INDICATIONS AND USAGE
Gallium Ga 68 Gozetotide Injection is a radioactive diagnostic agent 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.
DOSAGE FORMS AND STRENGTHS
Injection: supplied as a clear, colorless solution in a multiple-dose vial containing 18.5 MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL) of gallium Ga 68 gozetotide in approximately 11 mL at calibration time.
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Risk for Misdiagnosis: Image interpretation errors can occur with gallium Ga 68 gozetotide PET.A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer.The performance of Gallium Ga 68 Gozetotide Injection for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease [See Clinical Studies (14)].The performance of Gallium Ga 68 Gozetotide Injection for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score [See Clinical Studies (14)].Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget's disease, fibrous dysplasia, and osteophytosis.Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
Radiation Risks: Gallium Ga 68 Gozetotide Injection contributes to a patient's overall long-term cumulative radiation exposure.Long-term cumulative radiation exposure is associated with an increased risk for cancer.Ensure safe handling to minimize radiation exposure to the patient and health care workers.Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration (2.1, 2.3)].
ADVERSE REACTIONS
The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of < 1%.
DRUG INTERACTIONS
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.