其他血液学反应,表现为白细胞于第12~14天降至最低,偶见抑制持续超过几周。

(2)恶心呕吐和其他胃肠道反应:常见。静脉持续滴注可减轻恶心呕吐和其他胃肠道反应反应。

(3)皮肤粘膜反应:粘膜炎及皮肤红疹偶见

(4)其他反应:1)腹泻:常见。2)神经系统反应:肌肉疼痛、虚弱、嗜睡及昏迷,少见。3)肝毒性:罕见,但可能严重。4)暂时性发热:偶见。

*FDA于04年5月19日宣布批准Vidaza(商品名:维达扎;通用名:azacitidine<阿扎胞苷>)注射液为治疗骨髓增生异常综合症(Myelodysplastic Syndrome, MDS)的第一个有效药物。

DA代理专员Lester M. Crawford博士说:

“通过恢复骨髓细胞的正常生长和分化,该新药将向有此种罕见的并且在一些病例中恶化为白血病的那些患者提供一个非常需要的治疗手段。FDA将继续给予这类具有显著疗效的产品的批准以最高的优先权。

”MDS是由骨髓细胞功能异常、正常血细胞生成减少而引起的一系列疾病的总称。MDS可由治疗其它疾病的药物或放射治疗所致,也可由未知病因引起。

MDS的某些类型会恶化为急性髓细胞样白血病(AML)。AML是白细胞增生过度活跃的一种癌症。

FAB(法国-美国-英国)协作组织将MDS分为5型,分别是:

顽固性贫血(RA)、环形铁粒幼红细胞性难治性贫血(RARS)、原始细胞过多性难治性贫血(RAEB)、转化型原始细胞过多性难治性贫血(RAEB-T)和慢性粒单核细胞白血病(CMMoL)。

Vidaza属于罕见病治疗药。罕见病治疗药用于治疗患者人数在美国少于20万的罕见疾病或症状。

《罕见病药物法》规定:

获得所指定罕见病药物上市批准的首个申报者将享有该药物在美国市场上7年期的独占上市权。据估计,美国每年有7000-12,000的MDS新病例被确诊。这种疾病在各年龄段都可能发生,但是60岁以上人群发病率最高。典型症状包括虚弱、疲劳、感染、易淤伤、出血和发热。MDS患者可能需要接受红血球和血小板的输入,以及针对感染的抗生素治疗。

英文版说明

IMPORTANT SAFETY INFORMATIONAbout VIDAZA(R)In December 2008, VIDAZA became the first and only drug approved by the European Commission to demonstrate a significant extension of overall survival compared to conventional care regimens, for patients with intermediate-2 and high-risk MDS and AML (20-30% blasts). Earlier in 2008, the U.S. FDA also included this extension of overall survival in its approved VIDAZA indication for treatment of all five French, American, British (FAB) MDS subtypes, which includes both low-risk and high-risk patients. These subtypes include: refractory anemia (RA), 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 (CMML). The more recent WHO classification system incorporates RAEB-T patients within the AML category. VIDAZA has received orphan drug designation in several markets including the European Union, the U.S. and Japan.VIDAZA(R) (azacitidine for injection) 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 INFORMATIONCONTRAINDICATIONS:– VIDAZA is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol and in patients with advanced malignant hepatic tumorsWARNINGS AND PRECAUTIONS:Anemia, Neutropenia and Thrombocytopenia:– 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 cycleSevere Pre-existing Hepatic Impairment:– Because azacitidine is potentially hepatotoxic in patients with severe preexisting hepatic impairment, caution is needed in patients with liver disease.Renal Abnormalities:– 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 functionUse in Pregnancy:– 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 VIDAZAUSE IN SPECIFIC POPULATIONS:Nursing Mothers:– Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the motherADVERSE REACTIONS:– 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%)Please see full Prescribing Information, including CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.About Acute Myeloid LeukemiaAcute myeloid leukemia (AML) is a cancer of myeloid blood cells that often transforms from MDS upon disease progression. AML is the proliferation of abnormal cells that accumulate in the bone marrow and interfere with the production of all types of normal blood cells (multi-lineage dysplasia). AML has traditionally been treated with high intensity chemotherapy, which is poorly tolerated by the majority of the patients who are afflicted – the elderly. Many of these patients may go untreated, and because they are ineligible for curative therapy, life expectancy is short and often measured in weeks to months.About Celgene International SarlCelgene International Sarl, located in Boudry, in the Canton of Neuchatel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at www.celgene.com.

 

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