Gadoterate Meglumine (3 brand names, 1 dosage form, 1 route)
Available dosage forms: SOLUTION.
Routes of administration: INTRAVENOUS.
Brand Names
- CLARISCAN
- DOTAREM
- GADOTERATE MEGLUMINE
Indications and Usage
Clariscan is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
Contraindications
History of clinically important hypersensitivity reactions to Clariscan [see Warnings and Precautions (5.3)].
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Nephrogenic systemic fibrosis [see Warnings and Precautions (5.2)] Hypersensitivity reactions [see Warnings and Precautions (5.3)] Gadolinium Retention [see Warnings and Precautions (5.4)]
Drug Interactions
Gadoterate does not interfere with serum and plasma calcium measurements determined by colorimetric assays. Specific drug interaction studies with gadoterate meglumine have not been conducted.
Mechanism of Action
Gadoterate is a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. The magnetic moment enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues. In magnetic resonance imaging (MRI), visualization of normal and pathological tissue depends in part on variations in the radiofrequency signal intensity that occurs with: 1)differences in proton density 2)differences of the spin-lattice or longitudinal relaxation times (T1) 3)differences in the spin-spin or transverse relaxation time (T2) When placed in a magnetic field, gadoterate shortens the T1 and T2 relaxation times in target tissues. At recommended doses, the effect is observed with greatest sensitivity in the T1-weighted sequences.
Overdosage
Clariscan administered to healthy volunteers and to adult patients at cumulative doses up to 0.3 mmol/kg was tolerated in a manner similar to lower doses. Adverse reactions to overdosage with gadoterate meglumine have not been reported. Gadoterate meglumine can be removed from the body by hemodialysis [see Clinical Pharmacology (12.3)].