Ferumoxytol Infusion in Pediatric Patients with Gastrointestinal Disorders: First Case Series

Hassan, Nabil; Cahill, Jill; Rajasekaran, Surender; Kovey, Karen

doi:10.1345/aph.1q283

Cited by 21 publications

(11 citation statements)

References 7 publications

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“…We did not observe any hypersensitivity reaction in the 49 pediatric patients. This is in accordance with previous case reports, stating lack of allergic reactions in a study of six pediatric patients (20). Hypersensitivity reactions were reported in 0.2% of adult CKD patients who received ferumoxytol for anemia treatment (1).…”

Section: Discussionsupporting

confidence: 94%

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Safety Report of Ferumoxytol for Magnetic Resonance Imaging in Children and Young Adults

Muehe

Feng

Eyben

et al. 2016

Investigative Radiology

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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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Section: Discussionsupporting

confidence: 94%

“…Hassen and colleagues reported that ferumoxytol was overall well tolerated in six pediatric patients with gastrointestinal disorders except for one case of mild pruritus (20). Klenk and colleagues found no objective or subjective adverse events in 22 patients (3) and neither did Thompson and colleagues in seven patients (4).…”

Section: Introductionmentioning

confidence: 99%

Safety Report of Ferumoxytol for Magnetic Resonance Imaging in Children and Young Adults

Muehe

Feng

Eyben

et al. 2016

Investigative Radiology

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“…Unfortunately, the associated stigma persists and is often linked to all IV iron formulations, including the much safer and highly effective newer formulations . The three primary formulations that have been used historically in pediatrics are iron sucrose (IS), low molecular weight iron dextran (LMWID), and sodium ferric gluconate complex (FG), though newer formulations such as ferric carboxymaltose and ferumoxytol are now being studied as well . A few studies in small pediatric cohorts, mostly in hematology patients with IDA, have demonstrated that IV iron is both safe and effective .…”

Section: Introductionmentioning

confidence: 99%

Utilization trends and safety of intravenous iron replacement in pediatric specialty care: A large retrospective cohort study

Boucher

Pfeiffer

Bedel

et al. 2018

Pediatric Blood & Cancer

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“…Iron oxide nanoparticles are not approved for clinical use in children and applications in the US are done through an investigational new drug (IND) application with the FDA. Safety data in paediatric patients are limited, but have not shown clinically significant side effects so far [52, 53]. The recently renewed safety discussion around iron products does not relate to new toxic effects [24], but has to be taken seriously and has led to a black box warning by the FDA.…”

Section: Discussionmentioning

confidence: 99%

Speeding up PET/MR for cancer staging of children and young adults

et al. 2016

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Objective Combining 18F-FDG PET with whole-body MR for paediatric cancer staging is practically feasible if imaging protocols can be streamlined. We compared 18F-FDG PET/STIR with accelerated 18F-FDG PET/FSPGR for whole-body tumour imaging in children and young adults. Methods Thirty-three children and young adults (17.5±5.5 years, range 10–30 years) with malignant lymphoma or sarcoma underwent a 18F-FDG PET staging exam, followed by ferumoxytol-enhanced STIR and FSPGR whole-body MR. 18F-FDG PET scans were fused with MR data and the number and location of tumours on each integrated exam was determined. Histopathology and follow-up imaging served as standard of reference. The agreement of each MR sequence with the reference and the whole-body imaging times were compared using Cohen’s kappa coefficient and student t-test, respectively. Results Comparing 18F-FDG PET/FSPGR to 18F-FDG PET/STIR, sensitivities were 99.3% for both, specificities were statistically equivalent, 99.8% versus 99.9% and the agreement with the reference based on Cohen’s kappa coefficient was also statistically equivalent, 0.989 versus 0.992. However, the total scan-time for accelerated FSPGR of 19.8±5.3 minutes was significantly shorter compared to 29.0±7.6 minutes for STIR (p=0.001). Conclusion 18F-FDG PET/FSPGR demonstrated equivalent sensitivities and specificities for cancer staging compared to 18F-FDG PET/STIR, but could be acquired with shorter acquisition time.

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Ferumoxytol Infusion in Pediatric Patients with Gastrointestinal Disorders: First Case Series

Cited by 21 publications

References 7 publications

Safety Report of Ferumoxytol for Magnetic Resonance Imaging in Children and Young Adults

Safety Report of Ferumoxytol for Magnetic Resonance Imaging in Children and Young Adults

Utilization trends and safety of intravenous iron replacement in pediatric specialty care: A large retrospective cohort study

Speeding up PET/MR for cancer staging of children and young adults

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