Hyperpolarized Xe-129

Hyperpolarized Xe-129
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]

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Overview

Hyperpolarized Xe-129 is a hyperpolarized contrast agent that is FDA approved for the procedure of use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.. Common adverse reactions include The adverse reactions (> one patient) in efficacy trials were oropharyngeal pain, headache, and dizziness..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• 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.
• Each bag contains at least 75 mL DE of hyperpolarized xenon Xe 129 with a recommended target DE range of 75 mL to 100 mL measured within 5 minutes of administration, in a volume of 250 mL to 750 mL total xenon with additional nitrogen, NF (99.999% purity) added to reach a total volume of 1,000 mL.
• Administer dose within 5 minutes of DE measurement.
• Initiate imaging immediately after inhalation.
• See Full Prescribing Information for detailed information regarding preparation, administration, image acquisition, and image interpretation.

• XENOVIEW is a clear, colorless, odorless gas contained in a 1,000 mL XENOVIEW Dose Delivery Bag. The bag contains at least 75 mL DE of hyperpolarized xenon Xe 129 in a volume of 250 mL to 750 mL total xenon.
• The strength is DE per 1,000 mL administered. 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hyperpolarized Xe-129 in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hyperpolarized Xe-129 in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Hyperpolarized Xe-129 FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hyperpolarized Xe-129 in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hyperpolarized Xe-129 in pediatric patients.

Contraindications

None.

Warnings

Risk of Decreased Image Quality from Supplemental Oxygen

• Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality due to depolarization of XENOVIEW.
• 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.

Risk of Transient Hypoxia

• 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.

Adverse Reactions

Clinical Trials Experience

Adverse Reactions in Adult Patients

• The safety of XENOVIEW was evaluated in two prospective efficacy trials that enrolled a total of 83 adult patients with various lung disorders who were being evaluated for possible lung surgery. Mean age of these patients was 62 years, 88% were White and 69% were male. In these two trials, mean xenon gas volume per XENOVIEW dose was 330.2 mL and 81 of 83 patients (98%) received a single administration of XENOVIEW. For safety assessment, the volume of administered xenon gas in the XENOVIEW dose is noted rather than the DE, because isotopic enrichment and hyperpolarization are not known to affect the safety profile of xenon gas.

Adverse reactions were reported in 12 (14%) of the 83 patients. Adverse reactions reported by more than one patient were oropharyngeal pain (n = 4 patients), headache (n = 2 patients), and dizziness (n = 2 patients).

• A hypersensitivity reaction that included transient pruritus and erythema occurred in one patient with a history of allergic reactions to several drugs, foods, and other substances.
• In pooled data of 123 adult patients from published literature, most of whom had lung disorders such as COPD, idiopathic pulmonary fibrosis, and asthma, who received 1 dose to 2 doses of hyperpolarized xenon Xe 129 with xenon volumes of approximately 500 mL to 1,000 mL of xenon gas per dose, the following transient adverse reactions were reported: numbness, tingling, euphoria, and dizziness. Overall frequency of these adverse reactions could not be determined from the published information.

Adverse Reactions in Pediatric Patients

• In pooled data of 120 pediatric patients aged 6 to 18 years from published literature, most of whom had either asthma or cystic fibrosis, who received 1 dose to 2 doses of hyperpolarized xenon Xe 129 with xenon volumes based on predicted total lung capacity (TLC), the following transient adverse reactions were reported: blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria. Overall frequency of these adverse reactions could not be determined from the published information. XENOVIEW is not approved for use in pediatric patients less than 12 years of age.
• In one of the published studies of 23 pediatric patients aged 6 to 18 years, 11 of whom had cystic fibrosis and 12 of whom were healthy, the mean difference of SpO2% from baseline was -6% following hyperpolarized xenon Xe 129 administration with xenon volumes based on predicted total lung capacity. In the same study, the mean change in heart rate from baseline was +6.6 beats per minute following hyperpolarized xenon Xe 129 administration. Both reported oxygen desaturation and heart rate elevation resolved by 2 minutes post-dose without intervention. XENOVIEW is not approved for use in pediatric patients less than 12 years of age.

Postmarketing Experience

There is limited information regarding Hyperpolarized Xe-129 Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Hyperpolarized Xe-129 Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

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.
• 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% O2 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% O2 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/O2 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.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hyperpolarized Xe-129 in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Hyperpolarized Xe-129 during labor and delivery.

Nursing Mothers

Risk Summary

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 [see Clinical Pharmacology (12.3)]. 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. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for XENOVIEW and any potential adverse effects on the breastfed child from XENOVIEW or from the underlying maternal condition.

Pediatric Use

• 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. Use of XENOVIEW in this age group is supported by evidence from adequate and well-controlled studies in adults with additional safety data from published literature.

• Although supportive safety data are available for pediatric patients 6 years to less than 12 years of age, use of XENOVIEW is not approved in this age group because the age-appropriate dose of XENOVIEW cannot be accurately administered.

• Safety and effectiveness of XENOVIEW have not been established in pediatric patients less than 6 years of age.

Geriatic Use

• Of the total number of patients in clinical studies of XENOVIEW, 36 (43%) were 65 years of age and older, while 6 (7%) were 75 years of age and older. No overall differences in safety or effectiveness have been observed between patients 65 years of age and older and younger adult patients although the number of patients in the trials was not large enough to allow definitive comparison.

Gender

There is no FDA guidance on the use of Hyperpolarized Xe-129 with respect to specific gender populations.

Race

There is no FDA guidance on the use of Hyperpolarized Xe-129 with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Hyperpolarized Xe-129 in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Hyperpolarized Xe-129 in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Hyperpolarized Xe-129 in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Hyperpolarized Xe-129 in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Hyperpolarized Xe-129 Administration in the drug label.

Monitoring

There is limited information regarding Hyperpolarized Xe-129 Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Hyperpolarized Xe-129 and IV administrations.

Overdosage

There is limited information regarding Hyperpolarized Xe-129 overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Hyperpolarized Xe-129 Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Hyperpolarized Xe-129 Mechanism of Action in the drug label.

Structure

There is limited information regarding Hyperpolarized Xe-129 Structure in the drug label.

Pharmacodynamics

There is limited information regarding Hyperpolarized Xe-129 Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Hyperpolarized Xe-129 Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Hyperpolarized Xe-129 Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Hyperpolarized Xe-129 Clinical Studies in the drug label.

How Supplied

There is limited information regarding Hyperpolarized Xe-129 How Supplied in the drug label.

Storage

There is limited information regarding Hyperpolarized Xe-129 Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Hyperpolarized Xe-129 Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Hyperpolarized Xe-129 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Hyperpolarized Xe-129 Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Hyperpolarized Xe-129 Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.