These data were presented in a poster session on Sunday, December 9, 2012 at the ASH annual meeting.
One Gram Total Dose Infusion Study
Dr. Michael Auerbach, Clinical Professor at Georgetown University Medical Center, presented new data at ASH from an exploratory study that evaluated the safety and efficacy of the administration of a full one gram dose of ferumoxytol as a single 15-minute infusion (the approved ferumoxytol dosing regimen is two 510 mg injections three to eight days apart). In this investigator-initiated, AMAG-supported study, which was conducted under an investigator-held investigational new drug application (IND), sixty adult subjects with IDA associated with a variety of underlying causes were studied and all received ferumoxytol. After a one-gram infusion of ferumoxytol, an increase of ≥ 2.0 g/dL in hemoglobin was reported in 58% of subjects by week 4 and 86% of subjects by week 8. The mean increase in hemoglobin from baseline was 2.1 g/dL at week 4 and 2.6 g/dL at week 8. Thirteen subjects reported mild, transient, transfusion-associated adverse events, one of which required treatment. Fourteen patients reported mild, self-limited arthralgias, myalgias and/or headache within 24-48 hours after treatment. No serious adverse events were reported in this study.
Dr. Auerbach commented, “Many patients with IDA do not benefit from oral iron therapy and suffer daily from anemia-related side effects. In this study, a full one gram course of ferumoxytol therapy was administered in a 15-minute infusion with no unexpected adverse events. Additionally, clinically meaningful improvements in hemoglobin levels were achieved in a majority of study participants after one 15-minute dose.”These data are being presented in a poster session today at the ASH annual meeting. About AMAG AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company that manufactures and markets Feraheme® (ferumoxytol) Injection for Intravenous (IV) use in the United States. For additional company information, please visit www.amagpharma.com. About Feraheme® (ferumoxytol)/Rienso 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 US Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the US shortly thereafter. Ferumoxytol received marketing approval in Canada in December 2011, where it is marketed by Takeda as Feraheme®, and in the European Union in June 2012 and Switzerland in August 2012, where it is marketed by Takeda as Rienso®. For additional product information, please visit www.feraheme.com. The important safety information below is based on the United States prescribing information.