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Illuccix® is the most widely available and convenient radiotracer for prostate cancer detection1,2

Produced by both cyclotrons and generators, with scan time ≤30 minutes1-3

Illuccix (68Ga-PSMA-11) is widely accessible to physicians and eligible patients across the United States. With the flexibility of either high-volume production (via cyclotrons) or on-site, on-demand production (via generators), Illuccix can meet the high patient volume and flexible scheduling demands of your practice.4,5

Consistent supply and reliable distribution from more than 190 radiopharmacies nationwide5-7

United States map of national distribution radiopharmacy network

Convenient ordering with Illuccix

Can be ordered directly from local radiopharmacies7

Immediate confirmation of dose availability7

Mornings, Saturdays, extended-hour and STAT doses available based on location4

Exceptional on-time delivery, ensuring availability when your PET camera is ready8

The broad dosing range of Illuccix (3-7 mCi) offers a wide injection window3

Dedicated industry-leading support for your practice at every step

Nationwide Peer-to-Peer Network

Educational opportunities for doctors and their staff

Reader Training

Comprehesive imaging training for nuclear medicine professionals

Telix Network of Support logo

Nuclear Medicine Department Support

Nuclear imaging experts who provide on-site onboarding prior to first dose and continued guidance on scanner protocol tailored to each clinic’s PET camera

Reader Training

Comprehesive imaging training for nuclear medicine professionals

Patient and Community Education and Outreach

Educational materials to help inform your provider network about Illuccix

Need help with image interpretation?

Reader Assistance Program

The key to adopting a new imaging modality is being prepared. To ensure your success, Telix Pharmaceuticals (US) Inc. has partnered with American Molecular Imaging (AMI) to offer educational support for image optimization and interpretation so you can take full advantage of Illuccix PSMA imaging.

TelixU Reader Training

Access an on-demand series of learning modules designed to help enhance PSMA-11 PET/CT reader skills.

Visit TelixU.com

CT, computed tomography; PET, positron emission tomography; PSMA, prostate-specific membrane antigen.

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Indications and Usage

ILLUCCIX, after radiolabeling with Ga 68, is 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 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 the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

In the VISION study, 1003 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi). 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% in the VISION study were diarrhea, dry mouth, injection site reactions, 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.

Please note that this information is not comprehensive.

Please see  the Full Prescribing Information.

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 by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.

References: 1. Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) prescribing information. 2. Hansen SB, Bender D. Advancement in Production of Radiotracers. Semin Nucl Med. 2021;523:266-275. 3. Data on File. Isotope Decay Rates. Telix Pharmaceuticals. 2022. 4. Velikyan I. 68Ga-based radiopharmaceuticals: production and application relationship. Molecules. 2015;20(7):12913-12943. 5. Massat MB. Nuclear medicine prepares for greater 68Ga demand. Appl Radiol. 2021;50(2):30-31. https://appliedradiology.com/articles/nuclear-medicine-prepares-for-greater-ga-68-demand. Accessed May 19, 2023. 6. Data on File. Activated Sites. Telix Pharmaceuticals. 2023. 7. Data on File. PETNET Solutions Overview. Telix Pharmaceuticals. 2023. 8. Data on File. Delivery. Telix Pharmaceuticals. 2022.

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