部份中文泰索帝处方资料（仅供参考） 英文品名：Taxotere Concentrate for solution for infusion 中文品名：泰索帝（多西紫杉醇浓缩物注射劑） 成分名：Docetaxel 產品分類:抗腫瘤藥物 批准日期：2010年8月20日 公司：赛诺菲 TAXOTERE（多西紫杉醇 docetaxel）注射液浓缩物，静脉输液（IV）。 最初的美国批准：1996年 警告： 毒性死亡，肝毒性，中性粒细胞，超敏反应和流体滞留，请参阅完整的处方信息以提供完整的警告 治疗相关的死亡率随着肝功能异常，剂量增加以及NSCLC患者和之前以100mg/m2接受TAXOTERE治疗的铂类疗法而增加。 如果胆红素> ULN，或者如果AST和/或ALT> 1.5×ULN伴随碱性磷酸酶> 2.5×ULN，则不应给予。 LFT升高会增加严重或危及生命的并发症的风险。在每个治疗周期之前获得LFT。 如果嗜中性粒细胞计数<1500个细胞/ mm3则不应给予。获取频繁的血液计数来监测中性粒细胞减少症。 在接受地塞米松前用药的患者中已经报道了严重超敏反应，包括非常罕见的致命性过敏反应。严重的反应需要立即停用TAXOTERE并给予适当的治疗。 如果对TAXOTERE或用聚山梨醇酯80配制的药物严重过敏反应史，禁忌。 尽管地塞米松可能会发生严重的液体潴留。 作用机制 多西他赛是一种抗肿瘤药物，通过破坏细胞中的微管网络来起作用，这对于有丝分裂和间期细胞功能是必不可少的。 多西紫杉醇与游离微管蛋白结合并促进微管蛋白装配成稳定的微管，同时抑制它们的分解。 这导致产生微管束而没有正常的功能，并导致微管的稳定化，导致细胞有丝分裂的抑制。 多西紫杉醇与微管的结合不会改变结合的微管中原丝的数量，这一点与目前临床使用的大多数纺锤体毒素不同。 指征和用法 TAXOTERE是一种微管抑制剂，适用于： 乳腺癌（BC）：化疗失败后局部晚期或转移性BC的单一药物;并用阿霉素和环磷酰胺作为手术节点阳性BC的辅助治疗。 非小细胞肺癌（NSCLC）：铂类治疗失败后局部晚期或转移性NSCLC的单一药物;顺铂用于不可切除的局部晚期或转移性未经治疗的NSCLC。 激素难治性前列腺癌（HRPC）：具有雄激素非依赖性（激素难治性）转移性前列腺癌中的泼尼松。 胃腺癌（GC）：用顺铂和氟尿嘧啶治疗未经治疗的晚期胃癌，包括胃食管交界处。 头颈部鳞状细胞癌（SCCHN）：用顺铂和氟尿嘧啶诱导治疗局部晚期SCCHN。 剂量和给药 在设施中管理可能的并发症（例如，过敏反应）。静脉注射（IV），每3周1小时。不建议使用PVC设备。只使用21号针头从小瓶中取出TAXOTERE。 BC局部进展或转移：60mg/m 2至100mg/m 2单一药剂。 BC佐剂：多柔比星50mg/m 2 1小时后给药75mg/m 2，每3周500mg/m 2的环磷酰胺6次。 NSCLC：铂类治疗失败后：单剂75mg/m2。 非小细胞肺癌：化疗初治：75mg/m2，顺铂75mg/m2。 HRPC：75mg/m2，连用5mg泼尼松，连续两次。 GC：顺铂75mg/m2，顺铂75mg/m2（仅在第1天），接着是氟尿嘧啶750mg/m2，作为24小时IV（第1-5天），从顺铂输注结束开始。 SCCHN：顺铂75mg/m2，继以顺铂75mg/m2静脉滴注（第1天），接着是氟尿嘧啶750mg/m2，每天24小时（1-5天） 4个周期， SCCHN：75mg/m2，随后是顺铂100mg/m2 IV（第1天），接着是氟尿嘧啶1000mg/m 2，作为24小时IV（第1-4天）。进行3个循环。 对于所有患者： 与口服coricosteroids premedicate 根据需要调整剂量。 用量形式和强度 一瓶TAXOTERE：一次性使用小瓶20mg /mL和80mg/4mL。 禁忌症 对多西紫杉醇或聚山梨酯80过敏。 中性粒细胞计数<1500个细胞/mm3。 警告和注意事项 急性粒细胞白血病：在接受TAXOTERE，阿霉素和环磷酰胺的患者中，监测延迟的骨髓增生异常或骨髓性白血病。 皮肤反应：可能会发生反应，包括四肢红肿伴水肿脱屑。严重的皮肤毒性可能需要调整剂量。 神经反应：可能会出现反应，包括感觉异常，感觉迟钝和疼痛。严重的神经感觉症状需要调整剂量或停药。 眼部疾病：黄斑囊样水肿（CME）已有报道，需要中止治疗。 虚弱：可能会出现严重的虚弱，可能需要停药。 酒精含量：TAXOTERE注射剂中的酒精含量可能影响中枢神经系统。这可能包括患者在输注后立即驾驶或使用机器的能力受损。 怀孕：对孕妇施用时可能会发生胎儿损害。在接受TAXOTERE时应该建议怀孕的妇女不要怀孕。 不良反应 所有TAXOTERE适应症最常见的不良反应是感染，嗜中性粒细胞减少症，贫血，发热性嗜中性白细胞减少症，超敏反应，血小板减少症，神经病，味觉障碍，呼吸困难，便秘，厌食，指甲障碍，体液潴留，虚弱，疼痛，恶心，腹泻，脱发，皮肤反应，肌痛。 包装规格 TAXOTERE ONE-VIAL 20MG/1ML SDV 1/EA  DOCETAXEL  SANOFI-AVENTIS  00075-8003-01   TAXOTERE ONE-VIAL 80MG/4ML SDV 1/EA  DOCETAXEL  SANOFI-AVENTIS  00075-8004-04  TAXOTERE INJ ONE-VIAL 80MG  DOCETAXEL  SANOFI U.S. LLC  00075-8004-04       TAXOTERE INJ ONE-VIAL 20MG  DOCETAXEL  SANOFI U.S. LLC  00075-8003-01 小瓶装在一个纸箱中的泡罩包装中。 存储 储存在2°C和25°C（36°F和77°F）之间。 保留在原包装避光。 冷冻不会对产品造成不利影响。 处理和处置 应考虑正确处理和处置抗癌药物的程序。 关于这个问题的几个指导方针已经出版了[见参考文献]。 处方修改日期：12/2015 完整说明书附件： https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636 Taxotere(Docetaxel) Generic Name: docetaxel (doe se TAX el) Brand Names: Taxotere What is Taxotere? Taxotere is a cancer medicine that slows the growth and spread of cancer cells in the body. Taxotere is used to treat breast cancer, lung cancer, prostate cancer, stomach cancer, and head/neck cancer. Taxotere may also be used for other purposes not listed in this medication guide. ------------------------------------------------------------- Important information about Taxotere Do not use this medication without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Before being treated with Taxotere, tell your doctor if you have ever been treated with cisplatin (Platinol), or if you have liver disease, congestive heart failure, fluid retention, swelling problems, or if you have ever had an allergic reaction to docetaxel. Taxotere can be harmful if it gets on your skin during an IV infusion. If this happens, wash the skin thoroughly with soap and warm water. Some people receiving a Taxotere injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, warm, or itchy, or if you have chest tightness or trouble breathing during the injection. Taxotere can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. It is important that you not miss any scheduled visits to your doctor. Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection, especially fever. There are many other drugs that can interact with Taxotere. