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Xenon Xe 133 (Systemic)


VA CLASSIFICATION
Primary: DX201

Commonly used brand name(s): MPI Xenon Xe 133 Gas; MPI Xenon Xe 133 Gas Ampul; Xenon Xe 133-V.S.S.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Diagnostic aid, radioactive (pulmonary disease; cerebrovascular disease)—

Indications

Accepted

Pulmonary function studies and
Lung imaging, radionuclide—Xenon Xe 133 for inhalation (in ventilation studies) is indicated to assess and evaluate pulmonary function and to provide images of the lungs in both cardiac and pulmonary diseases, such as asthma, pulmonary emphysema, bronchiectasis, carcinoma of the lung, and pulmonary embolism. {07} {16} {17} {23} {28} Lung ventilation imaging is almost always performed in conjunction with lung perfusion imaging in order to better differentiate pulmonary embolism from obstructive-type lung diseases. {12} {13} {20} {22}

Blood flow studies, cerebral—Xenon Xe 133 for inhalation is indicated to assess and evaluate regional cerebral blood flow, mainly in patients with cerebrovascular disease. {09} {10} {16} {17} {19} {21} {24}


Physical Properties

Nuclear data {01} {02} {03} {16} {28}:



Radionuclide
(half-life) *
Decay
constant
Mode of
decay
Principal
photons
(keV)
Mean number
of photons/
disintegration
Xe 133
(5.24 days)
0.00551 h -1
Beta
emission
Gamma (81.0)
0.37
* Xenon Xe 133 is produced by the fission of uranium U 235. At time of calibration, it contains no more than 0.3% xenon Xe 133m, 1.5% xenon Xe 131m, 0.06% krypton Kr 85, and 0.01% iodine I 131. {16}


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Xenon Xe 133 diffuses easily, passing through cell membranes and exchanging freely between blood and tissue. It is distributed in the lungs in a manner similar to that of air, thus representing the regions of the lung that are aerated. The gamma photons of xenon Xe 133 can then be employed to obtain counts per minute per lung or region of the lung, or to display their distribution as a scan. Scintigraphs taken during the washout period, as the patient breathes room air, will show any obstruction in the airways as regions of radioactive gas trapping or retention. (In the presence of an abnormal or near normal Tc 99m albumin aggregated perfusion study, a normal ventilation study favors a diagnosis of pulmonary emboli. However, the presence of xenon Xe 133 gas trapping, during washout imaging, in areas of abnormal perfusion, favors a diagnosis of chronic-type obstructive pulmonary disease.) {01} {02} {05} {16} {17} {26} {28}

Distribution:

When inhaled, xenon Xe 133 passes through the airways into the alveoli. Because of its insolubility, very little passes into the pulmonary venous circulation via capillaries. Most of it returns to the lungs and is exhaled after passing through the peripheral circulation. Inhaled xenon Xe 133 gas will mix with the air in the lungs and come to an equilibrium distribution if the patient is in a closed ventilation system. {08} {16} {17} {26}

Radiation dosimetry:


Estimated absorbed radiation dose*
With single inhalation
(30 sec breath-hold)
Organ
mGy/MBq
rad/mCi
Lungs
0.00077
0.0029
Bone surfaces
0.00012
0.00044
Breast
0.00012
0.00044
Red marrow
0.00012
0.00044
Small intestine
0.00011
0.00041
Large intestine wall
(upper)
0.00011
0.00041
Large intestine wall
(lower)
0.00011
0.00041
Liver
0.00011
0.00041
Pancreas
0.00011
0.00041
Spleen
0.00011
0.00041
Uterus
0.00011
0.00041
Adrenals
0.00010
0.00037
Bladder wall
0.00010
0.00037
Stomach wall
0.00010
0.00037
Kidneys
0.00010
0.00037
Ovaries
0.00010
0.00037
Testes
0.000099
0.00037
Thyroid
0.000099
0.00037
Other tissue
0.00010
0.00037
Effective dose: 0.00019 mSv/MBq (0.00070 rem/mCi)*


