IMPORTANT SAFETY INFORMATION

 

Risk for Misinterpretation

Image interpretation errors can occur with LOCAMETZ PET. Negative imaging does not rule out the presence of prostate cancer and a positive imaging does not confirm the presence of prostate cancer. ...

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Indication

LOCAMETZ® (kit for the preparation of gallium Ga 68 gozetotide injection), after radiolabeling with gallium-68, is 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
  • for selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated

Access

AAA PatientCONNECT™

Connect patients with support services for their experience with PSMA PET imaging using LOCAMETZ

What is AAA PatientCONNECT?

AAA PatientCONNECT is a patient-centric support program from Advanced Accelerator Applications (AAA) committed to delivering assistance for eligible patients.

 

After enrollment, AAA PatientCONNECT can assist with:

    Support begins with patient enrollment. To complete and submit an enrollment form, visit www.aaapatientconnect.com and access the AAA PatientConnect™ portal or download the enrollment form.

    Coding and Reimbursement

    Advanced Accelerator Applications (AAA) has developed a resource to provide you and your office staff general coding and reimbursement information for LOCAMETZ (kit for the preparation of gallium Ga 68 gozetotide injection).

     

    The coding and reimbursement guide contains:

    Coding and Reimbursement Guide

    Use this guide as a resource to find coding and reimbursement information for LOCAMETZ and helpful examples for navigating the claim process.

    Download guide

    DISCLAIMERS

    This document is presented for informational purposes only and is not intended to provide reimbursement or legal advice.

    • Laws, regulations, and policies concerning reimbursement are complex and are updated frequently:
      • While AAA has made every effort to be current as of the issue date on this document, the information may not be as current or comprehensive when you view it
      • Similarly, all Current Procedural Terminology (CPT®) and Healthcare Common Procedure Coding System (HCPCS) codes are supplied for informational purposes only, and this information does not represent any statement, promise, or guarantee by AAA about coverage, levels of reimbursement, payment, or charge
    • Consult the payer organization(s) for coverage and reimbursement policies and determination processes
    • Consult with your internal reimbursement specialist for any reimbursement or billing questions specific to your institution
    • It is the provider’s responsibility to determine and submit accurate information on claims and comply with payer
    • The existence of billing codes does not guarantee coverage and payment
    Find a LOCAMETZ scanning center near you or your patient

    Indication

    LOCAMETZ® (kit for the preparation of gallium Ga 68 gozetotide injection), after radiolabeling with gallium-68, is 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
    • for selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated

     

    IMPORTANT SAFETY INFORMATION

    Risk for Misinterpretation

    Image interpretation errors can occur with LOCAMETZ PET. Negative imaging does not rule out the presence of prostate cancer and a positive imaging 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 nonmalignant processes. 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 LOCAMETZ seems to be affected by serum PSA levels and by site of disease for imaging of biochemically recurrent prostate cancer, and by Gleason score for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy.

    Imaging to select patients for lutetium Lu 177 vipivotide tetraxetan therapy

    The interpretation of LOCAMETZ PET may differ depending on imaging readers. LOCAMETZ PET interpretations to select patients for lutetium Lu 177 vipivotide tetraxetan therapy may be more consistent when judging gallium Ga 68 gozetotide uptake in any 1 tumor lesion compared with judging uptake for all lesions larger than size criteria. Multidisciplinary consultation is recommended, particularly for LOCAMETZ imaging that a single reader finds borderline or difficult to interpret, or when patient eligibility hinges only on judgment of gallium Ga 68 gozetotide uptake for all lesions larger than size criteria.

    Radiation Risk

    Gallium Ga 68 gozetotide contributes to a patient’s long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to be well hydrated prior to gallium Ga 68 gozetotide administration and to void immediately prior to and frequently during the first hours after image acquisition to reduce radiation exposure.

    Adverse Reactions

    Adverse reactions ≥0.5% in the VISION study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%). Adverse reactions occurring at a rate of <0.5% were diarrhea, dry mouth, injection site reactions, and chills.

     

    Please see accompanying full Prescribing Information.