Synopsis
An
observational post-marketing study was conducted in 10 countries to
prospectively collect safety data in adults and children who were scheduled to
undergo routine Magnetic Resonance Imaging (MRI) with administration of
gadoterate meglumine (Dotarem®). The incidence of Nephrogenic Systemic Fibrosis
(NSF) in routine practice was assessed through specific follow-up of patients
with moderate to severe renal impairment. Final results in a large pediatric
sub-population of over 1,600 children showed a very good safety profile of
gadoterate meglumine with only one adverse event reported in a child and no
suspicion of NSF reported.Objective
To assess the safety profile of gadoterate meglumine and the incidence
of Nephrogenic Systemic Fibrosis (NSF) in routine practice.
Materials
This global observational study recruited 35,499 patients scheduled for gadoterate meglumine (Dotarem®) -enhanced Magnetic Resonance Imaging (MRI). A large pediatric sub-population
of 1,631 patients (53.5% male, mean (±SD) age of 10.2 (±4.9) years) from 9 countries
and including 106 children (6.5%) less than 2 years old was analyzed. Risk
factors, MRI indications, conditions of product administration and adverse
events were recorded. A follow-up of at least 3 months was planned for
detection of any NSF suspicion in patients with moderate to severe renal
impairment (514 patients including 3 children).
Results
The main MRI
indication for the pediatric population was examination of the central nervous
system (80.4%) followed by musculoskeletal system imaging (11.1%) and the most
frequent risk factors were nervous system disorders (16.6%), any stage of renal
impairment (9.8%; with a mean estimated creatinine clearance or eGFR of 74.1
mL/min (/1.73 m2), [range: 28-89]) and allergies (5.2%). Only one
pediatric patient (<0.1%), 2 years old with brain tumor, experienced one
adverse event (vomiting), reported as non-serious, mild in intensity and doubtfully
related to gadoterate meglumine. No suspicion of NSF was reported.
Conclusion
This study confirmed
the very good safety profile of gadoterate meglumine in a broad
pediatric population.
Acknowledgements
No acknowledgement found.References
No reference found.