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PSMA PET Options for Patients and Practices

Telix puts patients first by making accurate and reliable tracers to enable clinical decision-making. With technologies to meet the needs of different institutions and ensure broad product availability, the TelixPSMA™ PET franchise has patients and practices covered.
illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) logo. Click to visit the illuccix website for health care professionals
Gozellix (kit for the preparation of gallium Ga 68 gozetotide injection) logo. Click to visit the Gozellix website for health care professionals
"Telix is revolutionizing cancer care as the vanguard of next-gen molecular imaging — a cornerstone to precision medicine — thus setting a new standard in prostate cancer."
Paul M. Yonover, MD, FACS
Urology
"PSMA imaging from Telix Pharmaceuticals provides a clearer vision in the fight against prostate cancer. This allows for more accurate staging and effective treatment strategies to lead to optimal patient outcomes."
Ramji Rajendran, MD
Radiation Oncology
"PSMA PET imaging made possible by Telix has been an immensely powerful diagnostic tool."
Brad Fehrenbach, MD
Nuclear Medicine
"PSMA PET CT is the standard of care and my first choice for precise staging and treatment planning for my patients with prostate cancer."
Paul Dato, MD
Urology
"68Ga-PSMA-11 has revolutionized prostate cancer staging and surveillance at our cancer center. It gives us great confidence in our treatment recommendations knowing that we have a sensitive and accurate scan with minimal indeterminate findings."
Amir Lavaf, MD
Radiation Oncology

“Telix is revolutionizing cancer care as the vanguard of next-gen molecular imaging — a cornerstone to precision medicine — thus setting a new standard in the diagnosis of prostate cancer”

Paul M. Yonover, MD, FACS

Urology

“PSMA imaging from Telix Pharmaceuticals provides a clearer vision in the fight against prostate cancer. This allows for more accurate staging and effective treatment strategies to lead to optimal patient outcomes”

Ramji Rajendran, MD

Radiation Oncology

“PSMA PET imaging made possible by Telix has been an immensely powerful diagnostic tool across the entire life-cycle of prostate cancer, making better diagnosis and treatment a reality”

Brad Fehrenbach, MD

Nuclear Medicine

“PSMA PET CT is the standard of care and my first choice for precise staging and treatment planning for my patients with prostate cancer”

Paul Dato, MD

Urology

“68Ga-PSMA-11 has revolutionized prostate cancer staging and surveillance at our cancer center. It gives us great confidence in our treatment recommendations knowing that we have a sensitive and accurate scan with minimal indeterminate findings”

Amir Lavaf, MD

Radiation Oncology

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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. Gallium 68 (Ga 68) gozetotide binds to PSMA.1 It binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Ga 68 is a β+ emitting radionuclide that allows PET.2
References: 1. 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. 2. Gozellix (kit for the preparation of gallium Ga 68 gozetotide injection) prescribing information. 

INDICATIONS AND USAGE

GOZELLIX, after radiolabeling with Ga-68, is 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 Misinterpretation
Image interpretation errors can occur with GOZELLIX 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 GOZELLIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of GOZELLIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.
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.
Hypersensitivity Reactions to Sulfites
Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

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%.

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 Pharmaceuticals (US) by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.

Please contact the Telix Customer Service team to get access to Telix products, request information/status on orders or expedite an order, schedule product onboarding for your site or request technical support, or any other general inquiry. Our customer support team is available to provide any resources you may need.

Customer Service Telephone (Mon-Fri, 8:00 AM – 5:00 PM ET): 463-235-2159

Customer Service Email (response time less than 1 business day): customerservice.americas@telixpharma.com

INDICATIONS AND USAGE

ILLUCCIX, after radiolabeling with Ga-68, is 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 who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products

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.
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.
Injection site pain has been identified during postapproval use of ILLUCCIX.

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 at illuccix.com/prescribinginformation

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 Pharmaceuticals (US) by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.

Please contact the Telix Customer Service team to get access to Telix products, request information/status on orders or expedite an order, schedule product onboarding for your site or request technical support, or any other general inquiry. Our customer support team is available to provide any resources you may need.

Customer Service Telephone (Mon-Fri, 8:00 AM – 5:00 PM ET): 463-235-2159

Customer Service Email (response time less than 1 business day): customerservice.americas@telixpharma.com