2023-11-09 15:18:10
Prostate cancer is the most common cancer in men (26% of incident cancers).
In prostate cancer, LOCAMETZ 25 µg kit for radiopharmaceutical preparation (gallium [68Ga] gozetotide) is a new hospital specialty for diagnostic use only.
Following gallium-68 radiolabeling, LOCAMETZ is indicated for the detection of prostate-specific membrane antigen (PSMA)-positive lesions by positron emission tomography (PET) in adults with prostate cancer (PC). ) in the following clinical situations:
initial staging of patients with high-risk PC before initial curative treatment; suspicion of recurrent PCa in patients with increased serum prostate-specific antigen (PSA) levels following initial curative treatment; Identification of patients with progressive, PSMA-positive, metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated.
In his opinion of April 4, 2023 [1]the Transparency Commission (CT) awarded LOCAMETZ a significant actual benefit (SMR) in the indications of the marketing authorization (AMM).
LOCAMETZ is subject to additional monitoring which will enable the rapid identification of new safety-related information. Healthcare professionals report any suspected adverse reactions.
LOCAMETZ in practice
Reconstitution et radiomarquage avant injection IV
LOCAMETZ must be reconstituted and radiolabeled before administration to the patient. These preparation steps are described in the LOCAMETZ VIDAL monograph.
The recommended dose of gallium (68Ga) gozetotide is 1.8-2.2 MBq/kg body weight, with a minimum dose of 111 MBq up to a maximum dose of 259 MBq. Gallium-68 used for radiolabeling gozetotide is not included in the kit.
No dosage adjustment is necessary in patients aged 65 years and older.
LOCAMETZ is administered as a slow intravenous (IV) injection. The injection should be followed by an intravenous flush of sterile sodium chloride 9 mg/mL (0.9%) solution to ensure complete administration of the dose.
PET imaging begins 50 to 100 minutes following administration of LOCAMETZ.
LOCAMETZ comes in a bottle for multidose use.
Ensure patient hydration
Patients should be well hydrated before administration of gallium (68Ga) gozetotide. The following instructions must be explained:
urinate immediately before; and urinate frequently during the first hours following image acquisition to reduce radiation exposure.
Administrative identity
Liste I
Medication reserved for hospital use
10 mL Flacon, CIP 3400955092674
Approval for communities [2]
Laboratoires Advanced Accelerator Applications
1699544032
#radiopharmaceutical #specialty #prostate #cancer
