近日，FDA批准补铁创新药物Accrufer(ferric maltol)上市，用于治疗成年人缺铁症在。Accrufer的活性成分是麦芽酚铁（ferric maltol），一种非铁盐，稳定的新型化合物。Accrufer具有不同的吸收机制，其含有的铁元素可以被肠道细胞吸收并且仅吸收所需要的铁量。对于对基于铁盐的补铁药物不耐受的患者，Accrufer是理想的替代疗法。
批准日期：2019年7月25日 公司：Shield Therapeutics plc
ACCRUFER（铁麦芽酚[ferric maltol]）胶囊，用于口服
美国最初批准：2019年
作用机制
ACCRUFER提供铁用于穿过肠壁摄取并转移至转铁蛋白和铁蛋白。
适应症和用法
ACCRUFER是用于治疗的铁替代产品
成人缺铁症
剂量和给药
•空腹每日两次，每次30毫克
•根据需要继续补充身体铁储备
剂量形式和强度
胶囊：30mg
禁忌症
•对活性物质或任何赋形剂过敏
•血色素沉着症和其他铁超负荷综合征
•接受反复输血的患者
警告和注意事项
•IBD眩光：避免用于IBD眩光患者
•铁过载：意外过量的铁制品是导致6岁以下儿童致命中毒的主要原因。儿童无法接触。
不良反应
最常见的不良反应（发生率> 1％）是胃肠胀气，腹泻，便秘，粪便变色，腹痛，恶心，呕吐和腹部不适/腹胀。
要报告疑似不良反应，请通过[免费电话]或FDA 1-800-FDA-1088或www.fda.gov/medwatch联系[制造商名称]。
药物相互作用
•Dimercaprol：避免同时使用。
•口服药物：ACCRUFER与某些口服药物分开给药。适当监测临床反应。
包装提供/存储和处理
如何提供
ACCRUFER（铁麦芽糖醇）30毫克铁胶囊以高密度聚乙烯瓶装56粒胶囊，带有防静电聚丙烯推扣。
1瓶56计数30mg三价铁胶囊（NDC 73059-001-56）。
存储和处理
储存在20°C至25°C（68°F至77°F）; 允许偏移15°C至30°C（59°F至86°F）[见USP控制的室温]。
FDA Approves Accrufer (ferric maltol) for the Treatment of Iron Deficiency in Adults
U.S. Food and Drug Administration (FDA) has approved its lead product Accrufer(Feraccru® in the European Union and Switzerland) for the treatment of iron deficiency in adults.
About Accrufer
Accrufer(Feraccru) is a novel, stable, non-salt based oral treatment for adults with iron deficiency with or that has been shown to be an efficacious and well-tolerated therapy in a range of controlled phase 3 trials. Following the recently announced positive results of the Phase IIIb AEGIS-H2H study in which Feraccru® demonstrated it was non-inferior to intravenously-administered Ferinject® at delivering improvements in haemoglobin levels without requiring hospital-based administration, Feraccru®/Accrufer® offers a compelling alternative to IV Iron for those patients that cannot tolerate salt-based oral iron therapies and wish to avoid the complexities of infusion-based therapies.
When salt-based oral iron therapies are ingested they can cause a range of mild-to-severe gastrointestinal tract(GI) adverse events, including nausea, bloating and constipation. These lead to poor tolerability, reduced patient compliance and ultimately treatment failure. Feraccru®/ Accrufer® is not an iron salt; iron can be absorbed from the ferric maltol molecule and, as a result, it does not routinely cause the same treatment-limiting intolerance issues.
Prior to Feraccru®/ Accrufer®, IV iron therapies were the only realistic alternative treatment option for patients intolerant of or unwilling to take salt-based oral iron therapies. However, use of such an invasive, costly, inconvenient and complex to administer treatment option, which is associated with potentially life-threatening and spontaneous hypersensitivity reactions, means there remains a clear unmet medical need for patients with iron deficiency to have access to an effective therapy like Feraccru®/ Accrufer® that is well tolerated, convenient and does not require hospital-based administration.
About Iron Deficiency
The WHO state that iron deficiency is the most common and widespread nutritional disorder in the world. As well as affecting a large number of children and women in non-industrialized countries, it is the only nutrient deficiency which is also significantly preva lent in virtually all industrialized nations. There are no current global figures for iron deficiency, but using anaemia as an indirect indicator it can be estimated that most preschool children and pregnant women in non-industrialized countries, and at least 30-40% in industrialized countries, are iron deficient.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212320Orig1s000lbl.pdf