英文药名：Jevtana(Cabazitaxel Injection) 中文药名：卡巴他赛注射液 生产厂家：赛诺菲安万特 药品介绍 Jevtana（Cabazitaxel）是法国赛诺菲-安万特 （Sanofi-Aventis）公司开发的新一代紫杉烷类抗癌药物，2010年6月17日被美国FDA批准，作为二线疗法用于治疗前列腺癌。该药物与泼尼松(prednisone)联用，以治疗既往用含多烯紫杉醇治疗方案的转移性激素难治前列腺癌(mHRPC)患者。 JEVTANA（卡巴他赛）注射，静脉使用 美国首次批准：2010 警告：粒细胞减少及过敏症请参阅完整的黑框警告完整的处方信息。 中性粒细胞减少死亡报告。获取频繁血细胞计数来监测中性粒细胞减少。不要给JEVTANA如果中性粒细胞计数≤1,500个/ mm3。 严重的过敏症可发生，可能包括全身皮疹/红斑，低血压和支气管痉挛。停止JEVTANA如果立即剧烈反应发生和管理适当的治疗。 如果禁忌的严重过敏反应到JEVTANA或药物配制聚山梨酯80的历史 目前的主要变化 剂量和给药方法  06/2015 剂量和给药方法  06/2015 禁忌  06/2015 警告和注意事项  06/2015 适应症和用法 JEVTANA是在用泼尼松治疗患者的预先与含多西紫杉醇治疗方案治疗激素难治转移性前列腺癌的组合所表示的微管抑制剂。 用法用量 推荐剂量：JEVTANA 25毫克/米2施用每三周为一小时静脉输注结合每日整个JEVTANA治疗施用口服强的松10毫克。 JEVTANA需要两个稀释物给药之前 使用附带的稀释剂的全部内容，以实现10毫克/毫升JEVTANA的浓度。 聚氯乙烯设备不应使用 术前用药养生：管理JEVTANA每次服药前静脉30分钟： 抗组胺药（dexchloropheniramine 5毫克或苯海拉明25毫克或同等抗组胺药） 皮质类固醇（地塞米松8毫克或同等类固醇） H2受体拮抗剂（雷尼替丁50毫克或同等H2拮抗剂） 止吐预防（口服或静脉），根据需要推荐。 用法用量：修改：见完整处方信息 剂型和规格 单次剂量小瓶60毫克/1.5毫升，用稀释剂（5.7毫升）JEVTANA供给 禁忌 的≤1,500/立方毫米中性粒细胞计数 严重过敏JEVTANA或聚山梨酯80的历史 重度肝功能损害（总胆红素> 3×ULN） 警告和注意事项 骨髓抑制（尤其是粒细胞）及其临床后果（发热性中性粒，中性粒细胞减少感染）：监测血细胞计数频繁，以确定是否修改剂量的G-CSF或启动是必要的。用G-CSF初级预防的患者应以高风险临床特点加以考虑。请谨慎患者血红蛋白<10克/升。 过敏症：严重的过敏反应可能发生。 Premedicate用皮质类固醇和H2受体拮抗剂。立即停止输液，如果过敏是观察和治疗表示。 胃肠道疾病：恶心，可能会发生呕吐，和腹泻。死亡率相关腹泻有报道。再水化，并根据需要治疗与止吐药和抗痢疾。如果出现等级≥3腹泻，用药量应进行修改。 死亡时有发生，由于消化道出血，穿孔和中性粒细胞减少性小肠结肠炎。延迟或中断JEVTANA。 肾功能衰竭，包括与致命的后果的情况下，有报道。查明原因并积极管理。 老年患者：患者≥65岁更可能体验到不相关的疾病进展和一定的不良反应，包括中性粒细胞减少和发热性中性粒致命的后果。密切监测。 肝损害：降低JEVTANA剂量为20毫克/ m2的患者有轻度肝受损和15毫克/ m2的患者有中度肝功能损害。 当给予孕妇JEVTANA可导致胎儿伤害。 不良反应 最常见的所有级别的不良反应（≥10％）是中性粒细胞减少，贫血，白细胞减少，血小板减少，腹泻，乏力，恶心，呕吐，便秘，乏力，腹痛，血尿，腰部疼痛，食欲减退，外周神经病变，发热，呼吸困难，味觉障碍，咳嗽，关节痛，脱发等。 药物相互作用 避免JEVTANA合用具有很强的CYP3A酶抑制剂。如果患者需要一个强CYP3A抑制剂共同施用，考虑25％的JEVTANA剂量减少。 修订：6/2015 JEVTANA(cabazitaxel) Injection Important Safety Information for JEVTANA® (cabazitaxel) injection WARNING: 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® is contraindicated in 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® is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80. CONTRAINDICATIONS •JEVTANA® is contraindicated in patients with: -neutrophil counts of ≤1,500/mm3 -history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80 -severe hepatic impairment (total bilirubin > 3 x upper limit of normal (ULN)) WARNINGS AND PRECAUTIONS •Bone marrow suppression manifested as neutropenia, anemia, thrombocytopenia and/or pancytopenia may occur. Neutropenic deaths have been reported. -Monitoring 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 needed -Monitor blood