Gadoterate

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Gadoterate
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: NEPHROGENIC SYSTEMIC FIBROSIS (NSF):
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.

The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m2), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing (5.1).

For patients at highest risk for NSF, do not exceed the recommended DOTAREM dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration

Overview

Gadoterate is a Diagnostic Agent that is FDA approved for the diagnosis of areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity in brain (intracranial), spine and associated tissues with magnetic resonance imaging (MRI). There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea, headache, injection site pain, injection site coldness, and burning sensation.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Dosage

Dosing Guidelines For adult and pediatric patients (2 years and older), the recommended dose of DOTAREM is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second for adults and 1 - 2 mL/second for pediatric patients. Table 1 provides weight-adjusted dose volumes.

To ensure complete injection of DOTAREM the injection may be followed by normal saline flush. Contrast MRI can begin immediately following DOTAREM injection.

2.2 Drug Handling Visually inspect DOTAREM for particulate matter prior to administration. Do not use the solution if particulate matter is present or if the container appears damaged. DOTAREM should be a clear, colorless to yellow solution. Do not mix with other drugs or parenteral nutrition. Discard any unused portions of the drug.

When DOTAREM is to be injected using plastic disposable syringes, the contrast medium should be drawn into the syringe and used immediately.

3 DOSAGE FORMS AND STRENGTHS DOTAREM 0.5 mmol/mL is a sterile, clear, colorless to yellow, aqueous solution for intravenous injection containing 376.9 mg/mL gadoterate meglumine and is available in vials and pre-filled syringes.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Gadoterate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Gadoterate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

  • DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Dosage

Dosing Guidelines For adult and pediatric patients (2 years and older), the recommended dose of DOTAREM is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second for adults and 1 - 2 mL/second for pediatric patients. Table 1 provides weight-adjusted dose volumes.

To ensure complete injection of DOTAREM the injection may be followed by normal saline flush. Contrast MRI can begin immediately following DOTAREM injection.

2.2 Drug Handling Visually inspect DOTAREM for particulate matter prior to administration. Do not use the solution if particulate matter is present or if the container appears damaged. DOTAREM should be a clear, colorless to yellow solution. Do not mix with other drugs or parenteral nutrition. Discard any unused portions of the drug.

When DOTAREM is to be injected using plastic disposable syringes, the contrast medium should be drawn into the syringe and used immediately.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Gadoterate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Gadoterate in pediatric patients.

Contraindications

  • Condition1

Warnings

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF):
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.

The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m2), or Acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing (5.1).

For patients at highest risk for NSF, do not exceed the recommended DOTAREM 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 Gadoterate 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 Gadoterate 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 Gadoterate in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Gadoterate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Gadoterate 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 Gadoterate in the drug label.

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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