Dosing & Uses
Dosage Forms & Strengths
gas, oral inhalation
- Each 1,000-mL dose delivery bag contains at least 75mL dose equivalent (DE) of hyperpolarized xenon Xe 129 in a volume of 250-750 mL total xenon
Lung Ventilation Evaluation
Indicated for use with MRI for evaluation of lung ventilation
Dose equivalent (DE) is the volume (mL) of 100% hyperpolarized, 100% isotopically enriched xenon Xe 129 that provides the equivalent total Xe 129 magnetization (or MRI signal)
HPX polarization measurement station measures DE
Recommended target dose: 75-100 mL DE of hyperpolarized xenon Xe 129 by oral inhalation
DE defined by the following formula
- DE = (total volume xenon gas) × (fraction of xenon Xe 129 isotopic enrichment in the xenon gas) × (fraction of hyperpolarization)
- Total volume of xenon gas is 250-750 mL
- Fraction of xenon Xe 129 isotopic enrichment is >80% and mean fraction of hyperpolarization is at least 38-54% at completion of polarization of 250 mL of xenon gas
-
Example
- If 300 mL of total xenon gas with 83% enrichment of xenon Xe 129 is dispensed from HPX Hyperpolarizer at 40% hyperpolarization
- DE = 300 mL × 0.83 × 0.40 = 99.6 mL
Dosing Considerations
Limitations of use
- Not evaluated for use with lung perfusion imaging
Dosage Forms & Strengths
gas, oral inhalation
- Each 1,000-mL dose delivery bag contains at least 75mL dose equivalent (DE) of hyperpolarized xenon Xe 129 in a volume of 250-750 mL total xenon
Lung Ventilation Evaluation
Indicated for use with MRI for evaluation of lung ventilation in children aged ≥12 years
<12 years: Safety and efficacy not established
Dose equivalent (DE) is the volume (mL) of 100% hyperpolarized, 100% isotopically enriched xenon Xe 129 that provides the equivalent total Xe 129 magnetization (or MRI signal)
HPX polarization measurement station measures DE
Recommended target dose: 75-100 mL DE of hyperpolarized xenon Xe 129 by oral inhalation
DE defined by the following formula
- DE = (total volume xenon gas) × (fraction of xenon Xe 129 isotopic enrichment in the xenon gas) × (fraction of hyperpolarization)
- Total volume of xenon gas is 250-750 mL
- Fraction of xenon Xe 129 isotopic enrichment is >80% and mean fraction of hyperpolarization is at least 38-54% at completion of polarization of 250 mL of xenon gas
-
Example
- If 300 mL of total xenon gas with 83% enrichment of xenon Xe 129 is dispensed from HPX Hyperpolarizer at 40% hyperpolarization
- DE = 300 mL × 0.83 × 0.40 = 99.6 mL
Dosing Considerations
Limitations of use
- Not evaluated for use with lung perfusion imaging
Adverse Effects
Frequency Not Defined
Oropharyngeal pain
Headache
Dizziness
Hypersensitivity
Blood oxygen desaturation
Increased heart rate
Numbness
Tinging
Dizziness
Euphoria
Warnings
Contraindications
None
Cautions
Risk of decreased image quality from supplemental oxygen
- Supplemental oxygen administered simultaneously with xenon Xe hyperpolarized inhalation can cause degradation of image quality due to depolarization
- For patients on supplemental oxygen, withhold oxygen inhalation for 2 breaths before o xenon Xe hyperpolarized inhalation, and resume oxygen inhalation immediately following the imaging breath hold
Risk of transient hypoxia
- Inhalation of an anoxic gas may cause transient hypoxemia in susceptible
- Monitor all patients for oxygen desaturation and symptoms of hypoxemia, and treat as clinically indicated
Pregnancy & Lactation
Pregnancy
Minimally absorbed systemically following inhalation; maternal use not expected to result in fetal drug exposure
Animal studies
- Studies were conducted in rats by administering an 80% Xe/20% O2 gas mixture for 2 hr twice weekly for 2 and 10 weeks, with no observed effects on fertility or pregnancy
- Gas mixtures containing 70-75% Xe gas and 25-30% O2 gas were found to be non-teratogenic in rats when administered for 24 hr
- In a separate study, rats were administered an 80%/20% Xe/O2 gas mixture for 2 hr twice a week from 1-19 days of pregnancy with no observed effects on embryo-fetal development or signs of teratogenicity
Lactation
- Minimally absorbed systemically following inhalation; breastfeeding is not expected to result in drug exposure to the infant
- There is no information on presence of hyperpolarized xenon Xe 129 in human milk, effect on breastfed infants, or effect on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
When inhaled, a multi-nuclear capable MRI scanner is used to image of xenon Xe 129 distribution throughout the ventilated lung
Distribution
Readily diffusible gas; xenon inhalation results in dispersion in ventilated areas of the lung with uptake of a small amount of xenon into the pulmonary vessels followed by distribution to more distal organs
Solubility of xenon is higher in fatty tissues than in aqueous tissues and body compartments (eg, plasma)
Elimination
Half-life H4
75% Xe/25% N2 gas mixture: 14.5 seconds
25% Xe/75% N2 gas mixture: 14.3 seconds
Administration
Inhalation Preparation
Prepare hyperpolarized xenon Xe 129 in the HPX hyperpolarizer from the Xenon Xe 129 gas blend and add nitrogen, NF (99.999% purity) to fill remaining volume in the dose delivery bag to 1,000 mL, according to operator’s manual
Measure volume and doe equivalent (DE) in the dose delivery bag using the measurement station within 5 minutes before administration
DE measurement should be at least 75 mL
Do not use and discard dose of if volume is determined to be outside of the acceptable range or the DE is <75 mL
Administer dose within 5 minutes of DE measurement
Do not use and discard the dose 60 minutes after filling dose delivery bag
Administer according to directions provided in operator’s manual
Fit patient with an FDA-cleared Xe 129 chest coil in accordance with the chest coil manufacturer’s instructions for use
Position patient supine with arms either by their side or above their head
Perform conventional 1H localizer scan, position the desired Xe 129 slices, and prepare the Xe 129 scan
For patients on supplemental oxygen, withhold oxygen inhalation for 2 breaths before xenon Xe 129 hyperpolarized inhalation, and resume oxygen inhalation immediately following the imaging breath hold
Attach mouthpiece to dose delivery bag
Oral Inhalation
With patient positioned in the MRI scanner, place mouthpiece in the mouth and instruct patient to completely inhale the contents of the dose delivery bag with a single inhalation
Instruct to hold the inhaled breath (up to 15 seconds) during MR image acquisition
Once the full dose is inhaled, begin MRI scanning immediately
Upon scan completion, instruct to breathe normally
If image quality is insufficient or if the patient was unable to sufficiently inhale the contents of the dose delivery bag, the scan can be repeated with a new dose
Storage
Store at 20-25ºC (68-77ºF), with excursions permitted to 15-30ºC (59-86ºF)
Images
Formulary
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