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
Reliable Distribution
Gozellix harnesses the power of gallium-68 sourced from either cyclotron or generator1
More gallium-68 in more ways
Generators offer seamless scalability2
- Simple preparation process with ultralow failure risk
- Locally prepared doses by radiopharmacy with weekday, weekend, and evening deliveries
- Flexible dosing options not tethered to production schedules
- No “window of availability” or nonproduction days
- STAT dose availability
Cyclotron technology increases Ga-68 availability3
- Cyclotron-based production yields virtually unlimited supply of Ga-68 with higher activity that is not tied to generator runs
- Allows for larger-scale manufacturing and subsequent distribution
- Can also use cyclotrons at hospitals, radiopharmacies, and institutions
- Enables Ga-68–based PSMA imaging in both cities and remote areas
Gozellix meets the needs of patients when and where they need it
Harnessing the power of Ga-68 sources from either cyclotron or generator
aBased on location and supply availability.
Tell us your preferred mCi, time, day, and number of doses per time slot
- Site orders gallium with your preferred mCi, time, day, and number of doses per 15-minute time slot5
- Multiple doses calibrated at the same time, if appropriate
Widest injection window with ≤30-minute scan time2
Immediate confirmation of dose availability7
Flexible cancellation policy5,b
bCancellations determined at the sole discretion of the dispensing radiopharmacy. Eligible cancellation reasons may include, but are not limited to: patients not showing up for the procedure due to a situation outside of the healthcare provider’s control; PET camera intended to be used for procedure was inoperable due to repair/maintenance; patient could not be injected due to unanticipated medical condition on day of procedure; Ga-68 order was delivered by radiopharmacy partner too late for patient administration. Cancellations must be supported with appropriate documentation.5
ARTMS, Alternative Radioisotope Technologies for Medical Science; PET, positron emission tomography; PSMA, prostate-specific membrane antigen.
Keep up to date on Gozellix
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.
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.
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.
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. Data on File. TAM Slide Deck. Telix Pharmaceuticals. 2023. 3. Massat MB. Nuclear medicine prepares for greater ⁶⁸Ga demand. Appl Radiol. 2021;50(2):30-31. 4. Data on File. On-Time Delivery. Telix Pharmaceuticals. 2022. 5. Data on File. Telix Advantage. Telix Pharmaceuticals. 2024. 6. Velikyan I. ⁶⁸Ga-based radiopharmaceuticals: production and application relationship. Molecules. 2015;20(7):12913-12943. 7. Data on File. PETNET Solutions Overview. Telix Pharmaceuticals. 2023. 8. Data on File. Delivery. Telix Pharmaceuticals. 2022.