Hyperpolarized Xe-129: Difference between revisions

Jump to navigation Jump to search
Newer edit →
VisualWikitext
Created page with "{{DrugProjectFormSinglePage |authorTag={{PVS}} |indicationType=treatment |blackBoxWarningTitle='''<span style="color:#FF0000;">TITLE</span>''' |blackBoxWarningBody=''<span style="color:#FF0000;">Condition Name:</span>'' (Content) |offLabelAdultGuideSupport=There is limited information regarding ''Off-Label Guideline-Supported Use'' of Hyperpolarized Xe-129 in adult patients. |offLabelAdultNoGuideSupport=There is limited information regarding ''Off-Label Non–Guideline-S..."
 
No edit summary
Line 1: Line 1:
{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{PVS}}
|authorTag={{PVS}}
|indicationType=treatment
|genericName=hyperpolarized Xe-129
|aOrAn=a
|drugClass=hyperpolarized contrast agent
|indicationType=procedure
|indication=use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.
|adverseReactions=The adverse reactions (> one patient) in efficacy trials were oropharyngeal pain, headache, and dizziness.
|blackBoxWarningTitle='''<span style="color:#FF0000;">TITLE</span>'''
|blackBoxWarningTitle='''<span style="color:#FF0000;">TITLE</span>'''
|blackBoxWarningBody=''<span style="color:#FF0000;">Condition Name:</span>'' (Content)
|blackBoxWarningBody=''<span style="color:#FF0000;">Condition Name:</span>'' (Content)
|fdaLIADAdult=*The recommended target dose of XENOVIEW for adult and pediatric patients aged 12 years and older is 75 mL to 100 mL Dose Equivalent (DE) of hyperpolarized xenon Xe 129 by oral inhalation of the entire contents of one XENOVIEW Dose Delivery Bag.
*Each bag contains at least 75 mL DE of hyperpolarized xenon Xe 129 with a recommended target DE range of 75 mL to 100 mL measured within 5 minutes of administration, in a volume of 250 mL to 750 mL total xenon with additional nitrogen, NF (99.999% purity) added to reach a total volume of 1,000 mL.
*Administer dose within 5 minutes of DE measurement.
*Initiate imaging immediately after inhalation.
*See Full Prescribing Information for detailed information regarding preparation, administration, image acquisition, and image interpretation.
*XENOVIEW is a clear, colorless, odorless gas contained in a 1,000 mL XENOVIEW Dose Delivery Bag. The bag contains at least 75 mL DE of hyperpolarized xenon Xe 129 in a volume of 250 mL to 750 mL total xenon.
*The strength is DE per 1,000 mL administered. The minimum DE for a dose of XENOVIEW is 75 mL with a recommended DE target range of 75 to 100 mL. DE of greater than 100 mL is acceptable.
|offLabelAdultGuideSupport=There is limited information regarding ''Off-Label Guideline-Supported Use'' of Hyperpolarized Xe-129 in adult patients.
|offLabelAdultGuideSupport=There is limited information regarding ''Off-Label Guideline-Supported Use'' of Hyperpolarized Xe-129 in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding ''Off-Label Non–Guideline-Supported Use'' of Hyperpolarized Xe-129 in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding ''Off-Label Non–Guideline-Supported Use'' of Hyperpolarized Xe-129 in adult patients.
|offLabelPedGuideSupport=There is limited information regarding ''Off-Label Guideline-Supported Use'' of Hyperpolarized Xe-129 in pediatric patients.
|offLabelPedGuideSupport=There is limited information regarding ''Off-Label Guideline-Supported Use'' of Hyperpolarized Xe-129 in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding ''Off-Label Non–Guideline-Supported Use'' of Hyperpolarized Xe-129 in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding ''Off-Label Non–Guideline-Supported Use'' of Hyperpolarized Xe-129 in pediatric patients.
|contraindications=None.
|alcohol=Alcohol-Hyperpolarized Xe-129 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=Alcohol-Hyperpolarized Xe-129 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
}}
}}

Revision as of 12:08, 14 April 2025

Hyperpolarized Xe-129
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: Parth Vikram Singh, MBBS[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.

