Lutetium lu-177 vipivotide tetraxetan

PLUVICTO is a radioligand therapeutic agent indicated: Metastatic Androgen Pathway Modulation-Naïve or -Sensitive (mAPMN/S) Prostate Cancer in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer. Metastatic Androgen Pathway Modulation-Resistant (mAPMR) Prostate Cancer for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been treated with ARPI therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy.

Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent. The active moiety of lutetium Lu 177 vipivotide tetraxetan is the radionuclide lutetium-177 which is linked to a moiety that binds to PSMA, a transmembrane protein that is expressed in prostate cancer. Upon binding of lutetium Lu 177 vipivotide tetraxetan to PSMA-expressing cells, the beta-minus emission from lutetium-177 delivers radiation to PSMA-expressing cells, as well as to surrounding cells, and induces DNA damage which can lead to cell death.

Select patients for treatment using LOCAMETZ ® or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors. mAPMN/S Prostate Cancer: The recommended dosage of PLUVICTO in combination with ARPI is

None. None.

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. Myelosuppression: Perform complete blood counts. Withhold, reduce dose, or permanently discontinue PLUVICTO based on severity. Renal Toxicity: Advise patients to remain well hydrated and to urinate frequently. Perform kidney function laboratory tests. Embryo-Fetal Toxicity: Can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception. Infertility: PLUVICTO may cause temporary or permanent infertility.

The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression Renal Toxicity Most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased lymphocytes, decreased hemoglobin, fatigue, dry mouth, decreased neutrophils, nausea, decreased platelets, decreased estimated glomerular filtration rate, increased aspartate aminotransferase, decreased sodium, increased magnesium, increased potassium, decreased calcium, and increased alkaline phosphatase.

Store below 30°C (86°F). Do not freeze. Store in the original package to protect from ionizing radiation (lead shielding). Store PLUVICTO in accordance with local and federal laws on radioactive materials.