Objective To assess the safety profile of ferumoxytol as an intravenous magnetic resonance (MR) imaging contrast agent in children. Materials and Methods We prospectively evaluated the safety of ferumoxytol administrations as an “off-label” contrast agent for MR imaging in non-randomized phase IV clinical trials at two centers. From September 2009 to February 2015 49 pediatric patients (21 female and 28 male, 5-18 years old) and 19 young adults (8 female and 11 male, 18-25 years old) were reported under an investigator-initiated investigational new drug (IND) investigation with institutional review board (IRB) approval, in health insurance portability and accountability act (HIPAA) compliance, and after written informed consent of the child's legal representative or the competent adult patient was obtained. Patients received either a single dose (5 mg Fe/kg) or up to 4 doses of ferumoxytol (0.7-4 mg Fe/kg) intravenously, which were approximately equivalent to 1/3 of the dose for anemia treatment. We monitored vital signs and adverse events directly for up to one hour post injection. In addition, we examined weekly vitals, hematologic, renal and liver serum panels for one month after injection in over 20 pediatric patients. At fixed time points before and after ferumoxytol injection data were evaluated for significant differences by a repeated measures linear mixed model. Results Four mild adverse events, thought to be related to ferumoxytol, were observed within one hour of 85 ferumoxytol injections: Two episodes of mild hypotension and one case of nausea in 65 injections in pediatric patients without related clinical symptoms. One young adult patient developed warmness and erythema at the injection site. All adverse events were self-resolving. No spontaneous serious adverse events were reported. At a dose of 5 mg Fe/kg or lower, intravenous ferumoxytol injection had no clinical relevance or statistically significant effect (p>0.05) on vital signs, hematological parameters, kidney function or liver enzymes within one month of the injection. Conclusion Ferumoxytol was overall well tolerated among 49 pediatric and 19 young adult patients suffering from various tumors or kidney transplants without major adverse events or signs of hematologic and kidney impairment or liver toxicity. Larger studies are needed to determine the incidence of anaphylactic reactions.
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