Important Safety Information

Risk for MisinterpretationImage 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.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.Radiation RiskGallium 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 ReactionsAdverse 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 &lt;0.5% were diarrhea, dry mouth, injection site reactions, and chills.&nbsp;Please see full&nbsp;<a href="https://www.novartis.com/us-en/sites/novartis_us/files/locametz.pdf" target="_blank" data-show-disclaimer="false" rel="noopener">Prescribing Information</a>.

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:<ul><li>with suspected metastasis who are candidates for initial definitive therapy</li><li>with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level</li><li>for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products</li></ul>

Indication

Risk for MisinterpretationImage 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...

LOCAMETZ®&nbsp;(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...

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