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Important Safety Information Full Prescribing Information
Efficacy Safety Manufacturing Access Getting Started

Consider Illuccix® when evaluating patients with suspected prostate cancer metastasis, who are candidates for initial definitive therapy, or suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.1

Guided By Illumination

Positron emission tomography (PET) offers cancer care teams an enhanced ability to detect disease compared to conventional imaging modalities. Through the addition of lesion-illuminating prostate-specific membrane antigen (PSMA), this powerful imaging modality can now be used to successfully identify prostate cancer. Illuccix® for the preparation of 68Ga PSMA-11 (also known as gallium Ga 68 gozetotide) is poised to expand the detection potential of PSMA PET imaging and help guide more informed management decisions in prostate cancer.1-6

See Clinical Efficacy

Illuccix®, kit for the preparation of 68Ga-PSMA-11 Injection, offers both clinical and practice-related support1,4,5

National Comprehensive Cancer Network (NCCN) Guidelines and Society of Nuclear Medicine and Molecular Imaging (SNMMI) appropriate use criteria recommendations include 68Ga-PSMA-11 PET/CT or PET/MRI across different stages of prostate cancer7,8,a

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aThese guidelines do not recommend use of a particular radiopharmaceutical.

Diagnostic performance demonstrated across prostate cancer stages in clinical trials1

BCR, biochemical recurrence; mCRPC, metastatic castration-resistant prostate cancer; nmCRPC, nonmetastatic castration-resistant prostate cancer; PCa, prostate cancer; PSA, prostate-specific antigen.

Early detection and accurate assessment of prostate cancer are crucial across prostate cancer stages as they are often essential for determining treatment decisions.7,8

Review Illuccix®  PET/CT Efficacy

Mechanism of Action

68Ga harnesses the power of PSMA PET/CT

PSMA has become a major breakthrough in prostate cancer diagnostics and the growing field of nuclear medicine.3,9 PSMA is overexpressed in primary and metastatic prostate cancer cells, but its expression is low or absent in healthy cells, which makes PSMA an ideal target for prostate cancer imaging3,9,10:

  • More than 90% of primary lesions show moderate to high PSMA expression11
  • Higher PSMA levels are associated with advanced disease and increased PSA levels3

68Ga-PSMA-11 is a radiotracer that binds with high affinity to PSMA and in doing so can reveal prostate cancer cells in the body.3

Important Safety Information

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%.

Please see additional Important Safety Information below.
Please see full Prescribing Information.

Accessibility

Well-established and reliable national distribution network

68Ga is a widely accessible radioisotope for PSMA PET imaging

68Ga is a widely available radioisotope that can be accessed through a nationwide distribution network of generators and cyclotrons, including those within major academic centers and community health systems. 68Ga extends the reach of PSMA imaging to enable people throughout the United States to benefit from this important technology.5

68Ga delivers the flexibility of either high-volume production (via cyclotrons) or on-site, on-demand production (via generators) that may enhance the efficiency of day-to-day workflow4,5

  • Ability to fill STAT orders and accommodate patient schedule changes4
  • Flexibility to image patients throughout the day, even on short notice4
  • Well-established distribution network for an efficient administrative and purchasing process5

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. Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) prescribing information. 2. Griffeth LK. Use of PET/CT scanning in cancer patients: technical and practical considerations. Proc (Bayl Univ Med Cent). 2005;18(4):321-330. 3. Dorff TB, Fanti S, Farolfi A, Reiter RE, Sadun TY, Sartor O. The evolving role of prostate-specific membrane antigen-based diagnostics and therapeutics in prostate cancer. Am Soc Clin Oncol Educ Book. 2019;39:321-330. 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 July 13, 2021. 6. 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. 7. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Prostate cancer (Version 1.2022). 8. Jadvar H, Calais J, Fanti S, et al. Appropriate use criteria for prostate-specific membrane antigen PET imaging. J Nucl Med. 2022;63(1):59-68. 9. Eiber M, Fendler WP, Rowe SP, et al. Prostate-specific membrane antigen ligands for imaging and therapy. J Nucl Med. 2017;58(suppl 2):67S-76S. 10. Ristau BT, O’Keefe DS, Bacich DJ. The prostate-specific membrane antigen: lessons and current clinical implications from 20 years of research. Urol Oncol. 2014;32(3):272-279. 11. Maurer T, Gschwend JE, Rauscher I, et al. Diagnostic efficacy of (68)Gallium-PSMA positron emission tomography compared to conventional imaging for lymph node staging of 130 consecutive patients with intermediate to high risk prostate cancer. J Urol. 2016;195(5):1436-1443.

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