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Black Box Warning
WARNING:
See full prescribing information for complete Boxed 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:
chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
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
Overview
Gadopentetate is a Diagnostic Agent that is FDA approved for the diagnosis of lesions and abnormal vascularity in Central Nervous System, Extracranial/Extraspinal Tissues. There is a Black Box Warning for this drug as shown here. Common adverse reactions include headache, nausea, injection site coldness/localized coldness, and dizziness.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
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.
1.2 Extracranial/Extraspinal Tissues
Magnevist injection 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.
1.3 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.
Dosage
The recommended dosage of Magnevist injection is 0.2 mL/kg (0.1 mmol/kg) administered intravenously, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 lbs has not been studied systematically.
To ensure complete injection of Magnevist, administer 5-mL normal saline flush after the injection. The imaging procedure should be completed within 1 hour of injection of Magnevist injection.
Visually inspect for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored, if particulate matter is present or if the container appears damaged.
Discard any unused portion in accordance with regulations dealing with the disposal of such materials.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Gadopentetate in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Gadopentetate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indications
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.
1.2 Extracranial/Extraspinal Tissues
Magnevist injection 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.
1.3 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.
Dosage
The recommended dosage of Magnevist injection is 0.2 mL/kg (0.1 mmol/kg) administered intravenously, at a rate not to exceed 10 mL per 15 seconds. Dosing for patients in excess of 286 lbs has not been studied systematically.
To ensure complete injection of Magnevist, administer 5-mL normal saline flush after the injection. The imaging procedure should be completed within 1 hour of injection of Magnevist injection.
Visually inspect for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored, if particulate matter is present or if the container appears damaged.
Discard any unused portion in accordance with regulations dealing with the disposal of such materials.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Gadopentetate in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Gadopentetate in pediatric patients.
Contraindications
Condition1
Warnings
WARNING:
See full prescribing information for complete Boxed 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:
chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
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
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Gadopentetate in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Gadopentetate in the drug label.