Brand Name
Gozellix
Generic Name
gozetotide
View Brand Information FDA approval date: March 20, 2025
Form: Kit
What is Gozellix (gozetotide)?
GOZELLIX, after radiolabeling with Ga 68, 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. GOZELLIX, after radiolabeling with Ga 68, 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.
Approved To Treat
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Brand Information
Gozellix (GOZETOTIDE)
1INDICATIONS AND USAGE
GOZELLIX, after radiolabeling with Ga 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.
2DOSAGE FORMS AND STRENGTHS
Kit for the preparation of Gallium Ga 68 Gozetotide Injection contains:
- Vial 1 (Gozetotide): 25 mcg of gozetotide as a white to off-white lyophilized powder in a multiple-dose vial
- Vial 2A (2.5 mL) or Vial 2B (6.4 mL) (Acetate Buffer): 150 mg anhydrous sodium acetate as a sterile clear colorless solution
- Ampule (Ascorbic Acid Stabilizer): 500 mg/2 mL (250 mg/mL) of ascorbic acid (USP injection grade) as a sterile clear colorless solution
After radiolabeling with Ga 68, Vial 1 contains up to 18,500 MBq (500 mCi) of Gallium Ga 68 Gozetotide Injection in 10 mL at calibration date and time as a clear, colorless to slightly yellow solution in a multiple-dose vial.
3CONTRAINDICATIONS
None
4OVERDOSAGE
In the event of an overdose of gallium Ga68 gozetotide, 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.
5HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
GOZELLIX (kit for the preparation of gallium Ga 68 gozetotide injection) is available in two different configurations.
GOZELLIX Configuration "A" (NDC 84552-500-25), intended for use with Ga 68 produced from a cyclotron and purified via GE FASTlab or ARTMS QIS, or an Eckert & Ziegler GalliaPharm Ge 68/Ga 68 generator, contains:
- Vial 1 (Gozetotide): 25 mcg gozetotide as a sterile white to off-white lyophilized powder in a multiple-dose vial with a blue flip-off cap (NDC 84552-501-25)
- Vial 2A (Acetate Buffer): 150 mg/2.5 mL of anhydrous sodium acetate as a sterile clear colorless solution in a vial with a red flip off cap (NDC 84552-502-25)
- Ampule (Ascorbic Acid Stabilizer): 500 mg/2 mL (250 mg/mL) of ascorbic acid (USP injection grade) as a sterile clear colorless solution in a glass ampule (NDC 84552-504-25)
GOZELLIX Configuration "B" (NDC 84552-500-64), intended for use with Ga 68 produced from an IRE Galli Eo Ge 68/Ga 68 generator, contains:
- Vial 1 (Gozetotide): 25 mcg gozetotide as a sterile white to off-white lyophilized powder in a multiple-dose vial with a blue flip-off cap (NDC 84552-501-25)
- Vial 2B (Acetate Buffer): 150 mg/6.4 mL of anhydrous sodium acetate as a sterile clear colorless solution in a vial with a green flip off cap (NDC 84552-503-64)
- Ampule (Ascorbic Acid Stabilizer): 500 mg/2 mL (250 mg/mL) of ascorbic acid (USP injection grade) as a sterile clear colorless solution in a glass ampule (NDC 84552-504-25)
The radionuclide is not part of the kit. Before radiolabeling with Ga 68, the contents of this kit are not radioactive.
6PRINCIPAL DISPLAY PANEL - Kit Carton - Configuration A
Rx Only
NDC 84552-500-25
Gozellix™
25 mcg/vial gozetotide
Kit for the preparation of gallium Ga 68 gozetotide
- Prescribing Information
- Diagnostic label
- Vial 1 (Gozetotide vial) contains 25 mcg
- Vial 2A (Acetate Buffer Vial) contains
- Ampule (Ascorbic Acid stabilizer)
2D
For Intravenous
Multiple-Dose Kit
CONFIGURATION
Configuration A is for
7PRINCIPAL DISPLAY PANEL - Kit Carton - Configuration B
Rx Only
NDC 84552-500-64
Gozellix™
25 mcg/vial gozetotide
Kit for the preparation of gallium Ga 68 gozetotide
- Prescribing Information
- Diagnostic label
- Vial 1 (Gozetotide vial) contains 25 mcg
- Vial 2B (Acetate Buffer Vial) contains
- Ampule (Ascorbic Acid stabilizer)
2D
For Intravenous
Multiple-Dose Kit
CONFIGURATION
Configuration B is for
