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吉妥单抗(gemtuzumab ozogamicin/Mylotarg)

发布日期:2007-09-10 19:09:49  作者:佚名  来源:互联网  浏览次数:0  文字大小:【】【】【
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Mylotarg?/big>
Brand Name: Mylotarg?/big>
Active Ingredient:   gemtuzumab ozogamicin
Strength(s): 5mg per 20mL vial
Dosage Form(s):   Intravenous injection
Company Name:    Wyeth Ayerst
Availability:         Prescription only, hospital use only
*Date Approved by FDA:   May 17, 2000
*Approval by FDA does not mean that the drug is available for consumers at this time.

What is Mylotarg used for? 

Mylotarg is used to treat a form of bone marrow cancer (CD33 positive acute myeloid leukemia) in patients who are:

  • experiencing a return of the disease after the first treatment

  • 60 years of age or older, and

  • not considered able to take standard leukemia chemotherapy.

The safety and effectiveness of Mylotarg in patients with poor performance status and organ dysfunction is not known and has not been tested.  In addition, the effectiveness of Mylotarg in improving symptoms, keeping the disease from getting worse, or helping patients live longer compared with standard treatments is not known.

Special Warnings Concerning Mylotarg: 

Mylotarg should only be given by doctors who are experienced in the treatment of acute leukemia and in facilities equipped to monitor and treat leukemia patients.

Mylotarg causes a severe decrease in the body抯 ability to produce bone marrow.  Patients will be monitored by their doctor for the signs and symptoms of this condition.

Severe liver toxicity has been reported in patients taking Mylotarg.  Symptoms of this condition may include rapid weight gain, right-sided pain, and elevated liver function tests.  Extra caution should be used in patients with liver disease.

General Precautions with Mylotarg: 

When large numbers of leukemic cancer cells are being destroyed quickly, you may experience side effects which may cause pain in the joints (gout) or even kidney problems.

What should I tell my doctor or health care provider? 

Tell your doctor or health care provider if you have a history of liver problems.  Serious problems such as liver failure have occurred in people treated with Mylotarg.

Mylotarg can cause harm to an unborn baby when given to a pregnant woman.  Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.

What are some possible side effects of Mylotarg? (This is not a complete list of side effects reported with Mylotarg. Your health care provider can discuss with you a more complete list of side effects.)   

Common side effects include:

  • decrease in bone marrow production (see Special Warnings)

  • low red blood cell counts (anemia)

  • low blood platelets

  • infection

  • bleeding

  • transfusions

  • swelling of the membrane inside the mouth

  • liver problems

  • rash

If the following side effects occur, they will be soon after treatment with Mylotarg.  Other medicines can be prescribed to improve these conditions:

  • chills

  • fever

  • nausea

  • vomiting

  • headache

  • changes in blood pressure

  • low levels of oxygen in the body

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

责任编辑:p53

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