AMAG Pharmaceuticals, of Lexington, Mass., has received marketing clearance for Feraheme (ferumoxytol) Injection as a treatment for iron deficiency anemia in adult CKD patients.

“Feraheme 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,” said Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG.

Bryan Becker, MD, President of the National Kidney Foundation, said: “We welcome the availability of a new therapy option for chronic kidney disease patients affected by iron deficiency anemia.”

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The recommended dose of the drug is an initial 510-mg IV injection followed by a second 510-mg IV injection three to eight days later, according to an AMAG press release. Feraheme should be administered as an undiluted IV injection delivered at a rate of up to 1 mL/sec.

The drug is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.

In clinical trials, Feraheme significantly increased hemoglobin levels compared with oral iron across the spectrum of CKD. The most frequent adverse events were diarrhea (4% of Feraheme-treated patients compared with 8.2% of patients treated with oral iron), 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% vs. 3.2%).