卡巴他赛粉剂+溶液注射剂（Jevtana kit 60mg/1.5ml）

产地国家：西班牙 处方药：是 所属类别： 60毫克/1.5毫升/瓶 包装规格： 60毫克/1.5毫升/瓶 计价单位：瓶 生产厂家英文名：SANOFI AVENTIS A.S 原产地英文商品名：JEVTANA 60MG/1.5ML/VIAL 原产地英文药品名：CABAZITAXEL 中文参考商品译名：JEVTANA 60毫克/1.5毫升/瓶 中文参考药品译名：卡巴他赛

简介

赛诺菲安万特新的化疗药物Jevtana在美国获批后不久，目前已在欧洲获批。成功的临床试验表明，Jevtana（cabazitaxel）联合类固醇泼尼松可用于二线治疗晚期前列腺癌。欧洲药品管理局的人用药品委员会在III期 TROPIC研究之后曾表示认可，该III期研究显示这种联合用药对转移性激素难治性前列腺癌（mHRPC）患者有显著的生存利益。激素疗法是经常用于mHRPC患者的一线治疗方法，这些患者常常对化疗不再有反应。因此，化疗抵抗可能会成为下一个障碍，该病似乎没有成功的治疗策略。但是，赛诺菲的全球肿瘤部负责人Debasish Roychowdhury博士指出，Jevtana联合泼尼松/强的松使死亡风险减少了近1/3且延长了疾病无进展生存期。前列腺癌是男性第三大最常见癌症，在欧洲是第六大癌症杀手。在这种情况下，该药物在欧洲获批将对欧洲患者产生重大影响。 适应症：Jevtana是一种微管抑制剂适用于与泼尼松联用治疗既往用含多烯紫杉醇治疗方案激素难治转移性前列 腺癌患者。 用法用量：推荐剂量：每3周给予1次，Jevtana 25 mg/m2 1小时内静脉输注与口服泼尼松10 mg联用每天 给药JEVTANA治疗自始至终。(1)给药前JEVTANA需要两次稀释。(2)用伴随的稀释液完整内容稀释至达到10 mg/mL JEVTANA浓度。(3)不应使用聚氯乙烯(PVC)仪器。(4)预先给药方案：每次静脉给予JEVTANA30分钟前前给予： 抗组织胺(右氯苯那敏[dexchloropheniramine] 5 mg或苯海拉明25 mg或等同抗组织胺)。 皮质甾体(地塞米松[dexamethasone]8 mg或等同甾体) H2拮抗剂(雷尼替丁[ranitidine]50 mg或等同H2拮抗剂)。当需要时建议用抗吐剂预防(口服或静脉)。(5)剂量修改：见完整处方资料。 禁忌：(1)中性粒细胞计数of ≤1,500/mm3。(2)对JEVTANA或山梨醇80严重超敏性史。 注意事项：嗜中性白血球减少症，发热性中性粒细胞：中性粒细胞减少死亡的报道。经常监测血细胞计数，以确定是否需要启动G-CSF和/或剂量修改。卡巴他赛注射液价格初级预防与G-CSF，应考虑在高风险的临床特点患者。过敏症：可能会发生严重的过敏反应。Premedicate与皮质类固醇和H2受体拮抗剂。停止输液，立即如果过敏的观察和对待表示。胃肠道症状（恶心，呕吐，腹泻）：腹泻死亡率已报告。反催吐剂和需要反-diarrheals的的水化和治疗。如果遇到等级≥3腹泻，剂量应进行修改。肾功能衰竭，包括致命后果的案件，已报告。确定原因并积极管理。老年患者：患者≥65岁以上的人更有可能体验到不相关的疾病的进展和某些不良反应，包括中性粒细胞减少和发热性中性粒细胞减少的致命后果。密切监察。从随机临床试验，卡巴他赛注射液哪里卖肝功能不全：肝功能受损的患者被排除在外。肝功能受损可能增加cabazitaxel浓度。肝功能不全的病人不应给予JEVTANA。JEVTANA可以管理到孕妇对胎儿造成伤害。 贮藏：低温，避光保存。