Overview

Hyperpolarized Xe-129 is a hyperpolarized contrast agent that is FDA approved for the procedure of use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.. Common adverse reactions include The adverse reactions (> one patient) in efficacy trials were oropharyngeal pain, headache, and dizziness..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • The recommended target dose of XENOVIEW for adult and pediatric patients aged 12 years and older is 75 mL to 100 mL Dose Equivalent (DE) of hyperpolarized xenon Xe 129 by oral inhalation of the entire contents of one XENOVIEW Dose Delivery Bag.
  • Each bag contains at least 75 mL DE of hyperpolarized xenon Xe 129 with a recommended target DE range of 75 mL to 100 mL measured within 5 minutes of administration, in a volume of 250 mL to 750 mL total xenon with additional nitrogen, NF (99.999% purity) added to reach a total volume of 1,000 mL.
  • Administer dose within 5 minutes of DE measurement.
  • Initiate imaging immediately after inhalation.
  • See Full Prescribing Information for detailed information regarding preparation, administration, image acquisition, and image interpretation.
  • XENOVIEW is a clear, colorless, odorless gas contained in a 1,000 mL XENOVIEW Dose Delivery Bag. The bag contains at least 75 mL DE of hyperpolarized xenon Xe 129 in a volume of 250 mL to 750 mL total xenon.
  • The strength is DE per 1,000 mL administered. The minimum DE for a dose of XENOVIEW is 75 mL with a recommended DE target range of 75 to 100 mL. DE of greater than 100 mL is acceptable.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hyperpolarized Xe-129 in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hyperpolarized Xe-129 in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Hyperpolarized Xe-129 FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hyperpolarized Xe-129 in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hyperpolarized Xe-129 in pediatric patients.

Contraindications

None.

Warnings

There is limited information regarding Hyperpolarized Xe-129 Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Hyperpolarized Xe-129 Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Hyperpolarized Xe-129 Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Hyperpolarized Xe-129 Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Hyperpolarized Xe-129 in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hyperpolarized Xe-129 in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Hyperpolarized Xe-129 during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Hyperpolarized Xe-129 in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Hyperpolarized Xe-129 in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Hyperpolarized Xe-129 in geriatric settings.

Gender

There is no FDA guidance on the use of Hyperpolarized Xe-129 with respect to specific gender populations.

Race

There is no FDA guidance on the use of Hyperpolarized Xe-129 with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Hyperpolarized Xe-129 in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Hyperpolarized Xe-129 in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Hyperpolarized Xe-129 in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Hyperpolarized Xe-129 in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Hyperpolarized Xe-129 Administration in the drug label.

Monitoring

There is limited information regarding Hyperpolarized Xe-129 Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Hyperpolarized Xe-129 and IV administrations.

Overdosage

There is limited information regarding Hyperpolarized Xe-129 overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Hyperpolarized Xe-129 Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Hyperpolarized Xe-129 Mechanism of Action in the drug label.

Structure

There is limited information regarding Hyperpolarized Xe-129 Structure in the drug label.

Pharmacodynamics

There is limited information regarding Hyperpolarized Xe-129 Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Hyperpolarized Xe-129 Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Hyperpolarized Xe-129 Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Hyperpolarized Xe-129 Clinical Studies in the drug label.

How Supplied

There is limited information regarding Hyperpolarized Xe-129 How Supplied in the drug label.

Storage

There is limited information regarding Hyperpolarized Xe-129 Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Hyperpolarized Xe-129 |?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::Hyperpolarized Xe-129 |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Hyperpolarized Xe-129 Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Hyperpolarized Xe-129 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Hyperpolarized Xe-129 Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Hyperpolarized Xe-129 Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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

Retrieved from "https://www.wikidoc.org/index.php?title=Hyperpolarized_Xe-129&oldid=1740222"