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PADCEV EJFV ENFORTUMAB VEDOTIN 20 mg/2mL Injection, Powder, Lyophilized, For Solution — NDC 51144-0020-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PADCEV EJFV ENFORTUMAB VEDOTIN 20 mg/2mL Injection, Powder, Lyophilized, For Solution — NDC 51144-020-01 (Billing 51144-0020-01)

by SEAGEN INC. · 1 VIAL, SINGLE-DOSE in 1 BOX / 2 mL in 1 VIAL, SINGLE-DOSE

This is a package of PADCEV EJFV ENFORTUMAB VEDOTIN 20 mg/2mL Injection, Powder, Lyophilized, For Solution from SEAGEN INC., marketed since Dec 2019 and currently FDA-listed. It is this product's only package size.

NDC 51144-0020-01
🏷️ FDA NDC (as labeled) 51144-020-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 51144-020-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
51144 labeler · 020 product · 01 package
Package marketed since
Dec 18, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5114402001 1
Medicaid fills, this package
2,215 prescriptions in the last four reported quarters
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51144-020-01
Product NDC 51144-020
11-digit billing NDC 51144002001
NCPDP billing unit EA — each (per item)
RxCUI 2268311, 2268315, 2268317, 2268319
UNII DLE8519RWM
Application # BLA761137
SPL Set ID b5631d3e-4604-4363-8f20-11dfc5a4a8ed
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-12-18
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance ENFORTUMAB VEDOTIN
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 080567
GCN 47448
HICL code 046257
Ingredient (HICL) Enfortumab Vedotin-Ejfv
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1K
Therapeutic class — specific (HIC3) Antineoplastics Antibody/Antibody-Drug Complexes
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name PADCEV 20 MG VIAL
FDB brand name Padcev
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 080567
  • GCN: 47448
  • HICL (First Databank): 046257
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2268311
Why two NDCs? The FDA registers this code as 51144-020-01 — a 5-3-2 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 product segment → 51144-0020-01. 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 Other monoclonal antibodies and antibody drug conjugates class.

Drug family (ATC) Other monoclonal antibodies and antibody drug conjugates
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.

Clinical

Label name PADCEV 20 MG VIAL Ingredient Enfortumab Vedotin-Ejfv
📖 What it is MedlinePlus · NLM

Enfortumab vedotin-ejfv injection is used to treat certain types of urothelial cancer (cancer of the lining of the bladder and other parts of the urinary tract). Enfortumab vedotin-ejfv injection is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.

Read the full MedlinePlus article ↗

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.

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 $1,337.86 $2,675.72 / 2 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9177 $36.658 / J9177 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)51144-020-01
11-digit billing NDC51144-0020-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9177
DescriptorInjection, enfortumab vedotin-ejfv, 0.25 mg
Billing units / pkg80 units
How the units are derivedThis package is 1; the HCPCS unit is 0.25 MG, so one package = 80 billing units.
Medicare Part B spend (2026 (Q1))$215,913,978 · 16,557 claims · $13,040.65 per claim (all NDCs under J9177)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51144-0020-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 BOX / 2 mL in 1 VIAL, SINGLE-DOSE 2019-12-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Padcev Ejfv 20 mg/2mLthis 51144-0020-01 SEAGEN 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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 & biosimilar status

🏛️
2019
First FDA approval
Dec 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2031. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 18, 2019 ⏳ ~5.2 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Padcevenfortumab vedotin-ejfv
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2019 2021 2023 2025 2027 2029 2031
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateDec 18, 2031
Common questions
Is there a biosimilar for PADCEV 20 MG VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, 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 Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

  • 2.8 mg / 2 mL UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • 4.62 mg / 2 mL UNII X573657P6P
    Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
  • 0.4 mg / 2 mL UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • 110 mg / 2 mL UNII 7YIN7J07X4
    A natural sugar derived from plants and microorganisms. It acts as a filler to give the medication bulk and stability, and helps preserve the active ingredient during storage and manufacturing.

4 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.

Manufacturer & labeler

LabelerSEAGEN INC.
FDA applicationBLA761137 (BLA)
Labeler code51144
First marketedDec 2019
Product typeHuman Prescription Drug
Portfolio6 products on file

More NDCs from SEAGEN INC. labeler code 51144

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 180 words ▾

WARNING: SERIOUS SKIN REACTIONS • PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later. • Closely monitor patients for skin reactions. • Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions. • Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 ), and Adverse Reactions ( 6.1 )].

WARNING: SERIOUS SKIN REACTIONS See full prescribing information for complete boxed warning. • PADCEV can cause severe and fatal cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). • Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions. • Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions. ( 2.2 ), ( 5.1 ), ( 6.1 )

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC). PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). PADCEV, as a single agent, is indicated for the treatment of adult patients with la/mUC who: • have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or • are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

PADCEV is a Nectin-4-directed antibody and microtubule inhibitor conjugate indicated: • in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle invasive bladder cancer (MIBC). ( 1 ) • in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC).

( 1 ) • as a single agent for the treatment of adult patients with la/mUC who: ○ have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or ○ are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • For intravenous infusion only. Do not administer PADCEV as an intravenous push or bolus. Do not mix with, or administer as an infusion with, other medicinal products.

( 2.3 ) • MIBC: The recommended dose of PADCEV in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is 1.25 mg/kg (up to a maximum dose of 125 mg) given as an intravenous infusion over 30 minutes. For patients who: ○ are eligible for cisplatin-containing chemotherapy, PADCEV is administered as neoadjuvant treatment on Days 1 and 8 of each 21‑day cycle for 4 cycles or until disease progression that precludes curative intent cystectomy or unacceptable toxicity, followed by adjuvant treatment on Days 1 and 8 of each 21-day cycle for 5 cycles or until disease recurrence or unacceptable toxicity, or ○ are ineligible for cisplatin-containing chemotherapy, PADCEV is administered as neoadjuvant treatment on Days 1 and 8 of each 21‑day cycle for 3 cycles or until disease progression that precludes curative intent cystectomy or unacceptable toxicity, followed by adjuvant treatment on Days 1 and 8 of each 21‑day cycle for 6 cycles or until disease recurrence or unacceptable toxicity.

