Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The adverse reactions (> one patient) in efficacy trials in adults were oropharyngeal pain, headache, and dizziness.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Polarean, Inc.
at 1‑844-936-6843 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Adult Patients The safety of XENOVIEW was evaluated in two prospective efficacy trials that enrolled a total of 83 adult patients with various lung disorders who were being evaluated for possible lung surgery [see Clinical Studies ( 14 ) ] .
Mean age of these patients was 62 years, 88% were White and 69% were male.
In these two trials, mean xenon gas volume per XENOVIEW dose was 330.2 mL and 81 of 83 patients (98%) received a single administration of XENOVIEW.
For safety assessment, the volume of administered xenon gas in the XENOVIEW dose is noted rather than the DE, because isotopic enrichment and hyperpolarization are not known to affect the safety profile of xenon gas.
Adverse reactions were reported in 12 (14%) of the 83 patients.
Adverse reactions reported by more than one patient were oropharyngeal pain (n = 4 patients), headache (n = 2 patients), and dizziness (n = 2 patients).
5 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.
( 5.1 ) 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.
( 5.2 ) 5.1 Risk of Decreased Image Quality from Supplemental Oxygen Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality due to depolarization of XENOVIEW.
Like all medications, Xenoview can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: