Clariscan Mechanism of Action

Pharmacotherapeutic group: Paramagnetic contrast media for magnetic resonance imaging. ATC code: V08 CA 02 (Gadoteric Acid).
Pharmacology: Pharmacodynamics: This product has no specific pharmacodynamic activity.
Gadoteric acid is a paramagnetic agent for Magnetic Resonance Imaging (MRI). The contrast-enhancing effect is mediated by gadoteric acid which is an ionic gadolinium complex composed out of Gadolinium oxide and 1,4,7,10 tetraazacyclododecane N,N',N'',N''' tetraacetic acid (DOTA), and present as meglumine salt.
The paramagnetic effect (relaxivity) is determined from the effect on spin-lattice relaxation time (T1) about 3.4 mmol-1.L.sec-1 and on the spin-spin relaxation time (T2) about 4.27 mmol-1.L.sec-1.
Pharmacokinetics: Distribution: After intravenous injection, Gadoteric Acid (Clariscan) is distributed in the extracellular fluids of the body. The distribution volume was approx. 18 L which is approximately equal to the volume of extra-cellular fluid. Gadoteric acid does not bind to proteins like serum albumin. Gadoteric acid is poorly excreted in the milk and crosses slowly through the placenta barrier.
Biotransformation: No metabolites were detected.
Elimination: Gadoteric acid is eliminated rapidly (89% after 6 h, 95% after 24 h) in unchanged form through the kidneys by glomerular filtration. Excretion via the feces is negligible. The elimination half-life amounts to about 1.6 hours in patients with a normal renal function.
Special characteristics in patients with renal impairment: In renally impaired patients, the elimination half-life was increased to approximately 5 hours for a creatinine clearance between 30 and 60 mL/min and approximately 14 hours for a creatinine clearance between 10 and 30 mL/min.
Toxicology: Preclinical safety data: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or toxicity to reproduction.
Animal studies have shown negligible secretion (less than 1% of the dose) of gadoteric acid in maternal milk.