By Yael Waknine
Medscape Medical News


July 2, 2009 — On June 30, the US Food and Drug Administration approved ferumoxytol injection (Feraheme, AMAG Pharmaceuticals, Inc) for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.

The injection is expected to be available during the second half of July 2009 and will be marketed in 17-mL single-use vials containing 510 mg of elemental iron. An initial 510-mg intravenous injection, delivered at a rate of up to 1 mL/second (30 mg/second), should be followed by a second 510-mg dose given 3 to 8 days later. Additional 510-mg doses may be administered to patients with persistent or recurrent iron deficiency anemia.

FDA approval of the product was based on data from 3 randomized, open-label controlled clinical trials (n = 1726) that also included an uncontrolled, follow-up phase in which patients with persistent anemia could receive 2 additional doses.

Results showed that ferumoxytol yielded significantly greater mean increases in hemoglobin levels from baseline at day 35 compared with oral iron (ferrous fumarate, 200 mg elemental iron/day) in patients with all stages of chronic kidney disease.

"[The drug] offers patients across the continuum of chronic kidney disease, including patients not on dialysis and patients on dialysis, a new paradigm for the treatment of iron deficiency anemia," commented Brian J.G. Pereira, MD, president and chief executive officer of AMAG Pharmaceuticals, in a company news release.

The most common adverse reactions (incidence ? 2%) reported in clinical trial patients receiving ferumoxytol included diarrhea (4.0% vs 8.2% for iron tablets), nausea (3.1% vs 7.5%), dizziness (2.6% vs 1.8%), hypotension (2.5% vs 0.4%), constipation (2.1% vs 5.7%), and peripheral edema (2.0% vs 3.2%).

Because of the potential for hypersensitivity reactions and hypotension, patients should be observed for at least 30 minutes after each dose. To avoid iron overload and the potential for iatrogenic hemosiderosis, patients should be regularly monitored for hematologic response, with the caveat that serum and transferrin-bound iron values may be overestimated by laboratory assays performed during the first 24 hours.

As a superparamagnetic iron oxide, ferumoxytol can alter magnetic resonance imaging studies for up to 3 months after the last dose. X-ray, computed tomography, positron emission tomography, single photon emission computed tomography, ultrasound, and nuclear imaging are not affected.

According to the news release, the company will fulfill requirements of the Pediatric Research Equity Act by conducting 2 postmarketing studies of ferumoxytol in pediatric patients with chronic kidney disease both requiring and not requiring dialysis. About 150 patients will be enrolled in the studies, which are slated to begin in 2010.

The company notes on its Web site that ferumoxytol is currently being developed to treat iron deficiency anemia in women with abnormal uterine bleeding and in patients with cancer and gastrointestinal diseases. Because of its potential to improve the visualization of blood vessels, ferumoxytol may also be useful as a diagnostic agent for vascular-enhanced magnetic resonance imaging to assess peripheral arterial disease.


July 2, 2009 — 美國食品藥物管理局(FDA)於6月20日核准ferumoxytol注射劑(Feraheme,AMAG藥廠)用於治療成人慢性腎臟疾病患者的缺鐵性貧血。
  該注射劑預計於2009年7月下旬上市,上市的產品為17 ml的單次使用劑型,內含510 mg的元素鐵。起始使用510 mg的注射劑,以1 ml/sec的速度注射(30 mg/sec),接著在3~8天後注射第二次510 mg的劑量。若病患持續性貧血、或貧血再發可以接受額外的510 mg劑量注射。
  結果顯示,相較於口服鐵劑,ferumoxytol在注射後35天時可以顯著增加所有期別慢性腎臟疾病患者血紅素平均值(ferrous fumarate,每天200 mg元素鐵)。
  AMAG藥廠的總裁與總經理Brian J.G. Pereira醫師評論,這個藥物提供不同期別慢性腎臟疾病患者,包括未接受透析或正在接受透析患者,一個治療缺鐵性貧血的新選擇。




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