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.

Indications and Usage

ILLUCCIX, after radiolabeling with GA 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

  • With suspected metastasis who are candidates for initial definitive therapy
  • With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
  • For selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated

Important Safety Information

Warnings and Precautions

Risk for Misinterpretation

Image interpretation errors can occur with ILLUCCIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Indications and Usage

ILLUCCIX, after radiolabeling with GA 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

  • With suspected metastasis who are candidates for initial definitive therapy
  • With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
  • For selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated

Important Safety Information

Warnings and Precautions

Risk for Misinterpretation

Image interpretation errors can occur with ILLUCCIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy

The performance of ILLUCCIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of ILLUCCIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Imaging to Select Patients for Lutetium Lu 177 Vipivotide Tetraxetan Therapy

The interpretation of ILLUCCIX PET may differ depending on imaging readers. ILLUCCIX PET interpretations to select patients for lutetium Lu 177 vipivotide tetraxetan therapy may be more consistent when judging gallium Ga 68 gozetotide uptake in any one tumor lesion compared to judging uptake for all lesions larger than size criteria. Multidisciplinary consultation to select patients for lutetium Lu 177 vipivotide tetraxetan therapy is recommended, particularly for ILLUCCIX imaging that a single reader finds borderline or difficult to interpret, or when patient eligibility hinges only on judgment of gallium Ga 68 gozetotide uptake for all lesions larger than size criteria.

Radiation Risks

Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions

The safety of gallium Ga 68 gozetotide was evaluated in 960 patients in clinical studies, each receiving one dose of gallium Ga 68 gozetotide. The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

In a clinical study, 1003 patients received one dose of gallium Ga 68 gozetotide injection. Adverse reactions occurring at ≥0.5% in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in the clinical study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%).

Adverse reactions occurring at a rate of <0.5% were diarrhea, dry mouth, injection site reactions, and chills, including injection site hematoma and injection site warmth and chills.

Drug Interactions

Androgen deprivation therapy and other therapies targeting the androgen pathway

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

The safety information provided here is not complete. To learn more, talk about ILLUCCIX with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at illuccix.com.

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.

Please see the Full Prescribing Information.