DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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)

    New diagnostic tools for dehydration severity in children
    Source: GastroIntestinal / Gastroenterology News From Medical News Today [2015.08.21]
    System may improve intake of cholera, diarrhea casesDehydration from diarrhea, either from viral infection or cholera, accounts for 10 percent of all child deaths worldwide.

    Novel diagnostic tool for ethnically diverse non-small-cell lung cancer patients
    Source: Lung Cancer News From Medical News Today [2015.08.17]
    A new serum miRNA panel could lead to accurately and early diagnosing NSCLC in ethnically diverse patientsEarly-stage Non-small-cell Lung Cancer (NSCLC) is asymptomatic and difficult to detect...

    Diagnostic imaging can rule out coronary artery disease in patients with atypical chest pain
    Source: Radiology / Nuclear Medicine News From Medical News Today [2015.08.13]
    Non-invasive diagnostic imaging can rule out coronary artery disease (CAD) in about 50% of women with atypical chest pain who are at relatively low risk for CAD, while exposing them to only a modest...

    Delay in treatment, missed diagnostic testing found among lung cancer patients
    Source: Lung Cancer News From Medical News Today [2015.08.06]
    Study published in The Annals of Thoracic Surgery examines how long it takes to begin care and what steps are taken to determine appropriate treatmentPatients undergoing surgery for lung cancer...

    Study identifies delays in lung cancer treatment due to missed diagnostic testing
    Source: Lung Cancer News From Medical News Today [2015.07.31]
    Many patients with suspected lung cancer are missing diagnostic tests, which is leading to delays in treatment for the condition, according to new research.

    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)

    Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI [Recruiting]
    This research is being done to find out if using the contrast agent MultiHance can be used to show how a liver tumor responds to the chemotherapy given during Transcatheter Arterial Chemoembolization (TACE).

    MultiHance is approved by the Food and Drug Administration (FDA) for use as a contrast material for Magnetic Resonance Imaging (MRI) scans of the central nervous system. It is believed that using MultiHance may be able to help doctors tell normal liver cells apart from active tumor and from tumor affected by the chemotherapy. In this way, MultiHance may improve the way patients with hepatocellular carcinoma are managed clinically.

    We hypothesize that the Multi-Hance contrast material will provide better image definition of treated liver tumor(s) on MRI imaging in comparison to other commercially available contrast agents.

    Gadobutrol Magnevist-controlled Body Study [Recruiting]
    The purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the body/extremities regions. The results of the MRI with gadobutrol injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with Magnevist.

    Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries [Recruiting]
    To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries

    Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist [Recruiting]
    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.

    Safety and Efficacy Evaluation of DOTAREM� in MRI of Central Nervous System (CNS) Lesions [Recruiting]
    The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.

    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: 2015-08-21

    -- advertisement -- The American Red Cross
     
    Home | About Us | Contact Us | Site usage policy | Privacy policy

    All Rights reserved - Copyright DrugLib.com, 2006-2015