( 2.1 ) • La/mUC: The recommended dose of PADCEV in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is 1.25 mg/kg (up to a maximum dose of 125 mg) given as an intravenous infusion over 30 minutes on Days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity. ( 2.1 ) • La/mUC: The recommended dose of PADCEV as a single agent is 1.25 mg/kg (up to a maximum dose of 125 mg) given as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of a 28‑day cycle until disease progression or unacceptable toxicity.

( 2.1 ) • Avoid use in patients with moderate or severe hepatic impairment. ( 8.6 )

2.1Recommended Dosage The recommended dosages for PADCEV in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, and PADCEV as a single agent are presented in Table 1 and Table 2 . Administer PADCEV as an intravenous infusion over 30 minutes as recommended [ see Instructions for Preparation and Administration ( 2.3 ) ]. Administer PADCEV prior to pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph if administering on the same day.

Table 1. Recommended Dosages for PADCEV in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph Administer PADCEV prior to pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph if administering on the same day. For the recommended dosage of pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, refer to the respective Prescribing Information .

Indication Recommended PADCEV Dosage Duration of Therapy Neoadjuvant and Adjuvant Muscle Invasive Bladder Cancer (MIBC) PADCEV 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) on Days 1 and 8 of a 21-day cycle . Patients who are cisplatin-eligible Cisplatin ineligibility is defined as meeting at least one of the following criteria: Creatinine clearance of less than 60 mL/min, ECOG PS 2 or higher, Grade 2 or higher hearing loss, NYHA Class III or higher heart failure, or Grade 2 or higher peripheral neuropathy. : • Neoadjuvant: 4 cycles or until disease progression that precludes curative intent cystectomy or unacceptable toxicity. • Adjuvant: 5 cycles or until disease recurrence or unacceptable toxicity .

Patients who are cisplatin-ineligible : • Neoadjuvant: 3 cycles or until disease progression that precludes curative intent cystectomy or unacceptable toxicity. • Adjuvant: 6 cycles or until disease recurrence or unacceptable toxicity . Locally advanced or metastatic Urothelial Cancer (la/mUC) PADCEV 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) on Days 1 and 8 of a 21-day cycle . Until disease progression or unacceptable toxicity.

Table 2. Recommended Dosages for PADCEV as a single agent Indication Recommended PADCEV Dos… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 51 words ▾

3 DOSAGE FORMS AND STRENGTHS For Injection: 20 mg and 30 mg of enfortumab vedotin-ejfv as a white to off-white lyophilized powder in a single-dose vial for reconstitution. For Injection: 20 mg and 30 mg of enfortumab vedotin-ejfv as a lyophilized powder in a single-dose vial for reconstitution. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Hyperglycemia: Diabetic ketoacidosis may occur in patients with and without preexisting diabetes mellitus, which may be fatal. Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. Withhold PADCEV if blood glucose is >250 mg/dL.

( 2.2 , 5.2 ) • Pneumonitis/Interstitial Lung Disease (ILD): Severe, life-threatening or fatal pneumonitis/ILD may occur. Withhold PADCEV for Grade 2 pneumonitis/ILD and consider dose reduction. Permanently discontinue PADCEV for Grade 3 or 4 pneumonitis/ILD.

( 2.2 , 5.3 ) • Peripheral Neuropathy: Monitor patients for new or worsening peripheral neuropathy and consider dose interruption, dose reduction, or discontinuation of PADCEV. ( 2.2 , 5.4 ) • Ocular Disorders: Ocular disorders, including vision changes, may occur. Monitor patients for signs or symptoms of ocular disorders.

Consider prophylactic artificial tears for dry eyes and treatment with ophthalmic topical steroids after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV when symptomatic ocular disorders occur. ( 5.5 ) • Infusion Site Extravasation: Ensure adequate venous access prior to administration.

Monitor the infusion site during PADCEV administration and stop the infusion immediately for suspected extravasation. ( 5.6 ) • Embryo-Fetal Toxicity: PADCEV can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception.

( 5.7 , 8.1 , 8.3 )

5.1Skin Reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV. SJS and TEN occurred predominantly during the first cycle of treatment but may occur later. Skin reactions occurred in 65% (all grades) of the 570 patients treated with PADCEV in combination with intravenous pembrolizumab for the treatment of MIBC in clinical trials.

The majority of the skin reactions that occurred with combination therapy included rash and maculo-papular rash. Grade 3-4 skin reactions occurred in 13% of patients (Grade 3: 12%, Grade 4: 1.1%), including maculo-papular rash, rash, Stevens-Johnson syndrome, dermatitis, exfoliative generalized dermatitis, toxic skin eruption, acute generalized exanthematous pustulosis, bullous dermatitis, erythema, macular rash, and pruritic rash. A fatal reaction of TEN occurred in one patient (0.2%).

The median time to onset of severe skin reactions was 0.6 months (range: 0.1 to 24 months). Skin reactions led to discontinuation of PADCEV in 8% of patients [see Adverse Reactions ( 6.1 )] . Of the patients who experienced a skin reaction and had data regarding resolution (n=367), 87% had complete resolution and 13% had residual skin reactions at their last evaluation.

Of the patients with residual skin reactions at last evaluation, 31% (15/49) had Grade ≥2 skin reactions. Skin reactions occurred in 70% (all grades) of the 564 patients treated with PADCEV in combination with intravenous pembrolizumab for the treatment of la/mUC in clinical trials. When PADCEV was given in combination with intravenous pembrolizumab, the incidence of skin reactions, including severe events, occurred at a higher rate compared to PADCEV as a single agent.

The majority of the skin reactions that occurred with combination therapy included maculo-papular rash, macular rash, and papular rash. Grade 3-4 skin reactions occurred in 17% of patients (Grade 3: 16%, Grade 4: 1%), including maculo-papular rash, bullous dermatitis, dermatitis, exfoliative dermatitis, pemphigoid, rash, erythematous rash, macular rash, and papular rash. A fatal reaction of bullous dermatitis occurred in one patient (0.2%).

