Gallium-68 gozetotide
Approved Use: indicated for positron emission tomography (PET) of PSMA positive lesions in men with prostate cancer:
- with suspected metastasis who are candidates for initial definitive therapy.
- with suspected recurrence based on elevated PSA level.
- for selection of patients with metastatic prostate cancer, for whom lutetium Lu-177 vipivotide tetraxetan PSMA-directed therapy is indicated (only Locametz® includes this indication)
Brand Name: Illuccix®
Manufacturer: Telix
Package Insert
How Supplied: There are two different kit configurations, each containing 3 vials
Configuration “A” (NDC 74725-100-25) is intended for use with Ga-68 produced from a cyclotron and purified via GE FASTlab or Eckert & Ziegler GalliaPharm Ge-68/Ga-68 generator and includes:
Manufacturer: Telix
Package Insert
How Supplied: There are two different kit configurations, each containing 3 vials
Configuration “A” (NDC 74725-100-25) is intended for use with Ga-68 produced from a cyclotron and purified via GE FASTlab or Eckert & Ziegler GalliaPharm Ge-68/Ga-68 generator and includes:
- Vial 1 (Gozetotide Vial): contains 25 mcg gozetotide and 10 mcg D-mannose as a lyophilized powder in a sterile 10 mL vial with a blue flip-off cap (NDC 74725-101-25)
- Vial 2 (Acetate Buffer Vial, Configuration A): contains 150 mg anhydrous sodium acetate in 0.292 M HCl solution (2.5 mL volume) in a sterile 10 mL vial with a red flip off cap (NDC 74725-102-25)
- Vial 3 (Sterile Vacuumed Reaction Vial): an evacuated sterile vial with white flip off cap used to collect Ga-68 chloride from generators or cyclotron and radiolabeling reaction; a multiple-dose vial after radiolabeling
- Vial 1 (Gozetotide Vial): contains 25 mcg gozetotide and 10 mcg D-mannose as a lyophilized powder in a sterile 10 mL vial with a blue flip-off cap (NDC 74725-101-25)
- Vial 2 (Acetate Buffer Vial, Configuration B): contains 150 mg anhydrous sodium acetate in 0.175 M HCl solution (6.4 mL volume) in a sterile 10 mL vial with a green flip off cap (NDC 74725-103-64)
- Vial 3 (Sterile Vacuumed Reaction Vial): an evacuated sterile vial with white flip off cap used to collect Ga-68 chloride from generator and radiolabeling reaction; a multiple-dose vial after radiolabeling
Brand Name: Locametz®
Manufacturer: Advanced Accelerator Applications (AAA) / Novartis
Package Insert
NDC#: 69488-017-61
*More info coming soon*
Manufacturer: Advanced Accelerator Applications (AAA) / Novartis
Package Insert
NDC#: 69488-017-61
*More info coming soon*