Xtandi(enzalutamide)恩杂鲁胺 2012.docx

Xtandi(enzalutamide恩杂鲁胺)FDA 2012年8月31日批准上市厂家：Medivation公司（美国）及合作伙伴安思泰来（Astellas）公司（日本）美国食品药品管理局(FDA)和安斯泰来制药公司宣布，Xtandi(enzalutamide)已获准用于曾接受多西他赛治疗的转移性去势耐药性前列腺癌的治疗。Xtand是一种每日口服1次的雄激素受体抑制剂。Xtandi的疗效和安全性已在一项随机、安慰剂对照的多中心3期临床试验中得到了评估。这项试验招募了1,199例曾接受多西他赛治疗的转移性去势耐药性前列腺癌患者，旨在评价接受Xtandi治疗者与安慰剂组患者的总生存率。结果显示，Xtandi组患者的中位生存期为18.4个月，而安慰剂组患者仅为13.6个月。在临床研究中，患者最常发生的不良反应为虚弱/疲乏、背痛、腹泻、关节痛、潮热、外周水肿、肌肉骨骼痛、头痛、上呼吸道感染、肌无力、头晕、失眠、下呼吸道感染、脊髓压缩和马尾综合征、血尿、感觉异常、焦虑以及高血压。Xtandi组患者47%发生≥3级不良反应，这一比例在安慰剂组为53%。在这项随机临床试验中，0.9%的Xtandi组患者曾出现癫痫样发作，而安慰剂组未见这一现象。出现癫痫样发作的患者永久停止治疗，癫痫样发作均消除。有癫痫病史、服用可降低癫痫阈值的药物、或有其他癫痫危险因素的患者均被排除在之外。鉴于使用Xtandi伴随癫痫风险，应告知患者可能因突然丧失意识而导致严重伤害的风险。Xtandi的推荐剂量为160 mg(4个40 mg胶囊)，每日口服1次。该药可与食物同服，而且不要求同时使用类固醇。Xtandi(enzalutamide)批准日期：2012年8月31日；公司：Medivation Inc.和 Astellas Pharma Inc.HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use XTANDI? safely and effectively. See full prescribing information for XTANDI.?XTANDI? (enzalutamide) capsules for oral useInitial U.S. Approval: 2012?INDICATIONS AND USAGEXTANDI is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. (1)?DOSAGE AND ADMINISTRATIONXTANDI 160 mg (four 40 mg capsules) administered orally once daily. Swallow capsules whole. XTANDI can be taken with or without food. (2.1)?DOSAGE FORMS AND STRENGTHSCapsule 40 mg (3)?CONTRAINDICATIONSPregnancy (4, 8.1)?WARNINGS AND PRECAUTIONSSeizure occurred in 0.9% of patients receiving XTANDI. There is no clinical trial experience with XTANDI in patients who have had a seizure, in patients with predisposing factors for seizure, or in patients using concomitant medications that may lower the seizure threshold. (5.1)?ADVERSE REACTIONS-The most common adverse reactions (≥ 5%) are asthenia/fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness