For US Healthcare Professionals Only

Illuccix® is a PSMA-11 cold kit, designed to offer flexible and consistent preparation of 68Ga-PSMA-11a

National availability of kits for on-demand production of 68Ga-PSMA-11 doses1,2

The Illuccix® kit comes in 2 configurations:

Configuration A – For use with cyclotron-produced Ga 68 via GE FASTlab™ or Eckert & Ziegler GalliaPharm Generator

1 gozetotide Sterile Vial

1 Sterile Acetate Buffer Vial (2.5 mL)

1 Sterile Vacuumed Vial

Configuration B – For use with IRE Galli Eo Generator

1 gozetotide Sterile Vial

1 Sterile Acetate Buffer Vial (6.4 mL)

1 Sterile Vacuumed Vial

  • Rapid and consistent labeling chemistry suitable for the radiopharmacy setting3
  • High-quality images with minimal dose of radiation4,5
  • National commercial access with flexible production using cyclotron and the majority of 68Ga generators in the United States2

a 68Ga-PSMA-11 is also known as gallium Ga 68 gozetotide.

a 68Ga-PSMA-11 is also known as gallium Ga 68 gozetotide.

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

Important Safety Information

WARNINGS AND PRECAUTIONS

Risk for Misdiagnosis
Image interpretation errors can occur with gallium Ga 68 gozetotide 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. The performance of gallium Ga 68 gozetotide for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of gallium Ga 68 gozetotide for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. 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.

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 health care workers. 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, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). No serious adverse reactions were attributed to gallium Ga 68 gozetotide. The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of < 1%.

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.

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  full Prescribing Information.

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

References: 1. Velikyan I. 68Ga-Based radiopharmaceuticals: production and application relationship. Molecules. 2015;20(7):12913-12943. 2. 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 July 13, 2021. 3. ARTMS and Telix Pharmaceuticals announce successful production of PSMA-11 with cyclotron produced 68Ga from a solid target [news release]. Telix Pharmaceuticals; January 12, 2021. https://telixpharma.com/news-media/artms-and-telix-pharmaceuticals-announce-successful-production-of-68ga-psma-11-with-cyclotron-produced-68ga-from-a-solid-target/. Accessed October 6, 2021. 4. Calderoni L, Farolfi A, Pianori D, et al. Evaluation of an automated module synthesis and a sterile cold kit–based preparation of ⁶⁸Ga-PSMA-11 in patients with prostate cancer. J Nucl Med. 2019;61(5):716-722. 5. Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) prescribing information.