The median time to onset of severe skin reactions was 1.7 months (range: 0.1 to 17.2 months). Skin reactions led to discontinuation of PADCEV in 6% of patients [see Adverse Reactions ( 6.1 )] . Of the patients who experienced a skin reaction and had data regarding resolution (n=391), 59% had complete resolution and 41% had r… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Skin Reactions [see Boxed Warning , Warnings and Precautions ( 5.1 )] • Hyperglycemia [see Warnings and Precautions ( 5.2 )] • Pneumonitis/Interstitial Lung Disease (ILD) [see Warnings and Precautions ( 5.3 )] • Peripheral Neuropathy [see Warnings and Precautions ( 5.4 )] • Ocular Disorders [see Warnings and Precautions ( 5.5 )] • Infusion Site Extravasation [see Warnings and Precautions ( 5.6 )] The most common adverse reactions, including laboratory abnormalities, (≥20%) were: • PADCEV in combination with intravenous pembrolizumab for the treatment of MIBC: decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, rash, increased creatinine, decreased lymphocytes, fatigue, pruritus, decreased sodium, peripheral neuropathy, increased potassium, diarrhea, alopecia, dysgeusia, decreased appetite, nausea, constipation, urinary tract infection, dry eye, increased glucose, decreased weight, decreased potassium, hyperglycemia, decreased phosphate, and decreased neutrophils.

( 6.1 ) • PADCEV in combination with intravenous pembrolizumab for the treatment of la/mUC: increased aspartate aminotransferase, increased creatinine, rash, increased glucose, peripheral neuropathy, increased lipase, decreased lymphocytes, increased alanine aminotransferase, decreased hemoglobin, fatigue, decreased sodium, decreased phosphate, decreased albumin, pruritus, diarrhea, alopecia, decreased weight, decreased appetite, increased urate, decreased neutrophils, decreased potassium, dry eye, nausea, constipation, increased potassium, dysgeusia, urinary tract infection, and decreased platelets.

( 6.1 ) • PADCEV as a single agent: increased glucose, increased aspartate aminotransferase, decreased lymphocytes, increased creatinine, rash, fatigue, peripheral neuropathy, decreased albumin, decreased hemoglobin, alopecia, decreased appetite, decreased neutrophils, decreased sodium, increased alanine aminotransferase, decreased phosphate, diarrhea, nausea, pruritus, increased urate, dry eye, dysgeusia, constipation, increased lipase, decreased weight, decreased platelets, abdominal pain, and dry skin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 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. The safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to PADCEV 1.25 mg/kg in combination with intravenous pembrolizumab for the treatment of MIBC in 570 patients in EV-303 (NCT03924895) and EV-304 (NCT04700124) and for the treatment of la/mUC in 564 patients in EV-302 (NCT04223856) and EV-103 (NCT03288545); PADCEV as a single agent at 1.25 mg/kg in 720 patients in EV-301 (NCT03474107), EV‑201 (NCT03219333), EV-203 (NCT04995419), EV-101 (NCT02091999), and EV-102 (NCT03070990).

Ocular disorders reflect 384 patients in EV‑201, EV-101, and EV-102. Among 570 patients receiving PADCEV in combination with intravenous pembrolizumab for the treatment of MIBC, the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, rash, increased creatinine, decreased lymphocytes, fatigue, pruritus, decreased sodium, peripheral neuropathy, increased potassium, diarrhea, alopecia, dysgeusia, decreased appetite, nausea, constipation, urinary tract infection, dry eye, increased glucose, decreased weight, decreased potassium, hyperglycemia, decreased phosphate, and decreased neutrophils.

Among 564 patients receiving PADCEV in combination with intravenous pembrolizumab for… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 89 words ▾

7 DRUG INTERACTIONS Concomitant use of dual P-gp and strong CYP3A4 inhibitors with PADCEV may increase the exposure to monomethyl auristatin E (MMAE). ( 7.1 )

7.1Effects of Other Drugs on PADCEV Dual P-gp and Strong CYP3A4 Inhibitors Concomitant use with dual P-gp and strong CYP3A4 inhibitors may increase unconjugated MMAE exposure [see Clinical Pharmacology ( 12.3 )] , which may increase the incidence or severity of PADCEV toxicities. Closely monitor patients for signs of toxicity when PADCEV is given concomitantly with dual P-gp and strong CYP3A4 inhibitors.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on the mechanism of action and findings in animals, PADCEV can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available human data on PADCEV use in pregnant women to inform a drug-associated risk. In an animal reproduction study, administration of enfortumab vedotin-ejfv to pregnant rats during organogenesis caused maternal toxicity, embryo-fetal lethality, structural malformations, and skeletal anomalies at maternal exposures similar to the exposures at the recommended human dose of 1.25 mg/kg (see Data ) .

Advise patients of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.

Data Animal Data In a rat pilot embryo-fetal development study, administration of enfortumab vedotin-ejfv on gestation day 6 and 13 during the period of organogenesis resulted in a complete litter loss in all pregnant rats at the maternally toxic dose of 5 mg/kg (approximately 3 times the exposure at the recommended human dose). A dose of 2 mg/kg (similar to the exposure at the recommended human dose) resulted in maternal toxicity, embryo-fetal lethality, and structural malformations that included gastroschisis, malrotated hindlimb, absent forepaw, malpositioned internal organs, and fused cervical arch.

Additionally, skeletal anomalies (asymmetric, fused, incompletely ossified, and misshapen sternebrae, misshapen cervical arch, and unilateral ossification of the thoracic centra) and decreased fetal weight were observed.

8.2Lactation Risk Summary There are no data on the presence of enfortumab vedotin-ejfv in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment with PADCEV and for 3 weeks after the last dose.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating PADCEV treatment [see Use in Specific Populations ( 8.1 )] . Contraception Females PADCEV can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential to use effective contraception during treatment with PADCEV and for 2 months after the last dose.

Males Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose. Infertility Females Based on findings in animal studies with MMAE-containing antibody-drug conjugates (ADCs), PADCEV may impair female fertility. The effect on fertility is reversible [see Nonclinical Toxicology ( 13.1 )] .

Males Based on findings from animal studies, PADCEV may impair male fertility [see Nonclinical Toxicology ( 13.1 )] .

8.4Pediatric Use Safety and effectiveness of PADCEV in pediatric patients have not been established.

