Gadopentetate

Gadopentetate
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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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.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Gadopentetate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Gadopentetate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Gadopentetate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Gadopentetate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Gadopentetate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Gadopentetate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Gadopentetate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Gadopentetate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Gadopentetate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Gadopentetate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Gadopentetate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Gadopentetate in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Gadopentetate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Gadopentetate in the drug label.

Pharmacology

There is limited information regarding Gadopentetate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Gadopentetate01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Gadopentetate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Gadopentetate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Gadopentetate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Gadopentetate in the drug label.

How Supplied

Storage

There is limited information regarding Gadopentetate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Gadopentetate in the drug label.

Precautions with Alcohol

• Alcohol-Gadopentetate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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