泽娃灵Zeva lIN IN-111 1kit(Ibritumomab Tiuxetan/IN-111)

药店国别： 产地国家：美国 处方药：是 所属类别： 1套 包装规格： 1套 计价单位：套 生产厂家中文参考译名： 生产厂家英文名：SPECTRUM PHARMS 原产地英文商品名：Zeva lIN IN-111 1kit 原产地英文药品名：KIT FOR PREP INDIM-111/IBRITUMOMAB TIUXETAN/ALBUMIN HUMAN 中文参考商品译名：泽娃灵IN-111 1套 中文参考药品译名：KIT FOR PREP INDIM-111/替伊莫单抗/人血白蛋白 曾用名： 简介： 部份中文泽娃灵 IN-111处方资料(仅供参考)药品英文名Ibritumomab Tiuxetan药品别名替伊莫单抗、泽娃灵、Zeva lin IN-111 1kit, lIN-Y-90 1kit药物剂型111In-泽娃灵药盒：为111In放射标记的泽娃灵，含3.2mg泽娃灵的0.9%氯化钠溶液2.0ml，50mmol/L的醋酸钠，氯化铟(111InCl)溶液。90Y-泽娃灵药盒：为90Y放射标记的泽娃灵，含3.2mg泽娃灵的0.9%氯化钠溶液2.0ml，50mmol/L的醋酸钠，氯化钇(90YCl)溶液。 药理作用 异贝莫(Ibritumomab)是从中国仓鼠卵巢细胞中产生的一种鼠类IgG1，本品是异贝莫单克隆抗体通过硫脲共价键结合成的免疫交联物。该物质具有与111铟(111In)或90钇(90Y)高度亲和的结构限制性螯合位点。可以以鼠单克隆抗体为载体，运载同位素111 In或90Y。放射同位素111In或90Y以异贝莫抗体为载体，与非霍奇金淋巴瘤(NHL)癌变的B淋巴细胞表面的CD20抗原结合，杀死癌细胞。 药动学 不使用泽娃灵，单独使用111In(111In 5mCi)，肿瘤部位仅18%有放射活性，先使用泽娃灵1.0mg/kg或2.5mg/kg，再使用111In，平均放射活性分别为56%和92%90Y-泽娃灵的平均血浆消除半衰期为30h，平均活性持续时间为39h，使用本品7天后，7.2%的给药剂量以活性形式从尿中排出。本品可引起循环中的B细胞减少，使用本品4周后，循环中的B细胞降为0，约12周后开始恢复，9个月时恢复至正常范围(32～340/mm3)。血浆IgG、IgA水平保持正常，IgM水平下降至正常水平以下，但6个月后恢复正常。 适应证 用于治疗非霍奇金淋巴瘤(NHL)和B细胞单克隆抗体治疗失败的NHL。 禁忌证 1.对本品及其中成分(包括利妥昔单抗、氯化钇、氯化铟)过敏者禁用。 2.对鼠类蛋白有Ⅰ型变态反应和过敏反应者禁用。 3.生殖毒性分级为D，孕妇禁用。生殖期妇女使用本品期间应避免怀孕。 注意事项 1.本品原包装无放射活性，但在使用时尤其放射标记后应注意放射防护。 2.尚不知本品是否经乳汁分泌，哺乳期妇女使用本品应停止哺乳。 3.儿童用药安全性尚未研究。4.避光，2～8℃保存，避免剧烈摇晃。 不良反应 本品副作用明显，常见不良反应包括：血小板减少、嗜中性粒细胞减少、贫血、淤斑、胃肠道反应、咳嗽加重、呼吸困难、头晕、关节痛、食欲减退、焦虑等。严重不良反应包括：严重输液反应(低血压、血管性水肿、缺氧、支气管痉挛、呼吸窘迫综合征、室颤、心梗、心源性休克)、血小板减少(61%)、中性粒细胞减少(57%)、严重皮肤黏膜反应。全身反应：虚弱、感染、寒战、发热、腹痛、疼痛、头痛、背痛、咽喉刺激、面部发红。2.心血管系统：低血压。3.消化系统：恶心、呕吐、腹泻、食欲减退、腹胀、便秘。4.血液及淋巴系统：血小板减少、嗜中性粒细胞减少、贫血、淤斑。5.代谢：外周水肿、血管性水肿。6.肌肉骨骼：关节痛、肌痛。7.呼吸系统：呼吸困难、咳嗽加重、鼻炎、支气管痉挛。8.皮肤：瘙痒、皮疹。 用法用量 静注：首先单剂量输注利妥昔单抗250mg/m2，然后使用111In-泽娃灵，剂量为5.0mCi(6mg总抗体量)，静注10min。7～9天后，首先单剂量输注利妥昔单抗250mg/m2，然后使用90Y-泽娃灵0.4mCi/kg，10min静注。贮藏ndium-111 Zeva lin使用前应2~8℃(36~46°F)保存，放射标记后12小时内使用。Yttrium-90 Zeva lin使用前应2~8℃ (36~46°F)保存，放射标记后8小时内使用。 英文版说明书 dAnalysis of the influence of 111In on 90Y-bremsstrahlung SPECT based on Monte Carlo simulationObjective90Y-ibritumomab tiuxetan (Zeva lin) which is used for the treatment of malignant lymphomas can be used for SPECT imaging based on bremsstrahlung from 90Y beta particles. However, gamma rays emitted by 111In, which is administered to eva luate the indication for the treatment, contaminate the 90Y bremsstrahlung images. Our objective is to investigate the influence of 111In on the 90Y SPECT images using Monte Carlo simulation.MethodsWe used an in-house developed simulation code for the Monte Carlo simulation of electrons and photons (MCEP). Two hot spheres with diameters of 40 mm were put in an elliptical phantom. Both spheres (“sphere 1” and “sphere 2”) were filled with 90Y and 111In mixed solutions. The activities of 90Y in sphere 1 and sphere 2 were 241 and 394 kBq/mL, respectively, and the ones of 111In were 8.14 and 13.3 kBq/mL, respectively. The background activity of 90Y was 38.6 kBq/mL, whereas that of 111In was 1.30 kBq/mL; moreover, the acquisition time was 30 min. Two energy windows were used: one is 90–190 keV included the 111In photopeak; the other is 90–160 keV. To eva luate the quality of the SPECT images, the contrast recovery coefficient (CRC) and the constant noise ratio (CNR) of the SPECT images were derived.ResultsFor the energy window between 90 and 160 keV, the 111In count was 74 % of the total. In that case, the CRC values were 30.1 and 30.7 % for “sphere 1” and “sphere 2”, respectively, whereas the CNR values were 6.8 and 12.1, respectively. For the energy window between 90 and 190 keV, the 111In count reached 85 % of the total count. The CRC and CNR values were 38.6 and 40.0 % and 10.6 and 19.4, respectively.ConclusionsOur simulation study revealed that the cross talk between 111In and 90Y in SPECT imaging is rather serious. Even for the energy window excluding the 111In photopeak, the count ratio of 90Y was less than 30 % of the total. However, the influence of 111In on 90Y-SPECT imaging cannot be ignored, and the count ratio because of 111In is important to estimate the density of 90Y.