XENOVIEW 5651.5 L/1
xenon Xe 129 hyperpolarized · GAS · Polarean, Inc.
XENOVIEW is a gas containing xenon xe 129 hyperpolarized at 5651.5 L/1, taken respiratory (inhalation). Manufactured by Polarean, Inc..
Key Facts
- Brand Name
- XENOVIEW
- Generic Name
- xenon Xe 129 hyperpolarized
- NDC Code (Product)
80534-6350- Manufacturer
- Polarean, Inc.
- Strength
- 5651.5 L/1
- Dosage Form
- GAS
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- NDA214375
- Drug Class
- Hyperpolarized Contrast Agent [EPC]
- Marketing Start
- 12/23/2022
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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 & Administration
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. ( 2.2 , 2.3 ) 2.1 Recommended Dosage The recommended target dose of XENOVIEW for adults 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. Each bag contains at least 75 mL DE of hyperpolarized xenon Xe 129 measured within 5 minutes of administration, in a volume of 250 mL to 750 mL total xenon with additional nitrogen, NF (99.999% purity) added to reach a total volum…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
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 hy…
Frequently Asked Questions
What is XENOVIEW used for?
XENOVIEW contains xenon Xe 129 hyperpolarized. It is a gas taken respiratory (inhalation). Consult your doctor for specific uses.
Is XENOVIEW a controlled substance?
XENOVIEW is not classified as a controlled substance by the DEA.
What is the generic name for XENOVIEW?
The generic name for XENOVIEW is xenon Xe 129 hyperpolarized. There are no other listed brand versions of xenon Xe 129 hyperpolarized.
What is the NDC code for XENOVIEW 5651.5 L/1?
The NDC (National Drug Code) for XENOVIEW 5651.5 L/1 is 80534-6350, listed by Polarean, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)