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。单用该药治疗第一次复发未治CD33~+急性髓系白血病(AML)的疗效及安全性。
治疗类别名称
抗肿瘤药
抗肿瘤抗生素标记的抗CD33单克隆抗体
抗CD33
别名
Mylotarg 、CMA676、GO
来源
重组人源化抗CD33单抗与细胞毒药物卡奇霉素的复合物。其中单抗为人鼠源氨基酸序列，与细胞毒抗肿瘤抗生素（卡奇霉素）偶联而成。
作用机制
CD33表达于80%以上的急性髓性白血病（AML）患者白血病细胞上。本品静脉注射后，偶联屋中的抗体与复合物可被靶细胞胞饮。在细胞内，卡奇霉素从偶联物上水解游离，与DNA结合，使其双螺旋断列，导致细胞死亡。本品对表达CD33抗原的细胞毒性是不表达该抗原细胞的7万余倍。另外，由于造血干细胞不受药物治疗的影响，因而骨髓抑制较轻。作为一线药物治疗老年AML和高危MDS，Mylotarg 单药疗效不及化疗。目前正在进行Mylotarg 与氟达拉滨+阿糖胞苷、拓扑替康+阿糖胞苷和IL-11联合用药的临床研究。
药动学
首次推荐剂量9mg/m2,静脉点滴持续2小时，半衰期45小时。第二次予以9mg/m2,半衰期延长至60小时，曲线下面积也比初次用药后增加一倍。
适应症
首次复发的60岁以上CD33抗原阳性的急性髓细胞性白血病或不宜用细胞毒性药物治疗的CD33阳性的AML患者。
不良反应
全身反应：腹痛、乏力、背痛、寒战、发热、头痛、败血症、肿瘤溶解综合征。
循环系统：低血压、高血压、心律失常。
消化系统：食欲不振、恶心、呕吐、便秘、腹泻、腹胀、消化不良、胃炎、肝毒性、肝静脉血栓。
血液系统；骨髓抑制（较严重）、贫血、血小板减少、出血（鼻出血、脑出血、瘀斑、颅内出血、血尿、阴道出血）、弥漫性血管内凝血。
代谢系统：低钾血症、低镁血症、乳酸脱氢酶升高、高血糖。
肌肉骨骼：关节痛。
神经系统：抑郁、失眠、眩晕。
呼吸系统：呼吸困难、低氧血症、肺炎、咳嗽加重、咽炎、鼻炎。
皮肤及附属物：单纯疱疹、皮疹、局部反应、周围水肿。
禁忌症
禁用于对本品或者本品中其他组成成分过敏的患者。
规格
针剂，5mg/20ml；冻干粉剂。
开发公司：Wyeth-Ayerst

MYLOTARG Injection 5mg（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.
Usually, used for treatment of 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, lung disorder.
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, dullness, loss of appetite, vomiting, chill, headache, nose bleeding, weight loss, infection, tachycardia, sepsis (chill, fever, breathing difficulty), 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.
chill, fever, nausea [infusion reaction]
dullness, fever, bleeding tendency [hematological disorder (myelosuppression, etc.)]
sudden high fever with trembling, palpitation, discomfort in the chest [infection]
headache, abdominal pain, vomiting blood [bleeding]
dullness, loss of appetite, yellowing of the skin or whites of the 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.
Storage conditions and other information
Pfizer Pharmaceuticals Inc. Injection
Revised: 9/2012
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.
http://www.info.pmda.go.jp/go/pack/4239400D1030_2_05/4239400D1030_2_05?view=body
Mylotarg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
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产地国家：日本
所属类别：抗癌药物 ->白血病
原产地英文药品名：
Gemtuzumab Ozogamicin (Genetical Recombination)
中文参考药品译名：
奥吉妥单抗，GO单抗
原产地英文商品名：
MYLOTARG Injection(マイロターグ点滴静注用)5mg/vial
中文参考商品译名：
MYLOTARG(マイロターグ点滴静注用)5毫克/瓶
生产厂家英文名：
Pfizer Japan Inc.
生产厂家中文参考译名：
辉瑞公司