英文药名：LEUNASE Injection（L-Asparaginase） 中文药名： 左旋门冬酰胺酶冻干粉注射剂 生产厂家：协和发酵麒麟 ロイナーゼ注用5000／ロイナーゼ注用10000 药物分类名称 抗肿瘤酶制剂 批准日期：2005年12月 欧文商標名 LEUNASE Injection 5000 LEUNASE Injection 10000 蛋白质由4个亚基组成，由326个氨基酸组成 一般名 L-アスパラギナ－ゼ　L-Asparaginase 分子量 138,368（サブユニット1つあたり34,592：質量分析法による） 性状 属于柱状或针状单斜晶型的白色晶体 可溶性 它很溶于水，但几乎不溶于甲醇，丙酮或氯仿。 组成：5000单位 5000注射剂是一种注射剂，可以在使用时溶解在一个瓶子中，并含有下列成分。 有效成分 L-天冬酰胺酶冻干产品5000 K.U. （1 K.U.是当在37℃时，酶促降解L-天冬酰胺并且每分钟产生1μmole的NH 3时的量。 组成 10000单位 注射剂leinnze是一种注射剂，在使用时溶解在一个瓶子中，含有下列成分。 有效成分 L-天冬酰胺酶冻干产品10000 K.U. （1 K.U.是当在37℃时，酶促降解L-天冬酰胺并且每分钟产生1μmole的NH 3时的量。 药用药理学 1.抗肿瘤性质 小鼠淋巴母细胞样L5178Y，小鼠淋巴瘤6C3HED，大鼠肉瘤Walker 256等显示出抗肿瘤特性。 2.作用机制 它分解血液中的L-天冬酰胺，并通过使需要天冬酰胺的肿瘤细胞进入营养缺乏状态而发挥抗肿瘤作用。 适应病症 急性白血病（包括急性慢性白血病逆转） 恶性淋巴瘤 用法与用量 急性白血病（包括急性慢性白血病逆转） 恶性淋巴瘤 （静脉内给药）通常每隔一天或每隔一天通过滴注静脉内注射50至200KU / kg体重的日剂量。 根据年龄，一般情况相应增加。 （肌内给药）通常，每1m 2体表面积的每1m 2体表面积10,000KU每周1次肌肉注射，每周2次，或者每天1次，每周1次25000KU/m 2体表面积。 根据病人的情况适当减少。 （溶液制备方法） 请参阅“与剂量/剂量有关的使用说明” 临床结果 主要在36家家庭设施中进行造血肿瘤的临床试验的结果总结如下。 为了评价有效性，根据Kimura等人的急性白血病治疗效果标准，恶性淋巴瘤治疗效果判断标准和每个设施的判断标准，计算完全缓解病例和部分缓解病例作为有效例子。（见临床结果表） 病型名  種別  有効率  急性白血病  リンパ性白血病  75.0%（51/68）  急性白血病  骨髄性白血病  40.8%（29/71）  急性白血病  その他  44.4%（4/9）  悪性リンパ腫  ホジキン氏病  36.4%（4/11）  悪性リンパ腫  細網肉腫  53.8%（7/13）  悪性リンパ腫  リンパ肉腫  68.9%（13/19）  計    56.5%（108/191）  包装规格 5000：1瓶 10000：1瓶 制造商 协和发酵麒麟：Kyowa Hakko Kirin Co.Ltd. 提示：以上中文资料不够完整，使用者以原处方资料为准。 完整说明书附件：http://www.info.pmda.go.jp/go/pack/4291400A1033_1_06/ Regarding acquisition of additional indication for dosage and dose related to intramuscular administration of 5000 for leinase ® injection and 10,000 for leinase ® injection Kyowa Hakko Kirin Co., Ltd. (Head office: Tokyo, President: Chen Yu Hui, hereinafter referred to as "Kyowa Hakko Kirin") today announced that it has entered into a joint venture with "Loinase® Note 5000 and 10000" - Asparaginase, hereinafter referred to as "leukinase"), we are pleased to announce that we have obtained approval for the addition of dosage and dose for intramuscular administration. Leinnase is an antineoplastic enzyme preparation containing L-asparaginase as a main ingredient and suppresses proliferation of tumor cells by decomposing and reducing L-asparagine in the blood against L-asparagine-requiring tumor cells. This drug is widely used in the treatment of acute leukemia and malignant lymphoma, but one side effect is hypersensitivity such as anaphylactic symptoms. If you develop hypersensitivity during treatment, it will be impossible to administer this drug after that, so treatment can not be completed, so affecting prognosis is a challenge. Currently, the approval regimen for this product in Japan is limited to intravenous administration, but it has been reported that the incidence of hypersensitivity is lower in intramuscular administration than in intravenous administration. Based on these circumstances, a request to the L-asparaginase (leukinase) from the Japan Society of Pediatric Hematology and the Japanese Children's Cancer Association to require early approval of the dosage and dose for intramuscular administration will be welfare program in December 2011 It was submitted to the Minister of Labor. Furthermore, based on the evaluation at the unapproved drug /non-indication drug review meeting 1 high medical necessity highly recommended in the second division of the Pharmaceutical Affairs and Food Sanitation Council held in September 2012, As Kyowa Hakko giraffe was determined to carry out Note 2, Kyowa Hakko Kirin filed an application for partial change approval of drug manufacture and market approval matters concerning Leuanase in October of the same year with the scientific grounds of known literature There was. We hope that Kyowa Hakko Kirin will contribute to the treatment of acute leukemia and malignant lymphoma as a result of this approval acquisition. Note 1 Unconfirmed drugs with high necessity for medical treatment · Conference for review outside of indication Although it is approved for use in Europe and the US, in addition to evaluating the necessity of medicine for unapproved medicines and indications in the country, it is necessary to evaluate the necessity of medical treatment and to apply the applicability to the public application and examination It is aimed at contributing to the promotion of the development of "unapproved drugs and non-applicable drugs" by pharmaceutical companies by confirming the validity of the drugs. Note 2 Public application Under the application for approval of medicines (addition of indication etc.), the effectiveness and safety of the medicine are medically known and it is possible to apply for approval without newly implementing all or part of the clinical trial is. <Leinnase product overview> 1 Sales name (1) Leinase ® Note for injection 5000 (2) 10000 for Leinase ® Note 2 common name L-asparaginase 3 Manufacturing and sales Kyowa Hakko Kirin Co., Ltd. Ingredients/Content 1 Injection containing 5000 K units or 10000 K units of L-asparaginase lyophilized product in 1 vial 5 Usage·Dosage (intravenous administration) Usually, 50 to 200 K units per kg body weight of daily dose are injected intravenously by drip infusion every other day or every other day. Increase accordingly depending on age, general condition. (Intramuscular administration) Usually, inject 10,000 K units per m 2 of body surface area once a day three times per week or once per day 25,000 K units per m 2 of body surface per week intramuscularly. Depending on the condition of the patient, it is appropriately reduced. 6 Indications and effects Acute leukemia (including cases of acute inversion of chronic leukemia) Malignant lymphoma