Lutetium (177lu) Prostate Specific Membrane Antigen 617 (177lu-psma617)

What it is and how it works

Mechanism of Action 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.

Mechanism class: Radioligand Activity

Indications

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. Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer PLUVICTO is indicated 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.

Dosage and administration (summary)

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 GBq (200 mCi) every 6 weeks for 6 doses, or until disease progression or unacceptable toxicity. mAPMR Prostate Cancer : The recommended dosage of PLUVICTO is GBq (200 mCi) every 6 weeks for 6 doses, or until disease progression or unacceptable toxicity. Dose interruption, reduction, or permanent discontinuation may be required due to adverse reactions. Important Safety Instructions PLUVICTO is a radiopharmaceutical.

Contraindications

None. None.

Warnings and precautions

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. ( 2.4 , 5.2 ) Renal Toxicity : Advise patients to remain well hydrated and to urinate frequently. Perform kidney function laboratory tests.

Pregnancy

Pregnancy Risk Summary The safety and efficacy of PLUVICTO have not been established in females. Based on its mechanism of action, PLUVICTO can cause fetal harm . There are no available data on PLUVICTO use in pregnant females.

Storage and supply

Injection containing 1,000 MBq/mL (27 mCi/mL) of lutetium Lu 177 vipivotide tetraxetan at calibration time is a sterile, preservative-free and clear, colorless to slightly yellow solution for intravenous use supplied in a clear, colorless Type I glass 30 mL single-dose vial containing GBq (200 mCi) ± 10% of lutetium Lu 177 vipivotide tetraxetan at …

Source: Lutetium Lu 177 Vipivotide Tetraxetan (Pluvicto) — US FDA prescribing information, 2026-08-12, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.