AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a biopharmaceutical company
focused on the development and commercialization of a therapeutic iron
compound to treat anemia and novel imaging agents to aid in the
diagnosis of cancer and cardiovascular disease, today provided a safety
update on Feraheme® (ferumoxytol) Injection for intravenous use.
Since the commercial launch of Feraheme in July 2009, serious
adverse events have been reported at a rate consistent with that
contained in the U.S. package insert. Of the estimated 35,000 patient
exposures to date, 40 serious adverse events have been reported, an
approximate rate of 0.1 percent. No mortality signal has been observed.
A single reported death occurred in a patient two days post-Feraheme
treatment, which the Company does not believe was the result of Feraheme.
Important Safety Information about Feraheme
Feraheme is indicated for the treatment of iron deficiency anemia
in adult patients with chronic kidney disease. 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) of 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 for
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.
AMAG Pharmaceuticals, Inc.