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Technetium Tc 99m Generator
Overview
What is RadioGenix System?
Chemical Characteristics
The RadioGenix™ System provides sodium pertechnetate Tc 99m injection, USP for intravenous use, intravesicular use, ophthalmic use, or for preparing radiopharmaceutical kits. The RadioGenix™ System uses a non-uranium potassium molybdate Mo-99 source solution to produce sodium pertechnetate Tc 99m Injection, USP. The RadioGenixTM System uses potassium molybdate Mo-99 sources at an activity of 6 Ci/29 mL (222 GBq) at the date and time of calibration.
Elution of RadioGenix™ System produces Sodium Pertechnetate Tc-99m (Na99mTcO4) in approximately 5 mL of sterile 0.9% sodium chloride injection solution. The activity of Sodium Pertechnetate Tc-99m produced varies (30 mCi/mL to 1153 mCi/mL of technetium Tc-99m) and depends on the activity of potassium molybdate Mo-99 present in the source container originally, the decay time since the calibration time and the elapsed time since the previous Sodium Pertechnetate Tc-99m elution.
Sodium Pertechnetate Tc-99m is an inorganic compound with the formula Na99mTcO4. In solution, Sodium Pertechnetate exists as dissociated Na+ cations and pertechnetate TcO4- anions with the following molecular structure:
The eluted sodium pertechnetate Tc 99m injection, USP is sterile, non pyrogenic, clear and colorless solution. The pH of the solution is between 4.5 and 7.5.
Physical Characteristics
Technetium Tc-99m
Technetium Tc-99m decays by isomeric transition with a physical half-life of 6.01 hours. The principal photon that is useful for detection and imaging studies in shown in Table 8.
The air-kerma-rate (exposure-rate) constant for technetium Tc-99m is 5.23 m2·pGy·(MBq)-1·s-1 [0.795 cm2·R·(mCi)-1·h-1]. A range of values for the relative radiation attenuation by the various thicknesses of Pb is shown in Table 9. For example, the use of 3 mm thickness of Pb will attenuate the radiation exposure by a factor of about 1000.
Molybdenum Mo-99
Molybdenum Mo-99 decays to technetium Tc-99m with a molybdenum Mo-99 half-life of 66 hours. This means that 77.7% of the activity remains after 24 hours; 60.4% remains after 48 hours, see Table 10.
The physical decay characteristics of molybdenum Mo-99 are such that 88.6% of the decaying molybdenum Mo-99 atoms form Technetium Tc-99m. RadioGenixTM System elutions may be made at any time, but the amount of technetium Tc-99m available will depend on the time interval measured from the last elution cycle. Eluting the RadioGenixTM System every 24 hours will provide the maximal yield of Sodium Pertechnetate Tc-99m.
To correct for physical decay of technetium Tc-99m, the fractions that remain at selected intervals of time are shown in Table 11.
What does RadioGenix System look like?
What are the available doses of RadioGenix System?
The RadioGenix™ System provides sodium pertechnetate Tc 99m injection, USP, from a non – highly enriched uranium source of potassium molybdate Mo-99, as a clear, colorless solution containing 30 mCi/mL to 1153 mCi/mL (1110 to 42,661 MBq/mL) of technetium Tc-99m radioactivity in approximately 5mL of volume. The amount of Tc-99m radioactivity depends on the radioactivity in the potassium molybdate Mo-99 source. The source is supplied in vessels containing 6 Ci (222 GBq) at the date and time of calibration.
What should I talk to my health care provider before I take RadioGenix System?
Pregnancy
Risk Summary
There are no available data with Sodium Pertechnetate Tc-99m use in pregnant women to inform any drug-associated risks of developmental outcomes. Animal reproductive studies have not been conducted with Sodium Pertechnetate Tc-99m. All radiopharmaceuticals, including Sodium Pertechnetate Tc-99m, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Sodium Pertechnetate Tc-99m administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Sodium Pertechnetate Tc-99m and the gestational timing of exposure.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.
