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
Industry-Leading Support
A comprehensive network of support and materials for patients and practices
For patients—education and support
- Ongoing PSMA Education including take-home materials
- Prostate Cancer Patient Support
- Patient Advocacy Partnerships at local and national level
For practices to help their patients, Gozellix® Reimbursement Support can:
- Perform benefit investigations
- Assist with obtaining prior authorizations
- Assist with appealing denied claims
- Provide coverage policies from third-party payers and clinical guidelines from Radiology Benefit Managers (RBMs)
End-to-end support for your practice, including reimbursement, peer-to-peer education (TelixU), and application support
- With Gozellix, you’ll have a team dedicated to handling reimbursement and coding questions
- Peer-to-peer speaker programs, webinars, and live events
- Key opinion leader-designed reader training
- One-to-one virtual consultation with experienced readers
Enduring teamwork that supports and simplifies Gozellix use
Camera setup and optimization prior
to the first dose
to the first dose
On-site with you
for the first dose
for the first dose
Monthly and quarterly follow-ups to identify and resolve gaps
Create best practices onboarding procedures
Ongoing educational
support
support
Medical Information Requests and FAQs related to scan quality, technical questions
Representatives are
just a phone call or
text away
just a phone call or
text away
Robust reimbursement support
Dedicated to helping you with your patients’ reimbursement needs
Field Access Managers (FAM) are available to help with any reimbursement and coding questions. We recommend scheduling an onboarding call to meet your local FAM. You can email your FAM at us.reimbursement@telixpharma.com. They will get back to you Monday through Friday or schedule your onboarding call. You can also contact Gozellix Reimbursement Support to reach team members live by phone (1-844-45-TELIX), Monday through Friday from 9:00 AM to 5:00 PM EST or schedule an online consultation. We encourage you to set up an onboarding call to get to know the Reimbursement Support Team prior to addressing a specific reimbursement need.
Your trusted radiopharmaceutical partner
With you in the fight against prostate cancer
- At Telix, our teams are focused on developing radiopharmaceuticals that exceed your diagnostic expectations and enable you to put your patients first. We are committed to helping you make the most informed clinical decisions for all of your patients with prostate cancer
Telix is dedicated to maximizing the physician and patient experience
Gozellix is part of a franchise of accurate, reliable,
and patient-centric
imaging agents
Telix has a pipeline of products that is transforming the use of targeted radiation in cancer care from diagnosis and staging, to therapy and surgical intervention
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.