WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs.
Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
Do not administer Magnevist to patients with:
chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
acute kidney injury [see Contraindications (
Do not exceed the recommended Magnevist dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions (
MAGNEVIST ® (brand of gadopentetate dimeglumine) Injection is the N- methylglucamine salt of the gadolinium complex of diethylenetriamine pentaacetic acid, and is an injectable contrast medium for magnetic resonance imaging (MRI).
MAGNEVIST Injection is indicated for the following:
Central Nervous System
MAGNEVIST Injection is indicated for use with magnetic resonance imaging (MRI) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. MAGNEVIST Injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors.
MAGNEVIST is indicated for use with MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the head and neck.
MAGNEVIST Injection is indicated for use in MRI in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the body (excluding the heart).
Media Articles Related to Magnevist (Gadopentetate)
Using tau imaging as diagnostic marker for Alzheimer disease
Source: Medical Devices / Diagnostics News From Medical News Today [2016.07.26]
The accumulation of β-Amyloid (Aβ) and tau proteins in the brain is hallmark pathology for Alzheimer disease.
FDA Panel Backs Point-of-Care HbA1c Diabetes Diagnostic Test
Source: Medscape Diabetes & Endocrinology Headlines [2016.07.25]
Some members of the device advisory committee expressed reservations about use of the Afinion HBA1c Dx test in CLIA-waived settings, which lack proficiency testing requirements.
Medscape Medical News
FDA Panel Divided Over Diagnostic HbA1c Test
Source: MedPage Today Endocrinology [2016.07.22]
(MedPage Today) -- Called generally safe and accurate, but panel questions future of use
'Smart thread' enables 3-D tissue embedding for medical diagnostics
Source: Medical Devices / Diagnostics News From Medical News Today [2016.07.21]
Researchers have embedded thread-based microfluidic networks with sensors inside 3-D tissue to measure tissue properties and transmit them wirelessly.
Zika virus: Antibodies identified with therapeutic and diagnostic potential
Source: Immune System / Vaccines News From Medical News Today [2016.07.18]
A team of researchers from the Institute for Research in Biomedicine (IRB, USI Università della Svizzera italiana) and the Swiss biotech company Humabs BioMed SA has identified novel therapeutic...
Published Studies Related to Magnevist (Gadopentetate)
Multicenter, double-blind, randomized, intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for Breast MR imaging (DETECT Trial). [2011.02]
PURPOSE: To intraindividually compare 0.1 mmol/kg doses of gadobenate dimeglumine and gadopentetate dimeglumine for contrast material-enhanced breast magnetic resonance (MR) imaging by using a prospective, multicenter double-blind, randomized protocol... CONCLUSION: Gadobenate dimeglumine is superior to gadopentetate dimeglumine for breast cancer diagnosis. (c) RSNA, 2010 Clinical trial registration no. NCT00486473 (http://www.clinicaltrials.gov/). Supplemental material: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100968/-/DC1.
Multicenter, double-blind, randomized, intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for MR angiography of peripheral arteries. [2010.06]
PURPOSE: To prospectively compare the image quality and diagnostic performance achieved with doses of gadobenate dimeglumine and gadopentetate dimeglumine of 0.1 mmol per kilogram of body weight in patients undergoing contrast material-enhanced magnetic resonance (MR) angiography of the pelvis, thigh, and lower-leg (excluding foot) for suspected or known peripheral arterial occlusive disease... CONCLUSION: Higher-quality vessel visualization, greater contrast enhancement, fewer technical failures, and improved diagnostic performance are obtained with gadobenate dimeglumine, relative to gadopentetate dimeglumine, when compared intraindividually at 0.1-mmol/kg doses in patients undergoing contrast-enhanced MR angiography for suspected peripheral arterial occlusive disease. Copyright RSNA, 2010
Detection of cerebral metastases on magnetic resonance imaging: intraindividual comparison of gadobutrol with gadopentetate dimeglumine. [2009.10]
CONCLUSION: At equal gadolinium dosage, gadobutrol appears to offer significant advantages over gadopentetate dimeglumine for the visualization of brain metastases, with particular benefit for improving the conspicuity of detected lesions.
Multicenter, double-blind, randomized, intra-individual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine in MRI of brain tumors at 3 tesla. [2009.04]
PURPOSE: To prospectively compare 0.1 mmol/kg doses of gadobenate dimeglumine and gadopentetate dimeglumine for contrast-enhanced MRI of brain lesions at 3 Tesla (T)... CONCLUSION: Brain lesion depiction at 3T is significantly improved with 0.1 mmol/kg gadobenate dimeglumine.
Comparison of 1.0 M gadobutrol and 0.5 M gadopentetate dimeglumine-enhanced magnetic resonance imaging in five hundred seventy-two patients with known or suspected liver lesions: results of a multicenter, double-blind, interindividual, randomized clinical phase-III trial. [2009.03]
CONCLUSION: This study documents evidence for the noninferiority of a single i.v. bolus injection of 1.0 M gadobutrol (0.1 mmol/kg body weight) to 0.5 M gadopentetate (0.1 mmol/kg body weight) in the diagnostic assessment of liver lesions with contrast-enhanced MRI. The known excellent safety profile of gadobutrol was confirmed in this clinical trial and is similar to that of gadopentetate.
Clinical Trials Related to Magnevist (Gadopentetate)
Multihance at 3 Tesla in Brain Tumors [Completed]
The purpose of this study is to evaluate whether Multihance is superior to Magnevist in
terms of qualitative and quantitative assessment of unenhanced MRI and contrast-enhanced MRI
for the visualization of brain disease.
Magnevist Post-marketing Surveillance in Japan [Completed]
This study is a regulatory post-marketing surveillance in Japan, and it is a local
prospective and observational study of patients who have received Magnevist at a dose of
more than 0. 2 ml/kg for MR angiography of peripheral vasculature with continuous imaging
from the abdomen to the lower extremities. The objective of this study is to assess safety,
especially in relation to renal dysfunction, and efficacy of using Magnevist in clinical
practice. A total 2,000 patients will be recruited.
Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist [Completed]
Assess potential risk for NSF in subjects with renal impairment (moderate) post magnevist
injection. Subjects will be screened within 48 hours of previously scheduled MRI, those
meeting the enrollment criteria will be enrolled prior to MRI and followed for 2 years post
MRI with visits occuring at 1yr and 2 yr timepoints, in addition follow-up phone calls
conducted at 1, 3, 6 and 18 months to assess for skin changes suggestive of NSF.
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography [Completed]
The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of
0. 1 mmol/kg and 0. 2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three
regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179
not assessable: caused by contrast media in the evaluation of structural abnormalities.
Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with
arterial disease in the abdominal to leg regions. The safety of the 0. 2 mmol/kg dose was
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain Metastasis [Completed]
To verify the number of metastatic brain tumors detected in contrast-enhanced MRI, which is
the primary variable, increases after an additional dose of Magnevist (SH L 451A) comparing
images after an initial dose (0. 1 mmol/kg) with those after an additional dose (0. 1 mmol/kg,
a total dose of 0. 2 mmol/kg) intra-individually in patients with metastatic brain tumors.
Safety was also to be assessed.
Reports of Suspected Magnevist (Gadopentetate) Side Effects
Nephrogenic Systemic Fibrosis (284),
Skin Induration (158),
Mobility Decreased (134),
Skin Tightness (125),
Oedema Peripheral (122),
Emotional Distress (118),
Skin Hypertrophy (110), more >>
Page last updated: 2016-07-26