Safety assessment of gadoversetamide (OptiMARK�) administered by power injector
ABSTRACT To evaluate the safety of OptiMARK (gadoversetamide injection) administered via power injector.
The study population included 144 healthy volunteers aged 18 years or older randomly assigned to one of seven treatment groups (N = 20/group). The safety assessment was based on changes in physical examination, vital signs, electrocardiograms (ECGs), standard clinical laboratory tests, and adverse events (AEs) through a 24-hour postinjection period.
OptiMARK caused no serious AEs or unexpected changes in physical examinations or laboratory parameters. The changes observed in vital signs and ECG intervals did not vary with changes in injection rate and were not significantly (P < 0.05) different from those elicited by saline administration at the same rates.
This study demonstrated the safety of OptiMARK when administered via a power injector at rates of 2, 4, and 6 mL/second.
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ABSTRACT: To assess the safety data from two large, multicenter, phase 2 trials on the use of gadoversetamide (OptiMARK, Tyco Healthcare/Mallinckrodt, St. Louis, MO) as a contrast agent in delayed hyperenhancement magnetic resonance imaging (DE-MRI) in patients with acute and chronic myocardial infarction (MI). The study population from both trials comprised 577 patients who were randomly assigned to one of four dose groups (0.05, 0.1, 0.2, or 0.3 mmol/kg) before undergoing DE-MRI. Safety evaluations included physical and electrocardiographic (ECG) examinations. Vital signs, laboratory values, adverse events (AE), and serious adverse events (SAE) were monitored before and after contrast administration. Of the 577 patients who received gadoversetamide, 124 (21.5%) reported a total of 164 AEs; most were mild (139 AEs; 84.8%) or moderate (25 AEs; 15.2%). ECG-related changes were the most frequent AE. Site investigators judged only eight AEs as likely related to gadoversetamide and only two of the eight as clinically relevant. Further evaluation suggested neither AE was related to gadoversetamide. Two SAEs were reported, but none was judged related to gadoversetamide by the site investigators. Gadoversetamide is safe for use in patients with acute or chronic MI up to a dose of 0.3 mmol/kg.Journal of Magnetic Resonance Imaging 12/2008; 28(6):1368-78. DOI:10.1002/jmri.21502 · 2.79 Impact Factor
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ABSTRACT: This clinical trial examined the pharmacokinetics of gadoversetamide, a magnetic resonance imaging contrast agent, in normal pediatric subjects. Seventeen healthy pediatric subjects received a single intravenous injection of gadoversetamide (0.1 mmol/kg, 0.2 mL/kg). Sixteen subjects that were evaluable for pharmacokinetic analysis fell into 2 stratified age groups: 2 years to <5 years and 5 years to <18 years of age. Serum samples were analyzed for total gadolinium as a measure of gadoversetamide concentration. Statistical analysis demonstrated significant (P < 0.05) age-related trends in the mean elimination half-life (t 1/2) of gadolinium with the older group having a slightly longer t 1/2 (1.39 hours) than the younger group (1.19 hours). No age-related changes occurred in volume of distribution or total body clearance, when normalized to body weight or body surface area. Based on this preliminary pharmacokinetic assessment, no adjustment from the approved adult gadoversetamide dose of 0.1 mmol/kg should be necessary for children aged 2 or older.Investigative Radiology 06/2004; 39(6):334-9. DOI:10.1097/01.rli.0000124455.11402.52 · 4.45 Impact Factor
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ABSTRACT: The injection of contrast media enables the visualization of various pathologies through X-ray, computed tomography, magnetic resonance imaging (MRI), or other medical imaging modalities. Safety and functionality of power injector systems must be evaluated at high magnetic fields (7-Tesla). The purpose of this study was to evaluate MRI issues for a power injection system (OptiStar Elite MR Contrast Delivery System, Mallinckrodt Pharmaceuticals, Hazelwood, MO) at 7-Tesla including magnetic field interaction and 31 injector performance tests. Additionally, effects of operation of the power injection system on MR images were evaluated through observation of image artifacts and signal to noise analysis. The components of the power injection system (powerhead, syringes) exhibited no translational attraction when close to 7-Tesla MR system. Translational attraction was detected for the power supply, power control, and cables, therefore there is a requirement to maintain these components fixed outside of the 0.1000 Tesla line. 7-Tesla MR scanning did not impact power injection performance. The power injection system produced no discernible image artifacts or degradation when the power controls and powerhead were positioned in the worst-case position. The power injection system tested for MRI issues passed evaluation for safety and operation at 7-Tesla and is labeled MR Conditional for use at 7-T. © 2015 Wiley Periodicals, Inc. Int J Imaging Syst Technol, 25, 50–55, 2015International Journal of Imaging Systems and Technology 03/2015; 25(1):50-55. DOI:10.1002/ima.22120 · 0.77 Impact Factor