Organ
Estimated absorbed radiation dose*
With inhalation
(rebreathing from closed spirometer)
For 5 minutes
For 10 minutes
mGy/
MBq
rad/
mCi
mGy/
MBq
rad/
mCi
Lungs
0.0011
0.0041
0.0012
0.0044
Red marrow
0.00084
0.0031
0.0014
0.0052
Breast
0.00083
0.0031
0.0014
0.0052
Bone surfaces
0.00080
0.0030
0.0013
0.0048
Small intestine
0.00074
0.0027
0.0012
0.0044
Large intestine
wall (upper)
0.00074
0.0027
0.0012
0.0044
Large intestine
wall (lower)
0.00074
0.0027
0.0012
0.0044
Pancreas
0.00074
0.0027
0.0012
0.0044
Uterus
0.00074
0.0027
0.0012
0.0044
Bladder wall
0.00073
0.0027
0.0012
0.0044
Liver
0.00073
0.0027
0.0012
0.0044
Ovaries
0.00073
0.0027
0.0012
0.0044
Spleen
0.00073
0.0027
0.0012
0.0044
Stomach wall
0.00072
0.0027
0.0012
0.0044
Kidneys
0.00072
0.0027
0.0012
0.0044
Adrenals
0.00071
0.0026
0.0012
0.0044
Testes
0.00069
0.0026
0.0011
0.0041
Thyroid
0.00069
0.0026
0.0011
0.0041
Other tissue
0.00070
0.0026
0.0012
0.0044


Radionuclide
Effective dose*
Rebreathing for
5 minutes

Rebreathing for
10 minutes

mSv/
MBq
rem/
mCi
mSv/
MBq
rem/
mCi
Xe 133
0.00080
0.0030
0.0013
0.0048
* In adults. Data based on the International Commission on Radiological Protection (ICRP) Publication 53—Radiation dose to patients from radiopharmaceuticals. {18}

Elimination:
    Pulmonary.


Precautions to Consider

Carcinogenicity/Mutagenicity

Long-term animal studies to evaluate carcinogenic or mutagenic potential of xenon Xe 133 have not been performed. {16} {17}

Pregnancy/Reproduction

Pregnancy—
Studies have not been done with xenon Xe 133 in humans.

The possibility of pregnancy should be assessed in women of child-bearing potential. Clinical situations exist where the benefit to the patient and fetus, based on information derived from radiopharmaceutical use, outweighs the risks from fetal exposure to radiation. In these situations, the physician should use discretion and reduce the radiopharmaceutical dose to the lowest possible amount. {14}

Studies have not been done in animals.

FDA Pregnancy Category C. {01} {16} {17}

Breast-feeding

It is not known whether xenon Xe 133 is distributed into breast milk. {16} {17} However, risk to the infant from radiation exposure is considered negligible. Because of xenon Xe 133's poorly soluble nature, the amount that enters the venous circulation is not significant. Also, the small amount of xenon Xe 133 gas that passes into the venous circulation returns rapidly to the lungs to be exhaled. {04} {26}

Pediatrics

There have been no specific studies evaluating the safety and efficacy of xenon Xe 133 in pediatric patients. However, no pediatrics-specific problems have been documented to date. {21} When this radiopharmaceutical is used in children, the diagnostic benefit should be judged to outweigh the potential risk of radiation. {14}


Geriatrics


Appropriate studies on the relationship of age to the effects of xenon Xe 133 have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date. {09} {20} {24}

Drug interactions and/or related problems
See Diagnostic interference.

Diagnostic interference
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With results of this test

Due to other medications
Anesthetics, inhalation or
Diazepam    (distribution of xenon Xe 133 in the lung may be affected, with more activity shifting to the top of the lung and less to the bottom, due to a change in the gradient of ventilation, from nondependent to dependent lung, caused by these medications {06})


Alcohol, chronic use or
Clofibrate or
Parenteral nutrition, total (TPN)    (these medications may alter hepatic function [e.g., fatty liver disease as a result of TPN therapy]; because xenon is lipid soluble, appearance of radioactivity in liver during washout phase of ventilation study is theoretically possible; hepatic retention of xenon Xe 133 may be incorrectly attributed to other disorders associated with fatty liver infiltration [e.g., diabetes mellitus] that may also promote accumulation of xenon Xe 133 in the liver {06} {26} {27})


Due to medical problems or conditions
Diabetes mellitus or
Hyperlipidemia or
Obesity    (fatty liver infiltration associated with these disorders may promote accumulation of lipid-soluble xenon in the liver {06})


Medical considerations/Contraindications
See Diagnostic interference.


