MRI with ferumoxytol: A single center experience of safety across the age spectrum

Abstract

PurposeTo summarize our single‐center safety experience with the off‐label use of ferumoxytol for magnetic resonance imaging (MRI) and to compare the effects of ferumoxytol on monitored physiologic indices in patients under anesthesia with those of gadofosveset trisodium.Materials and MethodsConsecutive patients who underwent ferumoxytol‐enhanced (FE) MRI exams were included. Adverse events (AEs) were classified according to the Common Terminology Criteria for Adverse Events v4.0. In a subgroup of patients examined under general anesthesia, recording of blood pressure, heart rate, oxygen saturation, and end‐tidal CO2 was performed. A comparable group of 23 patients who underwent gadofosveset‐enhanced (GE) MRI under anesthesia with similar monitoring was also analyzed.ResultsIn all, 217 unique patients, ages 3 days to 94 years, underwent FE‐MRI. No ferumoxytol‐related severe, life‐threatening, or fatal AEs occurred acutely or at follow‐up. Two patients developed ferumoxytol‐related nausea. Between‐group (FE‐ vs. GE‐MRI) comparisons showed no statistical difference in heart rate (P = 0.69, 95% confidence interval [CI] 96–113 bpm), mean arterial blood pressure (MAP) (P = 0.74, 95% CI 44–52 mmHg), oxygen saturation (P = 0.76, 95% CI 94–98%), and end‐tidal CO2 (P = 0.73, 95% CI 31–37 mmHg). No significant change in MAP (P = 0.12, 95% CI 50–58 mmHg) or heart rate (P = 0.25, 95% CI 91–105 bpm) was noted between slow infusion of ferumoxytol (n = 113) vs. bolus injection (n = 104).ConclusionIn our single‐center experience, no serious AEs occurred with the diagnostic use of ferumoxytol across a wide spectrum of age, renal function, and indications. Because of the limited sample size, firm conclusions cannot be drawn about the generalizability of our results. Thus, vigilance and monitoring are recommended to mitigate potential rare adverse reactions. Level of Evidence: 2J. Magn. Reson. Imaging 2017;45:804–812.

What Does the Boxed Warning Tell Us? Safe Practice of Using Ferumoxytol as an MRI Contrast Agent

“…16 While, a recently published single center investigation with 217 patients showed no serious adverse events (AEs) with the diagnostic use of ferumoxytol. 17 Our institution has over 10 years of experience using ferumoxytol as an MRI contrast agent in the CNS in subjects with or without compromised renal function; and as of December 31 st 2015, had completed 671 MRI studies with ferumoxytol in eight Institutional Review Board approved imaging protocols, in which AEs were closely monitored. This is the largest single institution safety data of ferumoxytol used in imaging research protocols.…”

Use of blood pool agents with steady‐state MRI to assess the vascular system

“…Ferumoxytol was initially investigated in 2003 as an MRI contrast agent, but later gained FDA approval as a treatment for iron‐deficiency anemia in adult patients with CKD (Feraheme, AMAG Pharmaceuticals, Waltham, MA). Its use as an MRI contrast agent is considered off‐label, but its preliminary safety and efficacy as a blood pool agent in MRI of the vascular system has been reported in the scientific literature . Ferumoxytol's mechanism of action and administration technique have previously been described in detail .…”

“…Its use as an MRI contrast agent is considered off-label, but its preliminary safety and efficacy as a blood pool agent in MRI of the vascular system has been reported in the scientific literature. [13][14][15][16][17][18] Ferumoxytol's mechanism of action and administration technique have previously been described in detail. 12,14,15,19 To summarize, the dextran coat that surrounds the iron oxide core of furomoxytol decreases its immunogenicity, thereby slowing phagocytosis of the agent and the release of free iron.…”

Ferumoxytol vs. Gadolinium agents for contrast‐enhanced MRI: Thoughts on evolving indications, risks, and benefits

“…These articles garnered immediate attention and reports of ferumoxytol‐enhanced MRA in children followed quickly afterwards . To date, all of the published imaging studies have reported outstanding results, with no safety concerns; albeit, these studies were in small patient populations, with the largest study encompassing 217 patients . Multicenter pooled analysis of safety data relating to the diagnostic use of ferumoxytol is underway.…”

“…Muehe et al reported on 68 patients aged 5–25 years and Ning et al reported on 86 subjects aged 1 day to 34 years and noted no SAE. Most recently, Nguyen et al found no SAE with the use of ferumoxytol for MRI in 217 patients aged 3 days to 94 years. Although their sample size was still small for a safety study, it represents the largest series to date on the diagnostic use of ferumoxytol.…”