AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today 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.
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes
its proprietary technology for the development and commercialization of
a therapeutic iron compound to treat iron deficiency anemia and novel
imaging agents to aid in the diagnosis of cancer and cardiovascular
disease. AMAG recently received approval from the U.S. Food and Drug
Administration to market Feraheme for the treatment of iron deficiency
anemia in chronic kidney disease patients. For additional company and
product information please visit www.amagpharma.com.
Feraheme™ is a trademark of AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc.
Kristen Galfetti, 617-498-3362
