驮瑞塞尔注射液TORISEL 25MG/ML W/DIL KIT(TEMSIROLIMUS )

药店国别： 产地国家：美国 处方药：是 所属类别： 25毫克/毫升/套 包装规格： 25毫克/毫升/套 计价单位：套件 生产厂家中文参考译名： 生产厂家英文名：PFIZER INC 原产地英文商品名：TORISEL 25MG/ML W/DIL KIT 1/EA 原产地英文药品名：TEMSIROLIMUS 中文参考商品译名：TORISEL注射液 25毫克/毫升/套 中文参考药品译名：驮瑞塞尔 曾用名： 简介： Torisel(temsirolimus)是雷帕霉素的衍生物，它是一种具有抗真菌，免疫抑制剂和抗肿瘤活性的药物。Torisel似乎阻止mTOR的作用，mTOR是调节控制细胞分裂的蛋白质合成中起重要作用的酶。因此，Torisel可能会停止生产对癌细胞增殖至关重要的蛋白质。Torisel作为25mg/mL注射液提供，设计用于注射的1.8mL稀释剂。药物的推荐初始剂量为25mg，每周30-60分钟一次。治疗直到疾病进展或不可接受的毒性。在用250mL 0.9%氯化钠注射液稀释所得溶液之前，必须首先用封闭的稀释液稀释多孔注射瓶内容物。 在每次剂量开始前约30分钟，患者应接受预防性静脉内苯海拉明25至50 mg(或类似的抗组胺药)。应避免使用强力CYP3A4抑制剂。如果共同施用，则应考虑将Torisel剂量减少至12.5mg /周。如果强抑制剂停药，则应在允许将Torisel剂量调整至之前使用的剂量前约1周的清洗期启动强CYP3A4抑制剂。 此外，应避免使用强力CYP3A4诱导剂。如果共同施用，则应考虑Torisel剂量从25mg /周增加至50mg /周。如果强诱导剂停止，则Torisel剂量应在开始强CYP3A4诱导剂之前返回到使用的剂量。批准日期：2007年5月30日 公司：PFIZER INCTORISEL Kit(替西罗莫司 temsirolimus)注射液，用于静脉注射美国最初批准：2007年最近的重大变化警告和注意事项，蛋白尿和肾病综合症 作用机制 替西罗莫司是mTOR(雷帕霉素的哺乳动物靶标)的抑制剂。 替西罗莫司与细胞内蛋白质(FKBP-12)结合，蛋白质 - 药物复合物抑制控制细胞分裂的mTOR活性。 mTOR活性的抑制导致处理的肿瘤细胞中G1生长停滞。 当mTOR被抑制时，其阻断PI3激酶/ AKT途径中mTOR下游的p70S6k和S6核糖体蛋白的能力被阻断。 在使用肾细胞癌细胞系的体外研究中，替西罗莫司抑制mTOR的活性并导致缺氧诱导因子HIF-1和HIF-2α以及血管内皮生长因子的水平降低。 适应症和用法 TORISEL®是一种激酶抑制剂，适用于治疗晚期肾细胞癌。 剂量和给药 TORISEL的推荐剂量为25mg，以30-60分钟的周期静脉输注，每周一次。 治疗直至疾病进展或不可接受的毒性。建议进行抗组胺药预处理。轻度肝功能损害患者需要减少剂量。TORISEL(temsirolimus)注射瓶内容物必须先用封闭的稀释剂稀释，然后用250 mL 0.9%氯化钠注射液稀释所得溶液。 剂量形式和强度 TORISEL注射液，25mg/mL，配有DILUENT for TORISEL。禁忌症胆红素>1.5×ULN的患者禁用TORISEL。 警告和注意事项 超敏/输注反应(包括一些危及生命和罕见的致命反应)可在TORISEL首次输注早期发生。应在整个输注过程中监测患者。为了治疗过敏反应，停止TORISEL并用抗组胺药治疗。 TORISEL可以由医生自行决定以较慢的速度重新启动。肝功能损害：治疗轻度肝功能损害患者时要小心，减少剂量。高血糖和高脂血症可能并且可能需要治疗。监测葡萄糖和脂质谱。免疫抑制可能导致感染。监测间质性肺病(ILD)的症状或影像学改变。如果怀疑患有ILD，请停止使用TORISEL，并考虑使用皮质类固醇和/或抗生素。可能发生肠穿孔。及时评估发烧，腹痛，血便和/或急腹症。肾功能衰竭，有时是致命的，已经发生。监测基线和TORISEL时的肾功能。由于伤口愈合异常，在围手术期谨慎使用TORISEL。可能发生蛋白尿和肾病综合征。在TORISEL治疗开始前监测尿蛋白，之后定期监测。在发生肾病综合征的患者中停用TORISEL。应避免接种活疫苗并与接种活疫苗的人密切接触。胚胎 - 胎儿毒性：可能导致胎儿伤害。告知患者对胎儿的潜在危害并使用有效的避孕措施。老年患者可能更容易出现某些不良反应，包括腹泻，水肿和肺炎。 不良反应 最常见的不良反应(发生率≥30%)是皮疹，虚弱，粘膜炎，恶心，水肿和厌食。最常见的实验室异常(发生率≥30%)是贫血，高血糖，高脂血症，高甘油三酯血症，碱性磷酸酶升高，血清肌酐升高，淋巴细胞减少，低磷血症，血小板减少，AST升高和白细胞减少。 药物相互作用 CYP3A4/5的强诱导物和CYP3A4的抑制剂可能影响TORISEL的初级代谢物的浓度。如果不能使用替代品，建议对TORISEL进行剂量修改。用于特定人群哺乳期：不要母乳喂养。 如何提供/存储和处理 NDC 0008-1179-01 TORISEL(替西罗莫司)注射液，25mg/mL。每个试剂盒都装在一个纸箱中，其中包含一个一次性使用的25mg/mL temsirolimus小瓶和一个DILUENT小瓶，其中包含1.8mL的可输送量，并且必须在2º-8ºC(36º-46ºF)下储存。 避光。TORISEL是一种细胞毒性药物。 遵循适用的特殊处理和处理程序。 英文版说明书 TORISEL® (temsirolimus) is indicated for the treatment of advanced renal cell carcinoma (RCC).Generic Name: temsirolimus (TEM sir OH li mus)Brand Names: ToriselTorisel (temsirolimus) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.Torisel is used to treat cancer of the kidneys, also called renal cell carcinoma.Torisel may also be used for purposes not listed in this medication guide.Important informationYou