Gadobenate Dimeglumine: Difference between revisions

Gadobenate Dimeglumine
	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 18:00, 27 April 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Black Box Warning

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS

See full prescribing information for complete Boxed Warning.

* 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 systemic 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 (e.g. 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 MultiHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration.

Overview

Gadobenate Dimeglumine is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

MRI of the Central Nervous System (CNS)

MultiHance is indicated for intravenous use in magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and children over 2 years of age to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues.

MRA of Renal and Aorto-ilio-femoral Vessels

MultiHance is indicated for use in magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.

Dosing and Imaging Instructions

MRI of the CNS

The recommended dose of MultiHance for MRI of the CNS is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid bolus intravenous injection. To ensure complete injection of the contrast medium, follow the injection with a saline flush of at least 5 mL. Imaging of the CNS can be performed starting immediately after the bolus injection of MultiHance.

MRA of Renal and Aorto-ilio-femoral Vessels

For MRA examination, the recommended dose is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid bolus intravenous injection followed by at least 20 mL saline flush either manually or using an automatic injector system. Start imaging immediately after the administration of MultiHance, with scan delay calculated by test bolus or automatic bolus detection technique. If an automatic contrast detection pulse sequence is not used for bolus timing, then a test bolus injection of 1-2 mL of MultiHance should be used to calculate the appropriate scan delay.

Dosing Table

This image is provided by the National Library of Medicine.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

Developed by:

Class of Recommendation:

Strength of Evidence:

Dosing Information

Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

Dosing Information

Dosage

Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

Dosing Information

Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Gadobenate Dimeglumine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

Developed by:

Class of Recommendation:

Strength of Evidence:

Dosing Information

Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

Dosing Information

Dosage

Condition2

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

Contraindications

Condition1

Warnings

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS

See full prescribing information for complete Boxed Warning.

* 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 systemic 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 (e.g. 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 MultiHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration.

Description

Precautions

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Gadobenate Dimeglumine 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 Gadobenate Dimeglumine 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 Gadobenate Dimeglumine in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

IV

Inspect the MultiHance vial visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present. Draw MultiHance into a syringe and inject using sterile technique.

Do not mix intravenous medications or parenteral nutrition solutions with MultiHance. Do not administer other medications in the same intravenous line with MultiHance.

MultiHance vials are intended for single use only. Administer immediately after opening and discard any unused product.

Monitoring

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

Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Gadobenate Dimeglumine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Gadobenate Dimeglumine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Gadobenate Dimeglumine Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

Alcohol-Gadobenate Dimeglumine 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.

↑ Empty citation (help)
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[1] Empty citation (help)

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[1]

[2]

@@ Line 1: / Line 1: @@
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+|genericName=gadobenate dimeglumine
 |aOrAn=a
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 |adverseReactions=<!--Black Box Warning-->
-|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
+|blackBoxWarningTitle=WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
-|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
+|blackBoxWarningBody=* 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 systemic fibrosis affecting the skin, muscle and internal organs.
-* Content
+* The risk for NSF appears highest among patients with:
-<!--Adult Indications and Dosage-->
+:*Chronic, severe kidney disease (GFR <30 mL/min/1.73m2), or
-<!--FDA-Labeled Indications and Dosage (Adult)-->
+:*Acute kidney injury.
-|fdaLIADAdult======Condition1=====
-* Dosing Information
+* 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 or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
+* For patients at highest risk for NSF, do not exceed the recommended MultiHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration.
+|fdaLIADAdult===Indications==
+'''MRI of the Central Nervous System (CNS)'''
-:* Dosage
+* MultiHance is indicated for intravenous use in magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and children over 2 years of age to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues.
-=====Condition2=====
+'''MRA of Renal and Aorto-ilio-femoral Vessels'''
-* Dosing Information
+* MultiHance is indicated for use in magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.
-:* Dosage
+==Dosing and Imaging Instructions==
-=====Condition3=====
+'''MRI of the CNS'''
-* Dosing Information
+* The recommended dose of MultiHance for MRI of the CNS is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid bolus intravenous injection. To ensure complete injection of the contrast medium, follow the injection with a saline flush of at least 5 mL. Imaging of the CNS can be performed starting immediately after the bolus injection of MultiHance.
-:* Dosage
+'''MRA of Renal and Aorto-ilio-femoral Vessels'''
-=====Condition4=====
+* For MRA examination, the recommended dose is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid bolus intravenous injection followed by at least 20 mL saline flush either manually or using an automatic injector system. Start imaging immediately after the administration of MultiHance, with scan delay calculated by test bolus or automatic bolus detection technique. If an automatic contrast detection pulse sequence is not used for bolus timing, then a test bolus injection of 1-2 mL of MultiHance should be used to calculate the appropriate scan delay.
-* Dosing Information
+== Dosing Table==
-:* Dosage
+[[ File:Multihance dosing table.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
-<!--Off-Label Use and Dosage (Adult)-->
-<!--Guideline-Supported Use (Adult)-->
 |offLabelAdultGuideSupport======Condition1=====
@@ Line 263: / Line 267: @@
 |useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
-<!--Administration and Monitoring-->
-|administration=* Oral
-* Intravenous
+|administration=* IV
+* Inspect the MultiHance vial visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present. Draw MultiHance into a syringe and inject using sterile technique.
+* Do not mix intravenous medications or parenteral nutrition solutions with MultiHance. Do not administer other medications in the same intravenous line with MultiHance.
+* MultiHance vials are intended for single use only. Administer immediately after opening and discard any unused product.
 |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.