8.5Geriatric Use Of the 570 patients treated with PADCEV in combination with intravenous pembrolizumab for the treatment of MIBC, 45% (n=259) were 65-74 years and 22% (n=125) were 75 years or older. Of the 564 patients treated with PADCEV in combination with intravenous pembrolizumab for the treatment of la/mUC, 44% (n=247) were 65‑74 years and 26% (n=144) were 75 years or older. Of the 720 patients treated with PADCEV as a single agent in clinical trials, 39% (n=282) were 65‑74 years and 24% (n=170) were 75 years or older.

No overall differences in effectiveness were observed between patients 65 years of age or older and younger patients. Patients 75 years of age or older treated with PADCE… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on the mechanism of action and findings in animals, PADCEV can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available human data on PADCEV use in pregnant women to inform a drug-associated risk. In an animal reproduction study, administration of enfortumab vedotin-ejfv to pregnant rats during organogenesis caused maternal toxicity, embryo-fetal lethality, structural malformations, and skeletal anomalies at maternal exposures similar to the exposures at the recommended human dose of 1.25 mg/kg (see Data ) .

Advise patients of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.

Data Animal Data In a rat pilot embryo-fetal development study, administration of enfortumab vedotin-ejfv on gestation day 6 and 13 during the period of organogenesis resulted in a complete litter loss in all pregnant rats at the maternally toxic dose of 5 mg/kg (approximately 3 times the exposure at the recommended human dose). A dose of 2 mg/kg (similar to the exposure at the recommended human dose) resulted in maternal toxicity, embryo-fetal lethality, and structural malformations that included gastroschisis, malrotated hindlimb, absent forepaw, malpositioned internal organs, and fused cervical arch.

Additionally, skeletal anomalies (asymmetric, fused, incompletely ossified, and misshapen sternebrae, misshapen cervical arch, and unilateral ossification of the thoracic centra) and decreased fetal weight were observed.

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of PADCEV in pediatric patients have not been established.

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Of the 570 patients treated with PADCEV in combination with intravenous pembrolizumab for the treatment of MIBC, 45% (n=259) were 65-74 years and 22% (n=125) were 75 years or older. Of the 564 patients treated with PADCEV in combination with intravenous pembrolizumab for the treatment of la/mUC, 44% (n=247) were 65‑74 years and 26% (n=144) were 75 years or older. Of the 720 patients treated with PADCEV as a single agent in clinical trials, 39% (n=282) were 65‑74 years and 24% (n=170) were 75 years or older.

No overall differences in effectiveness were observed between patients 65 years of age or older and younger patients. Patients 75 years of age or older treated with PADCEV in combination with intravenous pembrolizumab for the treatment of MIBC experienced a higher incidence of fatal adverse reactions than younger patients. The incidence of fatal adverse reactions was 3.6% in patients younger than 75 and 11% in patients 75 years or older.

Patients 75 years of age or older treated with PADCEV in combination with intravenous pembrolizumab for the treatment of la/mUC experienced a higher incidence of fatal adverse reactions than younger patients. The incidence of fatal adverse reactions was 4% in patients younger than 75 and 7% in patients 75 years or older. Patients 75 years of age or older treated with PADCEV as a single agent experienced a higher incidence of fatal adverse reactions than younger patients.

The incidence of fatal adverse reactions was 6% in patients younger than 75 years, and 11% in patients 75 years or older. No significant difference was observed in the pharmacokinetics of PADCEV between patients 65 years and older and younger patients [see Clinical Pharmacology ( 12.3 )].

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Enfortumab vedotin-ejfv is an ADC. The antibody is a human IgG1 kappa directed against Nectin-4, an adhesion protein located on the surface of cells. The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease-cleavable linker.

Nonclinical data suggest that the anticancer activity of enfortumab vedotin-ejfv is due to the binding of the ADC to Nectin-4-expressing cells, followed by internalization of the ADC-Nectin-4 complex, and the release of MMAE via proteolytic cleavage. Release of MMAE disrupts the microtubule network within the cell, subsequently inducing cell cycle arrest and apoptosis. The combination of enfortumab vedotin-ejfv with a PD-1 blocking antibody resulted in up-regulation of immune function and increased anti-tumor activity in syngeneic mouse tumor models expressing Nectin-4.

12.2Pharmacodynamics In an exposure-response analysis for safety, higher enfortumab vedotin-ejfv exposure was associated with higher incidence of some adverse reactions (e.g., Grade ≥2 peripheral neuropathy, Grade ≥3 hyperglycemia). The exposure‑response relationship for efficacy has not been fully characterized. Cardiac Electrophysiology At the recommended dose, PADCEV had no large QTc prolongation (>20 msec).

12.3Pharmacokinetics Enfortumab vedotin-ejfv (ADC) pharmacokinetics were characterized after single and multiple doses in patients with solid tumors. The pharmacokinetics of the ADC and unconjugated MMAE were consistent when assessed following PADCEV administration as a single agent and in combination with intravenous pembrolizumab after 1 treatment cycle. The exposure parameters of the ADC and unconjugated MMAE (the cytotoxic component of enfortumab vedotin-ejfv) are summarized in Table 19 below.

Peak ADC concentrations were observed near the end of intravenous infusion while peak unconjugated MMAE concentrations were observed approximately 2 days after PADCEV dosing. Minimal accumulation of the ADC and unconjugated MMAE was observed following repeat administration of PADCEV in patients. Steady-state concentrations of the ADC were reached after 1 treatment cycle for the ADC as a single agent and in combination with intravenous pembrolizumab.

Table 19. Exposure Parameters of the ADC and Unconjugated MMAE after First Treatment Cycle of 1.25 mg/kg of PADCEV Dose of Days 1, 8, and 15 C max = maximum concentration, AUC 0-28d = area under the concentration-time curve from time zero to 28 days, C trough,0-28d = pre-dose concentration on day 28. Parameter ADC Mean (± SD) Unconjugated MMAE Mean (± SD) C max 28 (6.1) µg/mL 5.5 (3.0) ng/mL AUC 0-28d 110 (26) µg∙d/mL 85 (50) ng∙d/mL C trough,0-28d 0.31 (0.18) µg/mL 0.81 (0.88) ng/mL Distribution The estimated mean steady-state volume of distribution of the ADC was

12.8L following administration of PADCEV. In vitro , plasma protein binding of unconjugated MMAE ranged from 68% to 82%. Elimination The ADC and unconjugated MMAE exhibited multi-exponential declines with an elimination half-life of 3.6 days and 2.6 days, respectively. The mean clearance (CL) of the ADC and unconjugated MMAE was

0.11 L/h and

2.11L/h, respectively. Elimination of unconjugated MMAE appeared to be limited by its rate of release from the ADC. Metabolism Catabolism of the ADC has not been studied in humans; however, it is expected to undergo catabolism to small peptides, amino acids, unconjugated MMAE, and unconjugated MMAE-related catabolites.

