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PLUVICTO lutetium Lu 177 vipivotide tetraxetan 27 mCi/mL Injection, Solution, 1 vial — NDC 00078-1217-61 package photo

PLUVICTO lutetium Lu 177 vipivotide tetraxetan 27 mCi/mL Injection, Solution, 1 vial

by Novartis Pharmaceuticals Corporation · 1 VIAL, GLASS in 1 PACKAGE (0078-1217-61) / 7.5 mL in 1 VIAL, GLASS
NDC 00078-1217-61
🏷️ FDA NDC (as labeled) 0078-1217-61 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 0078-1217-61
Product NDC 0078-1217
11-digit billing NDC 00078121761
NCPDP billing unit EA — each (per item)
RxCUI 2597057, 2597060
UNII G6UF363ECX
Application # NDA215833
SPL Set ID 14908037-2892-4d98-a053-253ce35afb1a
Established class (EPC) Radioligand Therapeutic Agent
Mechanism of action Radioligand Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-03-23
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
GCN Seq No 083207
GCN 52100
HICL code 047914
Ingredient (HICL) Lu-177 Vipivotide Tetraxetan
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1G
Therapeutic class — specific (HIC3) Radioactive Therapeutic Agents
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name PLUVICTO 1,000 MBQ (27 MCI)/ML
FDB brand name Pluvicto
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0078-1217-61 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00078-1217-61. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Radioligand Therapeutic Agent class.

Pharmacologic class Radioligand Therapeutic Agent
Drug family (ATC) Various therapeutic radiopharmaceuticals
How it works Radioligand Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerNovartis Pharmaceuticals Corporation
Application holderNOVARTIS PHARMACEUTICALS CORP
FDA applicationNDA215833 (NDA)
Labeler code00078
First marketedMar 2022
Product typeHuman Prescription Drug
Portfolio209 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PLUVICTO 1,000 MBQ (27 MCI)/ML Ingredient Lu-177 Vipivotide Tetraxetan
📖 What it is MedlinePlus · NLM

Lutetium Lu 177 vipivotide tetraxetan injection is used to treat a certain type of prostate cancer (cancer of a male reproductive gland) that has spread to other parts of the body and that has already been treated with other medications. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to cancer cells which damages and kills these cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Pluvicto is what's called a radioligand therapy — it's a targeted treatment that combines a homing molecule with a small amount of radioactive material. The homing molecule seeks o...
  • What exactly is Pluvicto, and how is it different from regular chemotherapy?
  • Because Pluvicto contains a radioactive material, your body will emit a small amount of radiation for several days after each dose — mainly through urine. To protect the people aro...
  • Why do I have to stay away from my family after each treatment?
📖 Read our full Lutetium Lu 177 Vipivotide Tetraxetan Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • UNII VP36V95O3T
    Gentisic acid is a naturally occurring organic compound used in pharmaceuticals as a buffer and pH stabilizer. It helps maintain the correct acidity level in medicines to improve stability and ensure consistent performance.
  • UNII 7A314HQM0I
    Pentetic acid is a chelating agent, a chemical that binds to metals. It's used in some medicines to prevent metal ions from interfering with drug stability or effectiveness.
  • UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • UNII S033EH8359
    Sodium ascorbate is a salt form of vitamin C. It serves as an antioxidant to prevent degradation of other ingredients and as a pH buffer to maintain stable acidity in the medicine.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pluvicto 27 mCi/mLthis 00078-1217-61 Novartis 1 vial — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2022
First FDA approval
Mar 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2041
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 23, 2022 RLD RS ⏳ ~15 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 12208102 — method of use (U-4169)
US 11951190 — method of use (U-4169)
US 11318121 — drug substance (U-4169)
US 10406240 — drug substance (U-4169)
US 10398791 — drug substance
Exclusivity I-965
Exclusivity NCE
2022 2024 2026 2028 2030 2032 2034 2036 2038 2040
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (5)
PatentTypeUse codeExpires
US 12208102 ↗ Method of use U-4169 Sep 18, 2041
US 11951190 ↗ Method of use U-4169 Nov 12, 2035
US 11318121 ↗ Drug substance U-4169 Aug 15, 2028
US 10406240 ↗ Drug substance U-4169 Aug 15, 2028
US 10398791 ↗ Drug substance — Mar 23, 2036
FDA exclusivity
CodeWhat it grantsExpires
I-965New indication (3-year)Mar 28, 2028
NCENew Chemical Entity (5-year)Mar 23, 2027
Common questions
Is there a generic version of PLUVICTO 1,000 MBQ (27 MCI)/ML?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for PLUVICTO 1,000 MBQ (27 MCI)/ML. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Sep 2041 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00078-1217-61 You're viewing this 1 VIAL, GLASS in 1 PACKAGE (0078-1217-61) / 7.5 mL in 1 VIAL, GLASS 2026-01-15 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0078-1217-61, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00078-1217-61, written without dashes as 00078121761. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00078-1217-61, the first segment (00078) is the labeler code FDA assigned to Novartis Pharmaceuticals Corporation; the middle segment (1217) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (61) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Novartis Pharmaceuticals Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Novartis Pharmaceuticals Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 185 words ▾

