Gallium 68 PSMA-11 - PET-Scan Imaging Agent | Illuccix®.

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Important Safety Information Full Prescribing Information View HCP Site

What to expect from your imaging experience with Illuccix^®

Preparing for your scan with Illuccix

If you are scheduled to have a scan, your doctor or a member of your care team will review specific preparation instructions with you, which may include:

Drink Plenty of Water: Make sure to hydrate with plenty of water before your scan appointment. Continue to drink water and urinate frequently after you receive the injection for your scan

Avoid Exercise: Try not to do strenuous exercise for at least 24 hours before the scan

Diet: Ask your doctor or care team about any foods or beverages you should avoid before your scan

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What to expect with Illuccix during your imaging appointment

When you arrive for your appointment, your doctor or a member of your care team will prepare you for the scan.

Below are some of the steps you can expect during your visit.

You will receive an intravenous or IV injection

You will be positioned on your back with your arms above your head for the scan

You will be asked to wait about an hour for the solution to make its way through your body and attach itself to any prostate-specific membrane antigen (PSMA) cells

You will be instructed to lie still for the scan and breathe normally. Someone from the care team will be there to assist you

You will likely be asked to urinate right before the scan

The scan time can vary, but usually takes about 30 minutes

What to expect after your scan with Illuccix

You should continue to drink water and empty your bladder for several hours after the appointment

Your doctor will contact you as soon as possible to discuss your scan results

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Understanding side effects

In clinical studies, the most common side effects included fatigue, nausea, diarrhea, constipation, vomiting, and dizziness.

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.

Warnings and precautions →

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.