Anemia in the News
New Intravenous Iron Therapy, Ferumoxytol, Approved by FDA
Iron injections are generally given to patients with a severe iron deficiency or those receiving erythropoiesis-stimulating agents (ESAs), but only a doctor can determine if they are right for you. To help patients prepare for this discussion, this article includes information about iron injections and treating iron deficiency and anemia.
Are Iron Injections Right for You?
The Food and Drug Administration (FDA) approved the market release of ferumoxytol, an intravenous iron therapy to treat iron deficiency in adult patients with chronic kidney disease (CKD) either on or off dialysis.
Approval of the drug has come following four Phase III studies involving a total of 1,726 CKD patients with iron deficiency. Each safety and efficacy study found intravenous iron therapy with ferumoxytol resulted in mean hemoglobin change from baseline to day 35 and demonstrated a statistically significant hemoglobin increase over oral iron therapy. Side effects experienced are similar to those in with other iron injections, including diarrhea, nausea, dizziness, hypotension, constipation and peripheral edema.
Unlike current intravenous iron preparations, ferumoxytol differs in that it can be administered to patients more quickly. A 510 mg undiluted dose of ferumoxytol can be delivered at a rate up to 1 mL/sec (30 mg/sec).
Ferumoxytol will be marketed under the name Feraheme™ by AMAG Pharmaceuticals with distribution beginning in the second half of July 2009. For more information about ferumoxytol, view the full prescribing information and the original press release available on the manufacturer’s website.
Last Updated: August 25, 2009
Last Updated: October 17, 2008
