Radiogenix System Dosage

2.1 Radiation Safety Drug Handling

• The potassium molybdate Mo-99 source solution and Sodium Pertechnetate Tc 99m Injection are radioactive and should be handled with appropriate safety measures to minimize radiation exposure to patients and healthcare providers. Use waterproof gloves and effective shielding, including syringe shields, throughout the entire preparation and handling for the RadioGenix System and technetium Tc-99m injection [see Warnings and Precautions (5.1)].

2.2 Important Administration Instructions

• Use aseptic technique in eluting generator and in all drug preparation and handling.
• Inspect the Sodium Pertechnetate Tc 99m Injection for particulate matter and discoloration prior to administration. Do not administer Sodium Pertechnetate Tc 99m Injection if there is any evidence of particulate matter and discoloration.
• Measure patient dose with a suitable radioactivity calibration system immediately prior to administration.
• Instruct patients to hydrate after intravenous or intravesicular administration. Encourage the patient to void as soon as the imaging study is completed and frequently for the next 12 hours to minimize the radiation absorbed dose to the bladder.
• Instruct patients to blow their nose and/or wash their eyes with sterile distilled water or an isotonic sodium chloride solution after ophthalmic administration to minimize the radiation absorbed dose.

2.3 Recommended Dose for Adults

The recommended doses for adult patients are shown in Table 1.

2.4 Recommended Dose for Pediatric Patients

The recommended doses for pediatric patients are shown in Table 2 [see Use in Specific Populations (8.4)].

2.5 RadioGenix System Maintenance

• For complete system maintenance and use follow the Operator Guide, RadioGenix System 1.2 (SYS-0060) P/N 40010570.
• Install the RadioGenix System in an operating environment which complies with local and national requirements for production of radiopharmaceutical products (ISO Class 8 or better environment as described in USP General Chapter 797 Pharmaceutical Compounding Sterile Preparations).
• The RadioGenix System is only for use by trained personnel.
• Only use potassium molybdate Mo 99, processing reagent, 0.9% Sodium Chloride Injection, USP and other components, including packs supplied by NorthStar Medical Radioisotopes, LLC [ see How Supplied/Storage and Handling (16.1)]
• Table 3 is a summary of RadioGenix System 1.2 scheduled maintenance and protocol actions. Perform all protocols according to the illustrated directions provided in the Operator Guide, RadioGenix System 1.2 (SYS-0060) P/N 40010570.

2.6 Directions for Eluting RadioGenix System

• The Sodium Pertechnetate Tc 99m Injection solution is produced using Elute Tc-99m protocol through the RadioGenix System home screen Follow step-by-step directions for use provided in the Operator Guide, RadioGenix System 1.2 (SYS-0060) P/N 40010570.
• The elution process to produce Sodium Pertechnetate Tc 99m Injection involves the initial installation and set-up of the equipment, reagent, sterilizing filters, and sterile final product collection vials provided by NorthStar Medical Radioisotopes, LLC [see Table 3].
• Use only isopropyl alcohol (IPA) wipes during the Elution Protocol for the RadioGenix System

• Implement the following prerequisites before the Elute Tc-99m protocol is initiated:

1. Connect the potassium molybdate Mo-99 source container using the Source Vessel Kit for RadioGenix System.
2. Aseptically install the PSC Pack for RadioGenix System 1.2 consisting of one reagent solution (5M sodium hydroxide NaOH) and the primary separation cartridge (PSC).
3. Aseptically assemble and install the Tc-99m Elution Pack for RadioGenix System 1.2 with the TPC consisting of an alumina column, 0.2-micron filter, and a 20 mL sterile collection vial.
4. Attach the supplied tubing contained in the Saline Tubing Pack to the saline port.
5. Attach the supplied sterile 0.9% sodium chloride injection,USP bag to the saline tubing.
6. Initiate the computer-controlled elution process to prepare Sodium Pertechnetate Tc 99m Injection.
7. After delivery of Sodium Pertechnetate Tc 99m Injection to the collection vial is complete, remove the collection vial and perform the quality control procedures [see Dosage and Administration (2.7)].
8. The first eluate from every Potassium Molybdate Mo-99 Source Vessel may be used for preparation. Discarding of the eluate is not necessary.

2.7 Quality Control of Sodium Pertechnetate Tc 99m Injection

Perform the following quality control procedures on each Sodium Pertechnetate Tc 99m Injection prior to its release for clinical use or for reconstitution with Tc-99m radiopharmaceutical kits.

Mo-99 Breakthrough Test

• Using a suitable radioactivity calibrator, determine the activity of technetium Tc-99m eluted.
• Place the Sodium Pertechnetate Tc-99m injection eluate in a calibrated Mo-99 assay shield. Place the lid on the container and put the entire container in the dose calibrator chamber.
• Record the activity of molybdenum Mo-99 on the most sensitive scale.
• Divide the activity of molybdenum Mo-99 by the activity of technetium Tc-99m. Correct for decay and shielding effect, if necessary.
• Determine the molybdenum Mo-99/technetium Tc-99m ratio at the time of elution and from that ratio, determine the expiration time of the eluate. Each Sodium Pertechnetate Tc 99m Injection eluate must meet the purity requirement of 0.15 microCi of Mo-99 per mCi of Tc-99m.
• The expiry time for each eluate of Sodium Pertechnetate Tc 99m Injection must be no later than 24 hours post-elution or the time where the Mo-99 to Tc-99m ratio reaches 0.15 microCi/mCi, whichever occurs earlier

Colorimetric Aluminum Ion Test Procedure

• Using an aluminum ion indicator kit, determine the aluminum ion concentration of the eluate per the manufacturer's instructions.
• The eluate concentration must not exceed 10 micrograms/mL.

Determination of pH

• Place a small drop of Sodium Pertechnetate Tc-99m injection on a colorimetric pH strip.
• Examine and compare the coloration of the test strip with the colors displayed on the pH cartridge.
• The pH range must be between 4.5 and 7.5.

2.8 Radiolabeling (Reconstitution) of Kits

• In general, use no more than 5 mL volume for radiolabeling kits with RadioGenix System produced Sodium Pertechnetate Tc 99m Injection, USP.
• Perform quality control of a radiolabeled kit per the directions in the package insert and only use the product if it meets the kit manufacturer’s quality control requirements.
• The radiolabeled product shall have an expiry no more than 24 hours from the time of sodium pertechnetate elution or the expiry time stated by the kit manufacturer, whichever occurs earlier.

2.9 Radiation Dosimetry


Intravenous Injection

Estimates of radiation absorbed dose per unit activity of Sodium Pertechnetate Tc 99m Injection administered to an adult of average size and weight and to pediatric patients of sizes and weights typical of representative ages are shown in Table 4.

Dacryoscintigraphy

Estimates of radiation absorbed dose to an adult patient from the nasolacrimal imaging procedure using a maximum dose of 3.7 megabecquerels (0.1 millicurie) of Sodium Pertechnetate Tc 99m Injection are shown in Table 5.

Cystography

Estimates of radiation absorbed dose per unit activity of Sodium Pertechnetate Tc 99m Injection administered through direct urinary-bladder infusion with no voiding over 30 minutes to an adult of average size and weight and to pediatric patients of sizes and weights typical of representative ages are shown in Table 6.