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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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Preparation and Patient Administration of XENOVIEW™

  • XENOVIEW™ is prepared in the HPX Hyperpolarizer according to the HPX Hyperpolarization System Operater’s Manual and dispensed into the XENOVIEW™ Dose Delivery Bag
  • The recommended dose of XENOVIEW™ for adults and pediatric patients aged 12 years and older is 75 mL to 100 mL dose equivalent (DE) of hyperpolarized Xenon Xe 129 Gas Blend by oral inhalation of the entire contents of one XENOVIEW™ Dose Delivery Bag
  • The volume and DE in the XENOVIEW™ Dose Delivery Bag are measured using the HPX Measurement Station no more than 5 minutes prior to patient administration
  • The dose is administered within 5 minutes of DE measurement (discard the dose of XENOVIEW™ 60 minutes after hyperpolarization)

Administration of XENOVIEW™ and image acquisition is a 3-step process that takes place in the magnetic resonance imaging (MRI) suite:

Not an actual patient.

Patient is fitted with a XENOVIEW™ Chest Coil and positioned supine inside the MRI scanner.

Not an actual patient or technician.

Mouthpiece is placed in the patient’s mouth and patient is instructed to completely inhale the full dose of XENOVIEW™ with a single breath.

Not an actual patient or technician.

MRI scanning begins immediately and is completed in a single 10 to 15 second breath hold.

Unlike X-ray, CT, or radioisotope gamma ray scintigraphy, there is no radiation exposure to patients with XENOVIEW™ MRI