英文药名：Farydak(Panobinostat Lactate Capsules) 中文药名：帕比司他胶囊 生产厂家：诺华制药 ファリーダックカプセル10mg／ファリーダックカプセル15mg 治疗类别名称 抗肿瘤药 组蛋白乙酰化酶（HDAC）抑制剂 商標名 Farydak capsules 構造式 一般名 パノビノスタット乳酸塩（Panobinostat Lactate） 化学名 （2E）-N-Hydroxy-3-［4-（｛［2-（2-methyl-1H-indol-3-yl）ethyl］amino｝methyl）phenyl］prop-2-enamide mono［（2RS）-2-hydroxypropanoate］ 分子式 C21H23N3O2・C3H6O3 分子量 439.50 性状 白色至是浅黄色或浅棕色粉末。水，微溶于甲醇或乙醇，和在1-辛醇中几乎不溶。 操作注意事项 为了避免潮湿，以指示服用期间检索来自PTP板胶囊。 审批条件 1.在制定药品风险管理计划，正确实施。 2. 由于临床试验的情况下在日本是非常有限，上市后，直到一定数量案件的数据被集成，通过实施的所有情况下，使用效果的调查，该药物以及了解病人使用的背景资料，搜集有关这种药物的安全性和有效性的数据在年初，采取必要措施，正确使用此药。 药效药理 1.作用机序 Panobinosutatto抑制去乙酰化酶（DAC）的活性。组蛋白和非组蛋白由DAC活性抑制乙酰化得到促进，通过细胞周期停滞和细胞凋亡的诱导造成的，肿瘤的生长已被估计要被抑制。然而，动作的详细的机理尚未阐明。 2. 药理作用 (1) Panobinosutatto从MM1.S，MM1.R人类多发性骨髓瘤，抑制U266，U266LR7和U266DOX4细胞系的生长。 (2) 体内 Panobinosutatto是在皮下植入小鼠MM1.S细胞系，抑制肿瘤的生长。 适应证和用途 用于治疗复发或难治性多发性骨髓瘤 用法用量 推荐剂量为20毫克，每周三剂口服隔日一次（按天数1，3，5，8，10，和12）周的1和2的每21天为一周期为8个周期。三个周为一个周期，重复给药。另外，适当通过患者的病情。 包装规格 胶囊： 10毫克*12粒（PTP） 15毫克*12粒（PTP） 生产商 日本诺华制药有限公司 Farydak(Panobinostat Lactate）临床用药方案 第一阶段治疗：第1－8个周期，每周期为3个星期（总时间为24周） •帕比司他:20mg口服，每日一次，每周三次，每周期使用两周休息一周。 •硼替佐米1.3mg/平米，每周两次静脉注射，每周期使用两周休息一周 •地塞米松20mg，口服，在用硼替佐米的当天和第二天 第二阶段治疗：第9－16个周期，每周期为3个星期（总时间为24周） 患者达到临床获益（评价标准为SD，PR，MR，nCR，或CR），没有严重的持续毒副反应，此时可考虑在修改剂量的基础上继续另外8个周期的治疗。 帕比司他:20mg口服，每日一次，每周三次，每周期使用两周休息一周。 •硼替佐米1.3 mg /平米，每周一次静脉注射，每周期使用两周休息一周 •地塞米松20 mg，口服，在用硼替佐米的当天和第二天 注：以上中文资料仅供参考，使用以原处方为准：http://www.info.pmda.go.jp/go/pack/4291040M1023_1_01/ www.120ty.net New release of anti-malignant agent "Farudac capsule" The first histone deacetylase (HDAC) inhibitor for multiple myeloma Novartis Pharma Co., Ltd. announced on August 31, 2015 "Fariduck capsule 10 mg, same capsule 15mg" (generic name: panovinostat lactate, hereinafter referred to as "Fali duck"), approved as a recurring or refractory multiple myeloma remedy ") Announced the start of sales. Development of Multiple Myeloma Treatment "Fariduck" In addition, an abnormal increase in histone deacetylase (hereinafter referred to as HDAC) activity is observed in multiple myeloma cells, and activation thereof is reported to lead to a process of promoting cancer. "Fariduck" is the first HDAC inhibitor to treat multiple myeloma and can be expected to have antitumor effects such as inhibition of proliferation of myeloma cells and induction of tumor cell death when used in combination with existing therapeutic agent bortezomib. In an international cooperative Phase III clinical trial conducted on relapsed or refractory multiple myeloma patients, when "Fariduck" was used in conjunction with existing therapy bortezomib and dexamethasone, progression free Survival period (PFS) significantly increased for 3.9 months. It has also been confirmed that the percentage of complete response (CR) and response close to complete response (nCR) is significantly higher in "Fariduck" combined group. Main adverse reactions accompanying administration of "Fariduck" and bortezomib and dexamethasone in combination, were thrombocytopenia, diarrhea, fatigue, anemia, neutropenia and the like. Onset of multiple myeloma Multiple myeloma is a refractory hematopoietic tumor that is difficult to heal, and is a disease that cancer cells, a type of leukocyte in bone marrow, become cancerous. Cancerated plasma cells (myeloma cells) inhibit the production of healthy blood and make the bones brittle, so that symptoms such as anemia, renal disorder, bone pain and bone fracture, and rise in calcium level in the blood Appears. The estimated total number of patients with multiple myeloma in Japan is reported to be about 14,000 and the annual number of deaths is reported to be 4,066. In addition, this disease often occurs more than 60 years old, and it is rare to develop onset below 40 years old