产地国家：日本

处方药：是

所属类别： 100毫克/粒 84粒/盒

包装规格： 100毫克/粒 84粒/盒

计价单位：盒

生产厂家英文名：Mundipharma Co.Ltd.

原产地英文商品名：mundesine（ムンデシンカプセル）100mg/Capsule 84Capsule/box

原产地英文药品名：forodesine

中文参考商品译名：mundesine（ムンデシンカプセル）100毫克/粒 84粒/盒

中文参考药品译名：呋咯地辛

简介：

近日，抗癌新药Mundesine（forodesine hydrochloride，100mg胶囊）已经在日本上市。Mundesine是一个嘌呤-核苷磷酸化酶抑制剂，也是首次批准其对复发性或难治性外周T细胞淋巴瘤的治疗。药物分类名称抗肿瘤药/ PNP注2）抑制剂注2）嘌呤核苷磷酸化酶批准日期：

商标名：mundesine Capsule 100mg

一般名：フォロデシン塩酸塩（JAN） forodesine（INN）

化学名：7-［（2S,3S,4R,5R）-3,4-Dihydroxy-5-（hydroxymethyl）pyrrolidin-2-yl］-1,5-dihydro-4H-pyrrolo［3,2-d］pyrimidin-4-one monohydrochloride

分子式：C11H14N4O4・HCl

分子量：302.71

性状：白色至微褐色白色粉末可溶性它微溶于水，几乎不溶于二甲基亚砜，几乎不溶于N，N-二甲基甲酰胺和乙醇（99.5）。熔点约294°C（分解）分配系数正辛醇/水分配系数是log P = -3.42。

处理注意事项：放在儿童接触不到的地方，避免高温。

批准条件：1.制定药品风险管理计划并适当实施。2.由于日本的临床试验数量非常有限，通过对所有病例进行使用结果调查，直到制造和销售后累积一定数量的病例数据为止， 除了掌握使用该药物的患者的背景信息外，还应尽快收集有关该药物安全性和有效性的数据，并采取必要措施正确使用该药物。

作用机制：Phorodecine抑制PNP，通过磷酸化细胞和2'-脱氧鸟苷三磷酸（dGTP）积累的2'-脱氧鸟苷（dGuo）诱导细胞凋亡，它被认为抑制肿瘤生长。Phollodecine抑制人红细胞来源的PNP，其IC 50（50％抑制浓度）值为1.19 nmol/L.

适应症：复发性或难治性外周T细胞淋巴瘤

用法用量：成人每天两次服用300毫克，每天一次。另外，根据患者的状况进行减重。

包装：胶囊，100毫克/84粒

英文版说明书：

Antineoplastic agent "Mundecin ® capsule 100 mg" Acquired manufacturing and marketing approval as a recurring or refractory peripheral T cell lymphoma (PTCL) treatment drug - Novel mechanism of action, approved in Japan ahead of the worldMundipharma Co.Ltd. (Headquarters: Minato-ku, Tokyo, President and CEO: Akira Kimura, hereinafter "Mundipharma") today announced that purine nucleosides with efficacy and effect as recurrent or refractory peripheral T cell lymphoma (PTCL) We are pleased to inform you that we have approved domestic manufacturing and marketing of phosphorylase (PNP) inhibitor "Mundecin® capsule 100 mg" (generic name: phorodecyn hydrochloride, hereinafter "Mundecin®"). Mundecin ® is the first medicine approved in Japan for the first time in the world.PTCL originates from mature T cells and natural killer (NK) cells and is a diverse group of diseases characterized by diverse organ infiltration by lymphoid tumor cells. In Japan, annual onset cases are estimated to be about 2,000 cases, accounting for 10-15% of intermediate-grade lymphoma. In addition, the good age is elderly people over 65 years old, and the older the older, the higher the incidence rate tends to be. Since CHOP therapy combining several anticancer drugs in the early 1990 became the standard primary treatment of intermediate-grade non-Hodgkin's lymphoma there has been little progress in treatment options for PTCL. In addition, standard treatment has not been established since PTCL secondary therapy has been established, it is known to be a disease with poor prognosis.This approved Mundeshin® is a PNP inhibitor of a novel mechanism of action that has been confirmed for the first time in the world. It is thought that inhibiting PNP accumulates 2-deoxyguanosine triphosphate in cells, induces apoptosis, and suppresses proliferation of T cell-derived tumor cells. In addition, it is the first oral treatment with a therapeutic drug whose recurrence or refractory PTCL has its indication or effect, and it is expected that the burden on hospital visits to patients will be reduced and treatment at home will be possible .Kosuke Kimura, President and Representative Director of the Company, stated the manufacturing and marketing approval for this time as follows. "I am delighted to be able to offer new treatment options to patients with recurrent or refractory PTCL in Japan through Mundecin® We have been working on development aiming for early approval in Japan ahead of the world We would like to express our sincere gratitude to the Japanese patients and their families who participated in the trial and to those involved with the clinical trial facility who cooperated and we will continue to challenge for patients in Japan.The cancer area is our priority area, and by offering Mundecin®, we will contribute to satisfying patients' treatment options. In addition, we will continue to contribute to various needs related to the health of patients and families by enriching products in the cancer area.Product overview of Mundecin®Product name: Mundecin® capsule 100 mgCommon name: Folodecin hydrochlorideDOSAGE AND ADMINISTRATION: Usually, adults are given 300 mg twice a day as foldecin once. Incidentally, weight reduction is made according to the condition of the patient.Indications: Recurrent or refractory peripheral T cell lymphomaManufacture and sale approval date: March 30, 2017Manufacturer and distributor: Mundipharma Co.,Ltd.