Vipivotide tetraxetan
Also known as: ¹⁷⁷Lu-PSMA-617, 177Lu-vipivotide tetraxetan, AAA617, Lu-PSMA-617, Lu‑177 vipivotide tetraxetan, Pluvicto, PSMA-617, Vipivotide tetraxetan
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Summary
Lutetium‑177 vipivotide tetraxetan (brand Pluvicto) is an intravenously administered radiopharmaceutical for PSMA‑positive metastatic castration‑resistant prostate cancer.
Mechanism of Action
Binds prostate-specific membrane antigen (PSMA) on cancer cells, is internalized, and delivers β‑particle radiation from ^177Lu, causing DNA damage and tumor cell death.
Routes of Administration
Goals & Uses
- Quality of life improvementOncology / Patient Reported OutcomesModerate
- Metastatic castration‑resistant prostate cancer (mCRPC)OncologyHigh
- Radiographic progression-free survival improvement in mCRPCOncology / Disease ControlHigh
- Overall survival improvement in mCRPCOncology / SurvivalHigh
- PSA response reductionOncology / Biomarker ResponseHigh
- Treatment of earlier-line PSMA-positive prostate cancerOncology / Expanding IndicationModerate
Contraindications
- PSMA-negative diseasePatient SelectionHigh
- Severely compromised bone marrow reserveHematologicHigh
- Severe renal impairment (eGFR <30 mL/min/1.73 m²)RenalModerate
- Known hypersensitivity to lutetium‑177 or DOTA‑based compoundsAllergicHigh
- Severe renal impairmentOrganHighKidney function concerns
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
Adverse Effects
- renal toxicityRenalUncommon
- Dry mouth (xerostomia)Salivary Gland ToxicityCommon
- Myelosuppression (anemia, thrombocytopenia, leukopenia)HematologicCommon
- Hematologic toxicity (anemia, thrombocytopenia, neutropenia)HematologicCommon
- NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
- FatigueGeneralCommonLow energy or tiredness
- Xerostomia (dry mouth)Salivary GlandCommon
- NephrotoxicityRenalUncommon
- Radiation exposure to caregivers/publicRadiation SafetyCommon
Drug Interactions
- Other myelosuppressive agentsModerate
- PSMA-targeting diagnostic agents (e.g., ¹⁸F-DCFPyL, ⁶⁸Ga-PSMA-11)Moderate
- Nephrotoxic drugs (e.g., cisplatin, NSAIDs)Moderate
- Other myelosuppressive agents (e.g., chemotherapy)High
- Nephrotoxic agents (e.g., aminoglycosides, NSAIDs, contrast agents)Moderate
Population Constraints
- Patients with significant renal impairment (eGFR <30 mL/min)Renal FunctionRelative
- Women of childbearing potential / breastfeedingReproductiveAbsolute
- Pediatric patientsAgeAbsolute
- Pregnant or lactating womenReproductiveAbsolute
- Patients with prior extensive pelvic radiationPrior TreatmentRelative
Regulatory Status
- European UnionApprovedApproved: PSMA‑positive metastatic castration‑resistant prostate cancerEMA approval (2023).
- United StatesApprovedApproved: PSMA‑positive metastatic castration‑resistant prostate cancerFDA approval (2022) under brand name Pluvicto.
- United KingdomApprovedApproved: PSMA‑positive metastatic castration‑resistant prostate cancerApproved by MHRA.
FDA approved March 2022 for PSMA-positive mCRPC in adults who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. EMA approved December 2022. Administered only in certified healthcare facilities due to radioactive nature. REMS program required in the US.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Vipivotide tetraxetan?
Lutetium‑177 vipivotide tetraxetan (brand Pluvicto) is an intravenously administered radiopharmaceutical for PSMA‑positive metastatic castration‑resistant prostate cancer.
What is Vipivotide tetraxetan used for?
Vipivotide tetraxetan is educationally associated with: Quality of life improvement, Metastatic castration‑resistant prostate cancer (mCRPC), Radiographic progression-free survival improvement in mCRPC, Overall survival improvement in mCRPC, PSA response reduction, Treatment of earlier-line PSMA-positive prostate cancer. Educational only — not medical advice.
How is Vipivotide tetraxetan administered?
Recorded routes of administration: Intravenous.
What are the potential side effects of Vipivotide tetraxetan?
Reported adverse effects include: renal toxicity, Dry mouth (xerostomia), Myelosuppression (anemia, thrombocytopenia, leukopenia), Hematologic toxicity (anemia, thrombocytopenia, neutropenia), Nausea, Fatigue, Xerostomia (dry mouth), Nephrotoxicity, Radiation exposure to caregivers/public. This list is not exhaustive — consult a qualified clinician.
Who should avoid Vipivotide tetraxetan?
Recorded contraindications: PSMA-negative disease, Severely compromised bone marrow reserve, Severe renal impairment (eGFR <30 mL/min/1.73 m²), Known hypersensitivity to lutetium‑177 or DOTA‑based compounds, Severe renal impairment, Pregnancy. Consult a qualified clinician before use.