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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For suspected metastatic or
recurrent prostate cancer...
Prostate Cancer: A Common but Impactful Condition
Every 2 minutes, someone is diagnosed. So by the time you read this, another man will have just received a diagnosis.
Even after treatment, prostate cancer can return in nearly 1 out of 3 men, making detection critical for improving care. If you or someone you love has prostate cancer, you’re not alone—and Telix wants to help.
Why a Rising PSA Level Is so Important
Prostate-specific antigen (PSA) is a protein produced by both healthy and cancerous cells of the prostate gland. A rising PSA level found in a blood test can serve as an early sign of prostate cancer or of prostate cancer that has been treated before and has returned or spread.
That’s when your doctor may recommend a PET/CT scan with Gozellix.
PSMA: A key to finding cancer
Prostate-specific membrane antigen (PSMA) is a protein found in high amounts on 95% of prostate cancers.
PSMA: A key to finding cancer
PSMA is also often found on prostate cancer that has spread beyond the prostate (or metastasized).
PSMA: A key to finding cancer
PSMA PET is an advanced imaging scan used to detect prostate cancer. This scan helps your care team create a tailored treatment plan based on your results.
Actor portrayals
PSMA: A key to finding cancer
Prostate-specific membrane antigen (PSMA) is a protein found in high amounts on 95% of prostate cancers.
PSMA: A key to finding cancer
PSMA is also often found on prostate cancer that has spread beyond the prostate (or metastasized).
PSMA: A key to finding cancer
PSMA PET is an advanced imaging scan used to detect prostate cancer. This scan helps your care team create a tailored treatment plan based on your results.
Actor portrayal
Gozellix® Lights the Path Forward With Precise Imaging
Gozellix is an advanced PET imaging agent that attaches to prostate cancer cells that have PSMA protein on the surface.
During a PET/CT scan, Gozellix lights up these proteins wherever they are in the body, so that your care team can see where prostate cancer is located, which may help them provide a more informed treatment plan for you.
Find Your Cancer. Change Your Story
Your story matters. Gozellix provides a detailed picture of your prostate cancer—no matter where it is—so that you and your care team can create a more informed treatment plan for you.
Support and Tools for You and Your Loved Ones
No matter where you are on your prostate cancer journey, Telix helps support you and your care plan.
Find a TelixPSMA™ PET Imaging Center Near You
Advanced imaging with Gozellix can give you and your care team the answers you need—no matter where you live.
CT, computed tomography; PET, positron emission tomography.
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.
Please contact the Telix Customer Service team to get access to Telix products, request information/status on orders or expedite an order, schedule product onboarding for your site or request technical support, or any other general inquiry. Our customer support team is available to provide any resources you may need.
Customer Service Telephone (Mon-Fri, 8:00 AM – 5:00 PM ET): 463-235-2159
Customer Service Email (response time less than 1 business day): customerservice.americas@telixpharma.com