英文药名：Xtandi Capsules（enzalutamide） 中文药名：恩杂鲁胺胶囊 生产厂家：安斯泰来制药 イクスタンジカプセル40mg 治疗类别名称 前列腺癌的治疗剂 上市时间：2014年5月 商標名 Xtandi Capsules 40mg 一般名 エンザルタミド（Enzalutamide） 化学名 4-｛3-［4-Cyano-3-（trifluoromethyl）phenyl］-5,5-dimethyl-4-oxo-2-sulfanylideneimidazolidin-1-yl｝-2-fluoro-N -methylbenzamide 構造式 分子式 C21H16F4N4O2S 分子量 464.44 性状 Enzarutamido是粉末或白色结晶。1-2 - 甲基 - 它是易溶于乙腈和吡咯烷酮，很容易微溶于甲醇，和微溶于乙醇（99.5），并且几乎不溶于水。 使用注意事项 注意： 因为本文试图改善由铝袋保持的质量，也能够保存，以避免开封后的高湿度的铝袋。 药效药理 1. 作用机序 这种药物是雄激素受体（AR）信号抑制剂。雄激素对AR竞争性抑制的结合，也抑制核转和AR和转录因子对AR的DNA结合区域的结合。 2. 抗肿瘤作用 本剂在体外，对人前列腺癌细胞系，抑制对AR-依赖性基因表达，抑制细胞增殖，诱导细胞死亡。在人前列腺癌衍生的LNCaP细胞系。此外，在用的LNCaP/ AR细胞系移植小鼠中高表达的AR皮下显示抑制肿瘤生长。 适应病症 去势抵抗前列腺癌 用法与用量 成年人，每天给药一次，每次口服160mg。 包装规格 40mg×56胶囊（14粒×4） 生产厂家：安斯泰来制药 完整处方资料附件：http://www.info.pmda.go.jp/go/pack/4291031M1024_1_07/ Xtandi Capsules 40 mg（イクスタンジカプセル40mg）  Brand name : Xtandi Capsules 40 mg 　Active ingredient: Enzalutamide 　Dosage form: white to slightly yellowish white capsule, major axis: approx. 21 mm, minor axis: approx. 10 mm 　Print on wrapping: (Face) イクスタンジ 40 mg, house-mark, (Back) イクスタンジ 40 mg, house-mark Effects of this medicine This medicine suppresses activity of androgen (male hormone) by binding androgen receptors which exist in prostate cancer tissues, and consequently inhibits the growth of cancer cells. It also exerts anti-tumor effects by inhibiting multiple proliferative pathways in 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 medicinal effects. 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 the instructions. •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 dose and 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 •The medicine may cause convulsive seizure. Pay attention when you drive a car, or operate dangerous machinery. Possible adverse reactions to this medicine The most commonly reported adverse reactions include hypertension, constipation, fatigue, appetite decreased, weight loss, nausea, flushing, 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 indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •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 your doctor 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 to discard. Astellas Pharama Inc.Internal Revised: 10/2014 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. This article Department of pharmacists/medical experts original translation finishing, welcome to reprint! At the same time the procurement of domestic scientific research institutions can contact us: 2363244352.3330889895