Terms of Use

Website Terms of Use for Telix Pharmaceuticals (US) Inc. and its associated companies.

Your use of this website is governed by the terms and conditions set out below, as updated by Telix from time to time.

Liability

This site has been produced by Telix to provide information within the USA only. The information on this site is not medical advice and should not be relied upon by any particular individual or for any specific purpose. Any medical questions should be referred to your healthcare professional. If in doubt, please seek medical advice.

To the extent permitted by law, neither Telix nor its affiliates makes any warranties or representations as to the accuracy, currency or completeness of the information contained on this site. Telix shall not be liable for any damage or injury which may arise from the use of or reliance upon any information provided in this website.

Further, neither Telix, its affiliates, nor any party involved in creating, producing or delivering this website shall be liable for any direct, incidental, consequential, indirect or punitive loss or damages arising out of access to, use of or inability to use this website, or any errors or omissions in its content. All users access and use this site and its content at their own risk.

Copyright

The contents of this website are the intellectual property of Telix. All rights reserved. Documents published by Telix may not be copied other than for non-commercial individual reference with all copyright or other proprietary notices retained, and thereafter may not be recopied, reproduced or otherwise redistributed.

Trademark

The brand names, logos and related tag-lines appearing on this website, whether or not appearing in large print or with the trademark symbol, are trademarks of Telix Pharmaceuticals Limited, its affiliates, related companies or its licensers or joint venture partners. The use or misuse of these trademarks or any other materials, except as permitted herein, is expressly prohibited.

Privacy

Telix acknowledges its obligations in relation to privacy and refers you to its Global Privacy Policy.

Governing Law

This legal statement shall be governed by and construed in accordance with the laws of the United States. If any provision of this legal statement shall be unlawful, void or for any reasons unenforceable, then that provision shall be deemed severable and shall not affect the validity and enforceability of the remaining provisions.

Links

Any links to third-party websites are provided for convenience only and the inclusion of any link does not imply any endorsement or verification by Telix. Telix does not accept any responsibility or liability in relation to any content on websites not under Telix’s direct control.

Contact Us

If you have any questions about this statement, please contact our legal officer at notices@telixpharma.com.

Indications and Usage

Illuccix®, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated 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 Misdiagnosis

Image interpretation errors can occur with gallium-68 gozetotide 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. The performance of gallium-68 gozetotide for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of gallium-68 gozetotide for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Gallium-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.

Indications and Usage

Illuccix®, after radiolabeling with gallium-68, is a radioactive diagnostic agent indicated 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 Misdiagnosis

Image interpretation errors can occur with gallium-68 gozetotide 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. The performance of gallium-68 gozetotide for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of gallium-68 gozetotide for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Gallium-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.

Radiation Risks

Gallium-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 health care workers. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions

The safety of gallium-68 gozetotide was evaluated in 960 patients, each receiving one dose of gallium-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). No serious adverse reactions were attributed to gallium-68 gozetotide. 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-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium-68 gozetotide PET has not been established.

You are encouraged to report negative side effects 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 by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.

Please see full Prescribing Information.

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US-2100028 03/2022