Xenoview
(Xenon Xe 129 Hyperpolarized)Xenoview Prescribing Information
Indications and Usage (1) 5/2025
Dosage and Administration 5/2025
Recommended Dosage (2.1)
Preparation, Administration, and Image Acquisition (2.2)
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.
XENOVIEW has not been evaluated for use with lung perfusion imaging.
XENOVIEW, prepared from the Xenon Xe 129 Gas Blend by the HPX Hyperpolarizer, is a clear, colorless, odorless gas contained in a 300 mL, 500 mL, 750 mL or 1,000 mL XENOVIEW Dose Delivery Bag. Each bag contains at least 75 mL Dose Equivalent (DE) of hyperpolarized xenon Xe 129 in a volume of 250 mL to 750 mL total xenon and a total volume administered of 300 mL, 500 mL, 750 mL, or 1,000 mL.
The strength is DE per volume administered (see Table 2). The minimum DE for a dose of XENOVIEW® is 75 mL with a recommended DE target range of 75 mL to 100 mL. DE of greater than 100 mL is acceptable.
| Dose Delivery Bag (mL) | Minimum Dose Equivalent (mL) | Total Volume Administered (mL) | Minimum Dosage Strength* |
| 300 | 75 | 300 | 75 mL DE per 300 mL total volume |
| 500 | 75 | 500 | 75 mL DE per 500 mL total volume |
| 750 | 75 | 750 | 75 mL DE per 750 mL total volume |
| 1,000 | 75 | 1,000 | 75 mL DE per 1,000 mL total volume |
| *Minimum Dosage Strength = mL Minimum Dose Equivalent per mL Total Volume Administered | |||
None.
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. Hyperpolarized xenon Xe 129 is chemically identical to non-polarized xenon Xe 129. Xenon is a clear, colorless, monoatomic, inert, stable, noble gas. It is naturally abundant in air at a level of 0.087 ppm. Atmospheric xenon is composed of nine non-radioactive isotopes, of which xenon Xe 129 comprises 26.4%. The atomic weight of xenon Xe 129 is 128.9.
XENOVIEW is a clear, colorless, odorless gas for oral inhalation use. Each XENOVIEW Dose Delivery Bag contains a Dose Equivalent (DE) volume of hyperpolarized xenon Xe 129 in a volume of 250 mL to 750 mL total xenon with additional nitrogen, NF (99.999% purity) added as an inert buffer to ensure the total volume of gas reaches the dose delivery bag volume (300 mL, 500 mL, 750 mL, or 1,000 mL). The minimum DE for a dose of XENOVIEW is 75 mL with a recommended DE target range of 75 to 100 mL. DE of greater than 100 mL is acceptable.
When hyperpolarized xenon Xe 129 gas is inhaled, a multi-nuclear capable MRI scanner can be used to image the hyperpolarized xenon Xe 129 distribution throughout the ventilated lung. Hyperpolarized xenon Xe 129 nuclei are directly detected by a Xe 129 MRI coil.