LEXINGTON, Mass., Mar 16, 2010 (BUSINESS WIRE) — AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that one
abstract has been accepted for presentation at the National Kidney
Foundation (NKF) 2010 Spring Clinical Meeting being held April 13-17,
2010 in Orlando, FL. The full abstract can now be viewed on the NKF
website at http://www.kidney.org/news/meetings/clinical/index.cfm.
The following abstract will be presented:
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“Aspects of IV Ferumoxytol Administration and Acute Adverse Events in
CKD Patients” (Sharma et al). Poster presentation; 6:00 pm – 7:30 pm,
Wednesday, April 14. Using pooled data from 3 pivotal studies in
patients with iron deficiency anemia and CKD, both on and not on
dialysis, the analyses evaluated the safety of 510 mg ferumoxytol by
injection number and interval between injections. The results of the
analyses support that the safety profile of ferumoxytol is comparable
between first and second administration regardless of the number of
days in between the administrations.
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. On June 30, 2009, AMAG received approval from the U.S. Food and
Drug Administration to market Feraheme(R) (ferumoxytol) Injection for
intravenous (IV) use for the treatment of iron deficiency anemia in
adult chronic kidney disease patients. For additional company and
product information, please visit www.amagpharma.com.
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.
Feraheme is a registered trademark of AMAG Pharmaceuticals, Inc.
SOURCE: AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals
Amy Sullivan, 617-498-3303
or
Carol Miceli, 617-498-3361
