Feature | December 16, 2014

Pharmacokinetic profile, safety of gadobutrol similar between infants and adults

December 16, 2014 — Data from a Bayer study in children less than 2 years of age (infants) was presented at the 2014 Radiological Society of North America (RSNA) scientific assembly and annual meeting. The primary endpoint of the study was the evaluation of the pharmacokinetics (PK) of Gadavist (gadobutrol) injection in plasma at the standard dose of 0.1 mmol/kg body weight. Safety was a secondary endpoint and the study also included a qualitative assessment of efficacy.

PK is the evaluation of the time required for a drug, once administered, to be distributed in the body and excreted, for example in the urine, and depends on patient-related factors as well as the drug's chemical properties. The data showed that the gadobutrol PK profile was similar to the PK profile in older children and adults and investigators also observed similar safety of gadobutrol in this pediatric population.

Ravi Bhargava, M.D., study investigator and pediatric radiologist, University of Alberta, Edmonton, Canada said, "Our study found that gadobutrol is distributed and eliminated from the body in children under the age of 2 in a similar way to adults and older children."

"Use of Gadavist in children less than 2 years of age to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system is currently under U.S. Food and Drug Administration (FDA) review and FDA has designated this a priority review. Currently there are no gadolinium-based contrast agents, including Gadavist, approved for use in pediatric patients younger than 2 years of age in the United States," said Christiane Pering, chief medical officer (CMO) and head of innovation, Bayer Medical Care.

For more information: www.bayer.com

Related Content

Videos | Coronavirus (COVID-19)

Scott Faro, M.D., professor of radiology and neurology and director, division of neuroradiology, head and neck, at ...

Time December 03, 2021
arrow
News | Magnetic Resonance Imaging (MRI)

December 1, 2021 — In the first MRI-based study to investigate prenatal alcohol exposure, researchers found significant ...

Time December 01, 2021
arrow
News | Coronavirus (COVID-19)

November 30, 2021 — COVID-19 of mild to moderate severity in pregnant women appears to have no effect on the brain of ...

Time November 30, 2021
arrow
News | Computed Tomography (CT)

November 30, 2021 — A three-year study of more than 1,000 patients found that the risk of delayed intracranial ...

Time November 30, 2021
arrow
News | Coronavirus (COVID-19)

November 29, 2021 — The largest multi-institutional international study to date on brain complications of COVID-19 has ...

Time November 29, 2021
arrow
News | Coronavirus (COVID-19)

November 29, 2021 — A small but significant percentage of college athletes with COVID-19 develop myocarditis, a ...

Time November 29, 2021
arrow
News | Magnetic Resonance Imaging (MRI)

November 24, 2021 — Royal Philips announced new AI-enabled innovations in MR imaging launching at the Radiological ...

Time November 24, 2021
arrow
News | Coronavirus (COVID-19)

November 24, 2021 — Significant decreases in CT imaging for cancer persisted even after the peak of the COVID-19 ...

Time November 24, 2021
arrow
News | Magnetic Resonance Imaging (MRI)

November 23, 2021 — Researchers at Yale University analyzing specialized MRI exams found significant changes in the ...

Time November 23, 2021
arrow
News | Interventional Radiology

November 23, 2021 — A minimally invasive ablation procedure offers long-term relief for patients who experience chronic ...

Time November 23, 2021
arrow
Subscribe Now