Xenon xe-129, xenon xe-129, hyperpolarized, helium, and nitrogen
Looking up MedlinePlus…
From MedlinePlus, U.S. National Library of Medicine
Hyperpolarized Contrast Agent
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Dosing in liver impairment
Preparation, Administration, and Image Acquisition Preparation Choose an appropriate Dose Delivery Bag according to Table 1 [see Dosage and Administration] . Prepare hyperpolarized xenon Xe 129 in the HPX Hyperpolarizer from the Xenon Xe 129 Gas Blend and add Nitrogen, NF (99.999% purity) as necessary to fill the remaining volume in the XENOVIEW Dose Delivery Bag, according to the HPX Hyperpolarization System Operator’s Manual.
Measure the volume and DE in the XENOVIEW Dose Delivery Bag using the HPX Polarization Measurement Station no more than 5 minutes prior to administration. The DE measurement should be at least 75 mL. Do not use and discard the dose of XENOVIEW ® if the volume is determined to be outside of the acceptable range or the DE is less than 75 mL.
Administer dose within 5 minutes of DE measurement. Do not use and discard the dose of XENOVIEW 60 minutes after filling of Dose Delivery Bag. Administration Administer XENOVIEW according to the directions provided in the HPX Hyperpolarization System Operator’s Manual, Administering XENOVIEW. Fit the patient with an FDA-cleared Xe 129 chest coil in accordance with the chest coil manufacturer’s instructions for use.
The chest coil and MRI scanner must be connected and compatible with one another. Position the patient supine with arms either by their side or above their head. Perform conventional 1 H localizer scan, position the desired Xe 129 slices, and prepare the Xe 129 scan. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold.
Attach the mouthpiece to the XENOVIEW Dose Delivery Bag. With the patient positioned in the MRI scanner, place the mouthpiece in the patient’s mouth and instruct the patient to completely inhale the contents of the XENOVIEW Dose Delivery Bag with a single inhalation. Instruct the patient to hold the inhaled breath (up to 15 seconds) during MR image acquisition.
Image Acquisition Once the patient has inhaled the full dose of XENOVIEW, begin MRI scanning immediately. Upon scan completion, instruct the patient to breathe normally. If the image quality is insufficient or if the patient was not able to sufficiently inhale the contents of the XENOVIEW Dose Delivery Bag, the scan can be repeated with a new dose of XENOVIEW.
Preparation and administration
Administration Administer XENOVIEW according to the directions provided in the HPX Hyperpolarization System Operator’s Manual, Administering XENOVIEW. Fit the patient with an FDA-cleared Xe 129 chest coil in accordance with the chest coil manufacturer’s instructions for use. The chest coil and MRI scanner must be connected and compatible with one another.
| TLC (L) | FVC†(L) | Dose Delivery Bag (mL) |
| <2.0 | <1.5 | 300 |
| 2.0 to <3.3 | 1.5 to <2.5 | 500 |
| 3.3 to <5.0 | 2.5 to <3.8 | 750 |
| ≥5.0 | ≥3.8 | 1,000 |
| †FVC is used when TLC is not available. | ||
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary XENOVIEW is minimally absorbed systemically following the inhalation route of administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )]. Adequately designed animal reproduction studies have not been conducted with hyperpolarized xenon Xe 129. Although not adequately designed to evaluate reproductive and developmental toxicity, there are animal reproduction data available in the literature. Animal reproduction studies were conducted in rats by administering an 80% Xe/20% O 2 gas mixture for 2 hours twice a week for 2 and 10 weeks, with no observed effects on fertility or pregnancy.
Gas mixtures containing 70% to 75% Xe gas and 25% to 30% O 2 gas were found to be non-teratogenic in rats when administered for 24 hours. In a separate study, rats were administered an 80%/20% Xe/O 2 gas mixture for 2 hours twice a week from the first to nineteenth day of pregnancy with no observed effects on embryo-fetal development or signs of teratogenicity. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.