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What is the minimum DE for a dose of XENOVIEW?

  • 75 mL (correct)
  • 100 mL
  • 250 mL
  • 500 mL

    • What is the recommended target dose of Xenoview for adults and pediatric patients aged 12 years and older?

  • 25 mL to 50 mL Dose Equivalent (DE
  • 50 mL to 75 mL Dose Equivalent (DE
  • 75 mL to 100 mL Dose Equivalent (DE (correct)
  • 100 mL to 125 mL Dose Equivalent (DE

    • What is XENOVIEW?

  • A drug used to treat lung disorders in adults and pediatric patients
  • A hyperpolarized xenon gas (correct)
  • A form of radiation therapy
  • A type of imaging technology

    • What is the minimum DE for a dose of XENOVIEW?

    <p>75 mL</p> Signup and view all the answers

    What is the recommended target dose of XENOVIEW for adult and pediatric patients aged 12 years and older?

    <p>75 mL to 100 mL Dose Equivalent (DE) of hyperpolarized xenon Xe 129</p> Signup and view all the answers

    What is the minimum DE for a dose of XENOVIEW?

    <p>75 mL</p> Signup and view all the answers

    How long after DE measurement should the dose be administered?

    <p>Within 5 minutes</p> Signup and view all the answers

    What type of gas is XENOVIEW?

    <p>Colorless</p> Signup and view all the answers

    What is the HPX Polarization Measurement Station used to measure?

    <p>All of the above</p> Signup and view all the answers

    What is the recommended DE range for XENOVIEW?

    <p>75 mL to 100 mL</p> Signup and view all the answers

    What type of gas is XENOVIEW?

    <p>All of the above</p> Signup and view all the answers

    How many patients reported adverse reactions in the efficacy trials?

    <p>12</p> Signup and view all the answers

    How long can XENOVIEW be administered after filling the Dose Delivery Bag?

    <p>60 minutes</p> Signup and view all the answers

    What was the most common adverse reaction reported in the efficacy trials?

    <p>Oropharyngeal pain</p> Signup and view all the answers

    What is the total volume of the XENOVIEW Dose Delivery Bag?

    <p>1,000 mL</p> Signup and view all the answers

    What is the recommended DE target range for XENOVIEW?

    <p>75 to 100 mL</p> Signup and view all the answers

    How much XENOVIEW is contained in a Dose Delivery Bag?

    <p>1000 mL</p> Signup and view all the answers

    What should the patient do after inhaling the contents of the XENOVIEW Dose Delivery Bag?

    <p>Immediately undergo MRI scanning</p> Signup and view all the answers

    What is the recommended DE target range for XENOVIEW?

    <p>75-100 mL</p> Signup and view all the answers

    What should be done prior to Xenoview inhalation for patients on supplemental oxygen?

    <p>Withhold oxygen inhalation for two breaths</p> Signup and view all the answers

    What type of reaction occurred in one patient with a history of allergies?

    <p>Pruritus and erythema</p> Signup and view all the answers

    What is the background risk of major birth defects and miscarriage for the indicated population?

    <p>Unknown</p> Signup and view all the answers

    When should imaging be initiated?

    <p>Immediately after inhalation</p> Signup and view all the answers

    How much XENOVIEW is contained in a Dose Delivery Bag?

    <p>1000 mL</p> Signup and view all the answers

    What is the risk of decreased image quality from supplemental oxygen administration when XENOVIEW is inhaled with oxygen?

    <p>Risk of decreased image quality</p> Signup and view all the answers

    What is the volume of the XENOVIEW Dose Delivery Bag?

    <p>1,000 mL</p> Signup and view all the answers

    What is the purpose of the XENOVIEW Dose Delivery Bag?

    <p>To provide the patient with a single inhalation</p> Signup and view all the answers

    What is the effect of supplemental oxygen on image quality when administered simultaneously with XENOVIEW?

    <p>Degradation of image quality</p> Signup and view all the answers

    What kind of effects may XENOVIEW inhalation have on patients?

    <p>Transient hypoxemia</p> Signup and view all the answers

    In what age group were the pediatric patients in the pooled data from the published literature?

    <p>6 to 18 years</p> Signup and view all the answers

    What is the key fact from the text?

    <p>XENOVIEW evaluation is based on its distribution</p> Signup and view all the answers

    What age group is XENOVIEW indicated for use with MRI?

    <p>Pediatric patients aged 12 years and older</p> Signup and view all the answers

    How many doses of hyperpolarized xenon Xe 129 were administered in the pooled data from the published literature?

    <p>2 doses</p> Signup and view all the answers

    What type of gas is Xenon Xe 129?

    <p>Colorless</p> Signup and view all the answers

    What should be monitored when administering XENOVIEW?

    <p>Oxygen levels</p> Signup and view all the answers

    What type of gas inhalation may cause transient hypoxemia in susceptible patients?

    <p>Anoxic</p> Signup and view all the answers

    What is the formula used to define DE?

    <p>(total volume xenon gas) × (fraction of xenon Xe 129 isotopic enrichment in the xenon gas) × (fraction of hyperpolarization</p> Signup and view all the answers

    How should patients be monitored for oxygen desaturation and symptoms of hypoxemia?

    <p>Continuously</p> Signup and view all the answers

    What is the purity of the nitrogen added to the XENOVIEW Dose Delivery Bag?

    <p>99.999%</p> Signup and view all the answers

    What should be done if a patient experiences symptoms of hypoxemia after XENOVIEW inhalation?

