产地国家：日本 处 方 药：是 所属类别：5毫克/瓶 包装规格：5毫克/瓶 计价单位：瓶 生产厂家中文参考译名：辉瑞公司 生产厂家英文名：Pfizer Japan Inc. 原产地英文商品名：MYLOTARG Injection(マイロターグ点滴静注用)5mg/vial 原产地英文药品名：Gemtuzumab Ozogamicin (Genetical Recombination) 中文参考商品译名：MYLOTARG冻干粉注射剂(マイロターグ点滴静注用)5毫克/瓶 中文参考药品译名：吉妥珠单抗奥佐米星重组

简介

部份中文吉妥珠单抗奥佐米星重组处方资料(仅供参考) 英文名：Gemtuzumab Ozogamicin 商品名：MYLOTARG Injection 中文药名：吉妥珠单抗奥佐米星重组冻干粉注射剂 生产厂家：辉瑞公司日本 药品介绍：Mylotarg(Gemtuzumab Ozogamicin,CMA-676)在日本获上市批准。Mylotarg(gemtuzumab)是奇霉素吉妥组单抗的合成制剂，是以抗体为基质的抗癌药物。该药是首个利用单克隆抗体技术研制的直接靶向癌细胞的化疗药物，目前主要用于治疗急性骨髓性白血病。奥吉妥单抗冻干粉剂，GO单抗(Mylotarg(Gemtuzumab Ozogamicin,CMA-676))是人源化抗CD33单克隆抗体与抗肿瘤抗生素Calicheamicin偶联而成的一个新的抗体导向化疗药药。 　治疗类别名称：抗肿瘤药，抗肿瘤抗生素结合的抗CD33单克隆抗体 批准日期：2008年6月 开发商：惠氏 商標名：MYLOTARG Injection 5mg 一般名：ゲムツズマブオゾガマイシン(遺伝子組換え) Gemtuzumab Ozogamicin(Genetical Recombination) 化学名：Immunoglobulin G4(human-mouse monoclonal hP67.6 γ4-chain anti-human antigen CD33), disulfide with human-mouse monoclonal hP67.6κ-chain, dimer, conjugate with methyl(1R,4Z,8S,13E)-13-[2-[[2-[[[p-(3-carbamoylpropoxy)-α-methylbenzylidene]hydrazino]carbonyl]-1,1-dimethylethyl]dithio]ethylidene]-8-[[4,6-dideoxy-4-[[[2,6-dideoxy-4-S-[4-[(6-deoxy-3-O-methyl-α-L-mannopyranosyl)oxy]-3-iodo-5,6-dimethoxy-o-toluoyl]-4-thio-β-D-ribo-hexopyranosyl]oxy]amino]-2-O-[2,4-dideoxy-4-(N-ethylacetamido)-3-O-methyl-α-L-threo-pentopyranosyl]-β-D-glucopyranosyl]oxy]-1-hydroxy-11-oxobicyclo[7.3.1]trideca-4,9-diene-2,6-diyne-10-carbamate 本質：小鼠通过从人免疫球蛋白G4恒定区(κ链和γ4链)的cDNA的表达和可变结构域框架序列和人源化鼠抗CD33单克隆抗体，包括鼠抗CD33单克隆抗体的互补决定区的骨髓瘤细胞(NS0细胞)组成的糖蛋白中产生1322个氨基酸残基(分子量：约150,000)和棘孢SSP缀合物从Calichensis细菌和分离的细胞毒性抗肿瘤抗生素卡奇霉素。 分子量：约153000 条件批准：试用情况在日本是非常有限的，另外，在临床试验中感染，出血，由于严重的副作用，如肝功能不全的发生已经观察到，商业之后，按照一定的数量的情况下的数据还有，直到它被集成，通过实现使用效果调查登记的所有情况下，要把握这种药物的使用患者的背景资料收集安全性和有效性，药物的适当性数据采取必要的措施来使用。 有效成分：吉妥珠单抗奥佐米星(基因重组)5mg 药效药理 1. 抗肿瘤作用 (1) 体外试验 针对CD33阳性人急性早幼粒细胞性白血病HL-60细胞，细胞毒活性已经观察到。此外，NOMO-1是表达CD33，NB4，NKM-1细胞杀伤活性的细胞对已观察到其他人白血病细胞。 (2) 体内试验 HL-60细胞显示出抗肿瘤作用通过静脉内施用在异种移植模型中皮下植入裸鼠中。 2. 作用机序 在该药物的加利车霉素的抗肿瘤剂缀合衍生物是抗肿瘤抗生素和人源化抗CD33抗体hP67.6，被掺入到细胞中后结合表达CD33抗原的白血病细胞示出了抗肿瘤效果发挥所释放的卡奇霉素衍生物的细胞杀伤活性。 顺便提及，在重复剂量在大鼠和食蟹猴中不表达CD33抗原，认为毒性研究来源于卡奇霉素衍生物的细胞毒性是由于吉妥单抗奥佐米星毒性的非特异性摄取目前有报道。 适应病症：急性髓性白血病复发性或难治性CD33阳性 用法与用量：成人，吉妥珠单抗单抗臭氧(为蛋白质量)蛾霉素1个剂量9毫克/米2，用2小时静脉内施用输注。施用的频率，以至少14天，2次的给药间隔。 包装规格：静脉内输注[冻干粉剂]，5mg：1瓶 生产和销售：辉瑞公司日本

英文版说明书

MYLOTARG Injection(Gemtuzumab Ozogamicin (Genetical Recombination)マイロターグ 点滴静注用5mg) Brand name:MYLOTARG Injection 5mg Active ingredient: Gemtuzumab ozogamicin(Genetical recombination) Dosage form:injection Print on wrapping: Effects of this medicine This medicine, a combination with humanized anti-CD33 antibodies and derivative of anti-tumor antibiotics, has an anti-tumor effect through cytocidal activation by ingesting into the leukemia cell that expresses CD33 antigen. It is usually used to treat recurrent or refractory CD33-positive acute myelocytic leukemia. Before using this medicine, be sure to tell your doctor and pharmacist If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have: liver disorder, renal disorder, infection or lung disease. If you are pregnant or breastfeeding. If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) Your dosing schedule prescribed by your doctor is << to be written by a healthcare professional>> In general, for adults, this medicine is administered intravenously for 2 hours at a time. This preparation is injected twice with dosing interval of at least 14 days. The treatment period with this medicine is determined according to the symptoms. Precautions while taking this medicine Avoid pregnancy, if you are at risk of becoming pregnant. Possible adverse reactions to this medicine The most commonly reported adverse reactions include fever, nausea, malaise, loss of appetite, vomiting, chills, headache, nose bleeding, weight loss, infection, tachycardia, sepsis (chills, fever, respiratory distress), feeling of weakness, diarrhea and abdominal pain. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. chills, fever, nausea [infusion reaction] general malaise, fever, bleeding tendency [hematological disorder (myelosuppression, etc.)] sudden high fever with trembling, palpitation, discomfort in the chest [infection] headache, abdominal pain, vomiting of blood [bleeding] general malaise, loss of appetite, yellowing of the skin and the white of eyes [liver disorder] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Injection Revised: 12/2015 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment