Fludeoxyglucose F 18: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{KS}}
|genericName=fludeoxyglucose f-18
|aOrAn=a
|aOrAn=a
|indicationType=treatment
|indicationType=treatment
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult===Indications==


* Dosing Information
* Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:


:* Dosage
'''Oncology'''


=====Condition2=====
* For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.


* Dosing Information
'''Cardiology'''


:* Dosage
* For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.


=====Condition3=====
'''Neurology'''


* Dosing Information
* For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.


:* Dosage
==Dosage==


=====Condition4=====
* Fludeoxyglucose F18 Injection emits radiation. Use procedures to minimize radiation exposure. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient.


* Dosing Information
'''Recommended Dose for Adults'''


:* Dosage
* Within the oncology, cardiology and neurology settings, the recommended dose for adults is 5 – 10 mCi (185 – 370 MBq) as an intravenous injection.


<!--Off-Label Use and Dosage (Adult)-->
'''Radiation Dosimetry'''


<!--Guideline-Supported Use (Adult)-->
* The estimated human absorbed radiation doses (rem/mCi) to a newborn (3.4 kg), 1-year old (9.8 kg), 5-year old (19 kg), 10-year old (32 kg), 15-year old (57 kg), and adult (70 kg) from intravenous administration of Fludeoxyglucose F18 Injection are shown in Table 1. These estimates were calculated based on human2 data and using the data published by the International Commission on Radiological Protection4 for Fludeoxyglucose 18F. The dosimetry data show that there are slight variations in absorbed radiation dose for various organs in each of the age groups. These dissimilarities in absorbed radiation dose are due to developmental age variations (e.g., organ size, location, and overall metabolic rate for each age group). The identified critical organs (in descending order) across all age groups evaluated are the urinary bladder, heart, pancreas, spleen, and lungs.
|offLabelAdultGuideSupport======Condition1=====


* Developed by:
[[File:Fludeoxyglucose table1.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


* Class of Recommendation:
==DOSAGE FORMS AND STRENGTHS==


* Strength of Evidence:
* Multiple-dose glass vial containing 0.74 - 11.1GBq (20 - 300 mCi/mL) of Fludeoxyglucose F18 Injection and 4.5 mg of sodium chloride in phosphate buffer per mL and ethanol (approximately 14 - 30 mL of total volume) for intravenous administration.


* Dosing Information


:* Dosage
|offLabelAdultGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


=====Condition2=====


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====


* Dosing Information


:* Dosage
|fdaLIADPed===Indications==


=====Condition2=====
* Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
'''Oncology'''


<!--Pediatric Indications and Dosage-->
* For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
'''Cardiology'''
|fdaLIADPed======Condition1=====


* Dosing Information
* For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.


:* Dosage
'''Neurology'''


=====Condition2=====
* For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.


There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
==Dosage==
* Within the neurology setting, the recommended dose for pediatric patients is 2.6 mCi, as an intravenous injection. The optimal dose adjustment on the basis of body size or weight has not been determined.


<!--Off-Label Use and Dosage (Pediatric)-->
==DOSAGE FORMS AND STRENGTHS==


<!--Guideline-Supported Use (Pediatric)-->
* Multiple-dose glass vial containing 0.74 - 11.1GBq (20 - 300 mCi/mL) of Fludeoxyglucose F18 Injection and 4.5 mg of sodium chloride in phosphate buffer per mL and ethanol (approximately 14 - 30 mL of total volume) for intravenous administration.
|offLabelPedGuideSupport======Condition1=====


* Developed by:
==Radiation Dosimetry==


* Class of Recommendation:
* The estimated human absorbed radiation doses (rem/mCi) to a newborn (3.4 kg), 1-year old (9.8 kg), 5-year old (19 kg), 10-year old (32 kg), 15-year old (57 kg), and adult (70 kg) from intravenous administration of Fludeoxyglucose F18 Injection are shown in Table 1. These estimates were calculated based on human2 data and using the data published by the International Commission on Radiological Protection4 for Fludeoxyglucose 18F. The dosimetry data show that there are slight variations in absorbed radiation dose for various organs in each of the age groups. These dissimilarities in absorbed radiation dose are due to developmental age variations (e.g., organ size, location, and overall metabolic rate for each age group). The identified critical organs (in descending order) across all age groups evaluated are the urinary bladder, heart, pancreas, spleen, and lungs.


* Strength of Evidence:
[[File:Fludeoxyglucose table1.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


* Dosing Information


:* Dosage


=====Condition2=====
|offLabelPedGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelPedNoGuideSupport======Condition1=====


* Dosing Information


:* Dosage
|contraindications=* None
|warnings='''Radiation Risks'''


=====Condition2=====
* Radiation-emitting products, including Fludeoxyglucose F18 Injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker.


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
'''Blood Glucose Abnormalities'''


<!--Contraindications-->
* In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. In these patients, consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to Fludeoxyglucose F18 Injection administration.
|contraindications=* Condition1
 
<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.


Line 321: Line 300:


<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
|brandNames=*FLUDEOXYGLUCOSE F18 ®<ref>{{Cite web | title =fludeoxyglucose f-18 injection, solution  | url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=edb15e3c-848d-433d-9f1c-c73a3c72861b }}</ref>
 


<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


<!--Drug Shortage Status-->
 
|drugShortage=
|drugShortage=
}}
}}

Revision as of 12:35, 23 April 2015

Fludeoxyglucose F 18
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: Kiran Singh, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Fludeoxyglucose F 18 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

  • Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:

Oncology

  • For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.

