Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a radioligand therapeutic agent that is indicated for adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Pluvicto was first approved in March 2022 for adults with PSMA-positive mCRPC who have already been treated with androgen-receptor pathway inhibition and taxane-based chemotherapy. It received approval for an expanded indication in 2025 for patients with PSMA-positive mCRPC who have been treated with androgen receptor pathway inhibitor therapy and are considered appropriate to delay chemotherapy.
Read on to learn more about Pluvicto, including its warnings and precautions, dosage and administration information, and more.
Medication Overview:
- Brand Name: Pluvicto
- Generic Name: lutetium Lu 177 vipivotide tetraxetan
- Treatment for: Prostate cancer
- Manufacturer(s): Novartis
- Initial FDA Approval: March 2022
| Indicated Condition | Indication | Age | Initial Date Approved |
|---|---|---|---|
| Prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) | 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 recieved prior taxane-based chemotherapy. | Adults | March 2022 |
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.
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.
Contraindications:
None.
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.
Related Clinical Guidance
- Diagnosis, Treatment and Follow-Up of Advanced and Metastatic Prostate Cancer
- European Society for Medical Oncology (ESMO)
- February 2026
- Prostate Cancer
- European Association of Urology (EAU), European Association of Nuclear Medicine (EANM), European Society for Radiotherapy and Oncology (ESTRO)
- March 2025
- Advanced Prostate Cancer
- American Urological Association (AUA), Society of Urologic Oncology (SUO)
- June 2023
Please note: This article is current as of June 9, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.
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