托西莫单抗(131I-tositumomab)是一种免疫调节抗肿瘤药

商品名： Bexxar

百克沙 Bexxar 131I-Tositumomab 其他名称：Bexxar。 作用机制：131I-Tositumomab是一种鼠抗CD20抗体IgG2a,用131I标记．131I能释放B和Y射线．作用机制包括抗体介导的细胞毒作用和细胞靶向放射免疫治疗。 主要适应症：化疗无效，CD20阳性，分化低的非霍奇金淋巴瘤。

Tositumomab (Bexxar®)

Usage: Tositumomab (Bexxar®) is a monoclonal antibody treatment targeted at the CD20 antigen. Tositumomab is used in the treatment of relapsed or refractory (treatment resistant) Non-Hodgkin's Lymphoma. Tositumomab is administered as 2 sets of infusions, a non-radioactive antibody and then a radioactive antibody. (1)

Mechanism: This treatment is different from most antibody-based treatmets. In this case, the antibody has been permanently linked to a radioactive form of iodine (I131). The antibody is used to deliver the radioactive iodine to cancer cells which are then destroyed by the radiation. This form of treatment is termed radioimmunotherapy. Note that the image shown is a general structure of an antibody. There are four proteins bound together in a 'Y' shape. The two top tips of the Y are where the antibody binds with its target. This means that each antibody molecule can bind to two identical target regions.

Side Effects: The most common side effect associated with tositumomab treatment is lowered blood cell count. Other common side effects include: weakness, fever, nausea, infection, cough. Severe allergic reactions may also occur. Patients who have already received murine proteins and may have mounted an anti-mouse immune response are at a higher risk for a reaction of this sort. In some patients hypothyroidism (reduced thyroid gland function) may occur. For this reason thyroid blocking agents must be administered with tositumomab. Treatment and screening for hypothyroidism should continue on an annual basis after treatment ends. Because this therapy includes a radioactive material that is inside the body for some period of time, patients should be given special instructions and precautions to prevent harm to any other person.

Contraindications: Patients should not become pregnant while undergoing tositumomab therapy and therapy should not be given before pregnancy is ruled out. Contraception should be used by males and females during and 12 months after treatment has ended.
131I-Tositumomab是一种鼠抗CD20抗体IgG2a,用131I标记．131I能释放B和Y射线．作用机制包括抗体介导的细胞毒作用和细胞靶向放射免疫治疗。主要适应症：化疗无效，CD20阳性，分化低的非霍奇金淋巴瘤。

百克沙处方资料  
131I-Tositumomab

其他名称：Bexxar。

作用机制：131I-Tositumomab是一种鼠抗CD20抗体IgG2a,用131I标记．131I能释放B和Y射线．作用机制包括抗体介导的细胞毒作用和细胞靶向放射免疫治疗。

主要适应症：化疗无效，CD20阳性，分化低的非霍奇金淋巴瘤。

常用剂量及方案：在放射和治疗剂量前，先给予醋酸酚650mg和苯海拉明50mg．碘化钾饱和液２~３滴，口服每日３次，放射剂量前２４小时开始服用，治疗剂量结束后再服用１４天．以防止甲状腺摄取131I。

１　放射测定剂量：先给予未标记的Tositumomab,450mg静滴１小时，继以131I-Tositumomab
5mCi(35mg)静滴２０分钟。以监测病人对131I-Tositumomab的最适剂量，然后给予治疗剂量65-75cGy，７－１５天。

２　治疗剂量：先给予未标记的Tositumomab450mg,静滴１小时，然后给予病人最适剂量的131I-Tositumomab35mg(平均90  mCi,范围为50-200  mCi)。

注意事项：

1）  淋巴瘤骨髓侵犯超过２５％，骨髓外照射超过２５％或有HAMAS(HACAS)病者慎用。

2）  放疗前24小时口服碘化钾饱和液，每天3次，每次2~3滴，连用14天。

毒性反应：

１　骨髓抑制和其他血液学毒性：髓系抑制十分常见。２０％病人出现IV级血小板减少或中性粒细胞减少。

２　恶心，呕吐和其他胃肠道反应：恶心常见，呕吐，腹痛和厌食偶见。

３　皮肤粘膜反应：瘙痒，皮疹偶见。

４　其他：

１）可能发生HAMAS或HACAS。
２）注射反应偶见至常见，大部分为自限性。
３）乏力或衰弱常见。
４）咳嗽水肿偶见，呼吸困难少见。
５）预防应用碘化钾时，甲状腺功能抑制少见。
６）治疗后２０~４０个月，偶见骨髓发育不良

[-产地国家-] 美国
[-所属类别-] 抗癌药物->治疗淋巴瘤药物
[-包装规格-] 20毫升/瓶
[-计价单位-] 瓶
[-生产厂家中文参考译名-] 葛兰素史克公司
[-生产厂家英文名-] GlaxoSmithKline
[-原产地址英文商品名-] BEXXAR 131 Iodine THERAP 20mL/Vial
[-原产地址英文药品名-] Tositumomab Iodine-131
[-中文参考商品译名-] 百克沙
[-中文参考药品译名-] 托西莫单抗 I-131
[-原产地址国家批准上市年份-] 2004/12/22
[-临床试验期-] 完成
[-中文适应病症参考翻译1-] 低级卵泡转移性非霍奇
[-中文适应病症参考翻译2-] 非霍奇金淋巴瘤
[-中文适应病症参考翻译3-] 淋巴瘤
[-中文适应病症参考翻译4-] 癌症