About Illuccix®
Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) may help your doctor get a more precise image of your prostate cancer.
llluccix is an advanced imaging tracer that is used with a positron emission tomography (PET) scan to detect cancer cells in your body. When you have rising prostate-specific antigen (PSA) levels, and if you have recurrent or metastatic disease, a PET scan with Illuccix may give your care team additional information to help them better determine an appropriate treatment plan.
How Illuccix Works
Illuccix works by targeting a specific protein that is abundant on prostate cancer called PSMA, “prostate-specific membrane antigen.” Illuccix attaches to PSMA proteins and during a PET scan, Illuccix lights up these proteins wherever they are in the body. This advanced imaging tracer may help your care team make more informed decisions about your treatment path forward.
The Benefits of a PET scan with Illuccix
- Illuccix may give doctors greater clarity regarding the extent of your prostate cancer and determine your eligibility for PSMA-directed radioligland therapy.
- A better understanding of your prostate cancer may help you and your doctors make more informed decisions about your treatment plan.
- The Illuccix tracer can be prepared on demand which can provide greater flexibility in scheduling your appointment.
- The Illuccix tracer reduces to minimal levels after 6 hours.
Safety and Side Effects
The Illuccix imaging tracer users a small amount of radiation that is in the body for a short amount of time. The use of radiation in medical imaging is quite common. Your care team is trained to use safe handling practices to help minimize any risk.
In clinical studies, the most commonly reported side effects (≥.5%) included fatigue, nausea, constipation, and vomiting.
Important Safety Information
APPROVED USES
ILLUCCIX® (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. ILLUCCIX 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. ILLUCCIX is also approved to help your healthcare provider determine whether you are appropriate for a certain treatment that is a PSMA-directed therapy.
IMPORTANT SAFETY INFORMATION
- There is a risk your PET scan image with ILLUCCIX 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 ILLUCCIX 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.
- ILLUCCIX 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.
- The most common side effects of ILLUCCIX 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 at www.ILLUCCIX.com.
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.
“Frequently Asked Questions”
Who is Illuccix for?
Scanning with Illuccix may be right for you if:
- You have been diagnosed with recurrent or metastatic prostate cancer
- Your PSA levels are rising after treatment
- You may be a candidate for PSMA-directed radioligand therapy
What is PSMA?
PSMA, which stands for prostate-specific membrane antigen, is abundant on prostate cancer cells, no matter where they are in the body, which makes it a good target for prostate cancer imaging. The discovery of PSMA has led to advances such as PET imaging with Illuccix, which may help your care team make more informed decisions about your prostate cancer care.
How should I prepare for an imaging scan?
Your care team will provide you with specific instructions on how to prepare for your scan. They will likely tell you to drink plenty of water and avoid exercise 24 hours before your scan. They may also talk to you about certain foods or beverages to avoid before your appointment.
What happens during an imaging scan?
You will receive an intravenous injection about an hour before your scan. During that time, the solution will make its way through your body and attach to any PSMA proteins. Your care team may ask you to drink water so that you can try to urinate right before the scan. During the scan, you’ll be positioned on your back with your hands above your head and instructed to lie still and breathe normally.
What happens after a scan?
You should continue to drink plenty of water and schedule a follow-up appointment to discuss results with your doctor.
How is a PET scan with Illuccix different from conventional imaging technologies?
Depending on the stage of prostate cancer and PSA levels, doctors may recommend different kinds of imaging, including CT, MRI, or bone scan. A PET scan with Illuccix is different from those because it targets the specific PSMA protein, so it may be able to detect cancer when PSA levels are low and when tumors are small or conventional imaging results are uncertain.