At a glance
What is it—and why does it matter?
The label warns that bone marrow suppression can be severe or life-threatening and includes multiple cytopenias. The dosage form/strength specifies concentration at calibration time and total activity per single-dose vial at administration time. The labeled use includes treating PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer in adults, with PLUVICTO given together with an ARPI.
Sources for this introduction: [1] [2] [3]
This published profile is a reference in progress. Findings retain their source context; missing topics are marked below.
What is it?
A molecule, not a product name.
This profile does not yet contain a published summary for this topic. This is a coverage gap, not evidence that no research exists.
How does it work?
Target, response, and disposition.
Pharmacokinetics
Systemic exposure (AUC) and peak blood concentration (Cmax) are reported as geometric mean values (with geometric mean coefficient of variation) at the recommended dosing regimen.
- Reported result
- AUC 52.3 ng.h/mL (31.4%); Cmax 6.58 ng/mL (43.5%)
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“The blood lutetium Lu 177 vipivotide tetraxetan area under the curve (AUC) is 52.3 ng.h/mL (31.4%) and the maximum blood concentration (Cmax) is 6.58 ng/mL (43.5%) at the recommended dosage.”
These highlights do not include all the information needed to use PLUVICTO safely and effectively. See full prescribing information for PLUVICTO.PLUVICTO®(lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous useInitial U.S. Approval: 2022 · 12.3 Pharmacokinetics
dailymed:14908037-2892-4d98-a053-253ce35afb1a:9f7e3d7af549:9f7e3d7af549
What has been studied?
What the evidence says.
This profile does not yet contain a published summary for this topic. This is a coverage gap, not evidence that no research exists.
Risks and interactions
Risks, organized for scanning.
Safety findings
The label includes a warning that kidney toxicity may be severe.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“PLUVICTO can cause severe renal toxicity.”
These highlights do not include all the information needed to use PLUVICTO safely and effectively. See full prescribing information for PLUVICTO.PLUVICTO®(lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous useInitial U.S. Approval: 2022 · 5.3 Renal Toxicity
dailymed:14908037-2892-4d98-a053-253ce35afb1a:9f7e3d7af549:9f7e3d7af549
Safety findings
The label warns that bone marrow suppression can be severe or life-threatening and includes multiple cytopenias.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“PLUVICTO can cause severe and life-threatening myelosuppression, including anemia, thrombocytopenia, leukopenia, and neutropenia.”
These highlights do not include all the information needed to use PLUVICTO safely and effectively. See full prescribing information for PLUVICTO.PLUVICTO®(lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous useInitial U.S. Approval: 2022 · 5.2 Myelosuppression
dailymed:14908037-2892-4d98-a053-253ce35afb1a:9f7e3d7af549:9f7e3d7af549
Products and regulatory status
Same ingredient. Different records.
Regulatory status
The labeled use includes treating PSMA-positive metastatic androgen pathway modulation-naïve or -sensitive prostate cancer in adults, with PLUVICTO given together with an ARPI.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“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.”
These highlights do not include all the information needed to use PLUVICTO safely and effectively. See full prescribing information for PLUVICTO.PLUVICTO®(lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous useInitial U.S. Approval: 2022 · 1.1 Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer
dailymed:14908037-2892-4d98-a053-253ce35afb1a:9f7e3d7af549:9f7e3d7af549
Administration context
The practical clinical context.
Dose records
The recommended regimen for lutetium Lu 177 vipivotide tetraxetan in mAPMN/S prostate cancer is a fixed activity dose administered on a 6-week cycle for up to 6 doses, alongside ARPI therapy, with stopping criteria for progression or toxicity.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“The recommended dosage of PLUVICTO in combination with ARPI is 7.4 GBq (200 mCi) every 6 weeks for 6 doses, or until disease progression or unacceptable toxicity.”
These highlights do not include all the information needed to use PLUVICTO safely and effectively. See full prescribing information for PLUVICTO.PLUVICTO®(lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous useInitial U.S. Approval: 2022 · 2.3 Recommended Dosage
dailymed:14908037-2892-4d98-a053-253ce35afb1a:9f7e3d7af549:9f7e3d7af549
Dose records
The recommended regimen for lutetium Lu 177 vipivotide tetraxetan in androgen pathway modulation-resistant metastatic prostate cancer is 7.4 GBq (200 mCi) given every 6 weeks for up to 6 administrations, with discontinuation for progression or toxicity.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“The recommended dosage of PLUVICTO is 7.4 GBq (200 mCi) every 6 weeks for 6 doses, or until disease progression or unacceptable toxicity.”
These highlights do not include all the information needed to use PLUVICTO safely and effectively. See full prescribing information for PLUVICTO.PLUVICTO®(lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous useInitial U.S. Approval: 2022 · 2.3 Recommended Dosage
dailymed:14908037-2892-4d98-a053-253ce35afb1a:9f7e3d7af549:9f7e3d7af549
Dose records
The dosage form/strength specifies concentration at calibration time and total activity per single-dose vial at administration time.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“Injection: 1,000 MBq/mL (27 mCi/mL) of lutetium Lu 177 vipivotide tetraxetan at calibration time as a clear and colorless to slightly yellow solution in a single-dose vial containing 7.4 GBq (200 mCi) ± 10% at administration time.”
These highlights do not include all the information needed to use PLUVICTO safely and effectively. See full prescribing information for PLUVICTO.PLUVICTO®(lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous useInitial U.S. Approval: 2022 · 3 DOSAGE FORMS AND STRENGTHS
dailymed:14908037-2892-4d98-a053-253ce35afb1a:9f7e3d7af549:9f7e3d7af549
Dose records
For certain adverse reactions, the label permits a single activity reduction to 5.9 GBq (160 mCi), explicitly prohibiting later re-escalation.
- Source records
- 1
- Regulatory records
- 1
Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.
Exact passages, locators, and provenance
- supports · Source-backed record
“The dose of PLUVICTO may be reduced by 20% to 5.9 GBq (160 mCi) once; do not re-escalate dose.”
These highlights do not include all the information needed to use PLUVICTO safely and effectively. See full prescribing information for PLUVICTO.PLUVICTO®(lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous useInitial U.S. Approval: 2022 · 2.4 Dosage Modifications for Adverse Reactions
dailymed:14908037-2892-4d98-a053-253ce35afb1a:9f7e3d7af549:9f7e3d7af549
Research status + gaps
What still needs better answers?
- No publishable claim yet for: administration, contraindication, effect, identity, interaction, mechanism
- 3 compiled claim(s) withheld by automated assurance: assurance_score_below_0.58 (2), assurance_score_below_0.72 (1), current_regulatory_source_required (1), extraction_ambiguity (3), high_risk_requires_regulatory_or_two_independent_sources (1), no_direct_support (3)
These are the limits of this profile, not an exhaustive list of scientific uncertainties.
References + discovery
Open the records yourself.
- These highlights do not include all the information needed to use PLUVICTO safely and effectively. See full prescribing information for PLUVICTO.PLUVICTO®(lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous useInitial U.S. Approval: 2022 ↗
dailymed · published 2026-08-12 · retrieved 2026-08-30T08:40:08Z
Publication history and provenance
Version 3 · Automated assessment · 2026-08-30T08:40:08Z
634810a5b9724891d622f198a9cfa64fffbb5d446dda78ef69fb856a16721725