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Gallium GA-68 PSMA-11
  • Professionals
  • FDA PI

Gallium GA-68 PSMA-11

Generic name: gallium ga-68 gozetotide
Dosage form: injection, solution
Drug class:Diagnostic radiopharmaceuticals

Medically reviewed by Drugs.com. Last updated on Nov 1, 2021.

Indications and Usage for Gallium GA-68 PSMA-11

Ga 68 PSMA-11 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.

Gallium GA-68 PSMA-11 Dosage and Administration

Radiation Safety – Drug Handling

Handle Ga 68 PSMA-11 Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.2)]. 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 PSMA-11 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 i...