PET imaging of prostate-specific membrane antigen (PSMA) in patients with prostate cancer with suspected metastasis or biochemical recurrence.
Dose per institutional nuclear medicine protocol. IV injection followed by PET imaging.
Kit for preparation of Ga-68 gozetotide injection
None listed in the prescribing information.
Nausea (4%), Headache (3%), Dysgeusia (2%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
Androgen deprivation therapy: May alter PSMA expression and affect imaging results.
Consult the full prescribing information for pregnancy-related considerations.
Refer to prescribing information for lactation guidance.
Pediatric safety and efficacy information is detailed in the full label.
Dose modifications for organ impairment are specified in the complete prescribing information.
Gallium-68 gozetotide binds to PSMA, which is overexpressed on prostate cancer cells. After radiolabeling with Ga-68, PET imaging detects PSMA-expressing lesions for staging and recurrence detection.
Rapid blood clearance. Renal elimination. Imaging performed 50-100 minutes post-injection.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
Gozellix has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:
Gozellix (gallium-68 gozetotide) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.
Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.
Gallium-68 gozetotide binds to PSMA, which is overexpressed on prostate cancer cells. After radiolabeling with Ga-68, PET imaging detects PSMA-expressing lesions for staging and recurrence detection.
Nausea (4%), Headache (3%), Dysgeusia (2%) Nausea 4% Headache 3% Dysgeusia 2%