Cardiology

  • For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.

Neurology

  • For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.

Dosage

  • Fludeoxyglucose F18 Injection emits radiation. Use procedures to minimize radiation exposure. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient.

Recommended Dose for Adults

  • Within the oncology, cardiology and neurology settings, the recommended dose for adults is 5 – 10 mCi (185 – 370 MBq) as an intravenous injection.

Radiation Dosimetry

  • The estimated human absorbed radiation doses (rem/mCi) to a newborn (3.4 kg), 1-year old (9.8 kg), 5-year old (19 kg), 10-year old (32 kg), 15-year old (57 kg), and adult (70 kg) from intravenous administration of Fludeoxyglucose F18 Injection are shown in Table 1. These estimates were calculated based on human2 data and using the data published by the International Commission on Radiological Protection4 for Fludeoxyglucose 18F. The dosimetry data show that there are slight variations in absorbed radiation dose for various organs in each of the age groups. These dissimilarities in absorbed radiation dose are due to developmental age variations (e.g., organ size, location, and overall metabolic rate for each age group). The identified critical organs (in descending order) across all age groups evaluated are the urinary bladder, heart, pancreas, spleen, and lungs.
This image is provided by the National Library of Medicine.

DOSAGE FORMS AND STRENGTHS

  • Multiple-dose glass vial containing 0.74 - 11.1GBq (20 - 300 mCi/mL) of Fludeoxyglucose F18 Injection and 4.5 mg of sodium chloride in phosphate buffer per mL and ethanol (approximately 14 - 30 mL of total volume) for intravenous administration.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

  • There is limited information regarding Off-Label Guideline-Supported Use of Fludeoxyglucose F 18 in adult patients.

Non–Guideline-Supported Use

  • There is limited information regarding Off-Label Non–Guideline-Supported Use of Fludeoxyglucose F 18 in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

  • Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:

Oncology

  • For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.

Cardiology

  • For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.

Neurology

  • For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.

Dosage

  • Within the neurology setting, the recommended dose for pediatric patients is 2.6 mCi, as an intravenous injection. The optimal dose adjustment on the basis of body size or weight has not been determined.

DOSAGE FORMS AND STRENGTHS

  • Multiple-dose glass vial containing 0.74 - 11.1GBq (20 - 300 mCi/mL) of Fludeoxyglucose F18 Injection and 4.5 mg of sodium chloride in phosphate buffer per mL and ethanol (approximately 14 - 30 mL of total volume) for intravenous administration.

Radiation Dosimetry

  • The estimated human absorbed radiation doses (rem/mCi) to a newborn (3.4 kg), 1-year old (9.8 kg), 5-year old (19 kg), 10-year old (32 kg), 15-year old (57 kg), and adult (70 kg) from intravenous administration of Fludeoxyglucose F18 Injection are shown in Table 1. These estimates were calculated based on human2 data and using the data published by the International Commission on Radiological Protection4 for Fludeoxyglucose 18F. The dosimetry data show that there are slight variations in absorbed radiation dose for various organs in each of the age groups. These dissimilarities in absorbed radiation dose are due to developmental age variations (e.g., organ size, location, and overall metabolic rate for each age group). The identified critical organs (in descending order) across all age groups evaluated are the urinary bladder, heart, pancreas, spleen, and lungs.
This image is provided by the National Library of Medicine.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

  • There is limited information regarding Off-Label Guideline-Supported Use of Fludeoxyglucose F 18 in pediatric patients.

Non–Guideline-Supported Use

  • There is limited information regarding Off-Label Non–Guideline-Supported Use of Fludeoxyglucose F 18 in pediatric patients.

Contraindications

  • None

Warnings

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Radiation Risks

  • Radiation-emitting products, including Fludeoxyglucose F18 Injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker.

Blood Glucose Abnormalities

  • In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. In these patients, consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to Fludeoxyglucose F18 Injection administration.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Fludeoxyglucose F 18 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 Fludeoxyglucose F 18 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 Fludeoxyglucose F 18 in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Fludeoxyglucose F 18 during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Fludeoxyglucose F 18 with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Fludeoxyglucose F 18 with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Fludeoxyglucose F 18 with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Fludeoxyglucose F 18 with respect to specific gender populations.

Race

There is no FDA guidance on the use of Fludeoxyglucose F 18 with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Fludeoxyglucose F 18 in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Fludeoxyglucose F 18 in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Fludeoxyglucose F 18 in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Fludeoxyglucose F 18 in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Fludeoxyglucose F 18 in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Fludeoxyglucose F 18 in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Fludeoxyglucose F 18 in the drug label.

Pharmacology

There is limited information regarding Fludeoxyglucose F 18 Pharmacology in the drug label.

Mechanism of Action

Structure

File:Fludeoxyglucose F 1801.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Fludeoxyglucose F 18 in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Fludeoxyglucose F 18 in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Fludeoxyglucose F 18 in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Fludeoxyglucose F 18 in the drug label.

How Supplied

Storage

There is limited information regarding Fludeoxyglucose F 18 Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Fludeoxyglucose F 18 |?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::Fludeoxyglucose F 18 |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Fludeoxyglucose F 18 in the drug label.

Precautions with Alcohol

  • Alcohol-Fludeoxyglucose F 18 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • FLUDEOXYGLUCOSE F18 ®[1]

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ "fludeoxyglucose f-18 injection, solution".
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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