Side/Adverse Effects
There are no known side/adverse effects associated with the use of xenon Xe 133 as a diagnostic aid. {01}



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Radiopharmaceuticals (Diagnostic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use
Action in the body: Localization in airways of the lung

Visualization of radioactivity in lungs and brain

Small amounts of radioactivity used in diagnosis; radiation received is low and considered safe

Before having this test
»   Conditions affecting use, especially:

Pregnancy—Risk to fetus from radiation exposure as opposed to benefit derived from use should be considered





Breast-feeding—Not known if distributed into breast milk; however, risk to infant from radiation exposure is considered negligible





Use in children—Risk of radiation exposure as opposed to benefit derived from use should be considered


Preparation for this test
Special preparatory instructions may be given; patient should inquire in advance

Precautions after having this test
No special precautions when used for diagnosis


General Dosing Information
Radiopharmaceuticals are to be administered only by or under the supervision of physicians who have had extensive training in the safe use and handling of radioactive materials and who are authorized by the Nuclear Regulatory Commission (NRC) or the appropriate Agreement State agency, if required, or, outside the U.S., the appropriate authority.

Xenon Xe 133 should not be allowed to stand in tubing or respirator containers since it adheres to some plastics and rubber, causing a reduction in the administered activity. {16} {17} {26}

Adequate trapping or exhausting of exhaled xenon Xe 133 is essential to reduce contamination of air by airborne Xe 133. {01} {28}

Ventilation imaging is performed as the patient inhales the radioactive xenon. Successive images are obtained while the patient holds his or her breath (single-breath-hold image) and during various phases of breathing (rebreathing and washout from lungs). {26} {27} {28}

Safety considerations for handling this radiopharmaceutical
Improper handling of this radiopharmaceutical may cause radioactive contamination. Guidelines for handling radioactive material have been prepared by scientific, professional, state, federal, and international bodies and are available to the specially qualified and authorized users who have access to radiopharmaceuticals. {29}


Inhalation Dosage Forms

XENON Xe 133 USP

Usual adult and adolescent administered activity
Pulmonary function studies and imaging
Inhalation, 74 megabecquerels to 1.1 gigabecquerels (2 to 30 millicuries) per 3 liters of air. {16} {17}

Blood flow studies, cerebral
Inhalation, 370 megabecquerels to 1.1 gigabecquerels (10 to 30 millicuries) per 3 liters of air. {16} {17}


Usual pediatric administered activity
Dosage must be individualized by physician. The minimum recommended total dosage is 74 megabecquerels (2 millicuries). {15} {26}

Usual geriatric administered activity
See Usual adult and adolescent administered activity .

Size(s) usually available:
U.S.—


370 megabecquerels (10 millicuries) per 2-mL-size vial (Rx) [MPI Xenon Xe 133 Gas]


370 megabecquerels (10 millicuries) ±20% per ampul capsule (Rx) [Xenon Xe 133-V.S.S.]


370 megabecquerels (10 millicuries) per 3-mL size vial (Rx)[Generic]


740 megabecquerels (20 millicuries) per 2-mL size vial (Rx) [MPI Xenon Xe 133 Gas]


740 megabecquerels (20 millicuries) per 3-mL size vial (Rx)[Generic]


1.11 gigabecquerels (30 millicuries) per 3-mL size vial (Rx)[Generic]


1.48 gigabecquerels (40 millicuries) per 3-mL size vial (Rx)[Generic]


1.85 gigabecquerels (50 millicuries) per 3-mL size vial (Rx)[Generic]


9.25 gigabecquerels (0.25 Curie) per mL per 4-mL size ampul (Rx) [MPI Xenon Xe 133 Gas Ampul]


12.33 gigabecquerels (0.333 Curie) per mL per 3-mL size ampul (Rx) [MPI Xenon Xe 133 Gas Ampul]

Canada—


370 megabecquerels (10 millicuries) per 2-mL size vial (Rx)[Generic]


740 megabecquerels (20 millicuries) per 2-mL size vial (Rx)[Generic]

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F).

Stability:
Adheres to some plastics and rubber; to avoid a reduction in the administered activity, do not allow to stand in tubing or respirator container. {16} {17} {26}

Xenon Xe 133 gas should not be administered 14 days from the date of calibration stated on the label. {16} {17}

Note: Caution—Radioactive material.




