Gallium Ga 68 gozetotide (Locametz)

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General information

Class/mechanism: Radioactive diagnostic agent for PET. The radionucleotide gallium-68 binds to PSMA (prostate-specific membrane antigen), a transmembrane protein that is expressed in prostate cancer, to allow detection of PSMA positive cells by PET. Gallium 68's half-life is 68 minutes.[1][2][3]
Route: IV
Extravasation: no information

For conciseness and simplicity, currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

  • 2020-12-01: FDA approved "for patients with suspected prostate cancer metastasis...who are potentially curable by surgery or radiation therapy. Ga 68 PSMA-11 is also indicated for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels."
  • 2022-03-23: FDA approved "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
    • for selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.

History of changes in EMA indication

Also known as

  • Generic names: Gallium 68 PSMA-11