恩杂鲁胺胶囊Enzalutamide（Xtandi Capsules 56×40mg）

药店国别： 产地国家：日本 处方药：是 所属类别： 40毫克/胶囊 56胶囊/盒 包装规格： 40毫克/胶囊 56胶囊/盒 计价单位：盒 生产厂家中文参考译名： 生产厂家英文名：Astellas Pharma Inc. 原产地英文商品名：Xtandi(イクスタンジカプセル)40mg/cap 56caps/box 原产地英文药品名：ESCITALOPRAM 中文参考商品译名：Xtandi(イクスタンジカプセル)40毫克/胶囊 56胶囊/盒 中文参考药品译名：恩杂鲁胺 曾用名： 简介：抗癌新药Xtandi(enzalutamide 中文药名 恩杂鲁胺胶囊)获美国及欧洲批准用于治疗已扩散或复发的晚期(转移性)男性晚期前列腺癌，即使其已接受过为减少睾酮的药物或手术治疗。Xtand是一种每日口服1次的雄激素受体抑制剂批准日期：2012年8月31日;公司：Medivation Inc.和Astellas Pharma Inc.XTANDI(恩杂鲁胺 enzalutamide)胶囊口服使用最初美国批准：2012目前的主要变化警告和注意事项 08/2015剂量调整 08/2015 作用机理 Enzalutamide是雄激素受体抑制剂，作用于雄激素受体信号传导途径的不同步骤。 Enzalutamide已经显示出竞争性抑制雄激素结合于雄激素受体和抑制雄激素受体核易位和相互作用与DNA。一个主要的代谢产物，N去甲基enzalutamide，展出的体外活性类似于enzalutamide。 Enzalutamide体外降低增殖和前列腺癌细胞的诱导的细胞死亡，并在小鼠前列腺癌异种移植模型中减少肿瘤体积。 适应症和用法 XTANDI是用于治疗转移性去势抗性前列腺癌的治疗表明雄激素受体抑制剂。 用法用量 XTANDI 160毫克(4个40毫克胶囊)，每天一次口服。吞咽胶囊整体。 XTANDI可采取或没有食物。 剂型和规格 胶囊40毫克 禁忌症 怀孕 警告和注意事项 •发作发生在接收谁先前接收多西紫杉醇和在患者谁是化疗幼稚0.1%XTANDI患者0.9%。有一个在谁曾癫痫发作患者XTANDI没有临床试用体验。谁在治疗期间制定发作的患者永久性停止XTANDI。 •可逆性后部脑病综合征(PRES)：请停止XTANDI。 不良反应 最常见的不良反应(≥10%)是虚弱/乏力，腰痛，食欲减退，便秘，关节痛，腹泻，潮热，上呼吸道感染，血管神经性水肿，呼吸困难，肌肉骨骼痛，体重明显下降，头痛，高血压，头晕/眩晕。 药物相互作用 •避免强CYP2C8抑制剂，因为它们能提高血浆暴露XTANDI。如果联合给药是必要的，降低XTANDI的剂量。•避免强CYP3A4诱导剂，因为他们可以降低血浆暴露XTANDI。如果联合给药是必要的，增加XTANDI的剂量。•避免CYP3A4，CYP2C9和CYP2C19基板具有窄的治疗指数，因为XTANDI可能会降低这些药物的血浆暴露。如果XTANDI是共同给予华法林(CYP2C9底物)，进行额外的监测INR。 英文版说明书：

XTANDI (Enzalutamide) Capsules 40mgImportant Safety InformationWarnings and PrecautionsSeizure In Study 1, conducted in patients with metastatic castration-resistant prostate cancer (CRPC) who previously received docetaxel, seizure occurred in 0.9% of XTANDI patients and 0% of placebo patients. In Study 2, conducted in patients with chemotherapy-naive metastatic CRPC, seizure occurred in 0.1% of XTANDI patients and 0.1% of placebo patients. There is no clinical trial experience readministering XTANDI to patients who experienced a seizure, and limited safety data are available in patients with predisposing factors for seizure. Study 1 excluded the use of concomitant medications that may lower threshold; Study 2 permitted the use of these medications. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity during which sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.Adverse ReactionsThe most common adverse reactions (≥ 10%) reported from two combined clinical studies that occurred more commonly (≥ 2% over placebo) in XTANDI patients were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo.In Study 1, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In Study 2, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups.• Lab Abnormalities: Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4).• Infections: In Study 1, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In Study 2, 1 patient in each treatment group (0.1%) had an infection resulting in death.• Falls (including fall-related injuries), occurred in 9% of XTANDI patients and 4% of placebo patients. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas.• Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of all patients.Drug InteractionsEffect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI.Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI.Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monito Xtandi Capsules 40mg（Enzalutamide イクスタンジカプセル40mg）Brand name:Xtandi Capsules 40 mgActive ingredient:EnzalutamideDosage form:white to slightly yellowish white capsule, major axis: approx. 21 mm,minor axis: approx. 10mmPrint on wrapping:(Face) イクスタンジ 40mg, house-mark, (Back) イクスタンジ 40mg, house-markEffects of this medicineThis medicine inhibits binding of androgen (male hormone) against androgen receptors which exist in prostate tissues,and consequently shows anti-tumor effects. It also exerts effectiveness by inhibiting multiple proliferative pathwaysin prostate cancer cells.It is usually used for the treatment of prostate cancer.Before using this medicine, be sure to tell your doctor and pharmacist・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.If you have: a history of convulsive disease such as epilepsy, a history of brain damage or stroke.・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinaleffects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)Dosing schedule (How to take this medicine)・Your dosing schedule prescribed by your doctor is(( to be written by a healthcare professional))・In general, for adults, take 4 capsules (160 mg of the active ingredient) at a time, once a day. Strictly follow theinstructions.・If you miss a dose, take the missed dose as soon as possible. If you miss a dose for a whole day, skip the missed doseand continue your regular dosing schedule from the following day. You should never take two doses at one time.・If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.・Do not stop taking this medicine unless your doctor instructs you to do so.Precautions while taking this medicine・In rare cases, this medicine may cause convulsive seizure. Pay attention when you drive a car, or operate dangerousmachinery.Possible adverse reactions to this medicineThe most commonly reported adverse reactions include hypertension, constipation, fatigue, appetite decreased,weight loss, nausea, hot flush, and asthenia. If any of these symptoms occur, consult with your doctor or pharmacist.The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicatedin brackets. If any of these symptoms occur, stop taking this medicine and see your doctorimmediately.・dizziness, tremor, muscle spasm [convulsive seizure]・nasal bleeding, bleeding from gums, subcutaneous bleeding [thrombopenia]The above symptoms do not describe all the adverse reactions to this medicine. Consult with yourdoctor or pharmacist if you notice any symptoms of concern other than those listed above.Storage conditions and other information・Keep out of the reach of children. Store away from direct sunlight, heat and moisture.・Capsules may become soft in high temperature/humidity environments.・Discard the remainder. Do not store them. Consult with your dispensing pharmacy or medical institution how todiscard。InternalRevised: 06/2018The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approvaldetails may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It isimportant to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,patients should understand their medication and cooperate with the treatment.