Revised: 08/02/1994



References
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  1. Maynard CD. Clinical nuclear medicine. Philadelphia: Lea & Febiger, 1971: 177-9; 196-9; 208-11.
  1. Subramanian G, Rhodes BA, Cooper JF, et al. (editors). Radiopharmaceuticals. New York: Society of Nuclear Medicine, 1975: 298.
  1. Reviewers' comments as per 12/87 monograph revision of xenon Xe 127.
  1. Chilton HM, Witcofski RL. Nuclear pharmacy—an introduction to the clinical application of radiopharmaceuticals. Philadelphia: Lea & Febiger, 1986: 141-3.
  1. Hladik WB, Saha GB, Study KT. Essentials of nuclear medicine science. Baltimore: Williams & Wilkins, 1987: 211.
  1. Herbert DL, Gur D, Shabason L, et al. Mapping of human local pulmonary ventilation by xenon enhanced computed tomography. J Computer Assisted Tomography 1982; 6(6): 1088-93.
  1. van der Mark TW, Rookmaker AEC, Kiers A, et al. Nitrogen-13 and xenon-133 ventilation studies. J Nucl Med 1984; 25: 1175-82.
  1. Tachibana H, Meyer JS, Okayasu H, et al. Changing topographic patterns of human cerebral blood flow with age measured by xenon CT. AJNR 1984; 5: 139-46.
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  1. Bone RC. Ventilation/perfusion scan in pulmonary embolism: `the emperor is incompletely attired.' JAMA 1990; 263: 2794-5.
  1. Hull RD, Hirsh J, Carter CJ, et al. Diagnostic value of ventilation-perfusion lung scanning in patients with suspected pulmonary embolism. Chest 1985; 88(6): 819-28.
  1. USP Radiopharmaceuticals Advisory Panel meeting of 05/08/91.
  1. Pediatric dosages recommended by USP Radiopharmaceuticals Advisory panelists, 8/92.
  1. Xenon Xe 133 Gas package insert (Mallinckdrot—US), Rev 8/90.
  1. MPI Xenon package insert (Medi-Physics—US), Rev 2/91.
  1. Task Group of Committee 2 of the International Commission on Radiological Protection. Annals of the ICRP. ICRP Publication 53—Radiation dose to patients from radiopharmaceuticals. New York: Pergamon Press, 1988: 344.
  1. Sackeim HA, Prohovnik I, Moeller JR, et al. Regional cerebral blood flow in mood disorders. II. Comparison of major depression and Alzheimer's disease. J Nucl Med 1993; 1090-101.
  1. Jacobson AF, Herzog SA. Open bronchial stump post-pneumonectomy: findings on xenon-133 ventilation imaging. J Nucl Med 1993; 34: 462-4.
  1. Numaguchi Y, Haller JS, Humbert JR, et al. Cerebral blood flow mapping using stable xenon-enhanced CT in sickle cell cerebrovascular disease. Neuroradiology 1990; 32(4): 289-95.
  1. PIOPED Investigators. Value of the ventilation/perfusion scan in acute pulmonary embolism: results of the prospective investigation of pulmonary embolism diagnosis (PIOPED). JAMA 1990; 263: 2753-9.
  1. Lee HK, Skarzynski JJ, Spadaro A. Bilateral basal Xe-133 retention and ventilation/perfusion patterns in mild and subclinical congestive heart failure. Clin Nucl Med 1989; 14(12): 885-8.
  1. Andersen AR, Friberg HH, Schmidt JF, et al. Quantitative measurements of cerebral blood flow using SPECT and Tc 99m-HM-PAO compared to xenon-133. J Cereb Blood Flow Metab 1988; 8(S1): S69-S81.
  1. MIRD Dose Estimate Report No. 9. J Nucl Med 1980; 21: 459-65.
  1. Reviewers' comments per 09/27/93 monograph revision.
  1. Swanson DP, Chilton HM, Thrall JH. Pharmaceuticals in medical imaging. New York: Macmillan, 1990: 409.
  1. Alderson PO, Line BR. Scintigraphic evaluation of regional pulmonary ventilation. Semin Nucl Med 1980; 10(3): 218-42.
  1. Reviewers' responses to Ballot of 5/11/94.
  1. Hayes M, Taplin GV. Lung imaging with radioaerosols for the assessment of airway disease. Semin Nucl Med 1980; 10(3): 243-51.
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