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 who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products 
​Dose:  3 - 7 mCi
Brand Name: Gozellix™
​Manufacturer: Telix
​Package Insert
​Product Website
How Supplied:  There are two different kit configurations:
  • Vial 1 (Gozetotide): contains 25 mcg gozetotide as a lyophilized powder in a multi-dose vial - blue cap
  • Vial 2 (Acetate Buffer) contains buffer, either:
  • Ampule (Ascorbic Acid Stabilizer) 
Storage:  kits must be refrigerated until use​
NDC #: 
  • Configuration A: 84552-500-25
  • Configuration B: 84552-500-64
Brand Name: Illuccix®
Manufacturer: Telix
Package Insert
​Product Website
How Supplied:  There are two different kit configurations, each containing 3 vials
  • Vial 1 (Gozetotide): contains 25 mcg gozetotide and 10 mcg D-mannose (stabilizer) as a lyophilized powder - blue cap
  • Vial 2 (Acetate Buffer) contains buffer, either:
  • Vial 3 (Sterile Vacuumed Reaction Vial) for the collection of Ga-68 chloride and radiolabeling reaction - white cap
Storage:  kits must be refrigerated until use
NDC #: 
  • Configuration A: 74725-100-25
  • Configuration B: 74725-100-64
Brand Name: Locametz®
Manufacturer: Advanced Accelerator Applications (AAA) / Novartis
Package Insert
Product Website
NDC#: 0078-1224-61

Letter from Manufacturer (November 2025) - NDC change
Clinical Guidelines: