Pharmacokinetics and Safety of Macrocyclic Gadobutrol in Children Aged Younger Than 2 Years Including Term Newborns in Comparison to Older Populations

Investigative Radiology
Christian Wilhelm KunzeGabriele Hahn

Abstract

This clinical study evaluated the pharmacokinetics (PK) and safety data of macrocyclic extracellular contrast agent gadobutrol in pediatric subjects aged younger than 2 years. Pediatric subjects (term newborns to those aged younger than 2 years) with normal renal function undergoing magnetic resonance imaging with gadobutrol (0.1 mmol/kg body weight [BW]) were prospectively enrolled in this open-label, multicenter clinical trial to evaluate PK as a primary end point. Plasma PK was analyzed using a population-based PK approach. Safety and qualitative efficacy (evaluation of images) were secondary end points. Safety and tolerability were assessed throughout study participation (approximately 7 days). Imaging efficacy variables were assessed by investigators. Forty-four subjects were evaluated for safety and efficacy; 43 subjects were eligible for PK evaluation including 9 term newborns and infants aged younger than 2 months. Gadobutrol PK in pediatric subjects aged younger than 2 years were adequately described by a linear 2-compartmental model with elimination from the central compartment. Total median systemic exposure (area under the curve) of gadobutrol was estimated at 776 μmol · h/L (range, 544-1470 μmol · h/L). Simulated m...Continue Reading

References

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May 1, 2002·Current Opinion in Pediatrics·Alfred Drukker, Jean-Pierre Guignard
Jun 4, 2002·European Radiology·Bernd Tombach, Walter Heindel
Jan 11, 2007·Investigative Radiology·Christoph U HerbornJörg Barkhausen
Nov 13, 2008·Investigative Radiology·Thomas FrenzelHanns-Joachim Weinmann
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Aug 7, 2012·European Radiology·Henrik S ThomsenUNKNOWN ESUR Contrast Medium Safety Committee
Sep 24, 2013·Pediatric Radiology·Beatrice NardoneDennis P West

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Citations

Sep 22, 2017·Magnetic Resonance Insights·Jan Endrikat, Nicoletta Anzalone
Aug 17, 2016·Investigative Radiology·Henrik J MichaelyJan Endrikat
Nov 16, 2019·AJNR. American Journal of Neuroradiology·D S EnterlineC Colosimo
Sep 21, 2018·Japanese Journal of Radiology·Yoshito TsushimaJan Endrikat
Apr 15, 2017·Pediatric Radiology·Eric M GaleMichael S Gee
Nov 14, 2019·The Journal of Pediatric Pharmacology and Therapeutics : JPPT : the Official Journal of PPAG·Shane C RaineyKeith A Hanson
Jul 15, 2018·Clinical Drug Investigation·Lesley J Scott

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