英文药名：AGRYLIN Capsules(Anagrelide Hydrochloride Hydrate) 中文药名：安归宁（盐酸阿那格雷胶囊） 生产厂家：希雷日本有限公司 アグリリンカプセル0.5mg 治疗类别名称 原发性血小板增多症治疗剂 批准日期：2014年11月 商標名 AGRYLIN Capsules 0.5mg 一般名 アナグレリド塩酸塩水和物 （Anagrelide Hydrochloride Hydrate） 化学名 6,7-Dichloro-1,5-dihydroimidazo［2,1-b］quinazolin-2（3H）-one monohydrochloride monohydrate. 分子式 C10H7Cl2N3O・HCl・H2O 分子量 310.56 構造式 外観 白色结晶性粉末 可溶性 几乎不溶于水 微溶于二甲亚砜 微溶于二甲基甲酰胺 条件批准 由于在日本试验病人是非常有限的，上市后，直至有关一定数量的病例数据集成，通过实现对一切案件的使用，结果调查显示，该药物这使得能够早期识别患者的背景信息，数据收集这些药物的安全性和有效性，采取必要的措施在正确使用这种药物。 药效药理 明确的目标分子的阿那格雷是未知的，通过抑制巨核细胞的形成和成熟，以产生血小板，它会降低血小板的数量。 适应病症 原发性血小板增多症 用法与用量 成人，每日口服二次，每次0.5mg开始。此外，根据由0.5mg的作为在一周或更长的时间间隔的每日剂量进行的患者的病情，体重增益进行调节，在不超过一天4次的范围内划分的口服给药。然而，不超过10毫克的为2.5mg和每日剂量单次剂量。 包装规格 胶囊 0.5毫克：10粒胶囊/ 1片（PTP） 1盒100封装（10个胶囊×10张） 制造厂商 希雷日本有限公司 完整资料附件：http://www.info.pmda.go.jp/go/pack/4299003M1020_1_03/ Essential thrombocythemia treatment agent "Agrillin (R) capsule 0.5 mg" Shire Japan Co., Ltd. (Headquarters: Shinjuku-ku, Tokyo, President: Glenn Snohara) announced today that it has entered into a definitive agreement with Agriirin (R) capsule 0.5 mg (generic name: Anagrelide hydrochloride hydrate capsule ) On November 25 today, we will inform you. Essential thrombocythemia is a disease that produces platelets more than necessary due to abnormal hematopoietic stem cells in the body, and the number of patients in the country is estimated to be about 30,000 rare diseases. It may cause thrombotic symptoms such as stroke and myocardial infarction, hemorrhagic symptoms such as gastrointestinal bleeding and hematuria, which may progress to myelofibrosis and acute leukemia. Cell depletion therapy such as antitumor drugs has been done so far, but there are patients who can not be treated with existing methods, and new treatment options were required. The agriirin capsule 0.5 mg released this time suppress platelet production by selectively acting on megakaryocytes which are platelet precursor cells. From this, we can expect long-term thrombocytopenia for essential thrombocythemia. Moreover, it is widely applied not only to patients newly diagnosed as essential thrombocythemia but also to patients who are ineffective or intolerable by existing treatments and are expected to be able to meet unmet medical needs Yes. In Japan Phase III clinical trial, it showed an excellent thrombocytopenic effect for high-risk patients who were ineffective or intolerable with other drugs. Also, in overseas Phase IIIb clinical trials, the new high-risk patients have a platelet reducing effect equivalent to that of hydroxycarbamide. Professor Kimurakura of Osaka University Graduate School of Medicine Graduate School of Medicine, Professor Kanakura, professor of blood and tumor internal science, said, "Anagrelide is a novel therapeutic agent for essential thrombocythemia with a selective mechanism of action on platelets Anticancer Because it is different from the agent, long-term tolerance can be expected.We welcome the birth of new options for patients with essential thrombocythemia. " In addition, Glenn Snohara, president and CEO of Shire Japan KK, said, "Agrillin is a new drug that can meet the expectation of patients of a wide range of age, we will continue to innovate to realize our mission of meeting unmet/medical needs We will strive for the introduction of medicinal products. " Until now, 0.5 mg of agrillin capsule has been approved in 47 countries abroad including the first US (March 1997) approved, including the European Union (November 2004, sales name Xagrid (R)) It is also approved in the area. In Japan, it was