Gallium Ga 68 PSMA-11 for Prostate Cancer: Drug Warnings

• Handle Ga 68 PSMA-11 Injection with appropriate safety measures to
  minimize radiation exposure. Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Ga 68 PSMA-11 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 Ga 68 PSMA11 Injection.
• Calculate the necessary volume to administer based on calibration time and required dose.
• Inspect Ga 68 PSMA-11 Injection visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored.
• Ga 68 PSMA-11 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 Ga 68 PSMA-11 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 Ga 68 PSMA-11 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 Ga 68 PSMA-11 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

• Ga 68 PSMA-11 binds to prostate-specific membrane antigen (PSMA). Based
  on the intensity of the signals, PET images obtained using Ga 68 PSMA-11
  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 Ga 68 PSMA-11 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 Ga 68 PSMA-11 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 Ga 68 PSMA-11 Injection

• Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of Ga 68 PSMA-11 in prostate cancer.
• The effect of these therapies on performance of Ga 68 PSMA-11 PET has not been established.

Is Gallium Ga 68 PSMA-11 safe to use while pregnant or breastfeeding?

• Ga 68 PSMA-11 Injection is not indicated for use in females.
• There are no available data with Ga 68 PSMA-11 Injection use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• Ga 68 PSMA-11 Injection is not indicated for use in females.
• There are no data on the presence of Ga 68 PSMA-11 in human milk, the effect on the breastfed infant, or the effect on milk production.