The ADC releases MMAE via proteolytic cleavage, and unconjugated MMAE is primarily metabolized by CYP3A4 in vitro . Excretion The excretion of the ADC is not fully characterized. Following a single-dose of another ADC that contains unconjugated MMAE, 17% of the total unconjugated MMAE administered was recovered in feces and 6% in urine over a 1-week period, primarily as unchanged form.

A similar excretion profile of unconjugated MMAE is expected after PADCEV administration. Specific Pop… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 124 words ▾

12.1Mechanism of Action Enfortumab vedotin-ejfv is an ADC. The antibody is a human IgG1 kappa directed against Nectin-4, an adhesion protein located on the surface of cells. The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease-cleavable linker.

Nonclinical data suggest that the anticancer activity of enfortumab vedotin-ejfv is due to the binding of the ADC to Nectin-4-expressing cells, followed by internalization of the ADC-Nectin-4 complex, and the release of MMAE via proteolytic cleavage. Release of MMAE disrupts the microtubule network within the cell, subsequently inducing cell cycle arrest and apoptosis. The combination of enfortumab vedotin-ejfv with a PD-1 blocking antibody resulted in up-regulation of immune function and increased anti-tumor activity in syngeneic mouse tumor models expressing Nectin-4.

📦 How Supplied / Storage and Handling 94 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied PADCEV (enfortumab vedotin-ejfv) 20 mg and 30 mg are supplied as a sterile, preservative-free, white to off-white lyophilized powder in single-dose vials. PADCEV vials are available in the following packages: • Carton of one 20 mg single-dose vial (NDC 51144-020-01) • Carton of one 30 mg single-dose vial (NDC 51144-030-01) Storage Store PADCEV vials refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton. Do not freeze.

Do not shake. Special Handling PADCEV is a hazardous drug. Follow applicable special handling and disposal procedures.

1

📋 Description ~1 min read ▾

11 DESCRIPTION Enfortumab vedotin-ejfv is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a fully human anti-Nectin-4 IgG1 kappa monoclonal antibody (AGS-22C3) conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE) via a protease-cleavable maleimidocaproyl valine-citrulline (vc) linker (SGD-1006). Conjugation takes place on cysteine residues that comprise the interchain disulfide bonds of the antibody to yield a product with a drug-to-antibody ratio of approximately 3.8:1.

The molecular weight is approximately 152 kDa. Figure 1. Structural Formula Approximately 4 molecules of MMAE are attached to each antibody molecule.

Enfortumab vedotin-ejfv is produced by chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells and the small molecule components are produced by chemical synthesis. PADCEV (enfortumab vedotin-ejfv) for injection is provided as a sterile, preservative-free, white to off-white lyophilized powder in single-dose vials for intravenous use.

PADCEV is supplied as a 20 mg per vial and a 30 mg per vial and requires reconstitution with Sterile Water for Injection, USP, (2.3 mL and 3.3 mL, respectively) resulting in a clear to slightly opalescent, colorless to slightly yellow solution with a final concentration of 10 mg/mL [see Dosage and Administration ( 2.3 )]. After reconstitution, each vial allows the withdrawal of 2 mL (20 mg) and 3 mL (30 mg). Each mL of reconstituted solution contains 10 mg of enfortumab vedotin-ejfv, histidine (1.4 mg), histidine hydrochloride monohydrate (2.31 mg), polysorbate 20 (0.2 mg), and trehalose dihydrate (55 mg) with a pH of 6.0.

Figure 1

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Skin Reactions Inform patients that severe skin reactions including SJS and TEN with fatal outcomes have occurred after administration of PADCEV, predominantly during the first cycle of treatment but may occur later. Advise patients to contact their healthcare provider immediately if they develop new target lesions, progressively worsening skin reactions, severe blistering, or peeling of the skin [see Boxed Warning and Warnings and Precautions ( 5.1 )].

Hyperglycemia Inform patients about the risk of hyperglycemia and how to recognize associated symptoms [see Warnings and Precautions ( 5.2 )] . Pneumonitis/ILD Advise patients to immediately report new or worsening respiratory symptoms [see Warnings and Precautions ( 5.3 )]. Peripheral Neuropathy Inform patients to report to their healthcare provider any numbness and tingling of the hands or feet or muscle weakness [see Warnings and Precautions ( 5.4 )].

Ocular disorders Advise patients to contact their healthcare provider if they experience any visual changes [see Warnings and Precautions ( 5.5 )] . In order to prevent or treat dry eyes, advise patients to use artificial tear substitutes. Infusion Site Extravasation Inform patients that infusion site reactions have occurred after administration of PADCEV.

These reactions generally occurred immediately after administration but, in some instances, had a delayed onset (e.g., 24 hours). Instruct patients to contact their healthcare provider immediately if they experience an infusion site reaction [see Warnings and Precautions ( 5.6 )] . Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to the fetus.

Advise females to inform their healthcare providers of a known or suspected pregnancy [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.1 )] . Females and Males of Reproductive Potential Advise female patients of reproductive potential to use effective contraception during treatment with PADCEV and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose [see Use in Specific Populations ( 8.3 )] .

Lactation Advise women not to breastfeed during treatment with PADCEV and for 3 weeks after the last dose [see Use in Specific Populations ( 8.2 )] . Infertility Advise females and males of reproductive potential that PADCEV may impair fertility [see Use in Specific Populations ( 8.3 )]. Manufactured and Marketed by: Astellas Pharma US, Inc.

Northbrook, Illinois 60062 Distributed and Marketed by: Seagen Inc. Bothell, WA 98021 1-855-4SEAGEN U.S. License 2124 PADCEV is a registered trademark jointly owned by Agensys, Inc. and Seagen Inc. ©2026 Agensys, Inc. and Seagen Inc.