1 INDICATIONS AND USAGE 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. ( 1.1 ) Metastatic Androgen Pathway Modulation-Resistant (mAPMR) Prostate Cancer for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been treated with ARPI therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy.

( 1.2 )

1.1Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer 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.

1.2Metastatic Androgen Pathway Modulation-Resistant Prostate Cancer PLUVICTO is indicated for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-resistant (mAPMR) prostate cancer who have been treated with ARPI therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Select patients for treatment using LOCAMETZ ® or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors. ( 2.2 ) mAPMN/S Prostate Cancer : The recommended dosage of PLUVICTO in combination with ARPI is

7.4GBq (200 mCi) every 6 weeks for 6 doses, or until disease progression or unacceptable toxicity. ( 2.3 ) mAPMR Prostate Cancer : The recommended dosage of PLUVICTO is

7.4GBq (200 mCi) every 6 weeks for 6 doses, or until disease progression or unacceptable toxicity. ( 2.3 ) Dose interruption, reduction, or permanent discontinuation may be required due to adverse reactions. ( 2.4 )

2.1Important Safety Instructions PLUVICTO is a radiopharmaceutical; handle with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.1)] . Use waterproof gloves and effective radiation shielding when handling PLUVICTO. Radiopharmaceuticals, including PLUVICTO, should be used by or under the control of healthcare providers who are qualified by specific training and experience in the safe use and handling of radiopharmaceuticals, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals.

2.2Patient Selection Select patients with metastatic prostate cancer for treatment with PLUVICTO using LOCAMETZ or another approved PSMA positron emission tomography (PET) product based on PSMA expression in tumors. Additional selection criteria were used in clinical studies [see Clinical Studies (14)] .

2.3Recommended Dosage Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer The recommended dosage of PLUVICTO in combination with ARPI is

7.4GBq (200 mCi) every 6 weeks for 6 doses, or until disease progression or unacceptable toxicity. Refer to the Prescribing Information for ARPI for recommended dosing information. Metastatic Androgen Pathway Modulation-Resistant Prostate Cancer The recommended dosage of PLUVICTO is

7.4GBq (200 mCi) every 6 weeks for 6 doses, or until disease progression or unacceptable toxicity. Patients receiving PLUVICTO for metastatic prostate cancer should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

2.4Dosage Modifications for Adverse Reactions Recommended dosage modifications of PLUVICTO for adverse reactions are provided in Table 1. Management of adverse reactions may require temporary dose interruption, dose reduction, or permanent discontinuation of treatment with PLUVICTO. If a treatment delay due to an adverse reaction persists for > 4 weeks, consider permanent discontinuation of PLUVICTO. The dose of PLUVICTO may be reduced by 20% to

5.9GBq (160 mCi) once; do not re-escalate dose. If a patient has further adverse reactions that would require an additional dose reduction, treatment with PLUVICTO must be discontinued. Table 1: Recommended Dosage Modifications of PLUVICTO for Adverse Reactions Abbreviations: CLcr, creatinine clearance; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ULN, upper limit of normal.

