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|Product NDC Code||69945-097|
|Pharm Class||Inhalation Diagnostic Agent [EPC],
Radiopharmaceutical Activity [MoA]
|Labeler Name||Curium US LLC|
Adverse reactionsInformation about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.
ADVERSE REACTIONS Adverse reactions specifically attributable to Xenon Xe 133 Gas have not been reported.
Clinical pharmacologyInformation about the clinical pharmacology and actions of the drug in humans.
CLINICAL PHARMACOLOGY Xenon Xe 133 is a readily diffusible gas which is neither utilized nor produced by the body. It passes through cell membranes, freely exchanges between blood and tissue, and tends to concentrate more in body fat than in blood, plasma, water or protein solutions. In the concentrations recommended for diagnostic studies, it is physiologically inactive. Inhaled Xenon Xe 133 Gas will enter the alveolar wall and the pulmonary venous circulation via capillaries. Most of the Xenon Xe 133 Gas that enters the circulation from a single breath is returned to the lungs and exhaled after a single pass through the peripheral circulation.
ContraindicationsInformation about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.
CONTRAINDICATIONS None known.
DescriptionGeneral information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
DESCRIPTION Xenon Xe 133 Gas is for diagnostic inhalation use only. It is supplied in vials containing either 370 or 740 megabecquerels (10 or 20 millicuries) of Xenon Xe 133 Gas in 2 milliliters of carrier xenon and atmospheric air. Xenon Xe 133 Gas is chemically and physiologically similar to elemental xenon, a non-radioactive gas which is physiologically inert except for anesthetic properties at high doses. Xenon Xe 133 is produced by fission of Uranium U 235. At the time of calibration, it contains no more than 0.3% Xenon Xe 133m, no more than 1.5% Xenon Xe 131m, no more than 0.06% Krypton Kr 85 and no more than 0.01% Iodine I 131, with no less than 99.9% total radioactivity as radioxenon. Table 1 shows the effect of time on radionuclidic composition. Table 1. Radionuclidic Composition Percent of Total Radioactivity Days % Xe-133 % Xe-133m % Xe-131m % Kr-85 % I-131 -5 >98.3 <0.6 <1.0 <0.03 <0.01 0 Calibration Date >98.1 <0.3 <1.5 <0.06 <0.01 7 >97.2 <0.08 <2.5 <0.15 <0.02 14 Expiration Date >95.7 <0.02 <4.1 <0.37 <0.02
Dosage and administrationInformation about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
DOSAGE AND ADMINISTRATION Xenon Xe 133 Gas is administered by inhalation from a closed respirator system or spirometer. The final patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. The recommended activity range employed for inhalation by the average patient (70 kg) is: Pulmonary function including imaging: 74 to 1110 megabecquerels (2 to 30 millicuries) Cerebral blood flow: 370 to 1110 megabecquerels (10 to 30 millicuries) This may be administered as a bolus into the tubing near the patient's mouthpiece or mask after the completion of a tidal exhalation, or by rebreathing for a period of approximately 5 minutes of the Xenon Xe 133 gas in equilibrium with the air contained in the closed system at concentrations of the radionuclide that may vary from 37 to 222 megabecquerels (1.0 to 6.0 millicuries) per liter.
Indications and usageA statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
INDICATIONS AND USAGE Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.
Spl product data elementsUsually a list of ingredients in a drug product.
Xenon, Xe-133 Xenon XENON XE-133 XENON XE-133 AIR Xenon, Xe-133 Xenon XENON XE-133 XENON XE-133 AIR
Carcinogenesis and mutagenesis and impairment of fertilityInformation about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.
Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential or whether this drug affects fertility in males or females.
Package label principal display panelThe content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL - 10 mCi XENON Xe 133 GAS 370 MBq (10 mCi)/vial CAUTION RADIOACTIVE MATERIAL Single Dose Container -Dispose in Accordance with Regulatory Requirements. For use with Xenotron™ I Xenon Gas Dispenser only. Rx only Curium US LLC A097V0 R03/2019 Label Label PRINCIPAL DISPLAY PANEL - 20 mCi XENON Xe 133 GAS 740 MBq (20 mCi)/vial CAUTION RADIOACTIVE MATERIAL Single Dose Container -Dispose in Accordance with Regulatory Requirements. For use with Xenotron™ I Xenon Gas Dispenser only. Rx only Curium US LLC A098V0 R03/2019 Label Label
Spl unclassified sectionInformation not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
PHYSICAL CHARACTERISTICS Xenon Xe 133 decays by beta and gamma emissions with a physical half-life of 5.245 days. Kocher, David C., "Radioactive Decay Data Tables," DOE/TIC-11026, 138 (1981). Photons that are useful for detection and imaging studies as well as the principal beta emission are listed in Table 2. Table 2. Principal Radiation Emission Data Radiation Mean % Per Disintegration Energy (keV) Beta-2 99.3 100.6 Avg. Gamma-2 36.5 81.0 K alpha x-rays 38.9 30.8 Avg. K beta x-rays 9.1 35.0 Avg. EXTERNAL RADIATION The specific gamma ray constant for Xenon Xe 133 is 0.51 R/hr-mCi at 1 cm. The first half-value thickness is 0.0035 cm of Pb. