Xenon xe-133 gas

Xenon xe-133 gas
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: Kiran Singh, M.D. [2]

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Overview

Xenon xe-133 gas is an odorless noble gas that is FDA approved for the diagnosis of pulmonary function and for imaging the lungs. Common adverse reactions include not reported.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Inhalation of Xenon Xe 133 Gas has proved valuable for the evaluation of pulmonary function and for imaging the lungs.
• It may also be applied to assessment of cerebral flow.

Dosage

• Xenon Xe 133 gas is administered by inhalation from closed respirator systems or spirometers.

• The suggested activity range employed for inhalation by the average adult patient (70 kg) is:

• Pulmonary function including imaging: 74-1110MBq (2-30mCi) in 3 liters of air.

• Cerebral blood flow: 370-1110MBq (10-30mCi) in 3 liters of air.

• The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

RADIATION DOSIMETRY

• The estimated absorbed radiation doses2 to an average patient (70 kg) for pulmonary perfusion and cerebral blood flow studies from a maximum dose of 1110 MBq (30mCi) of Xenon Xe 133 in 3 liters of air are shown in Table 4.

This image is provided by the National Library of Medicine.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Indications and Dosing

• Cerebral blood flow radionuclide study: 70-kg patient: 370 to 1110 megabecquerels (10 to 30 millicuries) INHALED in 3 L of air.
• Imaging of lung: 70-kg patient: 74 to 1110 megabecquerels (2 to 30 millicuries) INHALED in 3 L of air.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Xenon xe-133 gas in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Xenon xe-133 gas FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

• Safety and efficacy not established in pediatric patients

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Xenon xe-133 gas in pediatric patients.

Contraindications

• None known.

Warnings

• Xenon Xe 133 Gas delivery systems, i.e., respirators or spirometers, and associated tubing assemblies must be leakproof to avoid loss of radioactivity into the environs not specifically protected by exhaust systems.

• Xenon Xe 133 adheres to some plastics and rubber and should not be allowed to stand in tubing or respirator containers. The unrecognized loss of radioactivity from the dose for administration may render the study non-diagnostic.

• The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.

Adverse Reactions

Clinical Trials Experience

• Adverse reactions related to the use of this agent have not been reported to date.

Postmarketing Experience

There is limited information regarding Xenon xe-133 gas Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Xenon xe-133 gas Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Xenon xe-133 gas in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Xenon xe-133 gas in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Xenon xe-133 gas during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Xenon xe-133 gas in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Xenon xe-133 gas in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Xenon xe-133 gas in geriatric settings.

Gender

There is no FDA guidance on the use of Xenon xe-133 gas with respect to specific gender populations.

Race

There is no FDA guidance on the use of Xenon xe-133 gas with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Xenon xe-133 gas in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Xenon xe-133 gas in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Xenon xe-133 gas in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Xenon xe-133 gas in patients who are immunocompromised.

Administration and Monitoring

Administration

• Inhalation

Monitoring

There is limited information regarding Xenon xe-133 gas Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Xenon xe-133 gas and IV administrations.

Overdosage

There is limited information regarding Xenon xe-133 gas 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 Xenon xe-133 gas Pharmacology in the drug label.

Mechanism of Action

• Xenon Xe 133 is a readily diffusible gas which is neither utilized nor produced by the body. It passes through cell membranes and freely exchanges between blood and tissue. It tends to concentrate more in body fat than in blood, plasma, water or protein solutions. In the concentrations used for diagnostic purposes it is physiologically inactive. Inhaled Xenon Xe 133 Gas will enter the alveolar wall and enter the pulmonary venous circulation via the capillaries. Most of the Xenon Xe 133 that enters the circulation from a single breath is returned to the lungs and exhaled after a single pass through the peripheral circulation.

Structure

• XENON Xe 133 Gas is supplied in a mixture of xenon gas (5%) in carbon dioxide (95%). It is contained within septum sealed glass vials and is suitable for inhalation in the diagnostic evaluation of pulmonary function and imaging, as well as assessment of cerebral blood flow. Xenon Xe 133 Gas is reactor-produced as a by-product of Uranium U235 fission. Each vial contains the labeled amount of Xenon Xe 133 radioactivity at the time of calibration. The contents of the vial are in gaseous form, contain no preservatives, and are ready for use.

• Xenon Xe 133 is chemically and physiologically related to elemental Xenon, a non-radioactive monoatomic gas which is physiologically inert except for anesthetic properties at high doses.

PHYSICAL CHARACTERISTICS

• Xenon Xe 133 decays by beta and gamma emissions with a half-life of 5.245 days.1 Significant radiations which are emitted by the nuclide are listed in Table 1.

This image is provided by the National Library of Medicine.

EXTERNAL RADIATION

• The specific gamma ray constant for Xenon Xe 133 is 3.6 microcoulombs/Kg-MBq-hr (0.51R/hr-mCi) at 1 cm. The first half value thickness of lead is 0.0035 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from the interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 0.20 cm of Pb will decrease the external radiation exposure by a factor of 1,000.

This image is provided by the National Library of Medicine.

• To correct for physical decay of this radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3.

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Xenon xe-133 gas Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Xenon xe-133 gas Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Xenon xe-133 gas Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Xenon xe-133 gas Clinical Studies in the drug label.

How Supplied

The Xenon Xe 133 gas is supplied as part of the Calidose™ system, consisting of 3ml unit dose vials and the Calidose™ dispenser for shielded dispensing.

• Normally vials containing either 370 or 740MBq (10 or 20mCi)/vial, packed 1 vial or 5 vials per shield tube, are supplied.

• The NDC number for: 10mCi vial is 11994-127; 20mCi vial is 11994-128.

• This radiopharmaceutical is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.100 for the uses listed in 105 CMR 120. 547 or 120.552 or under equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.

The contents of the vial are radioactive. Adequate shielding and handling precautions must be maintained.

Storage

• Store at controlled room temperature 20°-25°C (68°-77°F) [See USP].

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Xenon xe-133 gas Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Xenon xe-133 gas interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

XENON

Look-Alike Drug Names

There is limited information regarding Xenon xe-133 gas 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.

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