Gabriele Hahn MD, Abstract Co-Author: Nothing to Disclose

Christian Kunze MD, Abstract Co-Author: Nothing to Disclose

Ravi Bhargava MD, Presenter: Consultant, Bayer AG

Robert Joseph Fleck MD, Abstract Co-Author: Nothing to Disclose

Rajesh Krishnamurthy MD, Abstract Co-Author: Research support, Koninklijke Philips NV Travel support, Koninklijke Philips NV

Delilah Marie Burrowes MD, Abstract Co-Author: Consultant, Guerbet SA

Gabriele Sutter, Abstract Co-Author: Employee, Bayer AG

Marta Santiuste, Abstract Co-Author: Employee, Bayer AG

Hans Joachim Mentzel MD, Abstract Co-Author: Research Consultant, Bayer AG Research Consultant, Novartis AG Research Consultant, General Electric Company Research Consultant, Falk Research Grant, Novartis AG Research Grant, BeamMed Ltd

To evaluate the pharmacokinetics (PK) of gadobutrol at the standard dose of 0.1 mmol/kg body weight in plasma of pediatric subjects aged <2 years as a primary objective. Safety, tolerability and efficacy are secondary endpoints.

Subjects <2 years of age (term newborn infants to 23 months of age) with normal renal function, undergoing routine MRI of any body region following administration of 0.1 mmol/kg gadobutrol. Plasma PK was analyzed using a population-based PK approach. Qualitative imaging efficacy variables were assessed by investigators.

47 subjects 0.2-23 months of age were enrolled, 44 subjects were evaluated for safety and efficacy, 43 subjects were eligible for PK evaluation including 9 term newborns to <2 months of age. The gadobutrol PK profile in pediatric subjects <2 years, including term newborns, was similar to the PK profile in older children and adults. The most common non-serious AEs unrelated to gadobutrol were cough, nasopharyngitis, rhinitis, pyrexia and vomiting. In one subject, vomiting was reported as a mild AE related to gadobutrol. Serious AEs were unrelated to gadobutrol and were reported in 3/44 subjects (6.8%). The evaluation of gadobutrol-enhanced images provided improved diagnosis, increased confidence in diagnosis, and contributed to subject clinical management.

The PK of gadobutrol is similar to that observed in adults and children >2 years of age and supports the effectiveness of gadobutrol in this pediatric population <2 years. Body weight dosing of gadobutrol at a standard dose (0.1 mmol/ kg) is therefore adequate for the pediatric population <2 years (including term newborns). Gadobutrol has shown a good safety profile and was well tolerated in children below 2 years of age.

First clinical study to evaluate PK, safety and tolerability of gadobutrol in pediatric population <2 years of age, including term newborns.

Hahn, G, Kunze, C, Bhargava, R, Fleck, R, Krishnamurthy, R, Burrowes, D, Sutter, G, Santiuste, M, Mentzel, H, Open-label, Multicenter, Pharmacokinetic and Safety Study in Children Below 2 Years of Age undergoing a Contrast-enhanced MRI with an Intravenous Injection of a Single Standard Dose of Gadobutrol.  Radiological Society of North America 2014 Scientific Assembly and Annual Meeting, - ,Chicago IL. http://archive.rsna.org/2014/14008140.html