PLUVICTO

Pharmacokinetics of lutetium Lu 177 vipivotide tetraxetan are expressed as geometric mean (geometric mean coefficient of variation) unless otherwise specified. The blood lutetium Lu 177 vipivotide tetraxetan area under the curve (AUC) is 52.3 ng.h/mL (31.4%) and the maximum blood concentration (C max ) is 6.58 ng/mL (43.5%) at the recommended dosage.

DistributionLutetium Lu 177 vipivotide tetraxetan volume of distribution is 123 L (78.1%). Within 2.5 hours after administration, lutetium Lu 177 ...

14.1 PSMA-Positive mCRPC Previously Treated With ARPI Therapy PSMAfore The efficacy of PLUVICTO was evaluated in PSMAfore (NCT04689828), a randomized (1:1), multicenter, open-label trial that evaluated PLUVICTO (N = 234) versus a change in ARPI (N = 234) in patients with progressive, PSMA-positive mCRPC. Randomization was stratified by setting of prior ARPI use [castration-resistant prostate cancer (CRPC) vs. hormone-sensitive prostate cancer (HSPC)] and by symptomatology [asymptomatic or mildly symptomatic vs. symptomatic]. Patients were required to have a castrate level of serum/plasma testo...

The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.2)] Renal Toxicity [see Warnings and Precautions (5.3)] Most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased lymphocytes, decreased hemoglobin, fatigue, dry mouth, decreased platelets, decreased estimated glomerular filtration rate, nausea, decreased neutrophils, decreased calcium, decreased sodium, increased aspart...

None. None. ( 4 )

Risk From Radiation Exposure : Minimize radiation exposure during and after treatment with PLUVICTO consistent with institutional good radiation safety practices and patient treatment procedures. Ensure patients increase oral fluid intake and advise patients to void as often as possible to reduce bladder radiation. ( 5.1 ) Myelosuppression : Perform complete blood counts. Withhold, reduce dose, or permanently discontinue PLUVICTO based on severity. ( 2.4 , 5.2 ) Renal Toxicity : Advise patients ...