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 3. For example, the use of 0.2 cm of Pb will decrease the external radiation exposure by a factor of about 1000. Table 3. Radiation Attenuation by Lead Shielding Shield Thickness (Pb), cm Coefficient of Attenuation 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 date of calibration are shown in Table 4. Table 4. Physical Decay Chart; Xenon Xe 133, Half-life 5.245 Days Days Fraction Remaining Days Fraction Remaining 0 Calibration Date 1.000 8 0.347 1 0.876 9 0.304 2 0.768 10 0.267 3 0.673 11 0.234 4 0.589 12 0.205 5 0.516 13 0.179 6 0.453 14 0.157 7 0.397 RADIATION DOSIMETRY The estimated absorbed radiation doses to an average patient (70 kg) for inhalation studies from a maximum dose of Xenon Xe 133 gas in 5, 7.5 and 10 liters are shown in Table 5. The values are the maximum absorbed dose that could be anticipated under the given conditions. Table 5. Radiation Dose Estimates of Xenon Xe 133 Atkins, Harold L., et al., Estimates of Radiation Absorbed Doses from Radioxenons in Lung Imaging. Task Group of the Medical Internal Radiation Dose Committee, Society of Nuclear Medicine, J. Nucl. Med., 21:459-465,1980. : Absorbed Dose per 1110 megabecquerels (30 millicuries) of Xenon Xe 133 Gas Administered by Inhalation Tissue Spirometer Volume (liters) 5 7.5 10 Absorbed Radiation Doses mGy Rad mGy Rad mGy Rad Lung 3.3 0.33 2.46 0.246 1.95 0.195 Red Marrow 0.45 0.045 0.36 0.036 0.27 0.027 Ovaries 0.39 0.039 0.30 0.030 0.24 0.024 Testes 0.36 0.036 0.27 0.027 0.21 0.021 Total Body 0.42 0.042 0.33 0.033 0.27 0.027 DIRECTIONS FOR DISPENSING Transfer the appropriate Xenon Xe 133 Gas dose from the Xenon Xe 133 Gas unit dose vial(s) to a breathing device or spirometer utilizing the Xenotron™ I Xenon Gas Dispenser. Follow the directions for use that are provided with the Xenotron™ I Xenon Gas Dispenser. Xenon Xe 133 Gas should not be used after 14 days from the date of calibration stated on the label. ACTIVITY MEASUREMENTS Calibrate a suitable commercial ionization chamber dose calibrator according to the manufacturer's instructions for that particular instrument. An instrument that gives direct radioactivity readouts is recommended. Use a National Institute of Standards and Technology (NIST) Xenon Xe 133 standard for the initial calibration. Also establish a secondary standard, such as Americium Am 241, at that time for subsequent routine use. Other suitable radionuclides may also be used. Determine the effective readout of the secondary standard compared to the Xenon Xe 133 standard over the range of activities expected for routine measurements. Determine the radioactivities of the dose for administration as follows: Check the dose calibrator for proper response with the secondary standard. Insert the Xenon Xe 133 Gas unit dose vial in the dose calibrator and measure the apparent radioactivity of the Xenon Xe 133. Correct for decay as necessary. The radioactivity determined by this method is within 25% of the true value. This degree of accuracy includes variations attributed to small differences in geometry and radiation attenuation between the NIST standard ampule and the Xenon Xe 133 Gas unit dose vial.
Nursing mothersInformation about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Xenon Xe 133 Gas is administered to a nursing woman.
Pediatric useInformation about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
PregnancyInformation about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)
Pregnancy Category C Animal reproduction 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, all examinations that use radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.
How suppliedInformation about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.
HOW SUPPLIED Xenon Xe 133 Gas is available in 2 milliliter vials with color-coded labels in 370 megabecquerel (10 millicurie; Catalog No. 097) and 740 megabecquerel (20 millicurie; Catalog No. 098) sizes. Both sizes are available in packages of 1, 3 and 5 vials, each with individual lead shielding.
Storage and handlingInformation about safe storage and handling of the drug product.
STORAGE Xenon Xe 133 Gas should be stored at controlled room temperature 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in Sections 35.200 and to persons who hold an equivalent license issued by an Agreement State. Curium and the Curium logo are trademarks of a Curium company. ©2018 Curium US LLC. All Rights Reserved. Curium US LLC Maryland Heights, MO 63043 USA A097I0 R12/2018 CURIUM™
General precautionsInformation about any special care to be exercised for safe and effective use of the drug.
General Xenon Xe 133 Gas 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 the 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.
PrecautionsInformation about any special care to be exercised for safe and effective use of the drug.
PRECAUTIONS General Xenon Xe 133 Gas 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 the 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, mutagenic potential or whether this drug affects fertility in males or females. Pregnancy Category C Animal reproduction 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, all examinations that use radiopharmaceuticals, especially those elective in nature, of 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 this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Xenon Xe 133 Gas is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established.
WarningsInformation about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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 laboratory environs not specifically protected by exhaust systems. Xenon Xe 133 Gas adheres to some plastics and rubber and should not be allowed to stand in tubing or respirator containers. Loss of radioactivity due to such adherence may render the study nondiagnostic.
Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API