Pluvicto 1000 MBq/mL Solution for Injection/Infusion

Manufacturer
Advanced Accelerator Applications (Italy) S.R.L.(ITALY)

Registraction Number
MAL24126007AZ

Content:
Each mL of solution contains:
-Lutetium (177Lu) vipivotide tetraxetan: 1000 MBq
Indications:
-Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC): Used in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition for the treatment of adult patients with progressive PSMA-positive mCRPC who have been treated with AR pathway inhibition and taxane-based chemotherapy2.
Instructions:
Dosage: The recommended treatment regimen is 7400 MBq intravenously every 6 weeks (±1 week) for up to a total of 6 doses, unless there is disease progression or unacceptable toxicity2.
Administration: Administer only by persons authorized to handle radiopharmaceuticals in designated clinical settings. Ensure patients increase oral fluid intake and advise them to void as often as possible to reduce bladder radiation2.