Since approval, the safety of scans using the PSMA imaging agent in Gozellix has been shown in a great deal of research in more than
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.
Actor portrayals
How Does Gozellix® Work?
Gozellix Scans Light Up Prostate Cancer
Informed treatment decisions after your prostate cancer has been diagnosed
Gozellix is an advanced imaging agent used with a PET/CT scan to detect prostate cancer. It is designed to help your doctor find cancer that has either come back or spread to other parts of the body.
How Gozellix works
Gozellix detects PSMA, a protein found on up to 95% of prostate cancers. Gozellix sticks to PSMA and “lights up” the cancer cells so your care team can see them.
A rising PSA level after treatment can be a sign of recurrent prostate cancer. If you are concerned about your rising PSA level, speak with your care team. They might recommend a PET/CT scan with Gozellix.
Gozellix safety information
The safety of Gozellix was evaluated in 2 clinical studies with 960 men:
- The most commonly reported side effects—nausea, diarrhea, and dizziness—only happened in less than 1% of patients
- There were no serious side effects after the injection of gallium 68Ga-PSMA-11, the main element in Gozellix
220,000 men
Actor portrayals
Gozellix uses a small amount of radiation, which is very common in medical imaging. Your care team is trained to help reduce any risk.
After your Gozellix PET/CT scan is done, you should continue to drink water and urinate often for several hours. Frequent urination helps remove Gozellix from the body.
You are encouraged to report side effects to Telix Pharmaceuticals (US) at 1-844-455-8638 (pharmacovigilance@telixpharma.com) or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Gozellix can accurately detect prostate cancer that has spread to other parts of the body, even when masses are too small for conventional imaging to find.
Gozellix at a glance
Gozellix is an advanced PET/CT imaging agent used to detect prostate cancer that has returned or spread to other parts of the body
Gozellix can detect prostate cancer more accurately than conventional imaging and can help your care team recommend a treatment plan for you
More than 220,000 men have received scans with the main element in Gozellix
CT, computed tomography; PET, positron emission tomography; PSA, prostate-specific antigen; PSMA, prostate-specific membrane 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.
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