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Magnevist (Gadopentetate Dimeglumine) - Summary

 
 



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.

  • Do not administer Magnevist to patients with: o chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
  • o acute kidney injury [see Contraindications ( 4 )].
  • 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 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 ( 5.1 )].

     

    MAGNEVIST SUMMARY

    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.

    Extracranial/Extraspinal Tissues

    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.

    Body

    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).


    See all Magnevist indications & dosage >>

    NEWS HIGHLIGHTS

    Media Articles Related to Magnevist (Gadopentetate)

    VIB scientists develop diagnostic tool for Familial Mediterranean Fever
    Source: Genetics News From Medical News Today [2016.11.25]
    Researchers at VIB and Ghent University have developed a tool to diagnose Familial Mediterranean Fever (FMF).

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    Join us at our Advances in Companion Diagnostics Congress and take part in high level discussions with key opinion leaders and gain insights into the latest challenges in the industry.

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    Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2016.11.22]
    Academics in the University of Surrey's Department of Chemistry have developed a new diagnostic test for cocaine and benzoylecgonine (the main metabolite for cocaine) in urine and oral fluid.

    Stereotactic Breast Biopsy: What Happens, Results, and Outlook
    Source: Breast Cancer News From Medical News Today [2016.11.17]
    Learn about stereotactic breast biopsies, their benefits, and what they are used for. This article describes what to expect with this diagnostic procedure.

    more news >>

    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.

    more studies >>

    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 also assessed.

    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.

    more trials >>

    Reports of Suspected Magnevist (Gadopentetate) Side Effects

    Nephrogenic Systemic Fibrosis (284)Pain (217)Skin Induration (158)Anxiety (135)Mobility Decreased (134)Pruritus (128)Skin Tightness (125)Oedema Peripheral (122)Emotional Distress (118)Skin Hypertrophy (110)more >>


    Page last updated: 2016-11-25

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