Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 10903, USA.
Am J Hematol. 2010 May;85(5):315-9. doi: 10.1002/ajh.21656.
On June 30, 2009, the United States Food and Drug Administration (FDA) approved ferumoxytol (Feraheme injection, AMAG Pharmaceuticals), an iron-containing product for intravenous (IV) administration, for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). The safety and efficacy of ferumoxytol were assessed in three randomized, open-label, controlled clinical trials. Two trials evaluated patients with nondialysis dependent CKD and a third trial assessed patients undergoing hemodialysis. Randomization was either to ferumoxytol or oral iron. Ferumoxytol was administered as two 510 mg IV injections, separated by 3-8 days. Oral iron, Ferro-Sequels, was administered at a dose of 100 mg twice daily for 21 days. In all three clinical trials, ferumoxytol administration increased the mean blood hemoglobin (Hgb) concentrations by approximately 1.0 g/dL over the 35 day period, a mean increase that was greater than what was observed in patients receiving oral iron. Patients receiving ferumoxytol also had increases in blood transferrin saturation (TSAT) and ferritin values. For the proposed ferumoxytol dosing regimen, 4.9% of patients had serum ferritin >or=800 ng/mL and TSAT >or=50% post-treatment. The most important ferumoxytol safety concerns were hypersensitivity reactions and/or hypotension. Anaphylaxis or anaphylactoid reactions were reported in 0.2% of subjects, and other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria, or wheezing) were reported in 3.7%. Hypotension was observed in 1.9%, including three patients with serious hypotensive reactions. Ferumoxytol administration may transiently affect the diagnostic ability of magnetic resonance imaging and the drug label provides further information regarding this effect.
2009 年 6 月 30 日，美国食品和药物管理局（FDA）批准了 ferumoxytol（Feraheme 注射液，AMAG 制药公司），一种用于静脉内（IV）给药的含铁产品，用于治疗慢性肾脏病（CKD）成人患者的缺铁性贫血。在三项随机、开放标签、对照临床试验中评估了 ferumoxytol 的安全性和疗效。两项试验评估了非透析依赖 CKD 患者，第三项试验评估了接受血液透析的患者。随机分组为 ferumoxytol 或口服铁剂。ferumoxytol 给予两次 510mg IV 注射，间隔 3-8 天。口服铁剂，Ferro-Sequels，每天两次给予 100mg，共 21 天。在所有三项临床试验中，ferumoxytol 给药使平均血液血红蛋白（Hgb）浓度在 35 天内升高约 1.0g/dL，高于接受口服铁剂的患者观察到的升高。接受 ferumoxytol 治疗的患者的血液转铁蛋白饱和度（TSAT）和铁蛋白值也有所增加。对于提议的 ferumoxytol 给药方案，4.9%的患者在治疗后血清铁蛋白≥800ng/ml 和 TSAT≥50%。最重要的 ferumoxytol 安全性问题是过敏反应和/或低血压。0.2%的受试者报告了过敏反应或类过敏反应，其他与过敏相关的不良反应（如瘙痒、皮疹、荨麻疹或喘息）报告了 3.7%。观察到低血压为 1.9%，包括 3 例严重低血压反应的患者。ferumoxytol 给药可能会暂时影响磁共振成像的诊断能力，药物标签提供了关于这种影响的进一步信息。
