英文药名：Feraheme(ferumoxytol Injection) 中文药名：纳米氧化铁注射剂 生产厂家：AMAG公司 药品介绍 AMAG制药公司已在美国推出Feraheme (ferumoxytol)静脉注射剂，该药属铁替代疗法，用于治疗慢性肾病患者缺铁性贫血症。今年6月30日，Feraheme刚通过了FDA的批准，AMAG将通过其在美国设立的商业机构销售这种药物。AMAG表明，那些被确诊为体内铁过量、对该药敏感度过高、非铁缺乏导致贫血的患者均不宜使用Feraheme进行治疗。 Feraheme(纳米氧化铁[ferumoxytol])注射，静脉注射用 首次美国批准：2009 近期重大变化 警告和注意事项：11/2010 上市后自发报告的不良反应：11/2010 警告和注意事项：06／2011 作用机理 Feraheme由超顺磁性氧化铁组成，其被覆有碳水化合物外壳，这有助于从血浆成分中分离生物活性铁，直到铁-碳水化合物复合物进入肝脏、脾脏和骨髓的网状内皮系统巨噬细胞。铁从巨噬细胞内的囊泡中的铁-碳水化合物复合体中释放出来。然后铁进入细胞内贮存铁池(例如，铁蛋白)或被转移到血浆转铁蛋白以转运到红系前体细胞以并入血红蛋白。 适应症及用法 Feraheme是一种铁替代品，用于治疗成人慢性肾病（CKD）患者缺铁性贫血。 剂量与给药 推荐的Feraheme剂量是初始510mg静脉注射，然后在3至8天后第二次510mg静脉注射。 以1毫升/秒（30毫克/秒）的速度，将Feraheme作为未稀释的静脉注射给药。 推荐的Feraheme剂量可重新给予持续性或复发性缺铁性贫血患者。 剂型和强度 Feraheme（30毫克/毫升）可用于静脉注射单次瓶。每个小瓶含有17mg的510毫克元素铁。 禁忌症 已知对铁血红素或其任何成分的超敏反应。 警告和注意事项 超敏反应：在Feraheme给药期间和之后至少30分钟观察超敏反应的体征和症状，直到每次给药完成后临床稳定。 低血压：铁血红素可能引起低血压。监测每次给药后低血压的症状和体征。 铁过载：定期监测血友病治疗过程中的血液反应。不要给铁过载患者服用铁氰化物。 磁共振成像：FalaHEME可以改变磁共振成像（MRI）研究。 不良反应 服用Feraheme后最常见的不良反应（≥2%）是腹泻、恶心、头晕、低血压、便秘和外周水肿。 包装供应/储存和搬运 供应 FRAAHEME可在单次使用小瓶在以下包装尺寸（表3）。 表3：铁血红素包装描述NDC代码剂量/总体积每瓶瓶/纸箱 FERAHEME 510 MG VL 17ML FERUMOXYTOL AMAG PHARMACEUTICALS INC. NDC：59338077501 FERAHEME 30MG/ML 17ML SDV 1/EA FERUMOXYTOL AMAG PHARMACEUTICALS.NDC：59338-0775-01 FERAHEME 30MG/ML 17ML SDV 10/PAC FERUMOXYTOL AMAG PHARMACEUTICALS. NDC：59338-0775-10 稳定性与贮存性 在室温（20°至25°C（68°至77°F]）下储存。允许15°至30°C（59°-86°F）的偏移。 FDA Strengthens Warning Label on Feraheme The U.S. Food and Drug Administration (FDA) is strengthening an existing warning on the anemia drug Feraheme (ferumoxytol) to reduce the risk of serious, potentially fatal allergic reactions. According to an FDA Safety Announcement dated March 30th, the agency has approved a boxed warning, which is the most serious type of warning, for the drug. Prescribing instructions have also been changed and a new contraindication has been added. The new warning advises against Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product. The FDA instructs healthcare professionals to follow the new recommendations in the drug label. If patients experience breathing problems, low blood pressure, lightheadedness, dizziness, swelling a rash or itching after Feraheme administration they should seek medical care immediately. Feraheme is a type of IV iron replacement product used to treat iron-deficiency anemia. People with this disorder have abnormally low levels of iron in the blood, resulting in a low number of oxygen-carrying red blood cells. Feraheme was approved in 2009 only for adults with iron deficiency anemia in patients with chronic kidney disease and is administered intravenously. There is a risk of potentially life-threatening allergic reactions with all IV iron products, the FDA notes. Feraheme’s label included this risk when the drug was approved in 2009. The FDA states that “Since then, serious reactions, including deaths, have occurred despite the proper use of therapies to treat these reactions and emergency resuscitation measures”. The FDA had several recommendations for health care professionals, including to only give IV iron products to patients who need it. Feraheme should not be given to patients with a known history of allergies to it or other IV iron products and if administered it should only be as a diluted infusion over a minimum of 15 minutes. Health care professionals should closely monitor signs of a serious allergic reaction and consider the risks versus benefits of the drug for each patient. https://pdf.hres.ca/dpd_pm/00031146.PDF https://www.feraheme.com/clinical-information-and-moa/ida-trials/