Gadoxetate: Difference between revisions

Gadoxetate
	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

VisualWikitext

Revision as of 18:06, 23 April 2015

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

Disclaimer

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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.

The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), 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 (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.

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

Overview

Gadoxetate is a Diagnostic Agent that is FDA approved for the diagnosis of known or suspected focal liver disease through MRI. There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea, headache, feeling hot, dizziness, and back pain.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

EOVIST is indicated for intravenous use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in patients with known or suspected focal liver disease.

Dosage

Recommended Dose The recommended dose of EOVIST is 0.1 mL/kg body weight (0.025 mmol/kg body weight).

2.2 Drug Handling and Administration Use sterile technique when preparing and administering EOVIST Visually inspect EOVIST, supplied in a single-use vial, for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or if particulate matter is present Use EOVIST immediately after obtaining appropriate dose from vial. The rubber stopper should never be pierced more than once. Discard any unused portion of an EOVIST vial Administer EOVIST undiluted as an intravenous bolus injection at a flow rate of approximately 2 mL/second Do not mix EOVIST with other medications and do not administer EOVIST in the same intravenous line simultaneously with other medications Flush the intravenous cannula with a normal saline solution after EOVIST injection Imaging can commence immediately following EOVIST administration 2.3 Imaging Liver lesions are detected and characterized with pre-contrast MRI and EOVIST MRI obtained during dynamic and hepatocyte imaging phases. Perform a pre-contrast MRI, inject EOVIST and begin dynamic imaging approximately 15–25 seconds after completion of the injection. Dynamic imaging consists of the arterial, the porto-venous (approximately 60 seconds post-injection), and the blood equilibrium (approximately 120 seconds) phases. Begin the hepatocyte imaging phase approximately 20 minutes post-injection. Hepatocyte phase imaging may be performed up to 120 minutes post-injection. Elevated intrinsic levels of bilirubin (>3 mg/dL) or ferritin can reduce the hepatic contrast effect of EOVIST. Perform MR imaging no later than 60 minutes following EOVIST administration to patients with these laboratory abnormalities, including patients who have elevated ferritin levels due to hemodialysis [see Warnings and Precautions (5.6) and Use in Specific Populations (8.6, 8.7)]. Lesions with no or minimal hepatocyte function (cysts, metastases, and the majority of hepatocellular carcinomas) generally will not accumulate EOVIST. Well-differentiated hepatocellular carcinoma may contain functioning hepatocytes and can show some enhancement in the hepatocyte imaging phase. Additional clinical information is therefore needed to support a diagnosis of hepatocellular carcinoma.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness in pediatric patients has not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Gadoxetate 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.

The risk for NSF appears highest among patients with: Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), 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 (for example, age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

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

Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Gadoxetate01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

{{#ask: Page Name::Gadoxetate |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Gadoxetate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

®^[1]

Look-Alike Drug Names

A® — B®^[2]

Drug Shortage Status

Price

References

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

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[1] Empty citation (help)

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[1]

[2]

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+Use sterile technique when preparing and administering EOVIST
-:* Dosage
+Visually inspect EOVIST, supplied in a single-use vial, for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or if particulate matter is present
+Use EOVIST immediately after obtaining appropriate dose from vial. The rubber stopper should never be pierced more than once. Discard any unused portion of an EOVIST vial
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+Administer EOVIST undiluted as an intravenous bolus injection at a flow rate of approximately 2 mL/second
+Do not mix EOVIST with other medications and do not administer EOVIST in the same intravenous line simultaneously with other medications
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+Flush the intravenous cannula with a normal saline solution after EOVIST injection
+Imaging can commence immediately following EOVIST administration
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+Liver lesions are detected and characterized with pre-contrast MRI and EOVIST MRI obtained during dynamic and hepatocyte imaging phases. Perform a pre-contrast MRI, inject EOVIST and begin dynamic imaging approximately 15–25 seconds after completion of the injection. Dynamic imaging consists of the arterial, the porto-venous (approximately 60 seconds post-injection), and the blood equilibrium (approximately 120 seconds) phases.
+Begin the hepatocyte imaging phase approximately 20 minutes post-injection. Hepatocyte phase imaging may be performed up to 120 minutes post-injection.
+Elevated intrinsic levels of bilirubin (>3 mg/dL) or ferritin can reduce the hepatic contrast effect of EOVIST. Perform MR imaging no later than 60 minutes following EOVIST administration to patients with these laboratory abnormalities, including patients who have elevated ferritin levels due to hemodialysis [see Warnings and Precautions (5.6) and Use in Specific Populations (8.6, 8.7)].
+Lesions with no or minimal hepatocyte function (cysts, metastases, and the majority of hepatocellular carcinomas) generally will not accumulate EOVIST. Well-differentiated hepatocellular carcinoma may contain functioning hepatocytes and can show some enhancement in the hepatocyte imaging phase. Additional clinical information is therefore needed to support a diagnosis of hepatocellular carcinoma.
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