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Omniscan (Gadodiamide) - Summary

 
 



WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)

Gadolinium-based contrast agents increase the risk for 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 and Precautions ].

 

OMNISCAN SUMMARY

OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is to be administered by intravenous injection. OMNISCAN is provided as a sterile, clear, colorless to slightly yellow, aqueous solution. Each mL contains 287 mg gadodiamide, 12 mg caldiamide sodium and water for injection. The pH is adjusted between 5.5 and 7.0 with hydrochloric acid and/or sodium hydroxide. OMNISCAN contains no antimicrobial preservative. OMNISCAN is a 0.

CNS (Central Nervous System)

OMNISCAN is indicated for intravenous use in MRI to visualize lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues.

Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

OMNISCAN is indicated for intravenous administration to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space.


See all Omniscan indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Omniscan (Gadodiamide)

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This systemic inflammatory disorder, which occurs most often in older men, can be tricky to diagnose and even harder to effectively treat.
Medscape Gastroenterology

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Source: Medical Devices / Diagnostics News From Medical News Today [2014.07.15]
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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]
New Speakers, Additional Learning Opportunities Available at the 5th Annual Clinical Affairs and Regulatory Approvals for Diagnostics ConferenceThe most popular meeting for clinical and...

Researchers review the effectiveness of rapid diagnostic tests in diagnosing patients with visceral leishmaniasis
Source: Tropical Diseases News From Medical News Today [2014.06.24]
Researchers from the Cochrane Infectious Disease Group, co-ordinated through the editorial base in LSTM, conducted an independent review into the effectiveness of rapid diagnostic tests in diagnosing...

Low-dose computed tomography screening shows improved diagnostic performance
Source: Lung Cancer News From Medical News Today [2014.06.17]
Investigators of the COSMOS (Continuous Observation of SMOking Subjects) study show good compliance and patient survival outcomes using a 5-year low-dose computed tomography (LDCT) screening protocol...

more news >>

Published Studies Related to Omniscan (Gadodiamide)

Comparison of gadobenate dimeglumine and gadodiamide in the evaluation of spinal vascular anatomy with MR angiography. [2010.06]
BACKGROUND AND PURPOSE: Spinal MRA has been increasingly used to evaluate non-invasively the spinal cord vasculature. Our aim was to prospectively compare gadobenate dimeglumine with gadodiamide in the assessment of the normal spinal cord vasculature by using contrast-enhanced MRA, with the hypothesis that high T1 relaxivity gadolinium compounds may improve visualization of the intradural vessels... CONCLUSIONS: Improved image quality and vascular contrast enhancement of spinal MRA at 1.5T is achieved with high T1 relaxivity gadolinium contrast agents compared with conventional agents at equivalent doses.

Comparison of gadodiamide-enhanced MR angiography to intraarterial digital subtraction angiography for evaluation of renal artery stenosis: results of a phase III multicenter trial. [2010.02]
PURPOSE: To evaluate the efficacy and safety of 0.1 mmol/kg gadodiamide administration for contrast-enhanced magnetic resonance angiography (MRA) in detecting hemodynamically relevant renal artery stenosis (RAS) when compared with intraarterial digital subtraction angiography (IA-DSA) as the gold standard... CONCLUSION: Gadodiamide administration at the labeled dose of 0.1 mmol/kg for contrast-enhanced MRA achieved equivalent results compared to IA-DSA in evaluation of RAS and was well tolerated.

Abdominal and iliac arterial stenoses: comparative double-blinded randomized study of diagnostic accuracy of 3D MR angiography with gadodiamide or gadopentetate dimeglumine. [2006.03]
PURPOSE: To prospectively evaluate accuracy of gadolinium-enhanced three-dimensional (3D) magnetic resonance (MR) angiography with gadodiamide and gadopentetate dimeglumine (0.1 mmol/kg), with intraarterial DSA as reference standard, for imaging abdominal and iliac arterial stenoses... CONCLUSION: Noninferiority of gadodiamide versus gadopentetate was verified based on the primary end point, which was accuracy for detection of the main stenosis with enhanced 3D MR angiography compared with DSA. Copyright RSNA, 2006.

