英文药名：Riona Tab(Ferric Citrate Hydrate) 中文药名：柠檬酸铁片 生产厂家：鸟居药品 リオナ錠250mg 类别名称 高磷血症的治疗剂 批准上市：2014年5月 商標名 Riona Tab.250mg 一般名 クエン酸第二鉄水和物 Ferric Citrate Hydrate 化学名 铁（III）柠檬酸水合物 Iron（III）citrate hydrate 分子式 C6H8O7・xFe・yH2O 性　状 精致的棕色至棕褐色粉末。它是易溶于盐酸，水和极微溶，几乎不溶在乙醇（99.5）。 操作注意事项 打开铝枕后可以被存储，以避免水分。 通过集中在磷酸铁（Fe3+的）的结合作用，以形成不溶性的（磷酸铁）沉淀通过偶联磷酸铁的膳食在胃肠道内，是磷酸盐结合剂，抑制磷的新的胃肠道吸收。 药效药理 1.作用与效果 （1）降低血磷浓度，钙磷乘积和血清PTH浓度 在腺嘌呤诱导的肾功能不全大鼠中，柠檬酸水合铁（1％或3％）的饮食施用导致血清磷浓度，钙磷乘积和血清PTH浓度的降低。 （2）异位钙化，继发性甲状旁腺功能亢进和肾性骨营养不良的抑制作用 在腺嘌呤诱导的肾衰竭大鼠中，柠檬酸铁水合物的饮食施用（1％或3％）减少肾和主动脉中的钙沉积物的量，抑制主动脉中的钙化（矿物质沉积） 观察到抑制甲状旁腺增生，并抑制孔隙，纤维化和骨组织的类骨质形成。 2. 作用机序 柠檬酸铁水合物与胃肠道中的磷酸结合，并抑制从胃肠道吸收磷，由此表现出血清磷水平降低作用。 适应症 控制慢性肾脏疾病患者透析过程中血清磷水平的磷酸盐结合剂。 用法用量 成人，起始剂量为500mg，饭后立即给药，一天3次，此后根据症状、血磷浓度进行调整，最高剂量为1日6000mg。 包装规格 片剂 250毫克：100片（10片×10 PTP包装用） 250毫克：500片（10片×50 PTP包装用） 250毫克：1000片（10片×100 PTP包装） 生产厂商 鸟居制药有限公司 完整处方资料附件：http://www.info.pmda.go.jp/go/pack/2190033F1022_1_04/2190033F1022_1_04?view=body FOR IMMEDIATE RELEASE Riona® Tablets 250mg for the treatment of hyperphosphatemia approved in Japan manufacturing and marketing approval of Riona® Tablets 250mg, jointly developed by JT and Torii, from the Japanese Ministry of Health, Labour and Welfare. The drug is indicated as an oral treatment for the improvement of hyperphosphatemia in patients1 with chronic kidney disease (CKD). Riona® Tablets is a novel phosphate binder containing ferric citrate hydrate as the active pharmaceutical ingredient. This new agent binds to phosphate in the gastrointestinal tract and decreases serum phosphorus concentration through inhibiting phosphate absorption into the body. Clinical efficacy in the decrease of serum phosphorus concentration was proven in Phase 3 studies, in both on dialysis and not on dialysis CKD patients with hyperphosphatemia in Japan. Furthermore, no clinically significant findings on the safety and tolerability of Riona® Tablets were observed in the long-term administration studies. JT and Torii expect Riona® Tablets to become a new therapeutic option for hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent CKD. Following its inclusion in the National Health Insurance (NHI) price list, Riona® Tablets will be sold exclusively by Torii in Japan. The drug’s launch date will be announced as soon as a decision is made. Outline of approval Product Name: Riona® Tablets 250mg Generic Name: Ferric Citrate Hydrate Indications: Improvement of hyperphophatemia in patients with chronic kidney disease Both dialysis and non-dialysis dependent CKD patients are included. Dosage and Administration: The usual adult dosage for oral use begins at 500 mg of ferric citrate three times daily immediately after meals. Thereafter, the dosage should be adjusted based on the degree of symptoms and serum phosphorus concentration. The maximum daily dosage is 6,000 mg. About ferric citrate hydrate JT and Torii hold the exclusive rights to develop and commercialize ferric citrate hydrate in Japan, which were licensed in September 2007 from Keryx Biopharmaceuticals, Inc. Since then, JT and Torii have jointly conducted the development of the drug, and JT submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare in January 2013. In the United States, Keryx filed its NDA with the U.S. Food and Drug Administration and has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014. About hyperphosphatemia Patients with CKD often suffer from hyperphosphatemia, as a result of lower phosphorous excretion from the kidney. Persisting hyperphosphatemia leads to calcareous deposition in various organs and periarticular tissues. In particular, a calcified blood vessel wall causes arterial sclerosis and increases the risk of cardiac infarct and angina. Furthermore, bone lesions can be caused by secondary hyperparathyroidism associated with the increase in secretion of parathyroid hormone, negatively affecting activities of daily living and quality of life. Therefore, it is important for hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent CKD, to maintain the target level of serum phosphorus.