Grading according to most current Common Terminology Criteria for Adverse Events (CTCAE). Adverse reaction Severity Dosage modification Myelosuppression (Anemia, thrombocytopenia, leukopenia, or neutropenia) [see Warnings and Precautions (5.2)] Grade 2 Withhold PLUVICTO until improvement to Grade 1 or baseline. Grade ≥ 3 Withhold PLUVICTO until improvement to Grade 1 or baseline.

Reduce PLUVICTO dose by 20% to

5.9GBq (160 mCi). Recurrent Grade ≥ 3 myelosuppression after one dose reduction Permanently discontinue PLUVICTO. Renal toxicity [see Warnings and Precautions (5.3)] Defined as: Confirmed serum creatinine increase (Grade ≥ 2) Confirmed CLcr < 30 mL/min; calculate using Cockcroft-Gault with actual body weight Withhold PLUVICTO until improvement. Defined as: Confirmed ≥ 40% increase from baseline serum creatinine and C…

💊 Dosage Forms and Strengths 67 words ▾

3 DOSAGE FORMS AND STRENGTHS 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

7.4GBq (200 mCi) ± 10% at administration time. Injection: 1,000 MBq/mL (27 mCi/mL) at calibration time in a single-dose vial containing

7.4GBq (200 mCi) ± 10% at administration time. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 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. ( 5.1 ) Myelosuppression : Perform complete blood counts.

Withhold, reduce dose, or permanently discontinue PLUVICTO based on severity. ( 2.4 , 5.2 ) 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. ( 2.4 , 5.3 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception.

( 5.4 , 8.1 , 8.3 ) Infertility : PLUVICTO may cause temporary or permanent infertility. ( 5.5 , 8.3 )

5.1Risk From Radiation Exposure PLUVICTO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Minimize radiation exposure to patients, medical personnel, and others during and after treatment with PLUVICTO consistent with institutional good radiation safety practices, patient treatment procedures, Nuclear Regulatory Commission patient-release guidance, and instructions to the patient for follow-up radiation protection at home.

Ensure patients increase oral fluid intake and advise patients to void as often as possible to reduce bladder radiation. Before the patient is released, inform patients about the necessary radioprotection precautions to follow to minimize radiation exposure to others [see Patient Counseling Information (17)] . After each administration of PLUVICTO, advise patients to: Limit close contact (less than 3 feet) with others for 2 days or with children and pregnant women for 7 days.

Refrain from sexual activity for 7 days. Sleep in a separate room from others for 3 days, from children for 7 days, or from pregnant women for 15 days.

5.2Myelosuppression PLUVICTO can cause severe and life-threatening myelosuppression, including anemia, thrombocytopenia, leukopenia, and neutropenia. In the PSMAddition study, Grade 3 or 4 decreased leukocytes (7%), decreased neutrophils (4.4%), decreased hemoglobin (4.3%), and decreased platelets (1.1%) occurred in patients treated with PLUVICTO. In the PSMAfore study, Grade 3 or 4 decreased hemoglobin (7%), decreased leukocytes (4.4%), decreased neutrophils (3.5%), and decreased platelets (2.7%) occurred in patients treated with PLUVICTO.

One death occurred due to bone marrow failure during long-term follow-up in a patient who received PLUVICTO. In the VISION study, Grade 3 or 4 decreased hemoglobin (15%), decreased platelets (9%), decreased leukocytes (7%), and decreased neutrophils (4.5%) occurred in patients treated with PLUVICTO. Grade ≥ 3 pancytopenia occurred in 1.1% (which includes two fatal events) of patients treated with PLUVICTO.

