GALLIUM GA 68 GOZETOTIDE

DistributionIntravenously injected gallium Ga 68 gozetotide is cleared from the blood and is accumulated preferentially in the liver (15%), kidneys (7%), spleen (2%), and salivary glands (0.5%). Gallium Ga 68 gozetotide uptake is also seen in the adrenals and prostate. There is no uptake in the cerebral cortex or in the heart, and usually lung uptake is low. Gozetotide exhibits a mean blood-to-plasma ratio (% CV) of 0.71 (26%) and is approximately 33% bound to human plasma proteins at 1 mcg/mL ...

14.1 Imaging Prior to Initial Definitive Therapy The efficacy of LOCAMETZ for PET of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy has been established based on a study of another formulation of gallium Ga 68 gozetotide injection. Below is a display of the results of the prospective, open label study PSMA-PreRP (NCT03368547 and NCT02919111, referred to as Study 1). This two-center study enrolled 325 patients with biopsy-proven prostate cancer who were considered candidates for prostatectomy and pelvic lymph node di...

The adverse reactions (incidence ≥ 0.5%) are fatigue, nausea, constipation, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and ma...

None. None. ( 4 )

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. ( 5.1 ) 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. ( 5.2 ) 5.1...

7 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 LOCAMETZ PET has not been established.