Brand Name

Ga-68 PSMA-11

Generic Name
Ga-68 Gozetotide
View Brand Information
FDA approval date: December 09, 2020
Classification: Radioactive Diagnostic Agent
Form: Injection

What is Ga-68 PSMA-11 (Ga-68 Gozetotide)?

Gallium Ga 68 gozeotide injection is indicated for positron emission tomography of prostate-specific membrane antigen 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 level. Gallium Ga 68 gozetotide injection is a radioactive diagnostic agent indicated for positron emission tomography of prostate-specific membrane antigen 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 level.

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Brand Information

Gallium Ga-68 PSMA-11 (GALLIUM GA-68 GOZETOTIDE)
1INDICATIONS 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.
2DOSAGE FORMS AND STRENGTHS
Injection: supplied as a clear, colorless solution in a 10 mL single-dose syringe containing 18.5 MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL) of Gallium Ga 68 gozetotide at calibration time.
3CONTRAINDICATIONS
None
4OVERDOSAGE
In the event of an overdose of gallium Ga 68 gozetotide injection, reduce the radiation absorbed dose to the patient where possible by increasing the elimination of the drug from the body using hydration and frequent bladder voiding. A diuretic might also be considered. If possible, an estimate of the radiation effective dose given to the patient should be made.
5CLINICAL STUDIES
The safety and efficacy of Gallium Ga 68 gozetotide injection were established in two prospective, open-label