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Radiogenix System

Generic Name: technetium tc 99m generator
Dosage Form: injection

Medically reviewed on March 1, 2018

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:

  • Thyroid Imaging
  • Salivary Gland Imaging
  • Urinary Bladder Imaging (direct isotopic cystography) for detection of vesicoureteral reflux
  • Nasolacrimal Drainage System Imaging (dacryoscintigraphy)

In Pediatric Patients for:

  • Thyroid Imaging
  • Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesicoureteral reflux.

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.

None.

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
Hypersensitivity reactions, including serious signs and symptoms of anaphylaxis, following administration of Sodium Pertechnetate Tc-99m injection have been reported. Always have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions

The following adverse reactions are described elsewhere in the label

  • Radiation Exposure Risk
  • Unintended Mo-99 Exposure

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.

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.

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.

Table 8 Principal Radiation Emission Data technetium Tc-99m

Radiation

Mean Percent Per Disintegration

Energy (keV)

Gamma-2

88.5

140.5

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.

Table 9 Radiation Attenuation by Lead Shielding

Shield

Thickness (Pb) mm

Coefficient

of Attenuation

0.25

0.5

1

10 -1

2

10 -2

3

10 -3

4

10 -4

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.

Table 10 Molybdenum Mo-99 Decay Chart half- life 66.0 hours

Days

Percent Remaining

Days

Percent Remaining

0 *

100

10

8

1

77.7

11

6.3

2

60.4

12

4.9

3

46.9

13

3.8

4

36.5

14

2.9

5

28.4

15

2.3

6

22.0

20

0.6

7

17.1

25

0.2

8

13.3

30

0.1

9

10.3

* calibration time

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.

Table 11 Physical Decay Chart. Technetium Tc-99m, half-life

6.01 Hours

Hours

Percent Remaining

Hours

Percent Remaining

0 *

100

7

44.7

1

89.1

8

39.8

2

79.4

9

35.5

3

70.8

10

31.6

4

63.1

11

28.2

5

56.2

12

25.1

6

50.1

* calibration time

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: Pertechnetate distributes throughout the body concentrating in the gastric mucosa, thyroid gland, salivary glands, and urinary bladder.

Elimination:

Excretion: Elimination by urinary route is 27% in 1 day, 31% in 4 days, and 34% in 8 days based on rate of excretion

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies have been performed to evaluate carcinogenic potential, mutagenicity potential, or to determine whether Sodium Pertechnetate Tc-99m injection may affect fertility in males or females.

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:

Table 12 Potassium Molybdate Mo-99 Solution Containers

Mo-99 Activity at Time of Calibration

Product Number

NDC Number

Curies

Gigabecquerels

6.0

222

40P03246

71612-006-01

The following kits, Tables 13- 17, are used in the operation of the RadioGenixTM System as described in the RadioGenix™ System Operator Guide, 94S05058.

Table 13 Materials Supplied in Source Vessel Kit for RadioGenix TM System, part number (p/n) 40P07954

Component Description

Component Part Number

Qty.

Catheter

77P07937

1

Air Filter

77C01237

1

Manifold

12D09014

1

Absorbent Cloth

73C05400

1

Black Cap

77C01489

1

Cap

77C05450

1

Luer Cap

77C05449

1

Table 14 Materials Supplied in Reagent Kit for RadioGenix TM System, p/n 40P05044

Component Description

Component Part Number

Qty.

Reagents

16P04143

1

Primary Separation Cartridge (PSC)

40P03354

1

Hydrogen Peroxide Wipe

16C07455

5

Table 15 Materials Supplied in Tc-99m Product Kit for RadioGenix TM System, p/n 40P05045

Component Description

Component Part Number

Qty.

Tc-99m Product Cartridge (TPC)

40P04600

1

Tc-99m Collection Vial

77C01318

1

Saline Syringe

16C05227

1

Product Port Cap

16C05212

1

Cap

16C04989

1

Hydrogen Peroxide Wipe

16C07455

3

Table 16 Materials Supplied in Sterilization Kit for RadioGenix TM System, p/n 40P05043

Component Description

Component Part Number

Qty.

