Pluvicto Lutetium (¹⁷⁷Lu) Vipivotide Tetraxetan Injection

1. Indications and Usage
PLUVICTO is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy.
2. Dosage and Administration
Patient Selection: Select patients for treatment using LOCAMETZ® or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors.
Recommended Dosage: Administer 7.4 GBq (200 mCi) every 6 weeks for 6 doses.
Administration: Administer as an intravenous infusion.
Dose Modifications: Dose interruption, reduction, or permanent discontinuation may be required due to adverse reactions (e.g., myelosuppression, renal toxicity).
3. Mechanism of Action
Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent. The radioactive isotope lutetium-177 is linked to a molecule that binds to PSMA. After binding to PSMA-expressing cells, the beta-minus radiation from lutetium-177 delivers radiation to the PSMA-expressing cells and surrounding cells, inducing DNA damage and resulting in cell death.
4. Safety and Warnings
Risk From Radiation Exposure: Minimize radiation exposure during and after treatment. 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 based on severity.
Renal Toxicity: Advise patients to remain well hydrated and to urinate frequently. Perform kidney function laboratory tests. Withhold, reduce dose, or permanently discontinue based on severity.
Infertility: May cause temporary or permanent infertility.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common (≥20%) adverse reactions include decreased lymphocytes, decreased hemoglobin, fatigue, dry mouth, decreased platelets, decreased eGFR, nausea, decreased neutrophils, decreased calcium, decreased sodium, increased AST, increased alkaline phosphatase, arthralgia, decreased appetite, increased potassium, constipation, and back pain.
Clinical Research: Efficacy and safety were evaluated in studies involving PSMA-positive mCRPC patients previously treated with ARPI therapy, with or without prior taxane-based chemotherapy.
6. Drug Interactions
No formal drug interaction studies with lutetium Lu 177 vipivotide tetraxetan have been conducted.
7. Pharmaceutical Information
Active Ingredient: Lutetium Lu 177 vipivotide tetraxetan.
Strength: 1,000 MBq/mL (27 mCi/mL) in a single-dose vial.
Description: A sterile, preservative-free solution.
Storage: Store in a lead shielded container at room temperature.