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Important Safety Information  |  Prescribing Information

Important Safety Information

Indication
XENOVIEW™, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.

Limitations of Use
XENOVIEW has not been evaluated for use with lung perfusion imaging.

CONTRAINDICATIONS
None.

WARNINGS AND PRECAUTIONS
Risk of Decreased Image Quality from Supplemental Oxygen:  Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold.

Risk of Transient Hypoxia:  Inhalation of an anoxic gas such as XENOVIEW may cause transient hypoxemia in susceptible patients. Monitor all patients for oxygen saturation and symptoms of hypoxemia and treat as clinically indicated.

ADVERSE REACTIONS
Adverse Reactions in Adult Patients: The adverse reactions (> one patient) in efficacy trials were oropharyngeal pain, headache, and dizziness.

Adverse Reactions in Pediatric Patients: In published literature in pediatric patients aged 6 to 18 years, the following transient adverse reactions were reported: blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria. In at least one published study of pediatric patients aged 6 to 18 years, transient decrease in SpO2% and transient increase in heart rate were reported following hyperpolarized xenon Xe 129 administration. XENOVIEW is not approved for use in pediatric patients less than 12 years of age.

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XENOVIEW™ Illuminates Distribution of Gas in the Lungs

Traditional magnetic resonance imaging (MRI) scans detect hydrogen nuclei (protons or 1H) found in anatomical structures. However, due to the unique composition of the lungs, it is not common to perform proton-based MRI. XENOVIEW™ MRI scans detect hyperpolarized xenon nuclei inhaled by the patient. The stable, inert xenon isotope exhibits an MRI signal (resonance frequency) that can be detected to determine the distribution of gas in the lungs, allowing clinicians to evaluate regional lung ventilation.

Patient with COPD
72-Year-Old Male Patient with COPD* FEV1: 56%
Patient with Asthma
52-Year-Old Male Patient with ILD* FEV1: 69%

FEV1, forced expiratory volume in one second.
*Example patients from the XENOVIEW™ phase 3 studies. Image shows the distribution intensity of XENOVIEW™ gas. Low to high distribution follows the hot to cold spectrum (red to blue,
respectively). Image processed using XENOVIEW VPD™ software.

XENOVIEW™ Transforms MRI Into a Lung Ventilation Imaging Platform

Not an actual technician.

  • Provides direct measurement of regional lung function in patients undergoing evaluation of lung ventilation
  • No radiation exposure to patient
  • Spatially distributes to image the smallest airways
  • Single, 10 to 15 second breath hold
  • Non-effort dependent procedure