Feature | December 16, 2014

New Data Presented on Use of Gadavist Contrast Injection in Children Under Two

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

Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
PQ Bypass Reports Positive Results for Detour System in Patients With Long Femoropopliteal Blockages
News | Peripheral Artery Disease (PAD)| September 13, 2017
A subset analysis of the DETOUR I clinical trial showed promising safety and effectiveness results of PQ Bypass’ Detour...
News | Cardiac Diagnostics| September 12, 2017
Contracting shingles, a reactivation of the chickenpox virus, increases a person’s risk of stroke and heart attack,...
Vascular screening for abdominal aortic aneurysm, peripheral artery disease and hypertension during the VIVA Study in Denmark

Vascular screening for abdominal aortic aneurysm, peripheral artery disease and hypertension during the VIVA Study. Photo credit: Lisbeth Hasager Justesen, Viborg Hospital.

News | Cardiac Diagnostics| September 12, 2017
September 12, 2017 — A new screening program for vascular disease saves one life for every 169 men assessed, accordin
News | Pharmaceuticals| September 12, 2017
September 12, 2017 — Inclisiran lowers low-density lipoprotein (LDL, or “bad”) cholesterol for up to one year in pati
Overlay Init