designated as a drug for rare diseases and received a request from the Ministry of Health, Labor and Welfare for development based on the results of "unapproved drugs for high medical necessity/non-indication drug review study meeting", September 2014 We obtained production approval on 26th. Features of Agriirin (R) capsule 0.5 mg - Agrilin inhibits platelet production by selectively acting on megakaryocytes, which are platelet precursor cells. · Inadequate or intolerable effects with other drugs, and excellent long-term thrombocytopenic effect on new high-risk patients. · Because it does not inhibit the synthesis of DNA, mutagenicity /leukemogenicity induction is not recognized. Product overview of Agrillin (R) capsule 0.5 mg Product name: Agrilin capsule 0.5 mg, English notation: AGRYLIN Capsules 0.5 mg Common name: anagrelide hydrochloride hydrate capsule Dosage form: hard capsule Efficacy/efficacy: essential thrombocythemia Dosage: Capacity: As an adult, anagrelide usually starts with 0.5 mg once daily orally. Incidentally, depending on the condition of the patient, increase and decrease may be appropriately made, but incremental dosage should be administered at 0.5 mg/day as a daily dose at intervals of 1 week or more, divided or divided in a range not exceeding 4 times a day and administered orally. However, it should not exceed 2.5 mg as a single dose and 10 mg as a daily dose. Manufacture and market approval date: September 26, 2014 Drug price criterion Listing date: November 25, 2014 Release date: November 25, 2014 Manufacturer Distributor: Shire Japan KK About domestic Phase III clinical trial The safety and efficacy of 0.5 mg of agrilin capsule for essential thrombocythemia has been confirmed in Phase III clinical trials in Japan (SPD 422 - 308). In this study, the risk factors of refractory or intolerance to existing cell depletion therapy (hydroxycarbamide) and thrombotic hemorrhagic event (platelet count greater than 1 million/μL, over 60 years old, or past history of thrombotic bleeding event) This study was conducted on patients with high-risk essential thrombocythemia who had the thrombocytopenic effect and evaluated for thrombocytopenic effect. As a result, 67.9% of all patients satisfied the platelet count reaction criteria (less than 600,000 /μL, lasting more than 4 weeks after 3 months from the start of administration). About overseas Phase IIIb clinical trial The effectiveness and safety of 0.5 mg of agrilin capsule and hydroxycarbamide were compared and evaluated in overseas Phase III b test (SPD 422 - 403). Registered patients are randomly assigned to this drug 0.5 mg · twice daily or hydroxycarbamide 500 mg · twice daily, and the number of platelets is less than 600,000/μL, preferably 150,000 to 400,000/μL In order to maintain that level, dosage was adjusted while adjusting the dose for each patient. As a result, the control rate for platelet count less than 400,000/μL was 56.8% in this product group and 55.9% in hydroxycarbamide group. In addition, the control rate to platelet count less than 600,000/μL was 77.0% in this product group and 83.8% in hydroxycarbamide group. About side effects Major side effects of administration of 0.5 mg of agrilin capsule include anemia, headache, palpitations, diarrhea, peripheral edema, etc. are reported. Reference material 1. Orphanet Report Series. Prevalence of rare disease, November 2013, No. 1 2. Brière JB. Orphanet J Rare Dis 2007; 2: 3 3. Shire-Japan Co., Ltd. "Agrillin capsule 0.5 mg" attached document 4. Int J Hematol (2014) 100: 353-360