WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:
- acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or
- acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration (see WARNINGS).
OptiMARK™ Pharmacy Bulk Package
OptiMARK™ 0.5 mmol/mL
OptiMARK® (gadoversetamide injection) is a formulation of a nonionic gadolinium chelate of diethylenetriamine pentaacetic acid bismethoxyethylamide (gadoversetamide), for use in magnetic resonance imaging (MRI). OptiMARK® Injection is to be administered by intravenous injection only. OptiMARK® Injection is provided as a sterile, nonpyrogenic, clear, colorless to pale yellow, aqueous solution of gadoversetamide. No preservative is added. Each mL of OptiMARK® Injection contains 330.9 mg of gadoversetamide (0.5 millimole), 28.4 mg of calcium versetamide sodium (0.05 millimole), 0.7 mg calcium chloride dihydrate (0.005 millimole), and water for injection. Sodium hydroxide and/or hydrochloric acid may have been added for pH adjustment.
CNS (CENTRAL NERVOUS SYSTEM)
OptiMARK® Injection is indicated for use with magnetic resonance imaging (MRI) in patients with abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues.
OptiMARK® Injection is indicated for use with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver in patients who are highly suspect for liver structural abnormalities on computed tomography.
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5th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference, October 27-29, Arlington, Virginia
Source: Conferences News From Medical News Today [2014.06.30]
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Published Studies Related to Optimark (Gadoversetamide)
Performance of delayed-enhancement magnetic resonance imaging with gadoversetamide contrast for the detection and assessment of myocardial infarction: an international, multicenter, double-blinded, randomized trial. [2008.02.05]
CONCLUSIONS: Gadoversetamide-enhanced MRI using doses of > or = 0.2 mmol/kg is effective in the detection and assessment of both acute and chronic MI. This study represents the first multicenter trial designed to evaluate an imaging approach for detecting MI.
Pharmacokinetics of gadoversetamide injection, a gadolinium-based contrast agent, in pediatric patients. [2009.05]
OBJECTIVE: The pharmacokinetics of gadoversetamide were examined in pediatric patients scheduled to undergo contrast-enhanced MRI of the central nervous system... CONCLUSIONS: The pharmacokinetic behavior of gadoversetamide was not significantly altered by differences in age or sex in pediatric patients from 2 to 18 years of age. Although significant differences in volumes of distribution, and clearance occurred between the age groups, these differences appeared to depend on body size rather than on age in pediatric patients between 2 and 18 years of age.
Nephrogenic systemic fibrosis associated with gadoversetamide exposure: treatment with sodium thiosulfate. [2009.01]
Nephrogenic systemic fibrosis (NSF) is a debilitating fibrosing disorder of patients with kidney disease that is associated with gadolinium-based contrast exposure... All 3 patients were treated early in their disease course with intravenous sodium thiosulfate and responded with improved skin changes and joint mobility.
Safety of gadoversetamide in patients with acute and chronic myocardial infarction. [2008.12]
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)... CONCLUSION: Gadoversetamide is safe for use in patients with acute or chronic MI up to a dose of 0.3 mmol/kg. (c) 2008 Wiley-Liss, Inc.
The safety and efficacy of neuroimaging with gadoversetamide injection in pediatric patients. [2006.12]
CONCLUSION: The administration of gadoversetamide injection (0.1 mmol/kg) was safe, well tolerated and produced clinically appropriate contrast enhancement for MRI of the CNS in the pediatric population.
Clinical Trials Related to Optimark (Gadoversetamide)
Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection [Recruiting]
The objective of this study is to prospectively monitor the incidence of adverse drug
reactions, specifically NSF during routine use of gadoversetamide in a large number of
patients with moderate renal insufficiency (eGFR 30-59) and severe renal insufficiency or
end-stage renal disease requiring dialysis (eGFR <30).
MRI Imaging of the Human Larynx [Recruiting]
Reports of Suspected Optimark (Gadoversetamide) Side Effects
Nephrogenic Systemic Fibrosis (177),
Mobility Decreased (87),
Skin Induration (80),
Emotional Distress (79),
Skin Tightness (78),
Oedema Peripheral (74),
Joint Range of Motion Decreased (64),
General Physical Health Deterioration (62), more >>
Page last updated: 2014-07-24