The FDA has approved gadobutrol (Gadavist, Bayer Healthcare), the first gadolinium-based MRI contrast agent deemed safe for use in patients aged 2 years or younger. The injection is used to detect areas with disrupted blood-brain barrier and/or abnormal vascularity of the central nervous system.
The FDA based this new approval on a study that showed that the pharmacokinetic and safety profiles of the drug were comparable for both patients under age 2 and those over age 2; the drug had already been approved for use at a standard dose of 0.1 mmol/kg in patients older than 2 years.
The open-label study included 47 patients aged 2 to 23 months. Of these patients, 44 were evaluated for safety and efficacy, and 43 also underwent pharmacokinetic evaluation.
The results indicated that the pharmacokinetic, safety, and adverse event profiles were similar in patients aged 2 and younger compared with results that had been recorded for older patients. Mild adverse events included vomiting; no serious adverse effects were attributed to the drug.
“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,” said researcher Ravi Bhargava, MD, of the University of Alberta in Edmonton, Canada.
With the approval of the drug, the FDA also released guidelines so that clinicians can learn how to administer gadobutrol to young patients.