Xenon Xe 129 Hyperpolarized
Generic Name: xenon xe 129 hyperpolarized
Brand Names:
Xenoview
11 DESCRIPTION XENOVIEW (xenon Xe 129 hyperpolarized) is a hyperpolarized contrast agent produced on site by the HPX Hyperpolarization System from the isotopically enriched Xenon Xe 129 Gas Blend. The Gas Blend cylinder distributed by Polarean contains xenon (1% total; > 80% isotopic purity Xe 129), nitrogen, NF (10%), and helium, NF (89%). The active pharmaceutical ingredient in XENOVIEW is hyperpolarized xenon Xe 129.
Overview
11 DESCRIPTION XENOVIEW (xenon Xe 129 hyperpolarized) is a hyperpolarized contrast agent produced on site by the HPX Hyperpolarization System from the isotopically enriched Xenon Xe 129 Gas Blend. The Gas Blend cylinder distributed by Polarean contains xenon (1% total; > 80% isotopic purity Xe 129), nitrogen, NF (10%), and helium, NF (89%). The active pharmaceutical ingredient in XENOVIEW is hyperpolarized xenon Xe 129.
Uses
1 INDICATIONS AND USAGE XENOVIEW ® , prepared from the Xenon Xe 129 Gas Blend, is 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. 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. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION The recommended target dose of XENOVIEW for adult and pediatric patients aged 6 years and older is 75 mL to 100 mL Dose Equivalent (DE) volume of hyperpolarized xenon Xe 129 by oral inhalation of the entire contents of one XENOVIEW Dose Delivery Bag. ( 2.1 ) Choose an appropriate size of the Dose Delivery Bag based on patient’s Total Lung Capacity (TLC) or Forced Vital Capacity (FVC). ( 2.1 ) Administer dose within 5 minutes of DE measurement. ( 2.2 ) Initiate imaging immediately after inhalation. ( 2.2 ) See Full Prescribing Information for detailed information regarding preparation, administration, image acquisition, and image interpretation.
Side Effects
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.
Warnings
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. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary XENOVIEW is minimally absorbed systemically following the inhalation route of administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )]. Adequately designed animal reproduction studies have not been conducted with hyperpolarized xenon Xe 129. Although not adequately designed to evaluate reproductive and developmental toxicity, there are animal reproduction data available in the literature.
Storage
16 HOW SUPPLIED How Supplied XENOVIEW (xenon Xe 129 hyperpolarized) is prepared from the Xenon Xe 129 Gas Blend by the HPX Hyperpolarizer and is contained in a XENOVIEW Dose Delivery Bag as a clear, colorless, odorless gas.
Frequently Asked Questions
What is Xenon Xe 129 Hyperpolarized used for?▼
1 INDICATIONS AND USAGE XENOVIEW ® , prepared from the Xenon Xe 129 Gas Blend, is 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. 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. ( 1 )
What are the side effects of Xenon Xe 129 Hyperpolarized?▼
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.
Can I take Xenon Xe 129 Hyperpolarized during pregnancy?▼
8.1 Pregnancy Risk Summary XENOVIEW is minimally absorbed systemically following the inhalation route of administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )]. Adequately designed animal reproduction studies have not been conducted with hyperpolarized xenon Xe 129. Although not adequately designed to evaluate reproductive and developmental toxicity, there are animal reproduction data available in the literature.
What are the important warnings for Xenon Xe 129 Hyperpolarized?▼
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. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.