IMPORTANT SAFETY INFORMATION

 

Risk for Misinterpretation

Image interpretation errors can occur with LOCAMETZ PET. Negative imaging does not rule out the presence of prostate cancer and a positive imaging does not confirm the presence of prostate cancer. ...

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Indication

LOCAMETZ® (kit for the preparation of gallium Ga 68 gozetotide injection), 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 with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated

Indication

LOCAMETZ® (kit for the preparation of gallium Ga 68 gozetotide injection), 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 with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated

 

IMPORTANT SAFETY INFORMATION

Risk for Misinterpretation

Image interpretation errors can occur with LOCAMETZ PET. Negative imaging does not rule out the presence of prostate cancer and a positive imaging does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as nonmalignant processes. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging prior to initial definitive or suspected recurrence therapy

The performance of LOCAMETZ seems to be affected by serum PSA levels and by site of disease for imaging of biochemically recurrent prostate cancer, and by Gleason score for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy.

Imaging to select patients for lutetium Lu 177 vipivotide tetraxetan therapy

The interpretation of LOCAMETZ PET may differ depending on imaging readers. LOCAMETZ PET interpretations to select patients for lutetium Lu 177 vipivotide tetraxetan therapy may be more consistent when judging gallium Ga 68 gozetotide uptake in any 1 tumor lesion compared with judging uptake for all lesions larger than size criteria. Multidisciplinary consultation is recommended, particularly for LOCAMETZ imaging that a single reader finds borderline or difficult to interpret, or when patient eligibility hinges only on judgment of gallium Ga 68 gozetotide uptake for all lesions larger than size criteria.

Radiation Risk

Gallium Ga 68 gozetotide contributes to a patient’s long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to be well hydrated prior to gallium Ga 68 gozetotide administration and to void immediately prior to and frequently during the first hours after image acquisition to reduce radiation exposure.

Adverse Reactions

Adverse reactions ≥0.5% in the VISION study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%). Adverse reactions occurring at a rate of <0.5% were diarrhea, dry mouth, injection site reactions, and chills.

 

Please see accompanying full Prescribing Information.