11817-EV-US

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Enfortumab vedotin-ejfv (ADC) pharmacokinetics were characterized after single and multiple doses in patients with solid tumors. The pharmacokinetics of the ADC and unconjugated MMAE were consistent when assessed following PADCEV administration as a single agent and in combination with intravenous pembrolizumab after 1 treatment cycle. The exposure parameters of the ADC and unconjugated MMAE (the cytotoxic component of enfortumab vedotin-ejfv) are summarized in Table 19 below.

Peak ADC concentrations were observed near the end of intravenous infusion while peak unconjugated MMAE concentrations were observed approximately 2 days after PADCEV dosing. Minimal accumulation of the ADC and unconjugated MMAE was observed following repeat administration of PADCEV in patients. Steady-state concentrations of the ADC were reached after 1 treatment cycle for the ADC as a single agent and in combination with intravenous pembrolizumab.

Table 19. Exposure Parameters of the ADC and Unconjugated MMAE after First Treatment Cycle of 1.25 mg/kg of PADCEV Dose of Days 1, 8, and 15 C max = maximum concentration, AUC 0-28d = area under the concentration-time curve from time zero to 28 days, C trough,0-28d = pre-dose concentration on day 28. Parameter ADC Mean (± SD) Unconjugated MMAE Mean (± SD) C max 28 (6.1) µg/mL 5.5 (3.0) ng/mL AUC 0-28d 110 (26) µg∙d/mL 85 (50) ng∙d/mL C trough,0-28d 0.31 (0.18) µg/mL 0.81 (0.88) ng/mL Distribution The estimated mean steady-state volume of distribution of the ADC was

12.8L following administration of PADCEV. In vitro , plasma protein binding of unconjugated MMAE ranged from 68% to 82%. Elimination The ADC and unconjugated MMAE exhibited multi-exponential declines with an elimination half-life of 3.6 days and 2.6 days, respectively. The mean clearance (CL) of the ADC and unconjugated MMAE was

0.11 L/h and

2.11L/h, respectively. Elimination of unconjugated MMAE appeared to be limited by its rate of release from the ADC. Metabolism Catabolism of the ADC has not been studied in humans; however, it is expected to undergo catabolism to small peptides, amino acids, unconjugated MMAE, and unconjugated MMAE-related catabolites.

The ADC releases MMAE via proteolytic cleavage, and unconjugated MMAE is primarily metabolized by CYP3A4 in vitro . Excretion The excretion of the ADC is not fully characterized. Following a single-dose of another ADC that contains unconjugated MMAE, 17% of the total unconjugated MMAE administered was recovered in feces and 6% in urine over a 1-week period, primarily as unchanged form.

A similar excretion profile of unconjugated MMAE is expected after PADCEV administration. Specific Populations No clinically significant differences in the pharmacokinetics of the ADC or unconjugated MMAE were identified based on age (24 to 90 years), sex, race (White, Asian, or Black), renal impairment, and mild hepatic impairment (total bilirubin of 1 to 1.5 × ULN and any AST, or total bilirubin ≤ULN and AST >ULN). The effect of end-stage renal disease with or without dialysis and moderate or severe hepatic impairment (total bilirubin >1.5 × ULN and any AST) on the pharmacokinetics of the ADC or unconjugated MMAE is unknown.

Drug Interaction Trials No clinical trials evaluating the drug-drug interaction potential of the ADC have been conducted. Physiologically Based Pharmacokinetic (PBPK) Modeling Predictions: Dual P-gp and Strong CYP3A4 Inhibitor: Concomitant use of PADCEV with ketoconazole (a dual P-gp and strong CYP3A4 inhibitor) is predicted to increase unconjugated MMAE C max by 15% and AUC by 38%. Dual P-gp and Strong CYP3A4 Inducer: Concomitant use of PADCEV with rifampin (a dual P-gp and strong CYP3A4 inducer) is predicted to decrease unconjugated MMAE C max by 28% and AUC by 53%.

Sensitive CYP3A Substrates: Concomitant use of PADCEV is predicted not to affect exposure to midazolam (a sensitive CYP3A substrate). In Vitro Studies Transporter Systems: MMAE is a substrate of P-glycopr… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 53 words ▾

12.2Pharmacodynamics In an exposure-response analysis for safety, higher enfortumab vedotin-ejfv exposure was associated with higher incidence of some adverse reactions (e.g., Grade ≥2 peripheral neuropathy, Grade ≥3 hyperglycemia). The exposure‑response relationship for efficacy has not been fully characterized. Cardiac Electrophysiology At the recommended dose, PADCEV had no large QTc prolongation (>20 msec).

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Urothelial Cancer Neoadjuvant and Adjuvant Treatment of Patients with MIBC Who Are Cisplatin-Eligible EV-304 The efficacy of PADCEV in combination with intravenous pembrolizumab as neoadjuvant treatment and then continued after radical cystectomy (RC) as adjuvant treatment was evaluated in EV-304 (NCT04700124), an open-label, randomized, active-controlled, multicenter trial that enrolled patients with previously untreated MIBC with predominant urothelial carcinoma histology and who were candidates for RC with pelvic lymph node dissection (PLND) and were eligible for cisplatin-based chemotherapy.

The study excluded patients with primary non-bladder (i.e., ureter, urethral, or renal pelvis) cancer of the urothelium and those with active autoimmune disease that required systemic therapy within 2 years of treatment or a medical condition that required immunosuppression. Randomization was stratified by tumor stage (T2N0 vs T3/T4aN0 vs T1-T4aN1), PD-L1 combined positive score (CPS ≥10 vs CPS <10), and geographic region (United States vs European Union vs Rest of World). Patients were randomized 1:1 to receive: • Neoadjuvant PADCEV 1.25 mg/kg as an intravenous infusion on Days 1 and 8 in combination with intravenous pembrolizumab 200 mg as an intravenous infusion on Day 1 of a 21-day cycle for 4 cycles prior to surgery, followed by adjuvant PADCEV for up to 5 cycles and intravenous pembrolizumab for up to 13 cycles (21 days per cycle) (n=405). • Neoadjuvant gemcitabine 1000 mg/m 2 on Days 1 and 8 and cisplatin 70 mg/m 2 on Day 1 of each 21-day cycle for 4 cycles prior to surgery, followed by observation (n=403).

