2006年7月24日，美国食品和药物管理局批准pegaspargase（Oncaspar，Enzon Pharmaceuticals，Inc）一线治疗急性淋巴细胞白血病（ALL）患者作为多药物化疗方案的一个组成部分。Oncaspar先前于1994年2月批准用于治疗对天然形式的L-天冬酰胺酶过敏的ALL患者。 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 •2500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。 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. Generic Name: pegaspargase Dosage Form: injection, solution ACTIVE INGREDIENTS: Contains 6.5 mg of L-asparaginase protein (conjugated to multiple 5kDa mPEGs) per mL. E.coli is used in the manufacture of the product. INACTIVE INGREDIENTS: Dibasic Sodium Phosphate.............5.58 mg Monobasic Sodium Phosphate.........1.2 mg Sodium Chloride.................................8.5 mg Water for Injection.....................qs to 1.0 mL Note:   Oncaspar® (2,500 International Units/m2 intramuscular) was administered on Day 3 of the 4-week induction phase. Native E. coli L-asparaginase (6,000 International Units/m2 intramuscular) was administered 3 times weekly for 9 doses during induction. CSF asparagine concentrations were determined in 50 patients during the induction phase. CSF asparagine decreased from a mean pretreatment concentration of 3.1µM to 1.7µM on Day 4± 1 and 1.5µM 25±1 days after administration of Oncaspar®. These findings were similar to those observed in the native E. coli L-asparaginase treatment arm. While the 3-year Event-Free Survival (EFS) for the Oncaspar® and native E. coli L-asparaginase study arms were similar and in the range of 80%, Study 1 was not designed to evaluate for differences in EFS rates. ALL Patients Hypersensitive to Asparaginase  The safety and effectiveness of Oncaspar® was evaluated in 4 open-label studies enrolling a total of 42 patients with multiply-relapsed, acute leukemia [39 (93%) with ALL] with a history of prior clinical allergic reaction to asparaginase. Hypersensitivity to asparaginase was defined by a history of systemic rash, urticaria, bronchospasm, laryngeal edema, hypotension, or local erythema, urticaria, or swelling, greater than 2 centimeters, for at least 10 minutes following administration of any form of native E. coli L-asparaginase. All patients received Oncaspar® at a dose of 2,000 or 2,500 International Units/m2 administered intramuscularly or intravenously every 14 days. Patients received Oncaspar® as a single agent or in combination with multi-agent chemotherapy. The re-induction response rate was 50% (95% confidence interval: 35%, 65%), based upon 36% complete remissions and 14% partial remissions. These results were similar to the overall response rates reported for patients with ALL receiving second-line, native E. coli L-asparaginase-containing re-induction chemotherapy. Anti-tumor activity was also observed with single-agent Oncaspar®. Three responses (1 complete remission and 2 partial remissions) were observed in 9 adult and pediatric patients with relapsed ALL and hypersensitivity to native E. coli L-asparaginase. How Supplied/Storage and Handling Oncaspar® (pegaspargase) is supplied as a sterile solution in Type I single-use vials containing 3,750 International Units of L-asparaginase per 5 mL solution (NDC 54482-301-01). 完整资料附件：https://www.drugs.com/pro/oncaspar.html ------------------------------------------------------------ 注：以下产品不同厂家规格和不同价格，采购以咨询为准 ------------------------------------------------------------ ONCASPAR 750U/ML 5ML VL DPSH 1/EA  PEGASPARGASE     54482-0301-01 ONCASPAR SDV 750IU/ML DS 5ML  PEGASPARGASE     54482-0301-01  ONCASPAR 750U/ML 5ML VL DPSH 1/EA  PEGASPARGASE     00944-3810-01