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Telix Pharmaceuticals Limited announces Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) with up to 50mCi for radiolabeling is available for use on 100mCi (millicurie) gallium generators, an important development in radioisotope production.
High activity generators from Eckert & Ziegler Strahlen- und Medizintechnik AG (EZAG) and IRE ELiT S.A. (the radiopharmaceutical subsidiary of IRE Group), increase activity from 50mCi to 100mCi and will be integral to expanding patient access to gallium-based radiopharmaceuticals as demand for PSMA-PET imaging in the United States continues to grow. This technology increases the number of daily elutions and activity in each elution, enabling hospitals and radiopharmacies to increase the number of daily doses produced, expand their service area and gain greater production efficiency.
Dr. Christian Behrenbruch, Group CEO and Managing Director of Telix said, “As the only commercially available kit that can take advantage of high activity generators for up to 50mCi radiolabeling, Illuccix gives hospitals, pharmacies, and physicians added confidence that their dose scheduling needs – and the needs of their patients – can be met today and in the future as the potential of 68Ga PSMA-11 is realized in the diagnostic market. We are pleased to continue our collaborative relationships with IRE ELiT and EZAG to continue to make 68Ga PSMA-11 accessible and convenient to use for customers across the United States.”
Jay Simon, Managing Director of Eckert and Ziegler North America said, “The high activity GalliaPharm® generator may allow for broader availability and expanded service areas. It is about delivering doses when and where they are needed, whether you’re a remotely located clinic, a busy metropolitan hospital or a pharmacy. We are pleased to be working with Telix to harness this innovation to maximize the efficiency for our customers and ultimately, their patients.”
Jean Bonnet, Head of Sales, Strategy and Marketing at IRE Group said, “While current generator technology is sufficient to meet today’s demands, the rollout of the higher activity 100mCi generators are future-proofing the ability to meet demand in a market which is growing exponentially. The use of high activity generators has the potential to increase daily elutions and increase the activity in each elution. When radiolabeled up to 50mCi with Illuccix, the result could potentially provide more flexibilitty in meeting the growing demand for 68Ga radiopharmaceuticals while giving customers the benefit of greater dose scheduling flexibility and efficient production.”
For more information about Illuccix, visit www.illuccix.com.
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:
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 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.
This information is not complete. Please see full Prescribing Information at www.illuccix.com/prescribinginformation
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange. For more information visit www.telixpharma.com.
Telix Media Relations U.S.
Mr. Greg Kueterman
Email: greg.kueterman@telixpharma.com
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: kyahn.williamson@telixpharma.com
