Frequently asked questions

If you have any questions, please reach out to your doctor or a member of your care team.

The basics of Illuccix® and prostate cancer

What is Illuccix?

Illuccix is an advanced imaging tracer that binds to prostate cancer cells in and around the prostate, or throughout the body. This imaging tracer is then detected with a positron emission tomography (PET) scan to reveal prostate cancer. It is one of the tools that can help doctors make more informed treatment decisions.

Who is Illuccix for?

Scanning with Illuccix may be right for you if:

  • Your risk levels are relatively high after an initial prostate cancer diagnosis
  • Your PSA levels are rising after treatment
  • You may be a candidate for PSMA-directed radioligand therapy

What do rising PSA levels mean?

Rising prostate-specific antigen (PSA) levels may mean you have prostate cancer, that it has come back, or the cancer is spreading. However, rising PSA levels can also be attributed to outside factors like particular forms of exercise, recent sexual activity, and certain medications. While PSA is not a definitive indicator for the presence of prostate cancer, it is a useful tool to help identify if someone may be at risk for prostate cancer.

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 can help your care team make more informed decisions about your prostate cancer care.

How does Illuccix work?

Illuccix targets a specific protein that is abundant in prostate cancer, called PSMA, and binds to it. Illuccix contains small amounts of radioactive material that light up with a PET scan, allowing detection of cancer cells that have PSMA and may have spread to other parts of the body.

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What to expect before, during, and after a scan with Illuccix

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 appointment?

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.

Questions you may have about radiopharmaceuticals

What can I expect with medical radiation?

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. You can help by making sure to drink plenty of water after scan appointments and to empty your bladder frequently. If you have any concerns, talk to your doctor or a member of your care team.

What should I do if I experience any side effects?

In studies of 960 men who had newly diagnosed prostate cancer or whose cancer came back after initial treatment, the most common side effects were nausea, diarrhea, and dizziness and they occurred in less than 1% of people. In another clinical study assessing eligibility of 1003 men for PSMA-targeted radioligand therapy, the side effects were fatigue, nausea, constipation, and vomiting and they occurred in more than or equal to 0.5% of people. Side effects that occurred at a rate of less than 0.5% were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth, and chills. Make sure to contact your doctor if you have any side effects that are troubling to you.

You are encouraged to report negative side effects 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 by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.

How is Illuccix different?

I had a negative magnetic resonance imaging (MRI) scan, computed tomography (CT) scan, and/or bone scan, but I have rising PSA levels. Can Illuccix help identify if my cancer has come back?

A PET scan with Illuccix may be recommended to help detect if prostate cancer has come back or spread. The results can give a more precise picture of your prostate cancer and help your doctor and care team choose a treatment path forward.

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.

Is a PET scan with Illuccix available in my area?

A PET scan with Illuccix is available through a large network of imaging centers across the United States. The imaging tracer Illuccix may be prepared for your scan on demand. This gives you and your doctor flexibility and convenience when choosing a location and appointment time for your scan.

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.

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 negative 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.