Imaging agents:

Indications for: LOCAMETZ

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; or for selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.

Adult Dosage:

See full labeling. Verify the total radioactivity in the syringe with a dose calibrator immediately before and after administration. Give 111–259MBq (3–7mCi), as a slow IV inj. Starting 50–100mins after IV inj, acquire PET image. The effective radiation dose from 259MBq (7mCi) dose is 4.4mSv.

Children Dosage:

Not established.

LOCAMETZ Warnings/Precautions:

Risk of radiation exposure. Ensure adequate hydration. Advise to void immediately prior to and frequently during the first hours after image acquisition. Should only be used by trained and experienced physicians in the safe use and handling of radionuclides to minimize radiation exposure. Risk for image misinterpretation and other errors.

LOCAMETZ Classification:

Radioactive diagnostic agent.

LOCAMETZ Interactions:

Androgen deprivation therapy and other therapies targeting the androgen pathway (eg, androgen receptor antagonists) can change the uptake of gallium Ga 68 gozeotide.

Adverse Reactions:

Fatigue, nausea, constipation, vomiting.

Generic Drug Availability:

NO

How Supplied:

Kit—1 (multiple-dose vial)