should not use Torisel if you are allergic to temsirolimus or if you have severe liver disease. Do not use Torisel if you are pregnant. It could harm the unborn baby. Use an effective form of birth control while you are using this medication and for at least 3 months after your treatment ends.Before you receive Torisel, tell your doctor if you have liver disease, high cholesterol, diabetes, an allergy to sirolimus (Rapamune), or a history of head injury, stroke, or brain tumor.Torisel can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Do not receive a live vaccine. Tell your doctor at once if you develop signs of infection.There are many other drugs that can interact with Torisel. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.There are many other drugs that can interact with Torisel. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.Before taking this medicineYou should not use Torisel if you are allergic to temsirolimus, or if you have:•severe liver disease.To make sure Torisel is safe for you, tell your doctor if you have ever had:•liver disease;•kidney disease;•high cholesterol or triglycerides (a type of fat in the blood);•diabetes;•a head injury, stroke, or brain tumor; or•an allergy to sirolimus (Rapamune).Torisel can harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman. Torisel use by either parent may cause birth defects.Keep using birth control for at least 3 months after your last dose of Torisel. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using temsirolimus.It is not known whether temsirolimus passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.How is Torisel given?Torisel is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. The injection must be given slowly, and the IV infusion can take up to 60 minutes to complete.Torisel is usually given once each week unless your cancer progresses or you have serious side effects from this medicine.You may be given medication to prevent certain side effects while you are receiving this medicine.Torisel can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your kidney function may also need to be tested. Your cancer treatments may be delayed based on the results of these tests.If you need surgery, tell the surgeon ahead of time that you are using Torisel.Torisel dosing informationUsual Adult Dose for Renal Cell Carcinoma:25 mg IV infusion over a 30 to 60 minute period once a weekDuration of therapy: Treat until disease progression or unacceptable toxicityComments: IV diphenhydramine 25 to 50 mg (or similar antihistamine) should be given approximately 30 minutes before the start of each doseWhat happens if I miss a dose?Call your doctor if you miss an appointment for your Torisel injection.