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

Preparation

Gozellix® is a PSMA-11 cold kit, designed to offer flexible and consistent preparation of 68Ga-PSMA-111a

National availability of kits for on-demand production of 68Ga-PSMA-11a doses2,3

The Gozellix kit comes in 2 configurations

Configuration A—GE FASTlab™, Alternative Radioisotope Technologies for Medical Science (ARTMS) QUANTM Irradiation System™ (QIS™), or Eckert & Ziegler GalliaPharm® Germanium 68/Gallium-68 (Ge 68/Ga-68) generator.1
1 gozetotide sterial vile + 1 sterile acetate buffer vial (2.5mL) + 1 ascorbic acid stabilizer ampule.
Configuration B—for use with IRE Galli Eo™ Ge 68/Ga-68 generator.1
1 gozetotide sterial vile + 1 sterile acetate buffer vial (6.4mL) + 1 ascorbic acid stabilizer ampule.
  • Rapid and consistent labeling chemistry suitable for the radiopharmacy setting4
    • High-quality images with minimal dose of radiation1,5
  • National commercial access with flexible production using cyclotron or the majority of Ga-68 generators in the United States3
a68Ga-PSMA-11 is also known as gallium Ga-68 gozetotide. All trademarks are the property of their respective owners.

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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.

References: 1. Gozellix (kit for the preparation of gallium Ga 68 gozetotide injection) prescribing information. 2. Velikyan I. 68Ga-based radiopharmaceuticals: production and application relationship. Molecules. 2015;20(7):12913-12943. 3. Massat MB. Nuclear medicine prepares for greater ⁶⁸Ga demand. Appl Radiol. 2021;50(2):30-31. 4. ARTMS and Telix Pharmaceuticals announce successful production of 68Ga PSMA-11 with cyclotron produced 68Ga from a solid target. [news release]. Telix Pharmaceuticals; January 12, 2021. Accessed February 8, 2025. 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 February 8, 2025. 5. 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. 2020;61(5):716-722.