counts frequently to determine if initiation of G-CSF and/or dosage modification is needed -Primary prophylaxis with G-CSF should be considered in patients with high-risk clinical features -Caution is recommended in patients with hemoglobin < 10 g/dl •Severe hypersensitivity reactions can occur. -Premedicate all patients with antihistamines, corticosteroids and H2 antagonists prior to the initiation of the JEVTANA® infusion -Observe patients closely for hypersensitivity reactions, especially during the first and second infusions -Discontinue infusion immediately if severe hypersensitivity is observed and treat as indicated •Mortality related to diarrhea has been reported. -Rehydrate and treat with anti-emetics and anti-diarrheals as needed -If 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 reported. -Risk 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 bleeding -Abdominal pain and tenderness, fever, persistent constipation, diarrhea, with or without neutropenia, may be early manifestations of serious GI toxicity and should be evaluated and treated promptly -JEVTANA® 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: -JEVTANA® is contraindicated in patients with severe hepatic impairment (total bilirubin > 3 x ULN) -Dose should be reduced for patients with mild (total bilirubin > 1 to ≤ 1.5 x ULN or AST > 1.5 x ULN) and moderate (total bilirubin > 1.5 to ≤ 3.0 x ULN and any AST) hepatic impairment, based on tolerability data in these patients -Administer JEVTANA® with caution in patients with mild and moderate hepatic impairment and closely monitor for safety •JEVTANA® can cause fetal harm when administered to a pregnant woman. -JEVTANA is not indicated for use in female patients -There are no adequate and well-controlled studies in pregnant women using JEVTANA® -Females 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. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa ------------------------------------------------ 产地国家: 美国 原产地英文商品名: JEVTANA concentrate perfusion 60MG/1.5ML/VIAL + solvent 4.5ml 原产地英文药品名: CABAZITAXEL 中文参考商品译名: JEVTANA 浓缩灌注60毫克/1.5毫升/瓶+4.5毫升溶剂 中文参考药品译名: 卡巴他赛 生产厂家中文参考译名: 赛诺菲-安万特 生产厂家英文名: SANOFI AVENTIS ------------------------------------------------------------ 产地国家：美国 原产地英文药品名： CABAZITAXEL 中文参考药品译名： 卡巴他赛 原产地英文商品名： JEVTANA KIT 60MG/1.5ML/VIAL SDV+1VIAL DILUENT/KIT 中文参考商品译名： JEVTANA套装 60毫克/1.5毫 生产厂家英文名： SANOFI AVENTIS US 生产厂家中文参考译名： 赛诺菲-安万特 该药品相关信息网址1： http://www.jevtana.com/