部份中文奥吉妥单抗处方资料（仅供参考）
英文名：Gemtuzumab Ozogamicin
商标名：MYLOTARG
中文名：奥吉妥单抗冻干粉注射剂
生产商：辉瑞公司
药品简介
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。
マイロターグ点滴静注用5mg
药用分类名称
抗肿瘤剂
抗肿瘤抗生素结合抗CD33单克隆抗体
批准日期：2008年6月
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
構造式
本質
人类免疫球蛋白G4的不变区域（β链和+4链）和可变区域框架序列和小鼠抗CD33单克隆抗体的互补性确定区域，由人源化小鼠抗CD33单克隆抗体衍生的cDNA表达在小鼠骨髓瘤细胞（NS0细胞）中产生 糖蛋白由1，322个氨基酸残基（分子量：约150，000）和Micromonospora echinospora ssp组成。从Calichensis细菌中分离的细胞毒性抗肿瘤抗生素卡利卡霉素的结合（分子量：约153，000）
药物药理学
1.抗肿瘤作用
（1）体外测试
已经观察到对于CD33阳性人急性早幼粒细胞白血病HL-60细胞具有细胞杀伤活性。在表达CD33的其他人类白血病细胞（例如NOMO-1，NB4和NKM-1细胞）上也观察到了细胞杀伤活性。
（2）体内试验
通过在异种移植模型中静脉内施用证明了抗肿瘤作用，其中将HL-60细胞皮下移植到裸鼠中。
2.作用机制
该药物是一种抗肿瘤药，将人源化抗CD33抗体hP67.6与抗肿瘤抗生素加利车霉素的衍生物结合在一起，可与表达CD33抗原的白血病细胞结合并被细胞吸收。另外，释放的加利车霉素衍生物发挥细胞杀伤活性并表现出抗肿瘤作用。
在使用不表达CD33抗原的大鼠和食蟹猴的重复剂量毒性试验中，由于吉妥单抗ozogamicin的非特异性摄取，被认为是源自加利车霉素衍生物的细胞毒性的毒性有报道。
适应症
复发性或难治性CD33阳性急性骨髓性白血病
用法与用量
通常成人，一次剂量9mg/m2（表示为蛋白质量）在2小时内静脉注射。 给药次数，施用间隔至少14天，两次。
临床结果
对于复发或难治性急性骨髓性白血病，与剂和其他治疗，没有比较测试，如改善和延长临床症状的寿命。
（1）在日本进行的CD33阳性复发或难治急性骨髓性白血病的I/II期临床试验的II阶段部分9mg/m2给药病例的完全缓解率为25%（5/20）。
（2）第二阶段临床试验对国外CD33阳性的首次复发性急性骨髓性白血病的完全缓解率为13%（35/277）。
包装
滴注
5mg：1小瓶
制造分销商
辉瑞公司
注：以上中文资料不够完整，使用者以原处方资料为准。
完整资料附件：
https://www.info.pmda.go.jp/go/pack/4239400D1030_2_07/
MYLOTARG Injection 5mg（Gemtuzumab ozogamicin[Genetical recombination]）
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-tumoreffect 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 twicewith 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 andabdominal 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 inbrackets.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 orpharmacist if you notice any symptoms of concern other than those listed above.Storage conditions and other information
Injection
Revised: 12/2015
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details mayvary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimizeadverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand theirmedication and cooperate with the treatment。