英文药名：ZOLINZA(Vorinostat Capsules) 中文药名：伏立诺他胶囊 生产厂家：ＭＳＤ/大鹏药业 ゾリンザカプセル100mg 治疗类别名称 抗肿瘤药 组蛋白去乙酰化酶抑制剂 商標名 ZOLINZA Capsules 100mg  一般名 ボリノスタット(Vorinostat) 化学名 N -Hydroxy-N '-phenyloctanediamide 结构式 分子式 C14H20N2O3 分子量 264.32 性状 它是一种白色至浅橙色粉末。 1-2 -甲基 - 吡咯烷酮，溶解于微溶于甲醇或乙醇（99.5），极微溶于水。 批准的条件 药物使用调查的所有患者中，通过执行一段时间，因为在试验患者是非常有限的，数据上市后，根据目标数的情况下，之前被集成，这种药物这是可以理解的背景信息的病人，及早收集的数据对这种药物的疗效和安全性，采取必要的措施进行适当的使用这种药物。 药效药理 1. 作用机序 伏立诺他是一种组蛋白脱乙酰酶（HDAC）HDAC1，HDAC2和HDAC3（I类），并抑制HDAC6（IIb类）的酶活性。当增加组蛋白的乙酰化，例如通过抑制HDAC，通过松弛，染色质结构，基因表达，包括肿瘤抑制基因的等增加，分化和凋亡诱导，据估计，肿瘤生长被抑制有。然而，作用的详细的机理尚未阐明。 2. 抗肿瘤作用 (1) In vitro（体外） 伏立诺他，抗人皮肤T细胞淋巴瘤来源的HH细胞系显示的细胞生长抑制作用。 (2) In vivo（体内） 人类皮肤T细胞淋巴瘤来源的小鼠HH细胞系皮下植入，倾向于通过观察伏立诺他给药以阻止肿瘤的生长。 适应病症 皮肤T细胞淋巴瘤 用法与用量 成人：每日口服一次，每次400毫克饭后口服。另外，也需要根据患者的病情来应用。 包装规格 胶囊： PTP 100mg：28胶囊（14胶囊×2） 制造厂商 MSD有限公司[联盟]大鹏药业有限公司 完整资料附件：http://www.info.pmda.go.jp/go/pack/4291025M1029_1_06/ ZOLINZA capsule 100mg（ゾリンザカプセル100mg）  Brand name : ZOLINZA capsule 100mg 　Active ingredient: Vorinostat 　Dosage form: White capsule, major axis: 15.9 mm, minor axis: 5.82 mm 　Print on wrapping: (Front)ゾリンザ100mg, 568, (Back) ゾリンザ100mg Effects of this medicine Zolinza's inhibition of histone deacetylases enhances transcription activity of DNA, resulting in augmentation of the expression of tumor-suppressor genes which are suppressed in tumor cells. Consequently, tumor proliferation is reduced.It is usually used for the treatment of cutaneous T cell lymphoma. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reaction (itch, rash etc.) to any medicine. If you are a patient with hepatic dysfunction or diabetes or suspected to have these diseases. •If you are pregnant, or breastfeeding. •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 (400 mg of the active ingredient) at a time, once a day after meal. However, the dosage may be decreased according to patient's condition. Strictly follow the instructions. •Swallow whole capsule without opening it. If the content from an opened or crushed capsule gets on your skin or your membrane, wash the contacted area immediately. •If you missed a dose, take a dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. 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 • Possible adverse reactions to this medicine The most commonly reported adverse reactions include diarrhea, nausea, vomiting, anorexia, constipation, dry mouth, fatigue, tiredness, chills, taste abnormality, muscle spasticity, alopecia, weight loss, headache and fever. 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. •chest pain, breathing difficulty, acute pain or swelling of one leg  [pulmonary embolus, deep vein thrombosis] •epistaxis, bleeding gums, subcutaneous hemorrhage in limbs  [thrombocytopenia] •breathlessness, dizziness, general malaise  [anemia] •general malaise, thirst, decreased urine output  [dehydration] •thirst, polyposia, excessive urination  [elevated blood glucose] 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 the medicine out of the reach of children. Store away from direct sunlight, heat and moisture. •Discard the remainder. Do not store them. Check with the pharmacy regarding how to discard. TAIHO Pharmaceutical Co.,LTD.Internal Published: 9/2011 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.