Quick answers
- What is Lutetium lu 177 vipivotide tetraxetan used for?
- The FDA-approved label (Pluvicto, Novartis Pharmaceuticals Corporation, August 12, 2026) says: “PLUVICTO is a radioligand therapeutic agent indicated: Metastatic Androgen Pathway Modulation-Naïve or -Sensitive (mAPMN/S) Prostate Cancer 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lutetium lu 177 vipivotide tetraxetan have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Lutetium lu 177 vipivotide tetraxetan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lutetium lu 177 vipivotide tetraxetan been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Lutetium lu 177 vipivotide tetraxetan?
- 1 company lists prescription products of Lutetium lu 177 vipivotide tetraxetan in the FDA NDC Directory, including Novartis Pharmaceuticals Corporation.
What Lutetium lu 177 vipivotide tetraxetan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PLUVICTO is a radioligand therapeutic agent indicated: Metastatic Androgen Pathway Modulation-Naïve or -Sensitive (mAPMN/S) Prostate Cancer 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. …
— FDA label: Pluvicto, Novartis Pharmaceuticals Corporation, effective August 12, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Pluvicto |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Novartis Pharmaceuticals Corporation1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA215833 PLUVICTO | Novartis | March 23, 2022 | 4, latest July 31, 2026 2026: Efficacy · 2026: Labeling · 2025: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2597057, 2597060 |
|---|---|
| SPL set ID of the quoted label | 14908037-2892-4d98-a053-253ce35afb1a |
| FDA labels (SPL) | 1 |
| FDA applications | NDA215833 |
| Active ingredients (FDA) | LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Pluvicto, Novartis Pharmaceuticals Corporation, effective August 12, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →