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吉妥单抗（gemtuzumab ozogamicin/Mylotarg）
药品介绍：
吉妥单抗（gemtuzumab ozogamicin/Mylotarg）
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]
1.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。
2.循环系统：低血压、高血压、心律失常。
3.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。
4.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。
5.代谢系统：低钾血症、低镁血症、乳酸脱氢酶升高、高血糖。
6.肌肉骨骼：关节痛。
7.神经系统：抑郁、失眠、眩晕。
8.呼吸系统：呼吸困难、低氧血症、肺炎、咳嗽加重、咽炎、鼻炎。
9.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
Brand names: Mylotarg®
Chemical formula:
Drug Forms:
- Gemtuzumab Ozogamicin injection (below)
- Gemtuzumab Ozogamicin Solution for injection
Español:
- Inyección de gemtuzumab ozogamicina
- Gemtuzumab Ozogamicina, Solución para inyección
Gemtuzumab Ozogamicin injection
What is gemtuzumab ozogamicin
injection do?
GEMTUZUMAB OZOGAMICIN (Mylotarg(TM)) is chemotherapy agent used for treating acute myelogenous leukemia (AML). Gemtuzumab ozogamicin is a special kind of drug (a monoclonal antibody) that targets the leukemia cells. Unfortunately, it also affects some good cells, which leads to some side effects. Generic gemtuzumab ozogamicin injections are not available.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
• difficulty breathing or any lung condition
• bleeding problems
• dental disease
• infection (especially cold sores or shingles)
• jaundice
• liver disease
• previous bone marrow or stem cell transplant
• an unusual or allergic reaction to gemtuzumab ozogamicin, mouse proteins, other chemotherapy, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding
How should I use this medicine?
Gemtuzumab ozogamicin is infused into a vein by a specially trained health care provider. It is usually administered in a hospital or clinic setting. You will receive medication (acetaminophen, Tylenol®, and diphenhydramine, Benadryl®) before your infusion to help decrease side effects related to the infusion. You will be closely monitored during and after the infusion for side effects.
What if I miss a dose?
It is important not to miss your dose. Notify your prescriber or health care professional if you are unable to keep an appointment.
What drug(s) may interact with gemtuzumab ozogamicin?
• vaccines
Talk to your prescriber or health care professional before taking any of these medicines:
• aspirin
• acetaminophen
• ibuprofen
• ketoprofen
• naproxen
Tell your prescriber or health care professional about all other medicines that you are taking, including nonprescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.
What should I watch for while taking gemtuzumab ozogamicin?
Visit your prescriber or health care professional for checks on your progress. You will need to have regular blood checks. The side effects of gemtuzumab ozogamicin may continue after you finish your treatment; report side effects promptly.
Gemtuzumab ozogamicin may make you feel generally unwell. This is not uncommon because gemtuzumab ozogamicin affects good cells as well as cancer cells.
Gemtuzumab ozogamicin will decrease your body's ability to fight infections. Call your prescriber or health care professional if you have a fever, chills, sore throat or other symptoms of a cold or flu. Do not treat these symptoms yourself. Try to avoid being around people who are sick. Gemtuzumab ozogamicin may increase your risk to bruise or bleed. Call your prescriber or health care professional if you notice any unusual bleeding. Be careful not to cut, bruise or injure yourself because you may get an infection and bleed more than usual.
Avoid taking aspirin, acetaminophen (Tylenol®), ibuprofen (Advil®), ketoprofen (Orudis KT®) or naproxen (Aleve®) products as these may mask a fever, unless instructed to by your prescriber or health care professional.
Be careful brushing and flossing your teeth or using a toothpick while receiving gemtuzumab ozogamicin because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are taking gemtuzumab ozogamicin.
Do not have any vaccinations without your prescriber's approval and avoid anyone who has recently had the oral polio vaccine.
Women of childbearing age should use effective birth control methods during and after gemtuzumab ozogamicin treatment. There is a risk of birth defects if gemtuzumab ozogamicin is given during pregnancy. Women should not become pregnant while being treated with gemtuzumab ozogamicin.
Drink several glasses of water a day. This will help to reduce the risk of possible kidney problems.
What side effects may I notice from receiving gemtuzumab ozogamicin?
Side effects that you should report to your prescriber or health care professional as soon as possible:
During and up to 4 hours after the infusion:
• chills
• difficulty breathing, wheezing
• dizziness
• headache
• nausea/vomiting
• shortness of breath
After the infusion of gemtuzumab ozogamicin:
• difficulty passing urine
• mouth or throat sores or ulcers
• low blood counts - gemtuzumab ozogamicin may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
• signs of decreased red blood cells - unusual weakness or tiredness, fainting spells, lightheadedness
• stomach pain
Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• back pain
• constipation
• diarrhea
• difficulty sleeping
• heartburn
• muscle or joint aches and pains
Where can I keep my medicine?
Gemtuzumab ozogamicin injection will be given to you in a hospital or clinic setting. You will not take this medicine at home.
Last updated: 7/1/2002 | 