Treatment continued until completion of the treatment, disease progression, not undergoing or refusal of RC and PLND, disease recurrence in the adjuvant phase, or unacceptable toxicity. Assessment of tumor status, including CT/MRI, was performed at baseline, within 5 weeks prior to RC and PLND, and at 6 weeks post-radical cystectomy. Following RC and PLND, assessment of tumor status, including cystoscopy and urine cytology for patients who did not undergo surgery, was performed every 12 weeks up to 2 years, and every 24 weeks thereafter.

The median age was 66 years (range: 35 to 85 years); 81% were male; 80% were White, 17% were Asian, 1.4% were multiple, 1.2% were Black or African American, 0.6% American Indian or Alaska Native, and race in 0.2% was missing; 90% were not Hispanic or Latino, 8% were Hispanic or Latino, and 1.7% ethnicity unknown/not reported. Patients had a baseline ECOG performance status of 0 (78%) or 1 (22%). Nineteen percent were T2N0, 73% T3/T4aN0, and 8% T1-T4aN1.

Eighty-nine percent of patients had pure urothelial carcinoma histology; 4.8% had urothelial carcinoma with squamous differentiation, 2.6% had urothelial carcinoma with glandular differentiation, and 3.1% had urothelial carcinoma with other variant histology. In the overall population, 351 (87%) patients in the PADCEV in combination with intravenous pembrolizumab arm and 361 (90%) patients in the chemotherapy arm underwent RC and PLND. A total of 25 (6%) of patients in the chemotherapy arm received adjuvant nivolumab.

The trial was not designed to isolate the effect of PADCEV in combination with intravenous pembrolizumab in each phase (neoadjuvant or adjuvant) of treatment. The major efficacy outcome measure was event-free survival (EFS) as assessed by blinded independent central review (BICR). Overall survival (OS) and pathological complete response (pCR) rate as assessed by blinded independent pathology review (BIPR) were additional efficacy outcome measures.

The trial demonstrated statistically significant improvements in EFS and OS in patients treated with neoadjuvant and adjuvant PADCEV in combination with intravenous pembrolizumab compared with neoadjuvant chemotherapy. Table 20 and Figures 2-3 summarize the efficacy results for EV-304. Table 20.

Efficacy Results in EV-304 NR = Not Reached. Endpoint Perioperative… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies with enfortumab vedotin-ejfv or the small molecule cytotoxic agent (MMAE) have not been conducted. MMAE was genotoxic in the rat bone marrow micronucleus study through an aneugenic mechanism. This effect is consistent with the pharmacological effect of MMAE as a microtubule-disrupting agent.

MMAE was not mutagenic in the bacterial reverse mutation assay (Ames test) or the L5178Y mouse lymphoma forward mutation assay. Fertility studies with enfortumab vedotin-ejfv or MMAE have not been conducted. However, results of repeat-dose toxicity studies indicate the potential for enfortumab vedotin-ejfv to impair female and male reproductive function and fertility.

In repeat-dose toxicology studies conducted in rats for up to 13 weeks, doses ≥2 mg/kg enfortumab vedotin-ejfv (at exposures similar to the exposures at the recommended human dose) resulted in decreases in testes and epididymis weights, seminiferous tubule degeneration, spermatid/spermatocyte depletion in the testes and cell debris, sperm granuloma, and hypospermia/abnormal spermatids in the epididymis. Findings in the testes and epididymis did not reverse by the end of the recovery period. MMAE-containing ADCs have been associated with adverse ovarian effects when administered to sexually immature animals.

Adverse effects included decrease in, or absence of, secondary and tertiary ovarian follicles after weekly administration to cynomolgus monkeys in studies of 4-week duration. These effects showed a trend towards recovery 6 weeks after the end of dosing; no changes were observed in primordial follicles.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies with enfortumab vedotin-ejfv or the small molecule cytotoxic agent (MMAE) have not been conducted. MMAE was genotoxic in the rat bone marrow micronucleus study through an aneugenic mechanism. This effect is consistent with the pharmacological effect of MMAE as a microtubule-disrupting agent.

MMAE was not mutagenic in the bacterial reverse mutation assay (Ames test) or the L5178Y mouse lymphoma forward mutation assay. Fertility studies with enfortumab vedotin-ejfv or MMAE have not been conducted. However, results of repeat-dose toxicity studies indicate the potential for enfortumab vedotin-ejfv to impair female and male reproductive function and fertility.

In repeat-dose toxicology studies conducted in rats for up to 13 weeks, doses ≥2 mg/kg enfortumab vedotin-ejfv (at exposures similar to the exposures at the recommended human dose) resulted in decreases in testes and epididymis weights, seminiferous tubule degeneration, spermatid/spermatocyte depletion in the testes and cell debris, sperm granuloma, and hypospermia/abnormal spermatids in the epididymis. Findings in the testes and epididymis did not reverse by the end of the recovery period. MMAE-containing ADCs have been associated with adverse ovarian effects when administered to sexually immature animals.

Adverse effects included decrease in, or absence of, secondary and tertiary ovarian follicles after weekly administration to cynomolgus monkeys in studies of 4-week duration. These effects showed a trend towards recovery 6 weeks after the end of dosing; no changes were observed in primordial follicles.

📚 References 8 words ▾

15 REFERENCES 1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION PADCEV ® (PAD-sev) (enfortumab vedotin-ejfv) for injection If your healthcare provider prescribes PADCEV in combination with the medicines pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, also read the Medication Guide that comes with these medicines for additional important information. What is the most important information I should know about PADCEV? PADCEV may cause serious side effects, including: Skin reactions.

Skin reactions including severe skin reactions have happened in people treated with PADCEV and may be more common when PADCEV is given with pembrolizumab. In some cases, these severe skin reactions have caused death. Most severe skin reactions occurred during the first cycle of treatment but may happen later.

Your healthcare provider will monitor you, may stop your treatment with PADCEV completely or for a period of time (temporarily), may change your dose, and may prescribe medicines if you get skin reactions. Tell your healthcare provider right away if you develop any of these signs of a new or worsening skin reaction: • target lesions (skin reactions that look like rings) • rash or itching that continues to get worse • blistering or peeling of the skin • painful sores or ulcers in mouth or nose, throat, or genital area • fever or flu-like symptoms • swollen lymph nodes See “What are the possible side effects of PADCEV?” for more information about side effects.