Two deaths (0.4%) occurred due to intracranial hemorrhage and subdural hematoma in association with thrombocytopenia, one death (0.2%) occurred due to sepsis and concurrent neutropenia, and one death (0.2%) occurred due to bone marrow failure in patients treated with PLUVICTO. Perform complete blood counts before and during treatment with PLUVICTO. Withhold, reduce dose, or permanently discontinue PLUVICTO based on the severity of myelosuppression [see Dosage and Administration (2.4)] .

5.3Renal Toxicity PLUVICTO can cause severe renal toxicity. In the PSMAddition study, Grade 3 or 4 acute kidney injury (1.6%) occurred in patients treated with PLUVICTO. In the PSMAfore study, Grade 3 or 4 acute kidney injury (1.3%) occurred in patients treated with PLUVICTO. In the VISION study, Grade 3 or 4 acute kidney injury (3.4%) occurred in patients treated with PLUVICTO. Advise patients to remain well hydrat…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.2)] Renal Toxicity [see Warnings and Precautions (5.3)] Most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased lymphocytes, decreased hemoglobin, fatigue, dry mouth, decreased neutrophils, nausea, decreased platelets, decreased estimated glomerular filtration rate, increased aspartate aminotransferase, decreased sodium, increased magnesium, increased potassium, decreased calcium, and increased alkaline phosphatase.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the pooled safety population for the PSMAddition, PSMAfore and VISION studies (N = 1320), the most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased lymphocytes (86%), decreased hemoglobin (68%), fatigue (51%), dry mouth (46%), decreased neutrophils (35%), nausea (35%), decreased platelets (33%), decreased estimated glomerular filtration rate (28%), increased aspartate aminotransferase (25%), decreased sodium (22%), increased magnesium (22%), increased potassium (21%), decreased calcium (21%), and increased alkaline phosphatase (20%).

Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer PSMAddition The safety of PLUVICTO in combination with ARPI was evaluated in the PSMAddition study in patients with PSMA-positive mAPMN/S prostate cancer [see Clinical Studies (14.1)] . Patients could have been treated with ARPI in the metastatic setting for up to 45 days prior to consent. Patients received at least one dose of either PLUVICTO

7.4GBq (200 mCi) administered every 6 weeks in combination with ARPI (N = 564) or ARPI alone (N = 565). Among patients who received PLUVICTO in combination with ARPI, the median duration of exposure to PLUVICTO was 8.3 months (range, 1.3 to 11.2) and the median number of doses of PLUVICTO received was 6 (range, 1 to 6). The median cumulative administered activity of PLUVICTO was

43.4GBq (range, 7.1 to 47.3). Serious adverse reactions occurred in 32% of patients who received PLUVICTO in combination with ARPI. Serious adverse reactions in > 1% of patients included acute kidney injury (1.6%), pneumonia and sepsis (1.4% each), anemia, basal cell carcinoma, general physical health deterioration, and syncope (1.1% each).

Fatal adverse reactions occurred in 2.7% of patients who received PLUVICTO in combination with ARPI, including general physical health deterioration (0.5%), respiratory failure and sudden death (0.4% each), arrhythmia, cardiac arrest, congestive heart failure, cholangiocarcinoma, COVID-19, malignant neoplasm of unknown primary site, multiple organ dysfunction syndrome, and subdural hemorrhage (0.2% each). PLUVICTO was permanently discontinued due to adverse reactions in 8% of patients who received PLUVICTO in combination with ARPI.

The most frequent (≥ 1%) adverse reaction leading to permanent discontinuation of PLUVICTO was anemia (1.1%). Adverse reactions leading to a dose interruption of PLUVICTO occurred in 12% of patients who received PLUVICTO in combination with ARPI. The most frequent (≥ 1%) adverse reactions leading to a dose interruption of PLUVICTO were neutropenia (2%), leukopenia, and COVID-19 (1.2% each).

