Gadobutrol in India—A Comprehensive Review of Safety and Efficacy

Abstract

Gadobutrol is a gadolinium (Gd)-based contrast agent for magnetic resonance imaging (MRI). In India, gadobutrol is approved for MRI of the central nervous system (CNS), liver, kidneys, breast and for MR angiography for patients 2 years and older. The standard dose for all age groups is 0.1 mmol/kg body weight. The safety profile has been demonstrated in 42 clinical phase 2 to 4 studies (>6800 patients), 7 observational studies, and by assessing pharmacovigilance data of 29 million applications. Furthermore, studies in children, adults, and elderly and in patients with impaired liver or kidney function did not show any increased adverse event rate. Diagnostic efficacy was demonstrated in numerous studies and various indications, such as diseases of the CNS, peripheral and supra-aortic vessels, kidneys, liver, and breast.

Gadobutrol: A Review in Contrast-Enhanced MRI and MRA

“…exhibits slow kinetics of decomplexation) and thermodynamic stability (Table 1 ) [ 5 – 7 ]. Its unique physiochemical profile means that gadobutrol is formulated at twice the concentration of Gd 3+ ions as other GBCAs (1.0 vs. 0.5 mol/L solution) [ 6 , 8 ]. The higher concentration of gadobutrol reduces its injection volume by 50%, providing a narrower bolus and thereby, improving dynamic image enhancement [ 9 , 10 ].…”

“…Gadobutrol exhibits the greatest shortening of proton T1 relaxation times amongst all macrocyclic GBCAs [ 7 ]. Shortening of proton relaxation time is a key determinant of signal and contrast enhancement in MRI [ 6 ].…”