Blank Primary Separation Cartridge (PSC)

40P04578

1

Blank Tc-99m Product Cartridge (TPC)

40P05377

1

Spike

NA

1

Air Filter

77C01237

1

Cap

16C04989

7

Product Port Cap

16C05212

1

Purge Water Container

77C05585

1

Sterile Water for Injection (SWFI)

16C04488

1

Hydrogen Peroxide Wipe

16C07455

13

Product Vial

NA

1

Table 17 Materials Supplied in Discarded Material Kit for RadioGenix TM System, p/n 40P05046 or *Discarded Material, Type A Kit for RadioGenix TM System, p/n 40P06162

Component Description

Component Part Number

Qty.

Discarded Material Container

12D05146

1

Silicone Tubing

77C05431

1

Luer Cap

77C05449

1

*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.

Storage

  • Receipt, transfer, storage, handling, possession or use of the potassium molybdate Mo-99 source solution, Sodium Pertechnetate Tc-99m injection, and radioactive components of the RadioGenix TM System are subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States.
  • Install and operate RadioGenix TM System, and store the potassium molybdate Mo-99 source solutions and kits [Sterilization Kit for RadioGenix TM System (p/n 40P05043), Reagent Kit for RadioGenix TM System (p/n 40P05044), Tc-99m Product Kit for RadioGenix TM System (p/n 40P05045), Discarded Material Kit for RadioGenix TM System (p/n 40P05046), Discarded Material, Type A Kit for RadioGenix TM System (p/n 40P06162) and Source Vessel Kit for RadioGenix TM System (p/n 40P07954)] at 20ºC-25ºC (68ºF-77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF).

Disposal

  • The maximum use period of a RadioGenixTM System is one year from the date of installation. After expiry, have NorthStar perform annual preventative maintenance and recertify the RadioGenixTM System.
  • The maximum use period of the ozone generator is 6 months. After expiry, have NorthStar replace the ozone generator.
  • When the potassium molybdate Mo-99 source has reached the end of its useful life or expiration date, remove the source vessel from the RadioGenixTM System and return to NorthStar for processing.
  • Dispose the radioactive waste (discarded material) container in accordance with applicable regulations.

Administration Instructions:

Intravenous or Intravesicular administration

Advise patients to hydrate before (4 hours) and after administration and to void as soon as the imaging study is completed and as often as possible thereafter for the next 12 hours to minimize radiation exposure [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)].

Ophthalmic Administration

After the termination of the nasolacrimal imaging procedure, Advise patient to blow their nose and/or wash their eyes with sterile distilled water to further minimize the radiation dose [see Dosage and Administration (2.2) and Warnings and Precautions (5.1)].

Pregnancy:

Advise pregnant women of the risk of fetal exposure to radiation dose if they undergo a radionuclide procedure [see Use in Specific Populations (8.1)].

Lactation:

Advise a lactating woman that exposure of the infant to technetium Tc-99m through breast milk can be minimized if breastfeeding is interrupted when technetium Tc-99m is administered. Advise a lactating woman to pump and discard breast milk for 12 to 24 hours based on injected dose [see Use in Specific Populations (8.2)].

Manufactured and Distributed by:

NorthStar Medical Radioisotopes LLC 1800 Gateway Blvd

Beloit, Wisconsin 53511

90Q03078, Rev 04

Radiogenix System 
technetium tc 99m generator injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:71612-006
Route of Administration INTRAVENOUS, INTRAVESICAL, OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TECHNETIUM TC-99M SODIUM PERTECHNETATE (TECHNETIUM TC-99M PERTECHNETATE) MOLYBDENUM MO-99 6 Ci  in 6 Ci
Packaging
# Item Code Package Description
1 NDC:71612-006-01 1 Ci in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202158 04/01/2018
Labeler - NorthStar Medical Radioisotopes, LLC (025677872)
Establishment
Name Address ID/FEI Operations
NorthStar Medical Radioisotopes, LLC 025677872 api manufacture(71612-006), pack(71612-006), label(71612-006)
 
NorthStar Medical Radioisotopes, LLC

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