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. ------------------------------------------------------------- Before using Taxotere Before being treated with Taxotere, tell your doctor if you have ever been treated with cisplatin (Platinol), or if you have: liver disease; congestive heart failure; fluid retention or swelling problems; or if you have ever had an allergic reaction to docetaxel. If you have any of these conditions, you may need a dose adjustment or special tests to safely receive Taxotere. FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use Taxotere without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether Taxotere passes into breast milk or if it could harm a nursing baby. Do not receive Taxotere without telling your doctor if you are breast-feeding a baby. Adults older than 65 may be more sensitive to the side effects of Taxotere. ------------------------------------------------------------- How is Taxotere used? Taxotere is given as an injection through a needle placed into a vein. You will receive this medicine in a clinic or hospital setting. Taxotere must be given slowly through an IV and it may take up to an hour to complete your dose. Your doctor may prescribe a steroid medicine for you to take for a few days before your injection. This will help prevent swelling or an allergic reaction to Taxotere. Do not miss any doses of the steroid. Taxotere must be given slowly through an IV and it may take up to an hour to complete your dose. Taxotere can be harmful if it gets on your skin during an IV infusion. If this happens, wash the skin thoroughly with soap and warm water. Taxotere is usually given once every 3 weeks, and you may receive other cancer medicines at the same time. Your doctor will determine a treatment schedule for you based on the type of cancer being treated and other factors. Taxotere can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments. ------------------------------------------------------------- What happens if I miss a dose? Call your doctor for instructions if you miss a dose of Taxotere or the steroid medicine. ------------------------------------------------------------- What happens if I overdose? Seek emergency medical attention if you think you have received too much of this medicine. Overdose symptoms may include fever, chills, body aches, flu symptoms, numbness, burning, pain, or tingly feeling, or white patches or sores inside your mouth or on your lips. ------------------------------------------------------------- What should I avoid while using Taxotere? Avoid getting a flu shot or vaccine while you are being treated with Taxotere. Vaccines may not work as well or could make you sick while you are using Taxotere. Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection, especially fever. Avoid allowing this medicine to get on your skin during an IV infusion. If this does happen, wash the skin thoroughly with soap and warm water. ------------------------------------------------------------- Taxotere side effects Some people receiving a Taxotere injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, warm, or itchy, or if you have chest tightness or trouble breathing during the injection. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: easy bruising or bleeding, unusual weakness; feeling like you might pass out; fever, chills, body aches, flu symptoms; severe diarrhea; skin changes or bruising where the IV was placed; nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); feeling short of breath, even with mild exertion; swelling of your ankles or feet, weight gain; a red, blistering, peeling skin rash; or numbness, burning, pain, or tingly feeling. Less serious side effects may include: feeling weak or tired; white patches or sores inside your mouth or on your lips; mild nausea, vomiting, diarrhea, constipation, or loss of appetite; watery eyes; changes in menstrual periods; temporary hair loss; or fingernail or toenail changes. This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088. ------------------------------------------------------------- What other drugs will affect Taxotere? Do not receive "live" vaccines during treatment with Taxotere. Administration of a live vaccine may be dangerous during treatment with Taxotere. There are many other drugs that can interact with Taxotere. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. ------------------------------------------------------------- Where can I get more information? Your doctor or pharmacist can provide more information about Taxotere. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. 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