What is PADCEV? PADCEV is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter, or urethra). • PADCEV may be used with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph before and after the surgical removal of your bladder when your bladder cancer has spread into the muscle layer of the bladder (muscle invasive bladder cancer [MIBC]) but not to other parts of the body. • PADCEV may be used with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph when your bladder or urinary tract cancer has spread or cannot be removed by surgery (locally advanced or metastatic). • PADCEV may be used alone when your bladder or urinary tract cancer has spread or cannot be removed by surgery (locally advanced or metastatic) if you: o have received PD-1 or PD-L1 immunotherapy medicine and chemotherapy that contains platinum, or o are not able to receive a chemotherapy that contains cisplatin and you have received 1 or more prior therapies.

It is not known if PADCEV is safe and effective in children. Before receiving PADCEV, tell your healthcare provider about all of your medical conditions, including if you: • are currently experiencing numbness or tingling in your hands or feet • have a history of high blood sugar or diabetes • have liver problems • are pregnant or plan to become pregnant. PADCEV can harm your unborn baby.

Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with PADCEV. Females who are able to become pregnant: o Your healthcare provider should do a pregnancy test before you start treatment with PADCEV. o You should use an effective method of birth control during your treatment and for at least 2 months after the last dose of PADCEV. Males with a female sexual partner who is able to become pregnant: o If your female partner is pregnant, PADCEV can harm the unborn baby. o You should use an effective method of birth control during your treatment and for at least 4 months after the last dose of PADCEV. • are breastfeeding or plan to breastfeed.

It is not known if PADCEV passes into your breast milk. Do not breastfeed during treatment and for 3 weeks after the last dose of PADCEV. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking PADCEV with certain other medicines may cause side effects. How will I receive PADCEV? • PADCEV will be given to you by intravenous (IV) infusion… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 27 words ▾

Indications and Usage ( 1 ) 07/2026 Dosage and Administration ( 2.1 ) 07/2026 Warnings and Precautions ( 5.1 ), ( 5.3 ), ( 5.4 ) 07/2026

📄 Package Label / Principal Display Panel 86 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 51144-020-01 PADCEV ® enfortumab vedotin-ejfv FOR INJECTION 20 mg/vial CAUTION: Cytotoxic Agent For intravenous infusion use only Must reconstitute and dilute before use Single-dose vial. Discard unused portion Rx Only Padcev (enfortumab vedotin-ejfv) for injection 20 mg/vial label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 51144-030-01 PADCEV ® enfortumab vedotin-ejfv FOR INJECTION 30 mg/vial CAUTION: Cytotoxic Agent For intravenous infusion use only Must reconstitute and dilute before use Single-dose vial. Discard unused portion Rx Only Padcev (enfortumab vedotin-ejfv) for injection 30 mg/vial label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.2K
Units reimbursed last 4 qtrs
8.8K
Gross reimbursed last 4 qtrs
$11.74M
Avg / prescription
$5,301.31
Avg / unit
$1,337.93
Latest quarter Q1 2026
456Rx
Fee-for-service vs managed care ⓘ
33% FFS 67% MCO
Fee-for-service · 741 Rx Managed care · 1,474 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 24 units · 0.3 per 100k residents WA Idaho: 6 units · 0.3 per 100k residents ID Montana: 33 units · 2.9 per 100k residents MT North Dakota: no data reported ND Minnesota: 95 units · 1.7 per 100k residents MN Wisconsin: no data reported WI Michigan: 89 units · 0.9 per 100k residents MI New York: 593 units · 3.0 per 100k residents NY Vermont: no data reported VT New Hampshire: 30 units · 2.1 per 100k residents NH Oregon: 41 units · 1.0 per 100k residents OR Nevada: 65 units · 2.0 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 45 units · 0.4 per 100k residents IL Indiana: 56 units · 0.8 per 100k residents IN Ohio: 148 units · 1.3 per 100k residents OH Pennsylvania: 38 units · 0.3 per 100k residents PA New Jersey: 131 units · 1.4 per 100k residents NJ Massachusetts: 789 units · 11.3 per 100k residents MA California: 609 units · 1.6 per 100k residents CA Utah: 73 units · 2.1 per 100k residents UT Colorado: 86 units · 1.5 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 11 units · 0.2 per 100k residents KY West Virginia: no data reported WV Virginia: 279 units · 3.2 per 100k residents VA Maryland: 4,092 units · 66.2 per 100k residents MD Connecticut: 35 units · 1.0 per 100k residents CT Rhode Island: no data reported RI Arizona: 37 units · 0.5 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: 93 units · 3.0 per 100k residents AR Tennessee: 54 units · 0.8 per 100k residents TN North Carolina: 288 units · 2.7 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 99 units · 2.4 per 100k residents OK Louisiana: 69 units · 1.5 per 100k residents LA Mississippi: 36 units · 1.2 per 100k residents MS Alabama: 32 units · 0.6 per 100k residents AL Georgia: 96 units · 0.9 per 100k residents GA D.C.: 8 units · 1.2 per 100k residents DC Hawaii: no data reported HI Texas: 137 units · 0.4 per 100k residents TX Florida: 306 units · 1.4 per 100k residents FL
Units reimbursed · per 100k residents
0.266.2
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Maryland 66.2 /100k
2 Massachusetts 11.3 /100k
3 Virginia 3.2 /100k
4 Arkansas 3.0 /100k
5 New York 3.0 /100k
6 Montana 2.9 /100k
7 North Carolina 2.7 /100k
8 Oklahoma 2.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PADCEV EJFV (this brand).

Top reported reactions

Rash945
Neuropathy Peripheral852
Malignant Neoplasm Progression837
Diarrhoea468
Pruritus419
Fatigue404
Death400

Age at onset

Adolescent1
Adult629
Elderly2,219

Reporter sex

7,224 reports
Male · 76%
Female · 24%
Unknown · 0%

Serious outcomes

Hospitalization2,448
Death1,434
Life-threatening316
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 2,437 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 SEAGEN INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SEAGEN INC. 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9177 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 51144-0003-01 · SEAGEN 51144-0030-01 · SEAGEN →
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.