Lactation
Risk Summary
There are limited data available in the published literature on the presence of technetium Tc-99m in human milk. There are no data available on the effects of Sodium Pertechnetate Tc-99m on the breast fed infant or the effects on milk production. Exposure of Sodium Pertechnetate Tc-99m to a breastfed infant can be minimized by temporary discontinuation of breast feeding (see Clinical Considerations). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Sodium Pertechnetate Tc-99m, any potential adverse effects on the breastfed child from Sodium Pertechnetate Tc-99m or from the underlying maternal condition.
Clinical Considerations
To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breastmilk after the administration of Sodium Pertechnetate Tc-99m for 12 to 24 hours, where the duration corresponds to the typical range of administrated activity, 259 MBq to 925 MBq (7mCi to 25mCi).
Pediatric Use
Safety and effectiveness have been established for Sodium Pertechnetate Tc-99m in pediatric patients from birth (term neonates) to 17 years of age of age for thyroid imaging and for urinary bladder imaging via direct isotopic cystography for the detection of vesicoureteral reflux based on clinical experience. Safety and effectiveness have not been established in pediatric patients for salivary gland imaging or nasolacrimal drainage system imaging. Although dose adjustment based on body size or weight is generally recommended, the administered dose should be adequate to obtain acceptable quality diagnostic information [see Dosage and Administration 2.4]. Radiation risks of Sodium Pertechnetate Tc-99m injection are greater in pediatric patients than adults See Warnings and Precautions 5.1.
Geriatric Use
Studies on the relationship of age to the effects of Sodium Pertechnetate Tc-99m injection have not been performed in the geriatric population. 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 dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
How should I use RadioGenix System?
The RadioGenix™ System is a technetium Tc-99m generator used to produce sterile, non-pyrogenic Sodium Pertechnetate Tc-99m injection. Sodium Pertechnetate Tc-99m injection is indicated for use in the preparation of FDA approved diagnostic radiopharmaceuticals.
Sodium Pertechnetate Tc-99m injection is also indicated:
In Adults for
In Pediatric Patients for:
What interacts with RadioGenix System?
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What are the warnings of RadioGenix System?
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What are the precautions of RadioGenix System?
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What are the side effects of RadioGenix System?
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What should I look out for while using RadioGenix System?
None.
Drug Interactions
Array
WARNINGS
What might happen if I take too much RadioGenix System?
Sorry No Records found
How should I store and handle RadioGenix System?
The RadioGenixTM System is a Technetium Tc-99m Generator supplied and installed by NorthStar Medical Radioisotopes. It produces Sodium Pertechnetate Tc-99m injection from a non-uranium potassium molybdate Mo-99 source solution. The potassium molybdate Mo-99 source solution is shielded within a source container which completely encases a vial that contains 29mL of solution. NorthStar supplies potassium molybdate Mo-99 solution with the referenced calibration date and time specified on the container label, Table 12:The following kits, Tables 13- 17, are used in the operation of the RadioGenixTM System as described in the RadioGenix™ System Operator Guide, 94S05058.*Discarded Material, Type A Kit is designed to be used to ship the dicarded material container back to NorthStar for disposal. Both Discarded Material Kits contain the same components. The RadioGenixTM System is a Technetium Tc-99m Generator supplied and installed by NorthStar Medical Radioisotopes. It produces Sodium Pertechnetate Tc-99m injection from a non-uranium potassium molybdate Mo-99 source solution. The potassium molybdate Mo-99 source solution is shielded within a source container which completely encases a vial that contains 29mL of solution. NorthStar supplies potassium molybdate Mo-99 solution with the referenced calibration date and time specified on the container label, Table 12:The following kits, Tables 13- 17, are used in the operation of the RadioGenixTM System as described in the RadioGenix™ System Operator Guide, 94S05058.*Discarded Material, Type A Kit is designed to be used to ship the dicarded material container back to NorthStar for disposal. Both Discarded Material Kits contain the same components. The RadioGenixTM System is a Technetium Tc-99m Generator supplied and installed by NorthStar Medical Radioisotopes. It produces Sodium Pertechnetate Tc-99m injection from a non-uranium potassium molybdate Mo-99 source solution. The potassium molybdate Mo-99 source solution is shielded within a source container which completely encases a vial that contains 29mL of solution. NorthStar supplies potassium molybdate Mo-99 solution with the referenced calibration date and time specified on the container label, Table 12:The following kits, Tables 13- 17, are used in the operation of the RadioGenixTM System as described in the RadioGenix™ System Operator Guide, 94S05058.*Discarded Material, Type A Kit is designed to be used to ship the dicarded material container back to NorthStar for disposal. Both Discarded Material Kits contain the same components.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mechanism of Action
The pertechnetate ion distributes in the body similarly to the iodide ion, but is not organified. In contrast to the iodide ion, the pertechnetate is released unchanged from the thyroid gland.
