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Multicenter Safety and Practice for Off-Label Diagnostic Use of Ferumoxytol in MRI
Radiology, 2019-12, Vol.293 (3), p.554-564
Nguyen, Kim-Lien
Yoshida, Takegawa
Kathuria-Prakash, Nikhita
Zaki, Islam H
Varallyay, Csanad G
Semple, Scott I
Saouaf, Rola
Rigsby, Cynthia K
Stoumpos, Sokratis
Whitehead, Kevin K
Griffin, Lindsay M
Saloner, David
Hope, Michael D
Prince, Martin R
Fogel, Mark A
Schiebler, Mark L
Roditi, Giles H
Radjenovic, Aleksandra
Newby, David E
Neuwelt, Edward A
Bashir, Mustafa R
Hu, Peng
Finn, J Paul
2019
Volltextzugriff (PDF)
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Autor(en) / Beteiligte
Nguyen, Kim-Lien
Yoshida, Takegawa
Kathuria-Prakash, Nikhita
Zaki, Islam H
Varallyay, Csanad G
Semple, Scott I
Saouaf, Rola
Rigsby, Cynthia K
Stoumpos, Sokratis
Whitehead, Kevin K
Griffin, Lindsay M
Saloner, David
Hope, Michael D
Prince, Martin R
Fogel, Mark A
Schiebler, Mark L
Roditi, Giles H
Radjenovic, Aleksandra
Newby, David E
Neuwelt, Edward A
Bashir, Mustafa R
Hu, Peng
Finn, J Paul
Titel
Multicenter Safety and Practice for Off-Label Diagnostic Use of Ferumoxytol in MRI
Ist Teil von
Radiology, 2019-12, Vol.293 (3), p.554-564
Ort / Verlag
United States
Erscheinungsjahr
2019
Quelle
MEDLINE
Beschreibungen/Notizen
Background Ferumoxytol is approved for use in the treatment of iron deficiency anemia, but it can serve as an alternative to gadolinium-based contrast agents. On the basis of postmarketing surveillance data, the Food and Drug Administration issued a black box warning regarding the risks of rare but serious acute hypersensitivity reactions during fast high-dose injection (510 mg iron in 17 seconds) for therapeutic use. Whereas single-center safety data for diagnostic use have been positive, multicenter data are lacking. Purpose To report multicenter safety data for off-label diagnostic ferumoxytol use. Materials and Methods The multicenter ferumoxytol MRI registry was established as an open-label nonrandomized surveillance databank without industry involvement. Each center monitored all ferumoxytol administrations, classified adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events (grade 1-5), and assessed the relationship of AEs to ferumoxytol administration. AEs related to or possibly related to ferumoxytol injection were considered adverse reactions. The core laboratory adjudicated the AEs and classified them with the American College of Radiology (ACR) classification. Analysis of variance was used to compare vital signs. Results Between January 2003 and October 2018, 3215 patients (median age, 58 years; range, 1 day to 96 years; 1897 male patients) received 4240 ferumoxytol injections for MRI. Ferumoxytol dose ranged from 1 to 11 mg per kilogram of body weight (≤510 mg iron; rate ≤45 mg iron/sec). There were no systematic changes in vital signs after ferumoxytol administration ( > .05). No severe, life-threatening, or fatal AEs occurred. Eighty-three (1.9%) of 4240 AEs were related or possibly related to ferumoxytol infusions (75 mild [1.8%], eight moderate [0.2%]). Thirty-one AEs were classified as allergiclike reactions using ACR criteria but were consistent with minor infusion reactions observed with parenteral iron. Conclusion Diagnostic ferumoxytol use was well tolerated, associated with no serious adverse events, and implicated in few adverse reactions. Registry results indicate a positive safety profile for ferumoxytol use in MRI. © RSNA, 2019
Sprache
Englisch
Identifikatoren
ISSN: 0033-8419
eISSN: 1527-1315
DOI: 10.1148/radiol.2019190477
Titel-ID: cdi_pubmed_primary_31638489
Format
–
Schlagworte
Adolescent
,
Adult
,
Aged
,
Aged, 80 and over
,
Child
,
Child, Preschool
,
Contrast Media - adverse effects
,
Drug-Related Side Effects and Adverse Reactions
,
Female
,
Ferrosoferric Oxide - adverse effects
,
Humans
,
Infant
,
Infant, Newborn
,
Magnetic Resonance Imaging
,
Male
,
Middle Aged
,
Off-Label Use
,
Registries
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