xenon Xe 129 hyperpolarized (Rx)

Brand and Other Names:Xenoview
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Dosing & Uses

AdultPediatric

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
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Adverse Effects

Frequency Not Defined

Oropharyngeal pain

Headache

Dizziness

Hypersensitivity

Blood oxygen desaturation

Increased heart rate

Numbness

Tinging

Dizziness

Euphoria

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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
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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.

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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

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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)

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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.