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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™ Provides Effective Measurement of Regional Lung Ventilation

Study Design

  • Two prospective, multicenter, randomized, open-label, crossover clinical studies that compared XENOVIEW™ magnetic resonance imaging (MRI) to xenon Xe 133 scintigraphy in adult patients with pulmonary disorders:
    ‒ Study 1: patients being evaluated for possible lung resection surgery (n = 32)*
    ‒ Study 2: patients being evaluated for possible lung transplant surgery (n = 49)†
  • Primary analysis: pre-specified equivalence interval between XENOVIEW™ and xenon Xe 133 imaging
  • Patient population with a broad representation of underlying pulmonary diseases
  • Six-zone analysis of regional lung ventilation
Patient Baseline Characteristics

COPD, chronic obstructive pulmonary disease.
*On each XENOVIEW™ and xenon Xe 133 scan, the fraction of total signal in the lungs was calculated in each of 6 zones consisting of upper, middle, and lower regions in each lung. These values were used to estimate the postoperative percentage of lung ventilation predicted to remain after planned resection of a pre-specified lung area.
†On each XENOVIEW™ and xenon Xe 133 scan, right lung signal and total signal in the lungs were calculated and used to estimate the percentage of overall lung ventilation contributed by the right lung.
‡Medical history may not be the primary reason for lung resection or lung transplant surgery.

Study Results

Both studies demonstrated equivalence of XENOVIEW™ to xenon Xe 133 scintigraphy in assessment of regional lung ventilation.

XENOVIEW™

Xenon Xe 133 Scintigraphy

Not typical XENOVIEW™ images; multiplane images were collapsed into a single image from a study participant in one of the phase 3 studies to allow comparison with 2D scintigraphy image.

Patient Baseline Characteristics

*One of the 32 subjects who completed both scans was excluded from the primary analysis because no planned resection area was recorded.

XENOVIEW™ Was Well Tolerated

  • Adverse reactions were reported in 14% (12/83) of patients (98% of whom received a single administration of XENOVIEW™)
  • The only adverse reactions reported by more than 1 patient were oropharyngeal pain (n = 4), headache (n = 2), and dizziness (n = 2)

Study results demonstrate well-tolerated, safe, and effective measurement of regional lung ventilation with XENOVIEW™