Ga Drug Information

Gallium Ga 68 gozeotide injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Radiation Safety – Drug Handling Handle Gallium Ga 68 gozetotide injection with appropriate safety measures to minimize radiation exposure. 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. Do not use the drug if the solution contains particulate matter or is discolored. Gallium Ga 68 gozetotide injection may be diluted with sterile 0.9% Sodium chloride injection, USP.

Assay the final dose immediately before administration to the patient in a dose calibrator. After injection of Gallium Ga 68 gozeotide injection, administer an intravenous flush of sterile 0.9% Sodium chloride injection, USP 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 Prior to PET Imaging

Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Gallium Ga 68 gozeotide injection and to continue to drink and void frequently following administration to reduce radiation exposure, particularly during the first hour after administration.

Image Acquisition Position the patient supine with arms above the head. Begin PET scanning 50 to 100 minutes after the intravenous administration of Gallium Ga 68 gozetotide injection. Patients should void immediately prior to image acquisition and that image acquisition should begin at the proximal thighs and proceed cranially to the skull base or skull vertex.

Adapt imaging technique according to the equipment used and patient characteristics in order to obtain the best image quality possible.

Image Interpretation Gallium Ga 68 gozetotide binds to prostate-specific membrane antigen (PSMA). Based on the intensity of the signals, PET images obtained using Gallium Ga 68 gozetotide injection indicate the presence of PSMA in tissues. Lesions should be considered suspicious if uptake is greater than physiologic uptake in that tissue or greater than adjacent background if no physiologic uptake is expected.

Tumors that do not bear PSMA will not be visualized. Increased uptake in tumors is not specific for prostate cancer.

Radiation Dosimetry

Estimated radiation absorbed doses per injected activity for organs and tissues of adult male patients following an intravenous bolus of Gallium Ga 68 gozetotide injection are shown in Table 1. 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. If CT or a transmission source are used for attenuation correction, the radiation dose will increase by an amount that varies by technique. Table 1: Estimated Radiation Absorbed Dose per Injected Activity in Selected Organs and Tissues of Adults after Intravenous Administration of Gallium Ga 68 gozetotide injection

The most commonly reported adverse reactions include nausea, diarrhea, and dizziness. To report SUSPECTED ADVERSE REACTIONS, contact Ionetix at 1-517-252-4069 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of Gallium Ga 68 gozetotide injection was evaluated in 960 patients, each receiving one dose of Gallium Ga 68 gozetotide injection. The average injected activity was mCi.

Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

Pregnancy Risk Summary Gallium Ga 68 gozetotide injection is not indicated for use in females. There are no available data with Gallium Ga 68 gozetotide injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. All radiopharmaceuticals, including Gallium Ga 68 gozetotide injection, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

Animal reproduction studies have not been conducted with gallium Ga 68 gozetotide injection.

Pediatric Use The safety and effectiveness of Gallium Ga 68 gozetotide injection have not been estabished in pediatric patients.

In the event of an overdose of gallium Ga 68 gozetotide injection, reduce the radiation absorbed dose to the patient where possible by increasing the elimination of the drug from the body using hydration and frequent bladder voiding. A diuretic might also be considered. If possible, an estimate of the radiation effective dose given to the patient should be made.