Gozetotide

LOCAMETZ, after radiolabeling with gallium-68, 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. for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products.

Gallium Ga 68 gozetotide binds to PSMA. It binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Gallium-68 is a β+ emitting radionuclide that allows PET.

Use appropriate radiation safety measures and aseptic precautions while handling and administering gallium Ga 68 gozetotide injection. The recommended amount of radioactivity is 111 MBq to 259 MBq (3 mCi to 7 mCi). Administered as slow intravenous injection. Advise patients to be well hydrated prior to the administration and to void immediately prior to and frequently after image acquisition. A diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection. Acquire PET whole body images 50 minutes to 100 minutes after administration. See the full prescribing information for detailed instructions on preparation, administration, imaging, and radiation dosimetry.

None. None.

Risk for Misinterpretation: Gallium Ga 68 gozetotide uptake may occur in other tumor types and in non-malignant processes. Interpretation of LOCAMETZ PET imaging with histopathology and/or other diagnostic procedures is recommended. Radiation Risk: Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure.

The adverse reactions (incidence ≥ 0.5%) are fatigue, nausea, constipation, and vomiting.

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 LOCAMETZ PET has not been established.

Before radiolabeling, store at 2°C to 25°C (36°F to 77°F). Do not freeze. After radiolabeling, store upright with an appropriate lead shielding to protect from radiation, below 30°C (86°F). Do not freeze.