培门冬酰胺酶注射剂|ONCASPAR(pegaspargase)injection
简介:
药品信息:Oncaspar is indicated for patients with acute lymphoblastic leukemia who require L-asparaginase in their treatment regimen, but have developed hypersensitivity to the native for ...
英文药名:ONCASPAR(pegaspargase Injection)
中文药名:培门冬酶注射剂
生产厂家:恩仲制药 药品介绍 本品为PEG化的L-门冬酰胺酶制剂。某些白血病细胞依赖于天门冬酰胺氨基酸存活,而L-门冬酰胺酶能够减少此种氨基酸。美国FDA于1994年2月批准本品用于治疗急性成淋巴细胞性白血病,在需要接受L-门冬酰胺酶治疗而又对天然L-门冬酰胺酶过敏的患者中使用。不但降低了免疫原性,而且用药更易为患者所接受——只需二周1次用药,而非重组的L-门冬酰胺酶需要一周2次用药。 Oncaspar®(培门冬酶 pegaspargase)注射,肌内或静脉内使用 美国初始批准:1994 作用机理 Oncaspar的作用机制®被认为是基于对白血病细胞的选择性杀伤由于等离子体天冬酰胺的枯竭。某些白血病细胞不能合成天冬酰胺由于缺少天冬酰胺合成酶和依赖于天冬酰胺的生存的外源来源。天冬酰胺的消耗,从治疗效果与酶左旋门冬酰胺酶,杀死白血病细胞。正常细胞,但是,受影响较小由耗尽由于它们的合成天冬酰胺的能力。 适应症和用法 Oncaspar®被表示为多剂化疗方案治疗的患者的一个组成部分的天冬酰胺酶特异性: •第一行急性淋巴细胞白血病 •急性淋巴细胞白血病和过敏门冬酰胺酶。 用法用量 •2,500多种单位/米2肌注或静滴超过每14天没有更频繁。 •对于肌肉注射,限制音量保持在一个单一的注射部位为2毫升,如果大于2毫升,使用多个注射部位。 •对于静脉内施用,得到了一段在100ml氯化钠或葡萄糖注射5%,1至2小时,通过这已经运行的输注。 •不要给予Oncaspar®如果药物已被冻结,储存在室温下超过48小时,或摇动或剧烈搅拌。 剂型和规格 ·在单次使用的小瓶3750国际单位/5ml溶液。 禁忌 •到Oncaspar严重过敏反应史® •事先左旋门冬酰胺酶治疗严重的血栓形成史 •事先左旋门冬酰胺酶治疗胰腺炎史 •事先左旋门冬酰胺酶治疗严重出血事件的历史 警告和注意事项 •过敏反应或严重过敏反应 - 观察患者用药后一小时。停止Oncaspar®患者的严重过敏反应。 •血栓 - 将停止Oncaspar®患者严重的血栓事件。 •胰腺炎 - 评估患者胰腺炎腹痛。停止Oncaspar®患者胰腺炎。 •糖耐量 - 监测血清葡萄糖。 •凝血功能障碍 - 进行适当的监控。 •肝 - 进行适当的监控。 不良反应 最常见的不良反应(≥2%)是过敏反应(包括过敏性反应),中枢神经系统(CNS)血栓形成,凝血,转氨酶升高,高胆红素血症,高血糖和胰腺炎。 --------------------------------------------------- 【原产地英文商品名】ONCASPAR-750IU/mL,5mL/Vial 【原产地英文药品名】PEGASPARGASE 【原产地英文化合物名称】PEGASPARGASE 【中文参考商品译名】昂卡司帕-750IU/毫升,5毫升/瓶 【中文参考药品译名】培门冬酶 【中文参考化合物名称】聚乙烯苷醇轭合物 【生产厂家中文参考译名】恩仲制药 【生产厂家英文名:Enzon
Oncaspar(pegaspargase、PEG+L-门冬酰胺酶) ONCASPAR (pegaspargase) is given to patients with acute lymphoblastic leukemia (ALL) as part of a group of chemotherapy medications. ONCASPAR is administered IM/IV* and should not be given more frequently than every 14 days. Indication and Usage ONCASPAR (pegasapragase) is indicated as a component of multi-agent chemotherapeutic regimen for treatment of patients with: •First-line Acute Lymphoblastic Leukemia (ALL) •ALL and hypersensitivity to native forms of L-asparaginase. Detailed Important Safety Information CONTRAINDICATIONS •History of serious allergic reactions to Oncaspar •History of serious thrombosis with prior L-asparaginase therapy •History of pancreatitis with prior L-asparaginase therapy •History of serious hemorrhagic events with prior L-asparaginase therapy WARNINGS and PRECAUTIONS Anaphylaxis and Hypersensitivity: Anaphylaxis or serious allergic reactions can occur; therefore, patients should be observed for one hour after administration. Discontinue ONCASPAR in patients with serious allergic reactions. Thrombotic Events: Serious thrombotic events, including sagittal sinus thrombosis can occur. Discontinue Oncaspar in patients with serious thrombotic events Pancreatitis: Pancreatitis can occur. Evaluate patients with abdominal pain for evidence of pancreatitis. Discontinue Oncaspar in patients with pancreatitis Glucose Intolerance: Glucose intolerance can occur. In some cases, glucose intolerance is irreversible. Monitor serum glucose. Coagulopathy: Increased prothrombin time, increased partial thromboplastin time, and hypofibrinogenemia can occur. Monitor coagulation parameters at baseline and periodically during and after treatment. Hepatotoxicity: Hepatotoxicity and abnormal liver function, can occur. Perform appropriate monitoring. ADVERSE REACTIONS The most common adverse reactions with ONCASPAR (≥2%) are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia, and elevated transaminases. Hyperlipidemia (hypercholesterolemia and hypertriglyceridemia) has been reported in patients exposed to ONCASPAR. 完整处方资料附件: 1):https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d933e1d1-06b7-4d70-981f-3e8984b0683f 2):https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d046ec54-9ac8-4c9f-87a7-69e9900d8016
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