Pharmacodynamics
Pertechnetate concentrates in the thyroid gland, salivary glands, gastric mucosa and choroid plexus. After intravenous administration, it equilibrates with the extracellular space.
Following the administration of Sodium Pertechnetate Tc-99m as an eye drop, the drug mixes with tears within the conjunctival space. Within seconds to minutes it leaves the conjunctival space and escapes into the inferior meatus of the nose through the nasolacrimal drainage system. During this process the pertechnetate ions pass through the canaliculi, the lacrimal sac and the nasolacrimal duct. In the event of any anatomical or functional blockage of the drainage system there will be a backflow resulting in tearing (epiphora). Thus, the pertechnetate escapes the conjunctival space in the tears.
The majority of the pertechnetate escapes within a few minutes of normal drainage and tearing.
Pharmacokinetics
Times to peak concentrations of pertechnetate following intravenous administration are 3.5 hours for cerebral spinal fluid (CSF) and 0.25 to 2 hours for thyroid (euthyroid patients).
The disappearance of pertechnetate from plasma is biexponential with an initial phase of 10 minutes and a terminal phase of 3 hours. The corresponding phases in CSF are less than 1 hour and 11-12 hours, respectively.
Distribution
Elimination
Excretion
Non-Clinical Toxicology
None.Array
Radiation Exposure Risk
Sodium Pertechnetate Tc-99m contributes to a patient's overall long term cumulative radiation exposure. Long term cumulative radiation exposure is associated with an increased risk of cancer. Use the lowest dose of Sodium Pertechnetate Tc-99m necessary for imaging and ensure safe handling and preparation to protect the patient and health care worker from unintentional radiation exposure. Encourage patients to drink fluids and void as frequently as possible after intravenous or intravesicular administration. Advise patients to blow their nose and wash their eyes with water after ophthalmic administration see Dosage and Administration 2.1.
Radiation risks associated with the use of Sodium Pertechnetate Tc-99m are greater in pediatric patients than in adults due to greater absorbed radiation doses and longer life expectancy. Ensure the diagnostic benefit of Sodium Pertechnetate Tc-99m outweighs these greater risks prior to administration in pediatric patients.
Unintended Mo-99 Exposure
Unintended exposure to Mo-99 radiation contributes to a patient’s overall cumulative radiation dose. To minimize the risk of unintended radiation exposure, strict adherence to the eluate testing protocol is required. Use only potassium molybdate Mo-99, processing reagents, saline, and other supplies, including kits, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc-99m injection after the 0.15microCi of Mo-99/mCi of Tc-99m limit has been reached and discard the Sodium Pertechnetate Tc-99m injection when the 12 hour expiration time is reached; whichever occurs earlier see Dosage and Administration 2.7.
Hypersensitivity Reactions
The following adverse reactions are described elsewhere in the label
Postmarketing Experience
The following adverse reactions associated with the use of Sodium Pertechnetate Tc-99m injection have been identified in post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Allergic reactions (skin rash, hives, or itching) including anaphylaxis has been reported following the administration of Sodium Pertechnetate Tc-99m.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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