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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.

Consumables and Accessories

Xenon Xe 129 Gas Blend

Hyperpolarized xenon is produced by the HPX Hyperpolarizer from the gas blend of helium (89%), nitrogen (10%), and isotopically enriched xenon (1% total; >80% isotopic purity xenon Xe 129). At least one Xenon Xe 129 Gas Blend cylinder is required for the proper operation of the HPX Hyperpolarization System.

XENON Gas Blend
XENOVIEW™ Dose Delivery Bags

XENOVIEW® Dose Delivery Bags

The single-dose XENOVIEW® Dose Delivery Bag is used to collect XENOVIEW® from the HPX Hyperpolarizer for transport to the HPX Polarization Measurement Station and delivery to the patient for administration. They are supplied in a carton of 50 with affixable dose labels and attachable mouthpieces that deliver the dose to the patient.

XENOVIEW® 3.0T Chest Coil

The patient wears a dedicated XENOVIEW® 3.0T Chest Coil, provided by Polarean, that is designed and optimized to detect the XENOVIEW® signal in the lungs.

XENOVIEW™ Chest Coil
HPX Phantom

HPX Phantom

The HPX Phantom (Phantom) is used to perform a quality control (QC) check of the XENOVIEW® 3.0T Chest Coil. The Phantom configuration is representative of a human torso that has inhaled XENOVIEW® for the purpose of performing QC checks. The Phantom provides a radiofrequency (RF) load comparable to an adult thorax wrapped in the XENOVIEW® 3.0 T Chest Coil. Prior to first use, and periodically thereafter, QC checks should be performed to ensure the performance of the XENOVIEW® 3.0T Chest Coil during its lifecycle.