Initial US Approval:
2022
Key Clinical Studies:
PSMAfore (NCT04689828)
Drug Class/Description:
PSMA-targeted radioligand therapy
Indications and Usage:
Pluvicto is a radioligand therapeutic agent 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.
Dosage and Administration:
- 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.
- Dose interruption, reduction, or permanent discontinuation may be required due to adverse reactions.
Dosage Forms and Strengths:
Injection: 1,000 MBq/mL (27 mCi/mL) in a single-dose vial.
Contraindications:
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.
- Renal Toxicity: Advise patients to remain well hydrated and to urinate frequently. Perform kidney function laboratory tests. Withhold, reduce dose, or permanently discontinue PLUVICTO based on severity.
- 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.
Adverse Reactions:
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 aspartate aminotransferase, increased alkaline phosphatase, arthralgia, decreased appetite, increased potassium, constipation, and back pain.
Adapted From:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215833s000lbl.pdf
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