AMAG Pharmaceuticals Announces U.S. Launch Of Feraheme ™ (ferumoxytol) Injection

Main Category: Urology / Nephrology
Article Date: 14 Jul 2009 - 6:00 PDT

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AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced that Feraheme ™ (ferumoxytol) Injection is now available for commercial sale in the United States. Feraheme is an intravenous (IV) iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme can provide patients with a 1 gram therapeutic course of iron in two 510 mg IV injections administered as quickly as 17 seconds each, within one week. Feraheme was approved by the U.S. Food and Drug Administration on June 30, 2009. The Company will be marketing and selling Feraheme in the U.S. through its commercial organization consisting of approximately 150 seasoned professionals, including an 80-person specialized sales force, an experienced account management and reimbursement team, and a contract nurse team. The wholesale acquisition cost (WAC) of Feraheme is $396.78 per 510 mg vial.

Feraheme is being distributed through wholesalers and specialty distributors. For more information please visit the Company's product web site at www.Feraheme .com.

Important Safety Information

Feraheme 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 studies, hypotension was reported in 1.9% (33/1,726) of subjects receiving Feraheme , including three patients with serious hypotensive reactions. Serious hypersensitivity reactions were reported in 0.2% (3/1726) patients. Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection and the drug should only be administered when treatment of hypersensitivity reactions is readily available. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging but will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging. In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients were diarrhea, nausea, dizziness, hypotension, constipation and peripheral edema.

Source
AMAG Pharmaceuticals, Inc.

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