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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 6 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.

Please see full Prescribing Information.

Changing
How We View
Lung Ventilation

Standard proton MRI scan

Modern
Respiratory
Imaging

MRI after inhalation of XENOVIEW®*

XENOVIEW® enables MRI visualization of lung ventilation.

*Patient in one of the phase 3 studies; image processed using MIM v7.1.3 software to show distribution intensity of XENOVIEW® gas.

XENOVIEW® is a hyperpolarized contrast agent produced on site by the HPX Hyperpolarization System, which includes a Xenon Xe 129 Gas Blend Cylinder, HPX Gas Handling Manifold, HPX Hyperpolarizer, HPX Polarization Measurement Station, and XENOVIEW® Dose Delivery Bags. This system is typically installed in a separate room near the magnetic resonance imaging (MRI) suite for ease of radiology workflow.

XENOVIEW® Transforms MRI
Into a Lung Ventilation Imaging Modality

Lung Ventilation

Evaluates regional lung ventilation

Spatially Distributes

Spatially distributes to image the smallest airways

No radiation exposure to patient

Breath Hold

Single, 10 to 15 second breath hold

Non-Effort

Non-effort dependent procedure