Pharmacokinetics, safety, and tolerability of gadoversetamide injection (OptiMARK) in subjects with central nervous system or liver pathology and varying degrees of renal function

Swan, Suzanne K.; Baker, James F.; Free, Richard; Tucker, Richard; Barron, Bruce; Barr, Richard G.; Seltzer, Steve; Gazelle, G. Scott; Maravilla, Kenneth R.; Barr, William H.; Stevens, Gary; Lambrecht, Lawrence J.; Pierro, Joseph A.

doi:10.1002/(sici)1522-2586(199902)9:2<317::aid-jmri25>3.0.co;2-b

Cited by 51 publications

(25 citation statements)

References 3 publications

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“…Swan et al and others have described in detail the pharmacokinetics and safety of gadoversetamide for use in imaging of the liver and CNS (12,13). In this report we present the safety data on the use of gadoversetamide as a contrast agent in patients with acute and chronic MI.…”

supporting

confidence: 93%

“…Mallinckrodt, St. Louis, MO) is a nonionic Gd-chelate approved by the FDA for use in imaging of the liver and central nervous system (CNS) (7)(8)(9)(10)(11)(12)(13). Swan et al and others have described in detail the pharmacokinetics and safety of gadoversetamide for use in imaging of the liver and CNS (12,13).…”

supporting

confidence: 56%

“…Third, no difference was detected in the QTc interval between different dose groups. This finding is consistent with those of previous studies in which the QTc interval did not differ between subjects administered either saline or gadoversetamide (7)(8)(9)(10)(11)(12).…”

Section: Discussionmentioning

confidence: 98%

“…Serum levels of calcium in the AMI and CMI studies were both higher and lower than baseline levels, and no systematic trend for hypercalcemia was seen. Other investigators have also reported no correlation between gadoversetamide administration and hypercalcemia (7)(8)(9)11,12). Furthermore, Baker et al (10) recently reported a minimal decrease in calcium concentration after gadoversetamide administration in pediatric patients.…”

Section: Discussionmentioning

confidence: 99%

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Safety of gadoversetamide in patients with acute and chronic myocardial infarction

Huber

Muthupillai

Cheong

et al. 2008

Magnetic Resonance Imaging

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Purpose: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). Materials and Methods: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. Results: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%). ECGrelated 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. Conclusion:Gadoversetamide is safe for use in patients with acute or chronic MI up to a dose of 0.3 mmol/kg.

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supporting

confidence: 93%

supporting

confidence: 56%

Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

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Safety of gadoversetamide in patients with acute and chronic myocardial infarction

Huber

Muthupillai

Cheong

et al. 2008

Magnetic Resonance Imaging

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“…In an adult population, gadoversetamide (0.1 mmol/kg) distributes through an apparent volume (V DSS ) approximately equal to the extracellular space [9,10]. In the current trial in pediatric patients, the mean V DSS for gadoversetamide for the 2-to 11-year age group and the 12-to 18-year age group appear similar to those found in healthy pediatric subjects [11].…”

Section: Discussionmentioning

confidence: 62%

Pharmacokinetics of gadoversetamide injection, a gadolinium-based contrast agent, in pediatric patients

Wible¹,

Tata²,

Lowe³

et al. 2009

Magnetic Resonance Imaging

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The OptiMARK clinical development program: Summary of safety data

Brown¹,

Kristy²,

Stevens³

et al. 2002

Magnetic Resonance Imaging

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Purpose: To describe and summarize the safety data from the OptiMARK clinical development program. Materials and Methods:In the 18 clinical studies comprising the clinical program, doses ranging from 0.1 to 0.7 mmol/kg were administered to healthy adult volunteers, patients with hepatic or renal impairment, and patients with confirmed or highly suspected central nervous system (CNS), liver, breast, vascular, bone, or soft tissue pathologies. A total of 2038 injections of OptiMARK, Magnevist, or placebo were administered to 1684 subjects. Safety assessments were performed at appropriate intervals during all Phase 1, 2, and 3 studies. Results:Of the 1684 subjects exposed to a study drug or placebo in the clinical development program, 646 subjects experienced 1293 adverse events. Thirty-one percent of the OptiMARK injections were associated with an adverse event. In comparison, 35% of Magnevist injections and 48% of placebo injections were associated with at least one adverse event.Conclusions: OptiMARK was safe and well-tolerated with a safety profile similar to that of Magnevist.

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Pharmacokinetics, safety, and tolerability of gadoversetamide injection (OptiMARK) in subjects with central nervous system or liver pathology and varying degrees of renal function

Cited by 51 publications

References 3 publications

Safety of gadoversetamide in patients with acute and chronic myocardial infarction

Safety of gadoversetamide in patients with acute and chronic myocardial infarction

Pharmacokinetics of gadoversetamide injection, a gadolinium-based contrast agent, in pediatric patients

The OptiMARK clinical development program: Summary of safety data

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