Diagnostic imaging: Inhalation: Target dose: 75 to 100 mL dose equivalent (DE) (entire contents of one dose delivery bag); minimum dose: 75 mL DE; >100 mL DE is acceptable.
DE is the volume (mL) of 100% hyperpolarized, 100% isotopically enriched xenon XE 129 that provides the equivalent total X2 129 magnetization (MRI signal) and is defined by the following formula:
DE = (total volume xenon gas) × (fraction of xenon XE 129 isotopic enrichment in the xenon gas) × (fraction of hyperpolarization)
where volume of xenon gas is 250 to 750 mL, the fraction of xenon Xe 129 isotropic enrichment is >80% and the mean fraction of hyperpolarization is ≥38% to 54% at the completion of polarization of 250 mL of xenon gas.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Xenon Xe-129 hyperpolarized: Pediatric drug information")
Diagnostic imaging:
Children ≥12 years and Adolescents: Oral inhalation: 75 to 100 mL Dose Equivalent (DE) via the entire contents of one dose delivery bag. Do not use dose delivery bag if the DE is <75 mL; DE of >100 mL is acceptable.
Note: DE is the total volume (mL) of 100% hyperpolarized, 100% isotopically enriched xenon Xe 129 that would provide the equivalent total Xe 129 magnetization (MRI) signal. DE is measured by the HPX Polarization Measurement Station and is defined by the following formula:
DE = (total volume xenon gas) × (fraction of xenon Xe 129 isotopic enrichment in the xenon gas) × (fraction of hyperpolarization)
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%:
Nervous system: Dizziness, headache
Respiratory: Oropharyngeal pain
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Hypoxia: Transient hypoxemia may occur; treat as clinically indicated.
Other warnings/precautions:
• Appropriate use: Has not been evaluated for use with lung perfusion imaging. Concomitant supplemental oxygen may decrease image quality due to depolarization; withhold oxygen inhalation for 2 breaths prior to xenon Xe 129 hyperpolarized inhalation and resume immediately following imaging breath hold.
Transient heart rate elevation, numbness, and tingling have been reported with use in pediatric patients 6 to 18 years of age.
Xenoview: FDA approved December 2022; anticipated availability currently unknown.
Inhalation: Administer by inhalation within 5 minutes of dose equivalent measurement; refer to the HPX Hyperpolarization System Operator’s Manual and manufacturer labeling for detailed administration instructions.
Oral inhalation: Administer within 5 minutes of dose equivalent measurement; refer to the HPX Hyperpolarization System Operator's Manual and/or manufacturer labeling for detailed administration instructions.
Diagnostic imaging: Diagnostic agent indicated for evaluation of lung ventilation in conjunction with MRI in patients ≥12 years of age.
None known.
There are no known significant interactions.
Due to minimal absorption following inhalation, maternal use is not expected to result in fetal exposure.
It is not known if xenon Xe 129 hyperpolarized is present in breast milk.
Due to minimal absorption following maternal inhalation, breastfeeding is not expected to provide exposure to an infant via breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Oxygen desaturation; symptoms of hypoxemia.
Contrast agent that when inhaled is distributed throughout the ventilated lung and can be used for imaging with a multi-nuclear capable MRI scanner; hyperpolarized xenon Xe 129 nuclei are directly detected by a Xe 129 MRI coil.
Duration: Ventilated areas of the lungs; small amount into pulmonary vessels leading to distal organ distribution. Solubility is greater in fatty tissue than aqueous tissue or body compartments (eg, plasma).
Half-life elimination: 14.5 seconds (75% Xe/25% N2 gas mixture); 14.3 seconds (25% Xe/75% N2 gas mixture).
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