英文药名：Zafatek tablets（trelagliptin succinate） 中文药名：曲格列汀琥珀酸盐片 日文药名：ザファテック錠 生产厂家：武田制药 药品介绍 通用名：曲格列汀琥珀酸盐片 商品名：Zafatek 英文名：Trelagliptin succinate 适应症：2型糖尿病 用法与用量：成人每周口服一次（100毫克） 包装规格：（盒） 50mg*20片 100mg*20片 生产厂家：武田制药 Zafatek Tablets（Trelagliptin succinate） Zafatek Tablets 50mg（ザファテック錠50mg） Brand name : Zafatek Tablets 50mg 　Active ingredient: Trelagliptin succinate 　Dosage form: pale yellowish red oval tablet, major axis: 8.2 mm, minor axis: 4.7 mm, thickness: about 3.1 mm 　Print on wrapping: （表）糖尿病治療薬 ザファテック錠 50mg D388 週1回のむ薬です,（裏）糖尿病治療薬 ザファテック錠 50mg Zafatek Tablets 50mg 週1回のむくすりです Zafatek Tablets 100mg（ザファテック錠100mg） Brand name : Zafatek Tablets 100mg 　Active ingredient: Trelagliptin succinate 　Dosage form: pale red oval tablet, major axis: 11.0 mm, minor axis: 5.6 mm, thickness: about 3.8 mm 　Print on wrapping: （表）糖尿病治療薬 ザファテック錠 100mg D389 週1回のむ薬です,（裏）糖尿病治療薬 ザファテック錠 100mg Zafatek Tablets 100mg 週1回のむくすりです Effects of this medicine This medicine inhibits DPP-4, an enzyme degrading incretin hormones that maintain a constant level of blood glucose, to stimulate insulin secretion when blood glucose is elevated and thereby to improve blood glucose control. It is usually used to treat type II diabetes mellitus. 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 ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, an injury, renal disorder, pituitary abnormality or adrenal disease. If you are in a pre- or post-operative status or weakened. If you do not consume an adequate diet. If you have been doing vigorous exercise or taking a large amount of alcohol. 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 2 tablets (100 mg of trelagliptin) at a time, once a week, on a fixed day of the week. The dosage may be reduced according to the degree of renal function in patients with moderate renal dysfunction. Strictly follow the instructions. If you miss a dose, take the missed dose as soon as possible and then follow your regular weekly 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 Strictly follow the instructions on dietary/exercise therapy. This medicine may cause hypoglycemia. Pay close attention to operating dangerous machinery, such as working at heights or driving a car. Tell your family members and other people around you that you are taking this medicine. When hypoglycemia symptoms occur, take an adequate amount of sugar (e.g., sugar, glucose, soft drinks). If you are taking the medicine concomitantly with an α-glucosidase inhibitor (medicines which delay absorption of sugar such as voglibose and acarbose), ingest glucose in case of any hypoglycemic symptoms. Possible adverse reactions to this medicine The most commonly reported adverse reactions include nasopharyngitis, rash and itching. 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. cold sweat, hungry feeling, trembling of limbs [hypoglycemia] 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. Discard the remainder. Do not store them. Takeda Chemical Industries, Ltd. Internal Published: 5/2015 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. 全球首个降糖药新药Zafatek获批每周口服一次（50mg/100mg） 2015年3月26日，日本制药巨头武田糖尿病新药Zafatek（trelagliptin succinate，曲格列汀琥珀酸盐）获日本卫生劳动福利部（MHLW）批准，用于2型糖尿病的治疗。 Trelagliptin（曲格列汀琥珀酸盐）是一种每周一次的二肽基肽酶IV（DPP-4）抑制剂，通过选择性、持续性抑制DPP-4，控制血糖水平。 DPP-4是一种酶，能够引发肠促胰岛素（胰高血糖素样肽-1（GLP-1）和葡萄糖依赖性促胰岛素多肽（GIP）的失活，而这2种肠降胰岛素在血糖调节中发挥着重要作用。抑制DPP-4，能够增加血糖水平依赖性胰岛素分泌，从而控制血糖水平。 Trelagliptin NDA的提交，是基于在日本2型糖尿病患者中开展的数个III期临床试验的疗效和安全性数据。trelagliptin的疗效在所有试验中均得到了证实，同时具有良好的安全性和耐受性。trelagliptin每周给药1次便可有效控制血糖水平，有望改善患者的用药依从性。 据了解，DPP-4抑制剂是首类可通过提高机体自身能力控制血糖水平的新型2型糖尿病药物，可用作单药，也可与其它口服降糖药联用。其作用机制独特，具有不产生低血糖、不引起体重增加，以及副作用小等独特优势，引起胃肠道不良反应的发生率亦很低。 http://www.takeda.co.jp/news/2015/20150326_6951.html http://www.amstock.com/proxyservices/Files/AR26348.pdf https://www.takeda.com/investor-information/annual/files/ar2013_10_en.pdf