奥吉妥单抗，奥吉妥单抗MYLOTARG Injection（Gemtuzumab Ozogamicin）

产地国家：美国 处方药：是 所属类别： 5毫克/20毫升/瓶 包装规格： 5毫克/20毫升/瓶 计价单位：瓶 生产厂家中文参考译名：无 生产厂家英文名：Wyeth 原产地英文商品名：MYLOTARG 5mg/20mL Vial 原产地英文药品名：Gemtuzumab Ozogamicin 中文参考商品译名：米罗他 5毫克/20毫升/瓶 中文参考药品译名：奥吉妥单抗，GO单抗 曾用名：无

简介

Mylotarg(Gemtuzumab Ozogamicin,CMA-676)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。

英文版说明

Wyeth-AyerstMylotargGeneric Name: gemtuzumab ozogamicin (gem-TOO-zoo-mab oh-zoh-ga-MYE-sin)Brand Name: MylotargMylotarg should not be used along with other chemotherapy medicines. Severe bone marrow problems occur even at normal doses of Mylotarg. Severe and sometimes fatal allergic reactions and lung problems have occurred with use of Mylotarg. Tell the doctor immediately if you experience rash; hives; difficulty breathing; swelling of the mouth, face, lips, or tongue; or severe dizziness. Mylotarg may also increase the risk of severe and sometimes fatal liver problems. This risk may be increased if you have liver problems, you have had a hematopoietic stem-cell transplant (HSCT), or you use Mylotarg in combination with other chemotherapy medicines. Contact your doctor immediately if you experience sudden weight gain, right-sided stomach pain, stomach swelling, yellowing of the eyes or skin, or dark urine. Your doctor will monitor you closely while you use Mylotarg.Mylotarg is used for:Treating acute myeloid leukemia (AML) in patients 60 years of age and older who cannot take other cancer medications. It may also be used for other conditions as determined by your doctor.Mylotarg is a chemotherapy agent. It works by binding to and breaking specific parts that the cancer cell needs to survive.Do NOT use Mylotarg if:•you are allergic to any ingredient in MylotargContact your doctor or health care provider right away if any of these apply to you.Before using Mylotarg:Some medical conditions may interact with Mylotarg. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:•if you are pregnant, plan to become pregnant, or are breast-feeding•if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement•if you have allergies to medicines, foods, or other substances•if you have liver or kidney problems or lung diseaseSome MEDICINES MAY INTERACT with Mylotarg. However, no specific interactions with Mylotarg are known at this time.This may not be a complete list of all interactions that may occur. Ask your health care provider if Mylotarg may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.How to use Mylotarg:Use Mylotarg as directed by your doctor. Check the label on the medicine for exact dosing instructions.•Mylotarg is usually administered as an infusion at your doctor's office, hospital, or clinic. If you are using Mylotarg at home, carefully follow the infusion procedures taught to you by your health care provider.•You may need to take certain other medicines (eg, acetaminophen, diphenhydramine) before using Mylotarg in order to help decrease the risk of certain side effects that may occur while using Mylotarg. Discuss any questions or concerns with your doctor.•If Mylotarg contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.•Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.•If you miss a dose of Mylotarg, or your dose is interrupted, contact your doctor immediately.Ask your health care provider any questions you may have about how to use Mylotarg.Important safety information:•Mylotarg may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Mylotarg. Using Mylotarg alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.•Mylotarg may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.•Mylotarg may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rashes, or chills.•LAB TESTS, including liver function tests, complete blood cell counts, platelet counts, and electrolytes, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.•Use Mylotarg with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.•PREGNANCY and BREAST-FEEDING: Mylotarg may cause harm to the fetus. Avoid becoming pregnant while you are using Mylotarg. If you think you may become pregnant, discuss with your doctor the benefits and risks of using Mylotarg during pregnancy. It is unknown if Mylotarg is excreted in breast milk. Do not breast-feed while taking Mylotarg.Possible side effects of Mylotarg:All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:Back pain; constipation; cough; diarrhea; dizziness; fatigue; headache; indigestion; joint pain; loss of appetite; mouth sores; nausea; pain or inflammation at the injection site; runny nose; sleeplessness; stomach pain; vomiting; weakness.Seek medical attention right away if any of these SEVERE side effects occur:Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in amount or frequency of urine; chest pain; dark urine; depression; fast or irregular heart rate; fever, chills, or sore throat; increased thirst; one-sided weakness; pink or red-colored urine; right-sided stomach pain; seizure; severe dizziness; severe headache; shortness of breath; slurred speech; stomach swelling; sudden weight gain; swelling of the arms, legs, or feet; unusual bleeding or bruising (eg, nosebleed, red or purple spots under the skin, unusual vaginal bleeding); vision changes; yellowing of the eyes or skin.This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.If OVERDOSE is suspected:Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Mylotarg:Mylotarg is usually handled and stored by a health care provider. If you are using Mylotarg at home, store Mylotarg as directed by your pharmacist or health care provider.General information:•If you have any questions about Mylotarg, please talk with your doctor, pharmacist, or other health care provider.•Mylotarg is to be used only by the patient for whom it is prescribed. Do not share it with other people.•If your symptoms do not improve or if they become worse, check with your doctor.•Check with your pharmacist about how to dispose of unused medicine.This information is a summary only. It does not contain all information about Mylotarg. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.