近日，美国食品和药品监督管理局（FDA）批准Injectafer，用于治疗缺铁性贫血（IDA）成年患者。Injectafer是第一个获得FDA批准用于治疗IDA的非右旋糖酐静脉铁剂，无论IDA患者的基础病因是什么，均可使用。Injectafer也可以用于治疗非透析依赖的慢性肾脏病（ND-CKD）成年患者的缺铁性贫血。
批准日期：2013年7月30日，公司：AMERICAN REGENT INC
INJECTAFER(羧甲麦芽糖[ferric carboxymaltose])注射液，静脉注射用
首次美国批准：2013
作用机理
羧基麦芽糖铁是一种胶体铁（III）氢氧化物与羧基麦芽糖，一种碳水化合物聚合物释放铁。
适应症及用法
注射剂是治疗缺铁的铁替代产品。
成人贫血：
·对口服铁不耐受或对口服铁有不良反应；
•谁有非透析依赖性慢性肾脏疾病。
剂量与给药
对于体重50公斤（110磅）或以上的患者：给予两种剂量的注射剂
至少7天。每次剂量为750mg，总累积剂量为1500毫克。
当然是铁。
对于体重小于50公斤（110磅）的患者，分两次注射。
每次至少7天，每次给药量为15mg/kg体重。
如果缺铁性贫血再次发生，可反复注射治疗。
剂型和强度
注射：750mg铁/15L单剂量小瓶。
禁忌症
对注射剂或其任何非活性成分过敏。
警告和注意事项
过敏反应：观察超敏反应的症状和体征
在Injectafer政府期间和之后至少30分钟，直到临床稳定的每个管理完成。
高血压：密切监测患者的高血压症状和体征每次注射后给药。
不良反应
最常见的不良反应（2%）是恶心、高血压、冲洗。
低磷血症和头晕。
在特定人群中的使用
哺乳期：监测母乳喂养的婴儿胃肠毒性。
包装供应/储存和搬运
NDC 0517-0650-01 750毫克铁/15毫升单剂量瓶单独装箱
NDC 0517-0650-02 750毫克铁/15毫升单剂量小瓶包装
储存在20°C到25°C（68°F到77°F）；准许漂移到15°C到30°C。（59°F至86°F）。（参见USP控制的室温）。不要冻僵。
完整资料附件：
1）：https://injectafer.com/iron-infusion-center#isi-container
2）：https://injectafer.com/prescribing-information-portlet/getDocument?product=IF&inline=true
Injectafer(ferric carboxymaltose injection)
IMPORTANT SAFETY INFORMATION
INDICATIONS/CONTRAINDICATIONS
Injectafer® (ferric carboxymaltose injection) is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, and in adult patients with non-dialysis dependent chronic kidney disease. Injectafer® is contraindicated in patients with hypersensitivity to Injectafer® or any of its inactive components.
WARNINGS AND PRECAUTIONS
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Injectafer®. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Injectafer® administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Injectafer® when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. In clinical trials, serious anaphylactic/anaphylactoid reactions were reported in 0.1% (2/1775) of subjects receiving Injectafer®. Other serious or severe adverse reactions potentially associated with hypersensitivity which included, but were not limited to, pruritus, rash, urticaria, wheezing, or hypotension were reported in 1.5% (26/1775) of these subjects.
In clinical studies, hypertension was reported in 3.8% (67/1775) of subjects. Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed in 6% (106/1775) of subjects. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Injectafer® administration.
In the 24 hours following administration of Injectafer®, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Injectafer®.
ADVERSE REACTIONS
In two randomized clinical studies, a total of 1775 patients were exposed to Injectafer®, 15 mg/kg of body weight, up to a single maximum dose of 750 mg of iron on two occasions, separated by at least 7 days, up to a cumulative dose of 1500 mg of iron. Adverse reactions reported by ≥2% of Injectafer®-treated patients were nausea (7.2%); hypertension (3.8%); flushing/hot flush (3.6%); blood phosphorus decrease (2.1%); and dizziness (2.0%).
The following serious adverse reactions have been most commonly reported from the post-marketing spontaneous reports: urticaria, dyspnea, pruritus, tachycardia, erythema, pyrexia, chest discomfort, chills, angioedema, back pain, arthralgia, and syncope.