Pharmacokinetics of gadoversetamide injection, a gadolinium-based contrast agent, in pediatric patients

Wible, James H.; Tata, Prasad N.V; Lowe, Lisa H.; Kearns, Gregory L.

doi:10.1016/j.mri.2008.08.002

Cited by 7 publications

(7 citation statements)

References 18 publications

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“…It is similar to the values of 1.5 to 1.6 hours that were reported in adults after gadoterate meglumine injection 15 , 16 and 1.6 hours reported in children aged 0 to younger than 2 years who received gadobutrol. 33 These values were also close to those obtained in older pediatric patients who received either gadobutrol, 34 or the linear GBCA gadoversetamide, 35 and in healthy pediatric subjects after administration of gadoversetamide. 36 …”

Section: Discussionsupporting

confidence: 82%

A Pharmacokinetics, Efficacy, and Safety Study of Gadoterate Meglumine in Pediatric Subjects Aged Younger Than 2 Years

M¹,

Koob²,

Buttet³

et al. 2018

Invest Radiol

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ObjectivesThe primary objective of this study was to investigate the pharmacokinetic profile of gadoterate meglumine in pediatric patients younger than 2 years; the secondary objectives were to document its efficacy and safety.Material and MethodsThis was a Phase IV open-label, prospective study conducted in 9 centers (4 countries). Forty-five patients younger than 2 years with normal estimated glomerular filtration rate and scheduled to undergo routine gadolinium-enhanced magnetic resonance imaging (MRI) of any organ were included and received a single intravenous injection of gadoterate meglumine (0.1 mmol/kg). To perform the population pharmacokinetics analysis, 3 blood samples per subject were drawn during 3 time windows at time points allocated by randomization.ResultsGadoterate meglumine concentrations were best fitted using a 2-compartmental model with linear elimination from central compartment. The median total clearance adjusted to body weight was estimated at 0.06 L/h per kg and increased with estimated glomerular filtration rate according to a power model. The median volume of distribution at steady state (Vss) adjusted to body weight was estimated at 0.047 L/kg. Estimated median terminal half-life (t1/2β) was 1.35 h, and the median systemic exposure (area under the curve) was 1591 μmol h/L. Efficacy was assessed by comparing precontrast +postcontrast images to precontrast images in a subset of 28 subjects who underwent an MRI examination of brain, spine, and associated tissues. A total of 28 lesions were identified and analyzed in 15 subjects with precontrast images versus 30 lesions in 16 subjects with precontrast + postcontrast images. Lesion visualization was improved with a mean (SD) increase in scores at subject level of 0.7 (1.0) for lesion border delineation, 0.9 (1.6) for internal morphology, and 3.1 (3.2) for contrast enhancement. Twenty-six adverse events occurred postinjection in 13 subjects (28.9%), including 3 serious reported in 1 subject (2.2%). One subject (2.2%) experienced 1 rash of moderate intensity considered as related to gadoterate meglumine.ConclusionsThe pharmacokinetic profile of gadoterate meglumine after a single intravenous injection of 0.1 mmol/kg was appropriately described in newborns and infants younger than 2 years, for whom no dose adjustment is required. The improved efficacy of gadoterate meglumine for contrast-enhanced MRI examination of brain, spine, and associated tissues, as well as its good safety profile, was also demonstrated in this population.

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Section: Discussionsupporting

confidence: 82%

A Pharmacokinetics, Efficacy, and Safety Study of Gadoterate Meglumine in Pediatric Subjects Aged Younger Than 2 Years

M¹,

Koob²,

Buttet³

et al. 2018

Invest Radiol

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“…A slightly greater apparent volume of distribution (0.36 ± 0.05 L/kg) was noted in our population compared with findings in adult subjects (0.074–0.158 L/kg; [27]) but this is to be expected in pediatric subjects; higher volumes of distribution in children aged 2 to 6 compared with older children and adults have been noted elsewhere in studies on the pharmacokinetics of other GBCAs . Regarding a slightly higher steady‐state volume of distribution in our study compared with studies with the conventional GBCA gadoversetamide this may be related to a higher and more efficient clearance of gadobenate dimeglumine (200 mL/h/kg in this study compared with 133–148 mL/h/kg for gadoversetamide [40,41]). Higher clearance values will clearly result in higher values for Vss because Vss = MRT * CL.…”

Section: Discussioncontrasting

confidence: 52%

“…There also did not appear to be a clinically important effect of gender on the pharmacokinetics of gadobenate dimeglumine within any of the age groups. Studies describing the pharmacokinetics of other GBCAs in children support these findings (39)(40)(41).…”

Section: Discussionmentioning

confidence: 75%

Pharmacokinetics of gadobenate dimeglumine in children 2 to 5 years of age undergoing MRI of the central nervous system

Pirovano

Kirchin

Lorusso³

et al. 2014

Magnetic Resonance Imaging

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“…The trials that were available typically included low numbers of pediatric patients in limited indications. [68][69][70][71] Studies to characterize contrast agent use specifically in pediatric MRI include pharmacokinetic and safety investigations of the 0.5 molar gadolinium-based contrast media [72][73][74] and the 1 molar agent, gadobutrol. 75,76 Factors Influencing Contrast Medium Choice Safety.…”

Section: Clinical Trials In Pediatric Mrimentioning

confidence: 99%

Contrast-enhanced Magnetic Resonance Imaging in Pediatric Patients: Review and Recommendations for Current Practice

Bhargava

Hahn

Hirsch³

et al. 2013

Magn Reson�Insights

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Magnetic resonance imaging (MRI), frequently with contrast enhancement, is the preferred imaging modality for many indications in children. Practice varies widely between centers, reflecting the rapid pace of change and the need for further research. Guide-line changes, for example on contrast-medium choice, require continued practice reappraisal. This article reviews recent developments in pediatric contrast-enhanced MRI and offers recommendations on current best practice. Nine leading pediatric radiologists from internationally recognized radiology centers convened at a consensus meeting in Bordeaux, France, to discuss applications of contrast-enhanced MRI across a range of indications in children. Review of the literature indicated that few published data provide guidance on best practice in pediatric MRI. Discussion among the experts concluded that MRI is preferred over ionizing-radiation modalities for many indications, with advantages in safety and efficacy. Awareness of age-specific adaptations in MRI technique can optimize image quality. Gadolinium-based contrast media are recommended for enhancing imaging quality. The choice of most appropriate contrast medium should be based on criteria of safety, tolerability, and efficacy, characterized in age-specific clinical trials and personal experience.

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Pharmacokinetics of gadoversetamide injection, a gadolinium-based contrast agent, in pediatric patients

Cited by 7 publications

References 18 publications

A Pharmacokinetics, Efficacy, and Safety Study of Gadoterate Meglumine in Pediatric Subjects Aged Younger Than 2 Years

A Pharmacokinetics, Efficacy, and Safety Study of Gadoterate Meglumine in Pediatric Subjects Aged Younger Than 2 Years

Pharmacokinetics of gadobenate dimeglumine in children 2 to 5 years of age undergoing MRI of the central nervous system

Contrast-enhanced Magnetic Resonance Imaging in Pediatric Patients: Review and Recommendations for Current Practice

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