The United States Food and Drug Administration has approved the use of a gadobutrol injection from Bayer HealthCare for use with magnetic resonance imaging (MRI) in pediatric patients less than 2 years old. First approved in the US in March 2011, Gadavist detects and visualizes areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. This latest approval enables the contrast agent’s use in the youngest patients, including term neonates.

“Until this study, there were limited data regarding the use of gadolinium-based contrast agents in pediatric patients younger than 2 years of age, and there has been a significant need to better understand how they work in our youngest patients,” said Ravi Bhargava, MD, study investigator and pediatric radiologist at the University of Alberta, Edmonton, Canada. “Ultimately, it’s important for us to have safe and effective tools to help us accurately detect abnormalities and visualize areas of the central nervous system in children of all ages.”

The study evaluated 47 pediatric patients ranging in age from term neonates to 23 months old with normal renal function from nine centers across the US, Canada, and Europe. Data found that the pharmacokinetic profile for these patients was similar to that in older children and adults. In one patient, vomiting occurred as a mild adverse drug reaction to Gadavist. Other adverse events unrelated to Gadavist included cough, nasopharyngitis, rhinitis, pyrexia, and vomiting.

“Gadavist is the first FDA-approved gadolinium-based contrast agent for pediatric patients under 2 years of age, including term neonates, and the approval provides guidance to physicians on how to use Gadavist in these young patients,” said Christiane Pering, chief medical officer and head of innovation within Bayer HealthCare’s medical care division. “With this label expansion, Gadavist is appropriate to use for MRI of the central nervous system at a standard dose of 0.1 mmol/kg for patients of all ages—term neonates to adults.”

For more information, visit Bayer HealthCare.