INDICATIONS AND USAGE
- With suspected metastasis who are candidates for initial definitive therapy
- With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
PSMA PrecisionAnytime, Anywhere
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Available when and
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INDICATIONS AND USAGE
- With suspected metastasis who are candidates for initial definitive therapy
- With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Image interpretation errors can occur with GOZELLIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image 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 non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
Gallium Ga-68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.
Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
ADVERSE REACTIONS
DRUG INTERACTIONS
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 gallium Ga-68 gozetotide PET has not been established.
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References: 1. Seifert R, Telli T, Opitz M, et al. Unspecific 18F-PSMA-1007 bone uptake evaluated through PSMA-11 PET, bone scanning, and MRI triple validation in patients with biochemical recurrence of prostate cancer. J Nucl Med. 2023;64(5):738-743. 2. Data on File. TAM Slide Deck. Telix Pharmaceuticals. 2022. 3. Bundschuh RA, Lütje S, Bundschuh L, et al. High interobserver agreement on PSMA PET/CT even in the absence of clinical data. Clin Nucl Med. 2023;48(3):207-212. 4. Gozellix (kit for the preparation of gallium Ga 68 gozetotide injection) prescribing information.