Anaphylaxis with elevated serum tryptase after administration of intravenous ferumoxytol

Abstract

Ferumoxytol is a newly approved preparation of intravenous iron with a modified dextran shell that is thought to confer upon it a low immunogenic potential. Serious adverse reactions have been very uncommon in clinical studies, but these studies excluded patients with prior adverse reactions to other preparations of intravenous iron. Furthermore, the reactions were classified clinically. We report on a patient with a history of hypersensitivity to iron dextran who experienced an anaphylactic reaction after receiving ferumoxytol. Laboratory testing revealed an elevated serum tryptase level, confirming mast cell activation. This is the first laboratory-proven case of anaphylaxis related to ferumoxytol.

Effect of surface charge on the colloidal stability and in vitro uptake of carboxymethyl dextran-coated iron oxide nanoparticles

“…Among these, dextran has been shown to provide the required stability with no reported toxicity index (Ravikumar et al 2012). In fact, dextran-coated iron oxide nanoparticles, marketed as Feridex IV.® and Ferumoxytol, have been approved by the U.S. Food and Drug Administration for use as contrast agents for MRI and iron deficiency anemia, respectively (de Chickera et al 2011; Santosh et al 2010). Carboxymethyl-substituted dextran (CMDx) is an anionic derivative of dextran commonly used as coating material for biosensors in both research and commercial settings due to its high density of carboxymethyl groups available for chemical conjugations (Ning et al 2011).…”

Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency Anemia

“…Feraheme (ferumoxytol) is a recently approved IV iron administered as two injections of 510 mg [2]. Although Feraheme was designed with a modified dextran shell to reduce immunogenic potential, anaphylaxis in individuals with previous hypersensitivity to iron dextran has been reported [12]. Ferric carboxymaltose (FCM), a novel IV iron, is a stable Type I polynuclear iron (III) hydroxide carbohydrate complex [1] that has been approved in Europe for the treatment of iron deficiency since 2007.…”

A comprehensive literatures update of clinical researches of superparamagnetic resonance iron oxide nanoparticles for magnetic resonance imaging

“…For a translational approach, toxicity assessments should be performed on case by case basis. A number of clinical safety issues of clinical approved SPIO have been described, thought the incidence is overall uncommon (14)(15)(16)(17)(18)(19). Importantly, SPIO is not indicated in pregnant women.…”