Adverse reactions leading to a dose reduction of PLUVICTO occurred in 3.9% of patients who received PLUVICTO in combination with ARPI. The most frequent (≥ 1%) adverse reaction leading to a dose reduction of PLUVICTO was dry mouth (1.1%). Table 3 and Table 4 summar…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary The safety and efficacy of PLUVICTO have not been established in females. Based on its mechanism of action, PLUVICTO can cause fetal harm [see Clinical Pharmacology (12.1)] . There are no available data on PLUVICTO use in pregnant females.

No animal studies using lutetium Lu 177 vipivotide tetraxetan have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, all radioactive emissions, including those from PLUVICTO, can cause fetal harm.

8.2Lactation Risk Summary The safety and efficacy of PLUVICTO have not been established in females. There are no data on the presence of lutetium Lu 177 vipivotide tetraxetan in human milk or its effects on the breastfed child or on milk production.

8.3Females and Males of Reproductive Potential Contraception Males Advise males with female partners of reproductive potential to use effective contraception during treatment with PLUVICTO and for 14 weeks after the last dose [see Clinical Pharmacology (12.1), Nonclinical Toxicology (13.1)] . Infertility The recommended cumulative dose of

44.4GBq of PLUVICTO results in a radiation absorbed dose to the testes within the range where PLUVICTO may cause temporary or permanent infertility.

8.4Pediatric Use The safety and effectiveness of PLUVICTO in pediatric patients have not been established.

8.5Geriatric Use Of the 564 patients who received at least one dose of PLUVICTO in combination with ARPI in the PSMAddition study, 379 patients (67%) were 65 years of age or older and 115 patients (20%) were 75 years of age or older. No overall differences in effectiveness were observed between patients ≥ 75 years of age and younger patients. Serious adverse reactions occurred in 43% of patients ≥ 75 years of age and in 29% of younger patients.

Grade ≥ 3 adverse reactions occurred in 59% of patients ≥ 75 years of age and in 49% of younger patients. Of the 227 patients who received at least one dose of PLUVICTO in the PSMAfore study, 177 patients (78%) were 65 years of age or older and 83 patients (37%) were 75 years of age or older. No overall differences in effectiveness were observed between patients ≥ 75 years of age and younger patients.

Serious adverse reactions occurred in 20% of patients ≥ 75 years of age and in 20% of younger patients. Grade ≥ 3 adverse reactions occurred in 39% of patients ≥ 75 years of age and in 34% of younger patients. Of the 529 patients who received at least one dose of PLUVICTO plus BSoC in the VISION study, 387 patients (73%) were 65 years of age or older and 143 patients (27%) were 75 years of age or older.

No overall differences in effectiveness were observed between patients ≥ 75 years of age and younger patients. Serious adverse reactions occurred in 41% of patients ≥ 75 years of age and in 35% of younger patients. Grade ≥ 3 adverse reactions occurred in 56% of patients ≥ 75 years of age and in 53% of younger patients.

8.6Renal Impairment Exposure of lutetium Lu 177 vipivotide tetraxetan is expected to increase with the degree of renal impairment [see Clinical Pharmacology (12.3)] . No dose adjustment is recommended for patients with mild (baseline CLcr 60 to 89 mL/min by Cockcroft-Gault) to moderate (CLcr 30 to 59 mL/min) renal impairment; however, patients with mild to moderate renal impairment may be at greater risk of toxicity. Frequently monitor renal function and adverse reactions in patients with mild to moderate renal impairment [see Dosage and Administration (2.4)] .

The pharmacokinetics and safety of PLUVICTO have not been studied in patients with severe (CLcr 15 to 29 mL/min) renal impairment or end-stage renal disease.

🤰 Pregnancy 77 words ▾

8.1Pregnancy Risk Summary The safety and efficacy of PLUVICTO have not been established in females. Based on its mechanism of action, PLUVICTO can cause fetal harm [see Clinical Pharmacology (12.1)] . There are no available data on PLUVICTO use in pregnant females.

