Overview
11 DESCRIPTION 11.1 Chemical Characteristics Gallium Ga 68 gozetotide injection is a radioactive diagnostic agent for intravenous administration. It contains 0.5 mcg/mL Gozetotide, 18.5 MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL) of gallium Ga 68 gozetotide at calibration time in 0.9% sodium chloride solution with not more than 10% ethanol (approximately 8 to 10 mL total volume).
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Gallium Ga 68 gozetotode binds to prostate-specific membrane antigen (PSMA). It binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Gallium-68 (Ga 68) is a β+ emitting radionuclide that allows positron emission tomography (PET). 12.2 Pharmacodynamics The relationship between galium Ga 68 gozetotide plasma concentrations and successful imaging was not explored in clinical trials. 12.3 Pharmacokinetics Distribution Intravenously injected gallium Ga 68 gozetotide is cleared from the blood and is accumulated preferentially in the liver (15%), kidneys (7%), spleen (2%), and salivary glands (0.5%). Gallium Ga 68 gozetotide uptake is also seen in the adrenals and prostate.
Indications
- 1 INDICATIONS AND USAGE Gallium Ga 68 gozeotide injection 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. Gallium Ga 68 gozetotide injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected...
Common Doses
- Refer to label
Dosage
2 DOSAGE AND ADMINISTRATION Use appropriate aseptic technique and radiation safety handling measures to maintain sterility during all operations involved in the manipulation and administration of Gallium Ga 68 gozetotide injection. ( 2.1 ) The recommended adult dose is 111 MBq to 259 MBq (3 mCi to 7 mCi) as a bolus intravenous injection. ( 2.2 ) A diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection. ( 2.2 ) Initiate imaging 50 to 100 minutes after administration. The patient should void immediately prior to initiation of imaging.
Contraindications
- 4 CONTRAINDICATIONS None None ( 4 )
Side Effects
- 6 ADVERSE REACTIONS The most commonly reported adverse reactions include nausea, diarrhea, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ionetix at 1-517-252-4069 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Interactions
- 7 DRUG INTERACTIONS Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.