AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that several Feraheme® (ferumoxytol) Injection for intravenous (IV) use abstracts have been accepted for presentation at the American Society of Nephrology (ASN) Renal Week meeting being held November 16 - 21, 2010 in Denver, CO, including two AMAG-authored abstracts:
- "Decreased Epoetin Utilization Associated with Conversion to Ferumoxytol IV Iron Protocol" (Sharma et al.) – Poster Board #F-PO1523, 10:00am-2:30pm Friday, Nov. 19, 2010
- "Increased Ferumoxytol Utilization Associated with Decreased Total Anemia Treatment Utilization" (Sharma et al.) – Poster Board #F-PO1524, 10:00am-2:30pm Friday, Nov. 19, 2010
Full abstracts can now be viewed on the ASN website at www.asn-online.org.
Important Safety Information about Feraheme
Indication and contraindications
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.
Warnings and precautions
In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects. 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 personnel and therapies are readily available for the treatment of hypersensitivity reactions. 1.9% (33/1,726) of Feraheme-treated subjects experienced hypotension. Please monitor for signs and symptoms of hypotension following each Feraheme injection. 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, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.
Adverse reactions
In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in ≥2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), 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 (2.0% vs. 3.2%). In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme-treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.
Please see full prescribing information for Feraheme at http://www.amagpharma.com/documents/feraheme-productinsert.pdf.
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. For additional company information, please visit www.amagpharma.com.
Feraheme is a registered trademark of AMAG Pharmaceuticals, Inc.
Contacts:
AMAG Pharmaceuticals, Inc.
Carol Miceli, 617-498-3361
