FERAHEME（Ferumoxytol）
制造商：
AMAG制药公司

药理分类：
补血药

活性成分（补）：
元素铁浓度30mg/ml（如ferumoxytol 510mg/17mL），为四胶体铁损伤;含有甘露醇44mg/mL;不含防腐剂。

指示（补）：
铁缺乏症在成人患者与慢性肾脏病（CKD）。

药理作用：
Feraheme是铁（超顺磁性氧化铁与polyglucose山梨醇carboxymethylether涂层）是与甘露醇制定胶体形态。碳水化合物有助于隔离涂层的生物活性铁，直到铁进入复杂碳水化合物在肝脏，脾脏网状内皮系统的巨噬细胞和骨髓。从复杂的后释放，铁进入细胞内铁的储存池（如铁），或者是运输转移到红细胞的血红蛋白等离子掺入前体细胞转。

Feraheme不透析。

临床试验：
三个随机，开放标签进行了对照临床试验，以评估对缺铁性贫血对慢性肾脏疾病患者治疗的安全性和偶发的Feraheme疗效。患者被随机分为口服铁剂治疗（富马酸亚铁200毫克铁/天，每天21）或Feraheme（二510mg注射）。试验1和2不登记的慢性肾病患者透析，登记和审判3血液透析的慢性肾病患者。在这三个试验中的血红蛋白从基线（克/分升），以35天的变化分别为1.2，0.8，基于研究药物组和1.0，0.5，0.2，及口服铁剂治疗组0.5。转铁蛋白饱和度和测量也显示，相对于口服铁剂治疗组的Feraheme有改善。这些试验还包括选修失控，后续阶段中，患者持续性缺铁性贫血是由于另外两个Feraheme 510mg注射。总体而言，这些患者（70％）均经历了血红蛋白，转铁蛋白饱和度和进一步增加。血红蛋白中的血红素上升与复治的病人基线水平的平均改变为0.86g/dL，并负责所有患者0.5g/dL。

法律分类：
接收

成人：
给在静脉注射稀释率高达1mL/sec（30mg/sec）。最初510mg，那么额外的剂量3-8天以后。可重复持续性或复发性缺铁性贫血。血液透析：血液透析开始后给血压稳定后至少1小时。

儿童：
不推荐。

禁忌（补）：
铁超载。贫血不是由于缺铁。

警告/注意事项：
监控低血压，以及过敏至少30分钟，注射后。评价血红蛋白，铁蛋白，铁，转饱和至少1个月后注射第二。有设备/人员可用于治疗过敏反应。妊娠（Cat.C）。哺乳母亲：不推荐。

互动（补）：
可瞬时（最多3个月）影响磁共振成像（见文献）的诊断能力。

不良反应（补）：
腹泻，恶心，低血压，头晕，便秘，周围水肿，输液反应，过敏反应（如皮疹，瘙痒，荨麻疹，喘息）。

如何提供：
一次性使用瓶（17mL）-1，10

Feraheme available for the treatment of iron deficiency anemia
Feraheme (ferumoxytol injection), an intravenous iron replacement therapy, has been made available by AMAG Pharmaceuticals for the treatment of iron deficiency anemia in adults with chronic kidney disease (CKD).

Feraheme is available in 17mL vials containing 510mg of ferumoxytol.

FERAHEME

Indication(s):

Iron deficiency anemia in adult patients with chronic kidney disease (CKD).

Pharmacology:

Feraheme is a colloidal form of iron (superparamagnetic iron oxide coated with polyglucose sorbitol carboxymethylether) that is formulated with mannitol. The carbohydrate coating helps isolate the bioactive iron until the iron-carbohydrate complex enters the reticuloendothelial system macrophages in the liver, spleen, and bone marrow. After its release from the complex, the iron enters the intracellular iron storage pool (eg, ferritin), or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into hemoglobin.

Feraheme is not dialyzed.

Clinical Trials:

Three randomized, open-label controlled clinical trials were conducted to assess the safety and efficacy of Feraheme for the episodic treatment of iron deficiency anemia in patients with chronic kidney disease. Patients were randomized to either oral iron therapy (ferrous fumarate 200mg iron/day for 21 days) or Feraheme (two 510mg injections). Trials 1 and 2 enrolled patients with CKD not on dialysis, and Trial 3 enrolled patients with CKD on hemodialysis. The changes in hemoglobin (g/dL) from baseline to day 35 in the three trials were 1.2, 0.8, and 1.0 for groups given the study drug, and 0.5, 0.2, and 0.5 for the oral iron therapy groups. Transferrin saturation and ferritin measurements also showed improvement for the Feraheme groups compared to the oral iron therapy groups. These trials also included an elective uncontrolled, follow-up phase in which patients with persistent iron deficiency anemia were given two additional 510mg injections of Feraheme. Overall, the majority of these patients (70%) experienced a further increase in hemoglobin, transferrin saturation and ferritin. The mean change in hemoglobin level from the retreatment baseline for patients with an increase in hemoglobin was 0.86g/dL and was 0.5g/dL for all patients.

Legal Classification:

Rx

Adults:

Give undiluted by IV injection at a rate up to 1mL/sec (30mg/sec). Initially 510mg, then an additional dose 3–8 days later. May repeat in persistent or recurrent iron deficiency anemia. Hemodialysis: give at least 1 hour after starting hemodialysis and after BP is stable.

Children:

Not recommended.

Contraindication(s):

Iron overload. Anemia not due to iron deficiency.

Warnings/Precautions:

Monitor for hypotension, and for hypersensitivity for at least 30 minutes, after injection. Evaluate hemoglobin, ferritin, iron, transferrin saturation at least 1 month after 2^nd injection. Have equipment/personnel available to treat hypersensitivity reactions. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interaction(s):

May transiently (up to 3 months) affect diagnostic ability of MRI (see literature).

Adverse Reaction(s):

Diarrhea, nausea, hypotension, dizziness, constipation, peripheral edema; infusion reactions, hypersensitivity reactions (eg, rash, pruritus, urticaria, wheeze).

How Supplied:

Single-use vials (17mL)—1, 10

Last Updated:

8/6/2009