No animal studies using lutetium Lu 177 vipivotide tetraxetan have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, all radioactive emissions, including those from PLUVICTO, can cause fetal harm.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of PLUVICTO in pediatric patients have not been established.

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Of the 564 patients who received at least one dose of PLUVICTO in combination with ARPI in the PSMAddition study, 379 patients (67%) were 65 years of age or older and 115 patients (20%) were 75 years of age or older. No overall differences in effectiveness were observed between patients ≥ 75 years of age and younger patients. Serious adverse reactions occurred in 43% of patients ≥ 75 years of age and in 29% of younger patients.

Grade ≥ 3 adverse reactions occurred in 59% of patients ≥ 75 years of age and in 49% of younger patients. Of the 227 patients who received at least one dose of PLUVICTO in the PSMAfore study, 177 patients (78%) were 65 years of age or older and 83 patients (37%) were 75 years of age or older. No overall differences in effectiveness were observed between patients ≥ 75 years of age and younger patients.

Serious adverse reactions occurred in 20% of patients ≥ 75 years of age and in 20% of younger patients. Grade ≥ 3 adverse reactions occurred in 39% of patients ≥ 75 years of age and in 34% of younger patients. Of the 529 patients who received at least one dose of PLUVICTO plus BSoC in the VISION study, 387 patients (73%) were 65 years of age or older and 143 patients (27%) were 75 years of age or older.

No overall differences in effectiveness were observed between patients ≥ 75 years of age and younger patients. Serious adverse reactions occurred in 41% of patients ≥ 75 years of age and in 35% of younger patients. Grade ≥ 3 adverse reactions occurred in 56% of patients ≥ 75 years of age and in 53% of younger patients.

🆘 Overdosage 60 words ▾

10 OVERDOSAGE In the event of administration of a radiation overdosage with PLUVICTO, reduce the radiation absorbed dose to the patient by increasing the elimination of the radionuclide from the body by frequent micturition or by forced diuresis and frequent bladder voiding. Estimate the effective radiation dose that was applied and treat with additional supportive care measures as clinically indicated.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent. The active moiety of lutetium Lu 177 vipivotide tetraxetan is the radionuclide lutetium-177 which is linked to a moiety that binds to PSMA, a transmembrane protein that is expressed in prostate cancer. Upon binding of lutetium Lu 177 vipivotide tetraxetan to PSMA-expressing cells, the beta-minus emission from lutetium-177 delivers radiation to PSMA-expressing cells, as well as to surrounding cells, and induces DNA damage which can lead to cell death.

12.2Pharmacodynamics Lutetium Lu 177 vipivotide tetraxetan exposure-efficacy relationships and the time course of pharmacodynamic response have not been fully characterized. Cardiac Electrophysiology At the recommended dosage, PLUVICTO does not cause large mean increases (> 20 ms) in the QTc interval.

12.3Pharmacokinetics Pharmacokinetics of lutetium Lu 177 vipivotide tetraxetan are expressed as geometric mean (geometric mean coefficient of variation) unless otherwise specified. 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 (C max ) is 6.58 ng/mL (43.5%) at the recommended dosage. Distribution Lutetium Lu 177 vipivotide tetraxetan volume of distribution is 123 L (78.1%).

Within 2.5 hours after administration, lutetium Lu 177 vipivotide tetraxetan distributes in gastrointestinal tract, liver, lungs, kidneys, heart wall, bone marrow, and salivary glands. Vipivotide tetraxetan and non-radioactive lutetium vipivotide tetraxetan are 60% to 70% bound to human plasma proteins. Elimination The lutetium Lu 177 vipivotide tetraxetan terminal elimination half-life is 41.6 hours (68.8%) and the clearance (CL) is

2.04L/h (31.5%). Metabolism Lutetium Lu 177 vipivotide tetraxetan does not undergo hepatic or renal metabolism. Excretion Lutetium Lu 177 vipivotide tetraxetan is primarily eliminated renally.

