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

LOCAMETZ Dosing & Administration

Radiation Safety

LOCAMETZ IS AVAILABLE AS A KIT FOR THE PREPARATION OF GALLIUM Ga 68 GOZETOTIDE SOLUTION FOR INJECTION1

Radiopharmaceuticals should be used by or under the control of health care providers who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the governmental agency authorized to license the use of radionuclides.

Graphic explaining how doctors should administer LOCAMETZ
Learn about the 3-step reconstitution and radiolabeling process
Learn about the 3-step radiolabeling process

Dosing and Administration

Process for preparing the patient, verifying the dose, and proper disposal1

The recommended amount of radioactivity to be administered for PET is 111 MBq (3 mCi) up to a maximum of 259 MBq (7 mCi). Administered as a slow intravenous injection.

Graphic explaining the administration process of LOCAMETZ

USP, US Pharmacopeia.

Graphic explaining the steps to take during administration

NIST, National Institute of Standards and Technology.

Graphic explaining the steps to take after administration

Storage and Handling

LOCAMETZ can be stored at controlled room temperature1

Infographic showing how to store and handle LOCAMETZ

HANDLING LOCAMETZ REQUIRES APPROPRIATE SAFETY MEASURES FOR MINIMIZING RADIATION EXPOSURE1,2

  • LOCAMETZ should be administered only under the control of trained/licensed HCPs
  • Use waterproof gloves
  • Use effective radiation shielding
  • Minimize handling time
  • Any unused product or waste material should be disposed of in accordance with local and federal laws

Receipt, transfer, handling, possession, or use of LOCAMETZ is subject to radioactive material regulations and licensing requirements. Please check with your institution’s radiation safety department and team for any further institution-specific requirements that should be followed for the administration of LOCAMETZ.

Resources

Radiolabeling LOCAMETZ

For the Eckert & Ziegler GalliaPharm® Generator

Watch this video to learn about the 3-step radiolabeling process for LOCAMETZ using the Eckert & Ziegler GalliaPharm® generator

For the IRE ELiT Galli Eo Generator

Watch this video to learn about the 3-step radiolabeling process for LOCAMETZ using the IRE ELiT Galli Eo generator

 

References: 1. LOCAMETZ [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc; 2022. 2. Centers for Disease Control and Prevention. ALARA - as low as reasonably achievable. https://www.cdc.gov/nceh/radiation/alara.html. Accessed September 15, 2021.

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.