The preparation of gallium ga 68 gozetotide

The effective radiation dose resulting from the administration of 259 MBq (7 mCi) is about 4.4 mSv. The radiation doses for this administered dose to the critical organs, which are the kidneys, urinary bladder, and spleen, are 96.2 mGy, 25.4 mGy, and 16.8 mGy, respectively. These radiation doses are for Gallium Ga 68 Gozetotide Injection alone.

The effective radiation dose resulting from the administration of 259 MBq (7 mCi) is about 4.4 mSv. The radiation doses for this administered dose to the critical organs, which are the kidneys, urinary bladder, and spleen, are 96.2 mGy, 25.4 mGy, and 16.8 mGy, respectively. These radiation doses are for Gallium Ga 68 Gozetotide Injection alone.

Radiation Safety - Drug Handling After reconstitution and radiolabeling of ILLUCCIX, the vial contains Gallium Ga 68 Gozetotide Injection. Handle Gallium Ga 68 Gozetotide Injection with appropriate safety measures to minimize radiation exposure [ see Warnings and Precautions ]. Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Gallium Ga 68 Gozetotide Injection.

Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

Recommended Dosage and Administration Instructions Recommended Dosage In adults, the recommended amount of radioactivity to be administered for PET is 111 MBq to 259 MBq (3 mCi to 7 mCi) administered as an intravenous bolus injection. Administration Use aseptic technique and radiation shielding when withdrawing and administering Gallium Ga 68 Gozetotide Injection.

Calculate the necessary volume to administer based on calibration time and required dose. Inspect Gallium Ga 68 Gozetotide Injection visually for particulate matter and discoloration before administration. Only use solutions that are clear, colorless to slightly yellow, and without visible particles. Gallium Ga 68 Gozetotide Injection may be diluted with sterile 0.9% Sodium Chloride Injection, USP.

Assay the final dose in a dose calibrator immediately before administration to the patient. After injection of Gallium Ga 68 Gozetotide Injection, administer an intravenous flush of sterile 0.9% Sodium Chloride Injection to ensure full delivery of the dose. Dispose of any unused drug in a safe manner in compliance with applicable regulations.

Unless contraindicated, a diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection to potentially decrease artifact from radiotracer accumulation in the urinary bladder and ureters.

Patient Preparation Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Gallium Ga 68 Gozetotide Injection and to continue to drink and void frequently following administration to reduce radiation exposure, particularly during the first hour after administration [see Warnings and Precautions] .

General Instructions for Drug Preparation Ga 68 Sources and ILLUCCIX Carton Configurations ILLUCCIX is supplied as a kit in two different configurations, A or B, for preparation of Gallium Ga 68 Gozetotide Injection with eluate from different Ga 68 sources. See Table 1 for ILLUCCIX carton configurations to be used with different Ga 68 sources. [See table below.] IRE ELiT Galli Eo Ge 68/Ga 68 generator B The Ge 68/Ga 68 generators and cyclotron are not supplied with ILLUCCIX.

Follow the instructions for use provided by the Ge 68/Ga 68 generator or cyclotron manufacturer. Components of ILLUCCIX consist of Vial 1 (Gozetotide), Vial 2A or Vial 2B (Acetate Buffer), and Vial 3 (Sterile Vacuumed Reaction Vial) [see How Supplied/Storage and Handling ] . General Instructions Before use, remove the ILLUCCIX kit containing all three components from the refrigerator and allow the kit to reach room temperature for 1 hour.

Follow aseptic techniques in all drug preparation and handling. Use suitable shielding to reduce radiation exposure. Wear waterproof gloves. Place a "radioactive" label on Vial 3 (Sterile Vacuumed Reaction Vial) with product name, lot number and date. Remove the vial cap from Vial 1 (Gozetotide), Vial 2A or Vial 2B (Acetate Buffer) and Vial 3 (Sterile Vacuumed Reaction Vial).

Swab the top of each vial with alcohol to disinfect the surface and allow the top of each vial to dry. Use the shortest possible needle for the transfer of the Gallium Ga 68 Chloride solution to minimize any potential metallic contamination. The needle should be clean and dilute acid resistant. Use only plastic syringes for preparation and administration.

Do not use syringes with rubber plungers. Prior to use of any vial, confirm the correct vial by a visual check of the vial label. Follow the specific preparation procedure dependent on Ga 68 source [see Dosage and Administration (2.5 , 2.6 , 2.7 , 2.8) ] .

Preparation with Cyclotron-Produced Ga 68 via GE FASTlab Liquid Target System Collection of Gallium Ga 68 Chloride Solution After purification by the FASTlab Liquid Target System, the Gallium Ga 68 Chloride solution is passed through a sterile filter and into the cassette product vial automatically by the FASTlab Liquid Target System.

When Ga 68 is cyclotron-produced, test for Ga 66 and Ga 67 (with specification of ≤2% combined total) when a new lot of Zn 68 is introduced for manufacturing. Radiolabeling Procedure Use ILLUCCIX "Configuration A" with cyclotron-produced Ga 68 via GE FASTlab Liquid Target System. A schematic diagram for the preparation is provided in Figure 1.

Pierce Vial 3 (Sterile Vacuumed Reaction Vial) with a sterile needle connected to a 0.2 micron sterile vented filter (not supplied) to maintain atmospheric pressure within the vial during the reconstitution process. Aseptically transfer 5 mL of Gallium Ga 68 Chloride solution made using the GE FASTlab Liquid Target System into Vial 3.

Insert a sterile 10 mL syringe with a needle into Vial 2 (Acetate Buffer Vial Configuration A) and draw up the contents of the vial (target 2.5 mL). Inject the contents of the 10 mL syringe into Vial 1 (Gozetotide Vial). Gently swirl Vial 1 to ensure the product is thoroughly dissolved. Insert a sterile 10 mL syringe with a needle into Vial 1 containing the dissolved gozetotide and draw up the entire contents of the vial.

Transfer the contents of the 10 mL syringe to Vial 3 (Sterile Vacuumed Reaction Vial) containing the Gallium Ga 68 Chloride. Wait for 5 minutes for radiolabeling to take place at room temperature (25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)). Assay the whole vial containing the Gallium Ga 68 Gozetotide Injection for total radioactivity using a dose calibrator, calculate the radioactivity concentration, and record the result.

Perform the quality control of Gallium Ga 68 Gozetotide Injection according to the recommended methods [see Dosage and Administration ] . Prior to use, visually inspect the solution behind a shielded screen for radioprotection purposes. Only use solutions that are clear without visible particles. Keep the vial containing the Gallium Ga 68 Gozetotide Injection upright in a radioprotective shield container at room temperature until use.

The final volume of the Gallium Ga 68 Gozetotide Injection is 7.5 mL. Use within 4 hours. Figure 1: Drug Preparation with Cyclotron-Produced Ga 68 via GE FASTlab Liquid Target System Figure 1