Specific Populations Exposure (AUC) of lutetium Lu 177 vipivotide tetraxetan increased with decreasing creatinine clearance (CLcr). The effect of baseline CLcr < 54 mL/min on lutetium Lu 177 vipivotide tetraxetan pharmacokinetics has not been studied. Drug Interaction Studies In Vitro Studies CYP450 enzymes: Vipivotide tetraxetan is not a substrate of cytochrome P450 (CYP450) enzymes.

Vipivotide tetraxetan did not induce CYP1A2, 2B6 or 3A4; and did not inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 or 3A in vitro. Transporters: Vipivotide tetraxetan is not a substrate of BCRP, P-gp, MATE1, MATE2-K, OAT1, OAT3 or OCT2. Vipivotide tetraxetan did not inhibit BCRP, P-gp, MATE1, MATE2-K, OAT1, OAT3, OATP1B1, OATP1B3, OCT1 or OCT2 in vitro.

🧬 Mechanism of Action 83 words ▾

12.1Mechanism of Action Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent. The active moiety of lutetium Lu 177 vipivotide tetraxetan is the radionuclide lutetium-177 which is linked to a moiety that binds to PSMA, a transmembrane protein that is expressed in prostate cancer. Upon binding of lutetium Lu 177 vipivotide tetraxetan to PSMA-expressing cells, the beta-minus emission from lutetium-177 delivers radiation to PSMA-expressing cells, as well as to surrounding cells, and induces DNA damage which can lead to cell death.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING PLUVICTO Injection containing 1,000 MBq/mL (27 mCi/mL) of lutetium Lu 177 vipivotide tetraxetan at calibration time is a sterile, preservative-free and clear, colorless to slightly yellow solution for intravenous use supplied in a clear, colorless Type I glass 30 mL single-dose vial containing

7.4GBq (200 mCi) ± 10% of lutetium Lu 177 vipivotide tetraxetan at administration time (NDC# 0078-1217-61). The solution volume in the vial can range from 7.5 mL to 12.5 mL in order to provide a total of

7.4GBq (200 mCi) of radioactivity at administration time. The product vial is enclosed within a lead shielded container (NDC# 0078-1217-61) for protective shielding and placed in a plastic sealed container. The product is shipped in a type A package.

The shelf life is 120 hours (5 days) from the date and time of calibration. Store below 30°C (86°F). Do not freeze.

Store in the original package to protect from ionizing radiation (lead shielding). Store PLUVICTO in accordance with local and federal laws on radioactive materials. Do not use PLUVICTO after the expiration date and time which are stated on the label.

Dispose of any unused medicinal product or waste material in accordance with local and federal laws. Lutetium-177 for PLUVICTO may be prepared using two different sources of stable nuclides (either lutetium-176 or ytterbium-176) that require different waste management. Lutetium-177 for PLUVICTO is prepared using ytterbium-176 (“non-carrier added”) unless otherwise communicated on the product batch release certificate.

📋 Description ~1 min read ▾

11 DESCRIPTION PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) is a radioligand therapeutic agent. Lutetium Lu 177 vipivotide tetraxetan is a PSMA-binding ligand bound to a DOTA chelator radiolabeled with lutetium-177. The chemical name is 2-[4-[2-[[4-[[(2S)-1-[[(5S)-5-carboxy-5-[[(1S)-1,3-dicarboxy propyl]carbamoylamino]pentyl]amino]-3-naphthalen-2-yl-1-oxopropan-2-yl]carbamoyl]cyclohexyl]methylamino]-2-oxoethyl]-4,7,10-tris(carboxylatomethyl)-1,4,7,10-tetrazacyclododec-1-yl]acetate; lutetium-177(3+).

