Xenon
Xenon Xe-133
Lantheus Medical Imaging, Inc.
Human Prescription Drug
NDC 11994-127Xenon also known as Xenon Xe-133 is a human prescription drug labeled by 'Lantheus Medical Imaging, Inc.'. National Drug Code (NDC) number for Xenon is 11994-127. This drug is available in dosage form of Gas. The names of the active, medicinal ingredients in Xenon drug includes Xenon Xe-133 - 10 mCi/1 . The currest status of Xenon drug is Active.
Drug Information:
| Drug NDC: | 11994-127 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Xenon |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Xenon Xe-133 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Lantheus Medical Imaging, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gas |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | XENON XE-133 - 10 mCi/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | RESPIRATORY (INHALATION)
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 10 Oct, 1974 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 27 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA017284 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Lantheus Medical Imaging, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175866
N0000000205
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | X3P9A5HNYF
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Radiopharmaceutical Activity [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Inhalation Diagnostic Agent [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class: | Inhalation Diagnostic Agent [EPC]
Radiopharmaceutical Activity [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 11994-127-11 | 1 VIAL in 1 CAN (11994-127-11) / 1 GAS in 1 VIAL | 10 Oct, 1974 | N/A | No |
| 11994-127-15 | 5 VIAL in 1 CAN (11994-127-15) / 1 GAS in 1 VIAL | 10 Oct, 1974 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Xenon xenon xe-133 xenon xe-133 xenon xe-133 carbon dioxide xenon xenon xe-133 xenon xe-133 xenon xe-133 carbon dioxide
Indications and Usage:
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.
Warnings:
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.
General 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.
Dosage and Administration:
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: 74-1110mbq (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 doses method 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). 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. table 4. radiation doses effective whole half-time lungs 99% of activity is in lungs. brain body mgy/1110mbq
Read more... (rads/30mci) 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)
Contraindications:
Contraindications: none known.
Adverse Reactions:
Adverse reactions: adverse reactions related to the use of this agent have not been reported to date.
Use in Pregnancy:
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.
Pediatric Use:
Pediatric use safety and effectiveness in the pediatric population has not been established.
Geriatric Use:
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.
Description:
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. kocher, david c., "radioactive decay data tables," doe/tic-11026, p. 138,1981. significant radiations which are emitted by the nuclide are listed in table 1. table 1. principal radiation emission data from xenon-133 mean mean % per radiation energy (kev) disintegration 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 k α2 x-ray 30.6 13.6 k α1 x-ray 31.0 25.3 k β x-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. table 2. radiation attenuation by lead shielding 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. table 3. xenon xe 133 physical decay chart (half life 5.245 days) fraction fraction day remaining day remaining 0 calibration day 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:
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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
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.
How Supplied:
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. 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 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. lantheus medical imaging, inc. 331 treble cove rd., n. billerica, ma 01862 usa for ordering tel. toll free 800-299-3431 (for massachusetts & international, call 978-667-9531) all other busi
Read more...ness 800-362-2668 patent: http://www.lantheus.com/patents/index.html printed in u.s.a. 515083-0719 july 2019
Package Label Principal Display Panel:
Principal display panel - 10mci vial label 515129-0811 370 lantheus medical imaging 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 - 10mci vial label
Principal display panel - 20mci vial label 515130-0811 740 lantheus medical imaging 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 principal display panel - 20mci vial label