LOCAMETZ Safety Profile

THE SAFETY OF GALLIUM Ga 68 GOZETOTIDE HAS BEEN ESTABLISHED IN 3 PROSPECTIVE STUDIES IN PATIENTS WITH PROSTATE CANCER

In the PSMA-PreRP and PSMA-BCR studies using another formulation of gallium Ga 68 gozetotide, 960 patients received 1 dose of gallium Ga 68 gozetotide intravenously with the amount (mean ± SD) of radioactivity 188.7±40.7 MBq (5.1±1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

In the VISION study, 1003 patients received 1 dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1±23.1 MBq (4.52±0.62 mCi). Adverse reactions occurring at ≥0.5% are presented in the following table.

MBq, megabecquerel; mCi, millicurie; SD, standard deviation.

Adverse reactions (≥0.5%) in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in VISION

Adverse reactions occurring at a rate of <0.5% in the VISION study were diarrhea; dry mouth; injection site reactions, including injection site hematoma and injection site warmth; and chills.