Indications and uses
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.
XENON Xe 133 GAS
- Manufacturer
- Shine Spect USA, LLC | Institut National des Radioelements
- Effective date
- 2026-09-10
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 2
- Source
- daily-update
- Hydrated at
- 2026-09-12 01:02:35
Label at a glance#
ProductXenon
Active ingredientXENON XE-133
Label structure11 sections
Dosage and administration
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: 74-1110 MBq (2-30 mCi) in 3 liters of air. Cerebral blood flow: 370-1110 MBq (10-30 mCi) in 3 liters of air. The patient dose should be measured by a suitable radioactivity calibration system...
Contacts and useful links#
Websitewww.shinefusion.com
www.shinefusion.com/patents
www.shinefusion.com/patentsLabel contents#
Full prescribing information#
DESCRIPTION:
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.
| Radiation | Mean Energy (KeV) | Mean % per Disintegration |
|---|---|---|
| 1Kocher, David C., "Radioactive Decay Data Tables," DOE/TIC-11026, p. 138, 1981. | ||
| Beta-2 | 100.6 | 99.3 |
| Ce-K-2 | 45.0 | 53.3 |
| Ce-L-2 | 75.3 | 8.1 |
| Ce-M-2 | 79.8 | 1.7 |
| Gamma-2 | 81.0 | 36.5 |
| Kα2X-ray | 30.6 | 13.6 |
| Kα1X-ray | 31.0 | 25.3 |
| KβX-ray | 35.0 | 9.1 |
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.
| cm of Pb | Radiation Attenuation Factor |
|---|---|
| 0.0035 | 0.5 |
| 0.037 | 10-1 |
| 0.12 | 10-2 |
| 0.20 | 10-3 |
| 0.29 | 10-4 |
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.
| Fraction | Fraction | ||
|---|---|---|---|
| Day | Remaining | Day | Remaining |
| *Calibration Day | |||
| 0* | 1.000 | 8 | .349 |
| 1 | .877 | 9 | .302 |
| 2 | .768 | 10 | .268 |
| 3 | .674 | 11 | .235 |
| 4 | .591 | 12 | .206 |
| 5 | .518 | 13 | .181 |
| 6 | .452 | 14 | .157 |
| 7 | .398 |
CLINICAL PHARMACOLOGY:
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.
INDICATIONS AND USAGE:
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.
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.
PRECAUTIONS:
General
Xenon Xe 133, as well as other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Also, care should be taken to minimize radiation exposure to patients consistent with proper patient management.
Exhaled Xenon Xe 133 Gas should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of radionuclides.
Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long term animal studies have been performed to evaluate carcinogenic potential or whether Xenon Xe 133 affects fertility in males or females.
Pregnancy
Animal reproductive studies have not been conducted with Xenon Xe 133 Gas. It is also not known whether Xenon Xe 133 Gas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Xenon Xe 133 Gas should be given to a pregnant woman only if clearly needed.
Ideally, examination using radiopharmaceuticals, especially those elective in nature in a woman of childbearing capability, should be performed during the first few (approximately 10) days following the onset of menses.
Nursing Mothers
It is not known whether Xenon Xe 133 is excreted in human milk. Many drugs are excreted in human milk, therefore formula feedings should be substituted for breast feeding, because of the potential for adverse reactions in nursing infants.
Pediatric Use
Safety and effectiveness in the pediatric population has not been established.
Geriatric Use
Clinical studies of Xenon Xe 133 Gas did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
ADVERSE REACTIONS:
Adverse reactions related to the use of this agent have not been reported to date.
DOSAGE AND ADMINISTRATION:
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: 74-1110 MBq (2-30 mCi) in 3 liters of air.
Cerebral blood flow: 370-1110 MBq (10-30 mCi) 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 (30 mCi) of Xenon Xe 133 in 3 liters of air are shown in Table 4.
| Effective | Whole | |||
|---|---|---|---|---|
| Half-Time | Lungs* | Brain | Body | |
| *99% of activity is in lungs. | ||||
| 2Method of Calculation: A Schema for Absorbed-Dose Calculation for Biologically Distributed Radionuclides, Supplement No. 1, MIRD pamphlet No. 1, J.Nucl. Med., p.7 (1968). | ||||
| mGy/1110 MBq | (rads/30 mCi) | |||
| Pulmonary Perfusion | 2 min. | 2.5(0.25) | 0.014(0.0014) | 0.027(0.0027) |
| Cerebral Blood Flow | 5 min. | 6.3(0.63) | 0.035(0.0035) | 0.068(0.0068) |
HOW SUPPLIED:
The Xenon Xe 133 Gas is supplied as part of the Calidose™ system, consisting of 3 mL unit dose vials and the Calidose™ dispenser for shielded dispensing.
Normally vials containing either 370 or 740 MBq (10 or 20 mCi)/vial, packed 1 vial or 5 vials per shield tube, are supplied.
The NDC number for: 10 mCi vial is 87333-127; 20 mCi vial is 87333-128.
Store at room temperature.
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 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.
SPL UNCLASSIFIED SECTION
SHINE™
SHINE SPECT USA, LLC
325 Treble Cove Rd., N. Billerica, MA 01862 USA
For Ordering Tel. Toll Free 800-657-5426
(For Massachusetts & International, Call 978-330-9548)
Patent: www.shinefusion.com/patents
Printed in U.S.A.
515083-0126
January 2026
PRINCIPAL DISPLAY PANEL - 10mCi Vial Label
515129-0126
370
SHINE™
SHINE SPECT USA, LLC
Xenon Xe 133 Gas
One Dose Vial
Exp. Date 10 Days
After Calibration
370 MBq (10mCi)
Vial Stopper Contains
Dry Natural Rubber Latex
CAUTION:
RADIOACTIVE
MATERIAL
PRINCIPAL DISPLAY PANEL - 20mCi Vial Label
515130-0126
740
SHINE™
SHINE SPECT USA, LLC
Xenon Xe 133 Gas
One Dose Vial
Exp. Date 10 Days
After Calibration
740 MBq (20mCi)
Vial Stopper Contains
Dry Natural Rubber Latex
CAUTION:
RADIOACTIVE
MATERIAL
Products#
Every source-derived product name is available through these pages.
- Xenon
- Xenon XE-133
- CARBON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 87333-127 | 87333-127-11, 87333-127-15 |
| 87333-128 | 87333-128-21, 87333-128-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| XENON XE-133 | X3P9A5HNYF | ACTIB |
| CARBON DIOXIDE | 142M471B3J | IACT |
| XENON XE-133 | X3P9A5HNYF | ACTIB |
| CARBON DIOXIDE | 142M471B3J | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017284-001 | XENON XE 133 | XENON XE-133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | ||
| N017284-002 | XENON XE 133 | XENON XE-133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N017284-001 | XENON XE 133 | 10mCi/VIAL | GAS / INHALATION | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N017284-002 | XENON XE 133 | 20mCi/VIAL | GAS / INHALATION | Approved before 1982 | 74a2ff9319b5… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Xenon | XENON XE-133 | Shine Spect USA, LLC | 74f95143-d3b4-4e69-b200-e09bf811516b | 2026-09-10 | Warnings, Adverse reactions | 87333-128-21 87333-127-15 87333-128-25 87333-127-11 87333-127 87333-128 87333012825 87333012711 87333012715 87333012821 a5956751-131b-4a35-9b1f-e3ec97585dc7 74f95143-d3b4-4e69-b200-e09bf811516b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.