AMAG Pharmaceuticals Announces Update to Feraheme® Label
Press Release Source: AMAG Pharmaceuticals, Inc. On Tuesday June 21, 2011, 5:05 pm EDT
LEXINGTON, Mass.--(BUSINESS WIRE)-- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG - News) today announced that the company has updated the product label for Feraheme® (ferumoxytol) Injection for Intravenous (IV) use. This update is based on the U.S. Food and Drug Administration’s approval of the company’s Label Supplement submission, which included additional post-marketing safety data. Feraheme is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients.
The updated product label, also called a package insert includes, among other things:
Modifications to the Contraindications section removing “evidence of iron overload” and “anemia not caused by iron deficiency.”
Modifications to the Hypersensitivity Reactions language of the Warnings and Precautions section to include:
The following revised text: “serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme,” and
A decrease in the observation period to monitor patients for signs and symptoms of hypersensitivity during and following Feraheme administration from 60 minutes to 30 minutes.
“We are pleased that the post-marketing safety data support reverting back to a 30-minute monitoring period following Feraheme administration,” commented Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG Pharmaceuticals, Inc. “The dosing schedule of Feraheme allows for a full course of IV iron to be delivered in two doses, just three to eight days apart. This dosing schedule, combined with the revised observation period, supports the differentiation of Feraheme in the marketplace.”
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia. For additional company information, please visit www.amagpharma.com.
About Feraheme
In the United States, Feraheme® (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the U.S. Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter. For additional product information, please visit www.feraheme.com.
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 known hypersensitivity to Feraheme or any of its components.
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