    <p>Increase oxygen levels</p> Signup and view all the answers

    What is the recommended target dose of XENOVIEW for adults and pediatric patients age 12 years and older?

    <p>75 mL to 100 mL</p> Signup and view all the answers

    What type of adverse reaction was reported in the pooled data of adult patients from the published literature?

    <p>Numbness</p> Signup and view all the answers

    What is the strength of XENOVIEW?

    <p>DE per 1,000 mL</p> Signup and view all the answers

    What type of adverse reaction was reported in the pooled data of pediatric patients from the published literature?

    <p>All of the above</p> Signup and view all the answers

    What should be done if the image quality is insufficient or if the patient was not able to sufficiently inhale the contents of the XENOVIEW dose delivery bag?

    <p>Repeat the scan with a new dose of XENOVIEW</p> Signup and view all the answers

    What should be avoided when administering XENOVIEW?

    <p>Supplemental oxygen</p> Signup and view all the answers

    What is the purity of the nitrogen added to the XENOVIEW Dose Delivery Bag?

    <p>99.999%</p> Signup and view all the answers

    What is the recommended target DE range of XENOVIEW?

    <p>75 mL to 100 mL</p> Signup and view all the answers

    What is the most common adverse reaction reported in patients who received XENOVIEW?

    <p>Oropharyngeal pain</p> Signup and view all the answers

    What is the fraction of hyperpolarization?

    <p>(total volume xenon gas) × (fraction of xenon Xe 129 isotopic enrichment in the xenon gas) × (fraction of hyperpolarization</p> Signup and view all the answers

    What is the overall frequency of adverse reactions in the pooled data of adult patients from the published literature?

    <p>Unknown</p> Signup and view all the answers

    What is the primary indication for XENOVIEW?

    <p>Evaluation of lung ventilation</p> Signup and view all the answers

    What should be done if a patient shows signs of oxygen desaturation and symptoms of hypoxemia?

    <p>Treat as clinically indicated</p> Signup and view all the answers

    What is the strength of XENOVIEW?

    <p>DE per 1000 mL</p> Signup and view all the answers

    What is the purpose of XENOVIEW?

    <p>To improve image quality</p> Signup and view all the answers

    What is XENOVIEW used for?

    <p>To improve image quality</p> Signup and view all the answers

    What is the total Xe 129 magnetization?

    <p>(total volume xenon gas) × (fraction of xenon Xe 129 isotopic enrichment in the xenon gas</p> Signup and view all the answers

    Is XENOVIEW approved for use in pediatric patients less than 12 years of age?

    <p>No</p> Signup and view all the answers

    Is there a risk of maternal exposure to xenon Xe 129 during breastfeeding?

    <p>No</p> Signup and view all the answers

    What is the risk of transient hypoxia when XENOVIEW is inhaled with oxygen?

    <p>Risk of transient hypoxia</p> Signup and view all the answers

    Study Notes

    • Xenon Xe 129 hyperpolarized contrast agent is used with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.
    • The recommended target dose for adult and pediatric patients is 75 mL to 100 mL 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 of 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.
    • Administrate 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 gas blend prepared from the xenon Xe 129 gas and is indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients age 12 years and older.
    • The recommended target dose of XENOVIEW for adults and pediatric patients age 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 measured within 5 minutes of administration, in a volume of 250 mL to 750 mL total x enon with additional nitrogen, NF (99.999% purity) added to reach a total volume of 1,000 mL. The minimum DE for a dose of XENOVIEW is 75 mL with a recommended DE target range of 75 mL to 100 mL. DE of greater than 100 mL is acceptable.
    • The preparation, administration, and image acquisition for using XENOVIEW is as follows:
    • Prepare hyperpolarized xenon Xe 129 in the HPX Hyperpolarizer from the Xenon Xe 129 G as Blend and add Nitrogen, NF (99.999% purity) to fill the remaining volume in the XENOVIEW Dose Delivery Bag to 1,000 mL, according to the HPX Hyperpolarization System Operator’s Manual.
    • Measure the volume and DE in the XENOVIEW Dose Delivery Bag using the HPX Polarization Measurement Station no more than 5 minutes prior to administration. The DE measurement should be at least 75 mL. Do not use and discard the dose of XENOVIEW if the volume is determined to be outside of the acceptable range or the DE is less than 75 mL.
    • Administer dose within 5 minutes of DE measurement.
    • Do not use and discard the dose of XENOVIEW 60 minutes after filling of the Dose Delivery Bag.
    • Administer XENOVIEW according to the directions provided in the HPX Hyperpolarization System Operator’s Manual, Administering XENOVIEW.
    • Xenon Xe 129 is a clear, colorless, odorless gas that is contained in a 1,000 mL XENOVIEW Dose Delivery Bag.
    • The strength of XENOVIEW is DE per 1,000 mL administered.
    • XENOVIEW is safe when administered in conjunction with supplemental oxygen.
    • Adverse reactions were reported in 14% of the 83 patients who received XENOVIEW.
    • The most common adverse reactions were oropharyngeal pain, headache, and dizziness.
    • Hyperpolarized xenon Xe 129 has been shown to be minimally absorbed systemically following the inhalation route of administration.
    • There is no risk of maternal exposure to xenon Xe 129 during breastfeeding.
    • Animal reproduction studies have not been conducted with hyperpolarized xenon Xe 129.
    • The background risk of major birth defects and miscarriage for the indicated population is unknown.

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