Hyperpolarized Xenon 129

What is Hyperpolarized Xenon 129?

• Hyperpolarized Xenon 129 (Xenoview) is a hyperpolarized contrast agent produced on site by the HPX Hyperpolarization System from the isotopically enriched Xenon Xe 129 Gas Blend.

What are the uses of this medicine?

• Hyperpolarized Xenon 129 (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 12 years and older.

Limitation of use:

• Xenoview has not been evaluated for use with lung perfusion imaging.

How does this medicine work?

• A contrast agent composed of hyperpolarized xenon Xe 129 gas (HP129Xe), with potential usage in diagnostic nuclear magnetic resonance (NMR)-based imaging (MRI).
• Upon inhalation, the hyperpolarized xenon 129 gas is distributed throughout the lungs.
• MRI, immediately following HP129Xe administration, allows for the visualization of lung structures based on the distribution pattern of the gas.
• This may aid in the diagnosis of certain lung abnormalities.
• Hyperpolarization of Xe 129 enhances NMR signals and thus improves imaging and assessment of lung function.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Xenon Xe 129 hyperpolarized, sold under the brand name Xenoview, was FDA approved in the year of 2022.
• The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.

How should this medicine be used?

Recommended dosage:

• The recommended target dose of Xenoview for adult and pediatric patients aged 12 years and older is 75 mL to 100 mL Dose Equivalent (DE) of hyperpolarized xenon Xe 129 by oral inhalation of the entire contents of one Xenoview Dose Delivery Bag.

Administration:

• Xenoview comes as a clear, colorless, odorless gas for oral inhalation use.
• Each Xenoview Dose Delivery Bag contains a Dose Equivalent (DE) 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 is 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.
• Administer dose within 5 minutes of DE measurement.
• Initiate imaging immediately after inhalation.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a clear, colorless, odorless gas contained in a 1,000 mL Xenoview Dose Delivery Bag.

This medicine is available in fallowing brand namesː

• Xenoview

What side effects can this medication cause?

The most common side effects of this medicine in Adult Patients include: oropharyngeal pain, headache, and dizziness

The most common side effects of this medicine in Pediatric Patients include:

• blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria.

What special precautions should I follow?

• Supplemental oxygen administered simultaneously with Xenoview inhalation can cause degradation of image quality. 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.
• Inhalation of an anoxic gas such as Xenoview may cause transient hypoxemia in susceptible patients. Monitor all patients for oxygen desaturation and symptoms of hypoxemia, and treat as clinically indicated.
• Xenoview is minimally absorbed systemically following the inhalation route of administration, and breastfeeding is not expected to result in exposure of the infant to the drug. There is no information on the presence of hyperpolarized xenon Xe 129 in human milk, the effect on the breastfed infant, or the effect on milk production.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• The safety and effectiveness of Xenoview have been established in pediatric patients aged 12 years and older for use with MRI to evaluate lung ventilation.
• Safety and effectiveness of Xenoview have not been established in pediatric patients less than 6 years of age.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• xenon xe-129
• nitrogen
• helium

Inactive ingredients:

• none

Who manufactures and distributes this medicine?

Manufactured for:

• Polarean, Inc.
• Meridian Parkway, Suite 175
• Durham, NC

• Xenoview is a trademark of Polarean, Inc.

What should I know about storage and disposal of this medication?

• Store Xenoview at 20° to 25°C (68° to 77°F) for no more than 5 minutes after final DE measurement.
• Do not use and discard Xenoview 60 minutes after filling of Dose Delivery Bag.
• Store Xenon Xe 129 Gas Blend at 20° to 25°C (68° to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F).

• Dailymed label info on Hyperpolarized Xenon 129
• FDA Hyperpolarized Xenon 129

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