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Important Safety InformationFull Prescribing Information

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Gozellix (kit for the preparation of gallium Ga 68 gozetotide injection) logo

GALLIUM
IS KEY

Every prostate cancer decision depends on the accuracy of your view. TelixPSMA™ delivers high-precision PSMA PET imaging and provides reliable, accurate results for patients with prostate cancer.

Clinical Evidence
Why Gallium?
Resources
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Performance

Detect micrometastases as small as 2 mm for more informed clinical decision-making at the earliest signs across a broad range of prostate cancer.

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specificity in detecting metastasis at initial staging

True

Scalability

Tailor PSMA PET imaging to your radiopharmacy’s existing infrastructure, using local generators instead of cyclotrons to scale Ga-68 production rapidly as patient demand grows.

Harnesses Ga-68 sourced from either cyclotron or generator

True

Flexibility

Take control of your daily scan schedule and eliminate tight logistical windows. Gozellix® features a 6-hour shelf life—the longest available for any approved Ga-68 PSMA agent—streamlining dose management across your entire practice.

6-hour shelf life: an injection window more than 3× that of 18F-based tracers at standard dose

True

Reach

Expand advanced prostate cancer care by connecting underserved imaging centers to precision Ga-68 PSMA PET capabilities.

Available from more than 230 radiopharmacies with flexible scheduling and on-time delivery

True

Confidence

Proven across diverse practice settings, TelixPSMA delivers the real-world dependability clinicians rely on. Every dose is backed by Telix end-to-end support to ensure seamless integration into your workflow.

Used in more than 220,000 patients

Gallium-68 thought leadership

Unlocking advances in
PET imaging and theranostics

Key thought leaders share their perspectives on the benefits of Gallium-68 and how it is playing a key role in shaping the future of theranostics.

Download the white paper
Gallium-68 is key
Industry experts

Jeremie Calais, MD, PhD
Nuclear Medicine Physician, Los Angeles

Heather Kaplan, MHA,

CNMT, ARRT (N)
Nuclear Medicine Technologist, Sarasota
Memorial Hospital

Amir Lavaf, MD, DABR
Radiation Oncologist, Desert Regional Medical Center

Jaideep Sohi, MD
Nuclear Medicine
Physician, American
Molecular Imaging

Jeffrey Spier, MD
Urologist,
Rio Grande Urology

Videos

68Ga and 18F PSMA PET/CT Skeletal Lesion Characterization in Men With Prostate Cancer

Presented by Drs. Munir Ghesani and Umesh Oza, this webinar covers why 18F shows more indeterminate bone lesions and why 68Ga has higher accuracy for true metastases.

Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) logoGozellix (kit for the preparation of gallium Ga 68 gozetotide injection) logo

Stay Updated on TelixPSMA Innovations

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

References: [TK]

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 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