APPROVED USES
GOZELLIX® (kit for the preparation of gallium Ga-68 gozetotide, for injection) is a prescription radioactive diagnostic agent that is prepared by a healthcare provider, and, then, injected. It is used with a medical imaging procedure called Positron Emission Tomography (PET) of lesions identified as prostate-specific membrane antigen (PSMA) positive. GOZELLIX is used in men with prostate cancer whose cancer may have spread to other parts of the body and may need initial therapy or whose cancer may have come back, based on elevated serum prostate-specific antigen (PSA) levels.
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Talking With Your Care Team About Gozellix®
Why a PET/CT Scan With Gozellix?
There are several reasons that your care team may recommend a PET/CT scan with Gozellix, including if:
You are considered to be at high risk after an initial prostate cancer diagnosis
Your PSA level has risen after treatment
Your doctor thinks your prostate cancer may have spread to other parts of the body
A PET/CT scan with Gozellix can help you and your care team find answers quickly, so you can focus on what matters most—your care.
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Gozellix moves you and your care team from detection to direction
With Gozellix, your care team can:
Identify suspected metastatic or recurrent prostate cancer in its early stages and act quickly
Get highly accurate information about whether your prostate cancer has spread, to make informed decisions
Accurately detect prostate cancer that has returned, even when PSA levels are low and masses are too small for other types of scans to find
When prostate cancer is detected early in your care journey, treatment success is increased.
Gozellix at a glance
There are many reasons why your doctor may recommend a PET/CT scan with Gozellix, including your risk factors and PSA level
Gozellix can detect prostate cancer more accurately than conventional imaging, such as MRI or CT
Although you may feel anxious about your prostate cancer journey, advanced imaging with Gozellix can help you and your care team create a treatment plan together
CT, computed tomography; MRI, magnetic resonance imaging; PET, positron emission tomography; PSA, prostate-specific antigen.
APPROVED USES
GOZELLIX® (kit for the preparation of gallium Ga-68 gozetotide, for injection) is a prescription radioactive diagnostic agent that is prepared by a healthcare provider, and, then, injected. It is used with a medical imaging procedure called Positron Emission Tomography (PET) of lesions identified as prostate-specific membrane antigen (PSMA) positive. GOZELLIX is used in men with prostate cancer whose cancer may have spread to other parts of the body and may need initial therapy or whose cancer may have come back, based on elevated serum prostate-specific antigen (PSA) levels.
IMPORTANT SAFETY INFORMATION
- There is a risk your PET scan image with GOZELLIX may be misinterpreted. A negative image does not rule out presence of prostate cancer, and a positive image does not confirm presence of prostate cancer. The GOZELLIX PET scan may be affected by other factors, like the presence of other tissue types, PSMA levels and site of disease. Your healthcare provider will consider other information to confirm prostate cancer and determine treatment.
- GOZELLIX involves exposure to small amounts of radioactivity, and long-term cumulative radiation exposure is associated with increased risk for cancer. Your healthcare provider will use safe handling techniques to minimize radiation exposure.
- You should drink water to hydrate before the scan and urinate immediately before the procedure and as often as possible during the first hours after the procedure to help reduce radioactivity exposure.
- GOZELLIX is used with an Ascorbic Acid Stabilizer, which contains sodium metabisulfite, a sulfite that may cause life-threatening hypersensitivity reactions including anaphylaxis.
- The most common side effects of GOZELLIX in clinical trials were fatigue, nausea, diarrhea, constipation, vomiting, and dizziness. These adverse reactions each typically occurred in ≤1.2% of patients in clinical trials.
The full Prescribing Information is available here.
You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report adverse reactions to Telix Pharmaceuticals (US) by calling or emailing pharmacovigilance@telixpharma.com.
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Customer Service Telephone (Mon-Fri, 8:00 AM – 5:00 PM ET): 463-235-2159
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