英文版说明书

Important Safety Information for JEVTANA® (cabazitaxel) InjectionWARNING: NEUTROPENIA AND HYPERSENSITIVITY•Neutropenic deaths have been reported. In order to monitor the occurrence of neutropenia, frequent blood cell counts should be performed on all patients receiving JEVTANA®. JEVTANA® should not be given to patients with neutrophil counts of ≤1,500 cells/mm3•Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the JEVTANA® infusion and administration of appropriate therapy. Patients should receive premedication•JEVTANA® must not be given to patients who have a history of severe hypersensitivity reactions to JEVTANA® or to other drugs formulated with polysorbate 80CONTRAINDICATIONS•JEVTANA® should not be used in patients with neutrophil counts of ≤1,500/mm3•JEVTANA® is contraindicated in patients who have a history of severe hypersensitivity reactions to JEVTANA® or to other drugs formulated with polysorbate 80WARNINGS AND PRECAUTIONS•Neutropenic deaths have been reportedMonitoring of complete blood counts is essential on a weekly basis during cycle 1 and before each treatment cycle thereafter so that the dose can be adjusted, if neededMonitor blood counts frequently to determine if initiation of G-CSF and/or dosage modification is neededPrimary prophylaxis with G-CSF should be considered in patients with high-risk clinical features•Severe hypersensitivity reactions can occurPremedicate with antihistamines, corticosteroids and H2 antagonistsPatients should be observed closely for hypersensitivity reactions, especially during the first and second infusionsDiscontinue infusion immediately if hypersensitivity is observed and treat as indicated•Mortality related to diarrhea has been reportedRehydrate and treat with anti-emetics and anti-diarrheals as neededIf experiencing grade ≥3 diarrhea, dosage should be modified•Nausea, vomiting and severe diarrhea, at times, may occur. Death related to diarrhea and electrolyte imbalance occurred in the randomized clinical trial. Intensive measures may be required for severe diarrhea and electrolyte imbalance•Gastrointestinal (GI) hemorrhage and perforation, ileus, enterocolitis, neutropenic enterocolitis, including fatal outcome, have been reportedRisk may be increased with neutropenia, age, steroid use, concomitant use of NSAIDs, anti-platelet therapy or anti-coagulants, and prior history of pelvic radiotherapy, adhesions, ulceration and GI bleedingAbdominal pain and tenderness, fever, persistent constipation, diarrhea, with or without neutropenia, may be early manifestations of serious GI toxicity and should be eva luated and treated promptlyJEVTANA® treatment delay or discontinuation may be necessary•Renal failure, including cases with fatal outcomes, has been reported. Identify cause and manage aggressively•Patients ≥65 years of age were more likely to experience fatal outcomes not related to disease progression and certain adverse reactions, including neutropenia and febrile neutropenia. Monitor closely•Patients with impaired hepatic function were excluded from the randomized clinical trialHepatic impairment is likely to increase the JEVTANA® concentrationsJEVTANA® should not be given to patients with hepatic impairment•JEVTANA® can cause fetal harm when administered to a pregnant womanThere are no adequate and well-controlled studies in pregnant women using JEVTANA®Women of childbearing potential should be advised to avoid becoming pregnant during treatment with JEVTANA®ADVERSE REACTIONS•Deaths due to causes other than disease progression within 30 days of last study drug dose were reported in 18 (5%) JEVTANA®-treated patients. The most common fatal adverse reactions in JEVTANA®-treated patients were infections (n=5) and renal failure (n=4)•The most common (≥10%) grade 1-4 adverse reactions were anemia, leukopenia, neutropenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysgeusia, cough, arthralgia, and alopecia•The most common (≥5%) grade 3-4 adverse reactions in patients who received JEVTANA® were neutropenia, leukopenia, anemia, febrile neutropenia, diarrhea, fatigue, and asthenia