Contrast-enhanced magnetic resonance angiography of the lower extremities: standard-dose vs. high-dose gadodiamide injection. [2005.04]
PURPOSE: To compare the efficacy and safety of two different doses (0.1 and 0.3 mmol/kg of body weight [BW]) of gadodiamide for contrast-enhanced magnetic resonance angiography (ce-MRA) of the lower extremities with intraarterial digital subtraction angiography (IA-DSA)... CONCLUSION: Ce-MRA with gadodiamide is safe and efficacious. Comparison of two different doses with IA-DSA as the standard of reference showed that the 0.3 mmol/kg dose is superior to the standard 0.1 mmol/kg dose with respect to contrast enhancement, vessel delineation, image quality, and detection of collaterals. However, the 0.1 mmol/kg dose was superior to the high dose in the grading of stenosis. Copyright 2005 Wiley-Liss, Inc.

Contrast-enhanced MRI of the inner ear after intratympanic injection of meglumine gadopentetate or gadodiamide hydrate. [2011.02]
CONCLUSION: The degree of contrast enhancement of the cochlea after intratympanic administration of meglumine gadopentetate (Gd-DTPA) or gadodiamide hydrate (Gd-DTPA-BMA) varies widely among patients with inner ear diseases. There was no morphological change in the stria vascularis after Gd-DTPA or Gd-DTPA-BMA was placed on the round window of guinea pigs. OBJECTIVES: We investigated the degree of contrast enhancement of the inner ear after intratympanic administration of ionized and nonionized gadolinium (Gd) contrast agents in patients with inner ear diseases. The inner ear toxicities of these agents were investigated in guinea pigs... CONCLUSION: The degree of contrast enhancement of the cochlea after intratympanic administration of meglumine gadopentetate (Gd-DTPA) or gadodiamide hydrate (Gd-DTPA-BMA) varies widely among patients with inner ear diseases. There was no morphological change in the stria vascularis after Gd-DTPA or Gd-DTPA-BMA was placed on the round window of guinea pigs. OBJECTIVES: We investigated the degree of contrast enhancement of the inner ear after intratympanic administration of ionized and nonionized gadolinium (Gd) contrast agents in patients with inner ear diseases. The inner ear toxicities of these agents were investigated in guinea pigs. METHODS: 3D-FLAIR MRI was conducted 1 day after the intratympanic injection of eightfold-diluted Gd-DTPA or Gd-DTPA-BMA in 73 patients with inner ear diseases. Gd enhancement of the basal turn of the cochlea was evaluated as the signal intensity (SI) ratio between the affected and nonaffected sides. In guinea pigs, nondiluted Gd-DTPA, Gd-DTPA-BMA or saline was placed on the round window for 1 h and the stria vascularis was observed using electron microscopy. RESULTS: The SI ratio ranged from 1.5 to 16.5 in the Gd-DTPA group and from 2.5 to 21 in the Gd-DTPA-BMA group. Electron microscopy showed no significant differences in the stria vascularis of guinea pigs in any of the groups.

more studies >>

Clinical Trials Related to Omniscan (Gadodiamide)

Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI) [Recruiting]
This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be administered intravenously at the medical discretion of the prescribing physician.

A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide [Completed]
Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body.

Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the renal artery vessels using MR.

The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in renal arteries. Intra-arterial Digital Subtraction Angiography will be used as the standard of truth.

A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-Iliac Arteries While Using Gadodiamide [Completed]
Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body.

Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the aorto-iliac vessels using MR.

The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in aorto-iliac arteries. Intra-arterial Digital Subtraction Angiography (IADSA) will be used as the standard of truth.

A Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain [Completed]
This study aims at a direct comparison between Multihance and a validated comparator like Omniscan in a cross-over individual design in patients with brain tumors to confirm the superior overall diagnostic performance of MuliHance for this indication

Early Detection of Glioblastoma Multiforme (GBM) Treatment Responses Using Multiple Magnetic Resonance Modalities [Recruiting]
The purpose of this study is to determine whether dynamic contrast enhanced MRI (DCE MRI) and high diffusion weighting MRI may be used to distinguish between favorable and unfavorable responses to therapy of glioblastoma multiforme. Imaging data will be correlated with histopathologic findings and clinical responses to radiation therapy with or without chemotherapy.

more trials >>

Reports of Suspected Omniscan (Gadodiamide) Side Effects

Nephrogenic Systemic Fibrosis (229)Pain (163)Skin Induration (108)Skin Tightness (97)Mobility Decreased (94)Skin Hypertrophy (93)Oedema Peripheral (92)Anxiety (85)Pain in Extremity (80)Emotional Distress (79)more >>


Page last updated: 2014-07-15

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