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.

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. All other brand names, logos, and related tag lines are the property of their respective owners. All rights reserved.

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.

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.

Questions about these Terms of Use may be forwarded to notices@telixpharma.com.

Approved Uses

ILLUCCIX® (kit for the preparation of gallium Ga-68 gozetotide, for injection) is a prescription radioactive diagnostic agent that is prepared by a healthcare provider, and, then, injected. It is used with a medical imaging procedure called Positron Emission Tomography (PET) of lesions identified as prostate-specific membrane antigen (PSMA) positive. ILLUCCIX is used in men with prostate cancer whose cancer may have spread to other parts of the body and may need initial therapy or whose cancer may have come back, based on elevated serum prostate-specific antigen (PSA) levels. ILLUCCIX is also approved to help your healthcare provider determine whether you are appropriate for a certain treatment that is a PSMA-directed therapy.

Important Safety Information

There is a risk your PET scan image with ILLUCCIX may be misinterpreted. A negative image does not rule out presence of prostate cancer, and a positive image does not confirm presence of prostate cancer. The ILLUCCIX PET scan may be affected by other factors, like the presence of other tissue types, PSMA levels and site of disease. Your healthcare provider will consider other information to confirm prostate cancer and determine treatment.

ILLUCCIX involves exposure to small amounts of radioactivity, and long-term cumulative radiation exposure is associated with increased risk for cancer. Your healthcare provider will use safe handling techniques to minimize radiation exposure.

Approved Uses

ILLUCCIX® (kit for the preparation of gallium Ga-68 gozetotide, for injection) is a prescription radioactive diagnostic agent that is prepared by a healthcare provider, and, then, injected. It is used with a medical imaging procedure called Positron Emission Tomography (PET) of lesions identified as prostate-specific membrane antigen (PSMA) positive. ILLUCCIX is used in men with prostate cancer whose cancer may have spread to other parts of the body and may need initial therapy or whose cancer may have come back, based on elevated serum prostate-specific antigen (PSA) levels. ILLUCCIX is also approved to help your healthcare provider determine whether you are appropriate for a certain treatment that is a PSMA-directed therapy.

Important Safety Information

  • There is a risk your PET scan image with ILLUCCIX may be misinterpreted. A negative image does not rule out presence of prostate cancer, and a positive image does not confirm presence of prostate cancer. The ILLUCCIX PET scan may be affected by other factors, like the presence of other tissue types, PSMA levels and site of disease. Your healthcare provider will consider other information to confirm prostate cancer and determine treatment.
  • ILLUCCIX involves exposure to small amounts of radioactivity, and long-term cumulative radiation exposure is associated with increased risk for cancer. Your healthcare provider will use safe handling techniques to minimize radiation exposure.
  • You should drink water to hydrate before the scan and urinate immediately before the procedure and as often as possible during the first hours after the procedure to help reduce radioactivity exposure.
  • The most common side effects of ILLUCCIX in clinical trials were fatigue, nausea, diarrhea, constipation, vomiting, and dizziness. These adverse reactions each typically occurred in ≤1.2% of patients in clinical trials.

The full Prescribing Information is available at www.ILLUCCIX.com

You are encouraged to report negative side effects to Telix Pharmaceuticals (US) at 1-844-455-8638 (pharmacovigilance@telixpharma.com) or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.