部份中文拉布立酶处方资料（翁供参考）
英文名：ELITEK (rasburicase for injection)
中文名：拉布立酶冻干粉注射剂
生产商：赛诺菲-安万特
药品简介
ELITEK（rasburicase）用于注射，用于静脉注射
美国初期审批：2002年
警告：
过敏反应，溶血，高铁血红蛋白血症和干扰尿酸测FULL看到完整的黑框警告处方信息。
超敏反应：精英会导致严重和致命的超敏反应，包括过敏反应。如果发生严重超敏反应，立即并永久停止Elitek。
溶血：不要给患有葡萄糖-6-磷酸脱氢酶（G6PD）缺乏症的患者服用精英。如果溶血发生，立即并永久停止使用Elitek。在开始Elitek治疗之前，患有G6PD缺陷风险较高的患者（例如非洲或地中海血统患者）。
高铁血红蛋白血症：Elite在某些患者中可导致高铁血红蛋白血症。如果发生高铁血红蛋白血症，立即永久中止Elitek。
干扰尿酸测量：Elitek酶促降解室温下留下的血液样品中的尿酸。在含有肝素的预先冷却的管中收集血液样本并立即。在采集后4小时内测定血浆样品。
作用机制
在人体中，尿酸是嘌呤分解代谢途径中的最后一步。 Rasburicase催化难溶性尿酸的酶促氧化成无活性和更易溶解的代谢物（尿囊素）。
适应症和用法
埃立特是重组尿酸氧化酶指示用于儿童和成人患者白血病，淋巴瘤，以及实体瘤恶性肿瘤血浆尿酸水平的初始管理谁正在接受预期导致肿瘤裂解和血浆尿酸随后海拔抗癌治疗，
使用限制：精英仅适用于单一疗程。
用法和管理
每天30分钟静脉输注0.2mg/kg，持续5天。
不要给予静脉推注。
剂型和强度
对于注射剂，1.5mg，冻干粉在单剂量小瓶中
对于注射剂，单剂量小瓶中的7.5mg冻干粉末
禁忌症
对rasburicase的以下反应史：过敏反应，严重超敏反应，溶血，高铁血红蛋白血症。
葡萄糖-6-磷酸脱氢酶（G6PD）缺乏。
不良反应
发热，外周水肿，焦虑，头痛，腹痛，便秘，腹泻，低磷血症，恶性肿瘤和抗癌治疗咽喉痛，丙氨酸转氨酶增加。
在特定人群中使用
怀孕：可能会对胎儿造成伤害。只有在母亲的潜在利益证明对胎儿有潜在风险时才使用。
护理母亲：停止护理或Elitek考虑药物对母亲的重要性。
如何提供/储存和处理
如何提供
NDC 0024-5150-10：一个纸箱包含3个含有1.5mg rasburicase的单剂量小瓶和3个安瓿，每个含有1 mL稀释剂。
NDC 0024-5151-75：一个纸箱包含1个含7.5mg rasburicase的单剂量小瓶和1个含5mL稀释液的安瓿。
存储和处理
冻干药品和稀释液应重新储存在2-8°C（36-46°F）。不要冻结。避光。
由赛诺菲开发的重组尿酸氧化酶冻干粉针制剂,商品名为Fasturtec ，Elitek该药于2001 年6月在德国和英国以Fasturtec的商品名首次批准上市。现已整个欧洲以及在美国上市，在美国以Elitek的名称于2002年7月被批准上市，用于预防及治疗血癌所引起的高尿酸血症注射液。
完整说明书附件：
1）：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0ae10bc4-6b65-402f-9db5-2d7753054922
2）：https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=9174
Important Safety Information for ELITEK (rasburicase)
WARNING: ANAPHYLAXIS, HEMOLYSIS, METHEMOGLOBINEMIA, AND INTERFERENCE WITH URIC ACID MEASUREMENTS
Anaphylaxis: ELITEK can cause severe hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue ELITEK in patients who experience a serious hypersensitivity reaction.
Hemolysis: Do not administer ELITEK to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue ELITEK in patients developing hemolysis.
Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting ELITEK.
Methemoglobinemia: ELITEK can result in methemoglobinemia in some patients.
Immediately and permanently discontinue ELITEK in patients developing methemoglobinemia.
Interference with Uric Acid Measurements: ELITEK enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection.
Among the 347 (265 pediatric; 82 adult) patients for whom all adverse reactions regardless of severity were assessed in Studies 1, 2 and 3, as well as an uncontrolled safety trial, the most frequently observed adverse reactions (incidence ≥10%) were vomiting (50%), fever (46%), nausea (27%), headache (26%), abdominal pain (20%), constipation (20%), diarrhea (20%), mucositis (15%), and rash (13%).
Among the 275 adult patients in Study 4, hypersensitivity reactions occurred in 4.3% of patients treated with the ELITEK alone and 1.1% of patients treated with the ELITEK/oral allopurinol combination. Hypersensitivity reactions included arthralgia, injection site irritation, peripheral edema, and rash. The most common Grade 3 or 4 adverse reactions regardless of relationship to study drug in the 3 arms of Study 4 (ELITEK alone; ELITEK combined with oral allopurinol; oral allopurinol alone) were sepsis (5.4%; 6.5%; 4.4%), hypophosphatemia (4.3%; 6.5%; 6.6%), anxiety (3.3%; 0%; 0%), abdominal pain (3.3%; 4.3%; 2.2%), hyperbilirubinemia (3.3%; 2.2%; 4.4%), and increased alanine aminotransferase (3.3%; 4.3%; 2.2%), respectively.
The following serious adverse reactions occurred with a difference in incidence of greater than or equal to 2% in patients receiving ELITEK compared to patients receiving oral allopurinol in randomized studies (Study 1 and Study 4): pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections.
Indication
ELITEK® is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid.
ELITEK is indicated only for a single course of treatment.
Please click here for ELITEK (rasburicase) full prescribing information, including boxed WARNING