The molecular mass is 1216.06 g/mol and the molecular formula is C 49 H 68 177 LuN 9 O 16 . The chemical structure for lutetium Lu 177 vipivotide tetraxetan is shown below: PLUVICTO Injection containing 1,000 MBq/mL (27 mCi/mL) of lutetium Lu 177 vipivotide tetraxetan at calibration time is supplied as a sterile, clear, colorless to slightly yellow solution for intravenous use containing

7.4GBq (200 mCi) ± 10% of lutetium Lu 177 vipivotide tetraxetan at administration time. Each single-dose vial contains acetic acid (0.30 mg/mL), sodium acetate (0.41 mg/mL), gentisic acid (0.39 mg/mL), sodium ascorbate (50.0 mg/mL), pentetic acid (0.10 mg/mL), and water for injection (q.s. to 1 mL). The pH range of the solution is 4.5 to 7.0. Chemical Structure of lutetium

11.1Physical Characteristics Lutetium-177 decays to a stable hafnium-177 with a physical half-life of 6.647 days by emitting beta-minus radiation with a maximum energy of 498 keV (79%) and photonic radiation (γ) of 208 keV (11%) and 113 keV (6.4%). The main radiations of lutetium-177 are detailed in Table 9. Table 9: Lutetium-177 Main Radiations Radiation Energy (keV) Iβ - % Iγ% β - 176.5 12.2 β - 248.1 0.05 β - 384.9 9.1 β - 497.8 78.6 γ 71.6 0.15 γ 112.9 6.40 γ 136.7 0.05 γ 208.4 11.0 γ 249.7 0.21 γ 321.3 0.22

11.2External Radiation Table 10 summarizes the radioactive decay properties of lutetium-177. Table 10: Physical Decay Chart: Lutetium-177 Physical Half-life = 6.647 days Hours Fraction remaining 0 1.000 1 0.996 2 0.991 5 0.979 10 0.958 24 (1 day) 0.901 48 (2 days) 0.812 72 (3 days) 0.731 120 (5 days) 0.594 168 (7 days) 0.482 336 (14 days) 0.232 720 (30 days) 0.044 1080 (45 days) 0.009

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Risk From Radiation Exposure Ensure patients increase oral fluid intake and advise patients to void as often as possible to reduce bladder radiation. Before the patient is released, inform patients about the necessary radioprotection precautions to follow to minimize radiation exposure to others. After each administration of PLUVICTO, advise patients to: Limit close contact (less than 3 feet) with others for 2 days or with children and pregnant women for 7 days.

Refrain from sexual activity for 7 days. Sleep in a separate room from others for 3 days, from children for 7 days, or from pregnant women for 15 days [see Warnings and Precautions (5.1)] . Myelosuppression Advise patients to contact their healthcare provider for any signs or symptoms of myelosuppression, such as tiredness, weakness, pale skin, shortness of breath, bleeding or bruising more easily than normal or difficulty to stop bleeding, or frequent infections with signs, such as fever, chills, sore throat or mouth ulcers [see Warnings and Precautions (5.2)] .

Renal Toxicity Advise patients to remain well hydrated and to urinate frequently before and after administration of PLUVICTO. Advise patients to contact their healthcare provider for any signs or symptoms of renal toxicity, such as passing urine less often than usual or passing much smaller amounts of urine than usual [see Warnings and Precautions (5.3)] . Embryo-Fetal Toxicity Advise males that PLUVICTO can cause fetal harm [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)] .

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PLUVICTO and for 14 weeks after the last dose [see Warnings and Precautions (5.4), Use in Specific Populations (8.1, 8.3)] . Infertility Advise males of reproductive potential that PLUVICTO may cause temporary or permanent infertility [see Warnings and Precautions (5.5), Use in Specific Populations (8.3)] . Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 ©2026 Novartis PLUVICTO ® is a registered trademark of Novartis AG and/or its affiliates.

U.S. Patents 10398791; 10406240; 11318121; 11951190; 12208102 T2026-26

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.