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Locametz Generic Name & Formulations
Legal Class
Rx
General Description
Gallium Ga 68 gozetotide; per kit; containing gozetotide 25mcg/vial; lyophilized pwd for IV inj after reconstitution and radiolabeling. After radiolabeling with gallium-68, contains up to 1369MBq (37mCi) in up to 10mL.
Pharmacological Class
Radioactive diagnostic agent.
How Supplied
Kit—1 (multiple-dose vial)
Manufacturer
Generic Availability
NO
Locametz Indications
Indications
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.
Locametz Dosage and Administration
Adult
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
Not established.
Locametz Contraindications
Not Applicable
Locametz Boxed Warnings
Not Applicable
Locametz Warnings/Precautions
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 Pharmacokinetics
See Literature
Locametz Interactions
Interactions
Androgen deprivation therapy and other therapies targeting the androgen pathway (eg, androgen receptor antagonists) can change the uptake of gallium Ga 68 gozeotide.
Locametz Adverse Reactions
Adverse Reactions
Fatigue, nausea, constipation, vomiting.
Locametz Clinical Trials
See Literature
Locametz Note
Not Applicable
Locametz Patient Counseling
See Literature
