Home › NDC Lookup › Ingredients › Tisotumab Vedotin › 51144-0003-01
💉image loading
(from DailyMed)

TIVDAK tisotumab vedotin 40 mg/4mL Injection, Powder, For Solution — NDC 51144-003-01 (Billing 51144-0003-01)

by SEAGEN INC. · 1 VIAL in 1 CARTON / 4 mL in 1 VIAL

This is a package of TIVDAK tisotumab vedotin 40 mg/4mL Injection, Powder, For Solution from SEAGEN INC., marketed since Sep 2021 and currently FDA-listed. It is this product's only package size.

NDC 51144-0003-01
🏷️ FDA NDC (as labeled) 51144-003-01 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 Jul 24, 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 51144-003-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
51144 labeler · 003 product · 01 package
Package marketed since
Sep 20, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0351144003014
Medicaid fills, this package
356 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51144-003-01
Product NDC 51144-003
11-digit billing NDC 51144000301
NCPDP billing unit EA — each (per item)
RxCUI 2571099, 2571104
UNII T41737F88A
UPC 0351144003014
Application # BLA761208
SPL Set ID c9fe3f32-4219-466e-acb9-3f609b4f4df1
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-09-20
Route INTRAVENOUS
Dosage form INJECTION, POWDER, FOR SOLUTION
Substance TISOTUMAB VEDOTIN
Biologic (Purple Book) 351(a)

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

GPI-14 21359280802120
GPI class Tivdak
GCN Seq No 082680
GCN 51026
HICL code 047582
Ingredient (HICL) Tisotumab Vedotin-Tftv
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 TIVDAK 40 MG VIAL
FDB brand name Tivdak
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 082680
  • GCN: 51026
  • GPI-14 (Medi-Span): 21359280802120
  • HICL (First Databank): 047582
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2571099
Why two NDCs? The FDA registers this code as 51144-003-01 — 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 → 51144-0003-01. 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 TIVDAK 40 MG VIAL Ingredient Tisotumab Vedotin-Tftv

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 $7,047.27 $28,189.09 / 4 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9273 $196.121 / J9273 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)51144-003-01
11-digit billing NDC51144-0003-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9273
DescriptorInjection, tisotumab vedotin-tftv, 1 mg
Billing units / pkg40 units
How the units are derivedThis package is 1; the HCPCS unit is 1 MG, so one package = 40 billing units.
Medicare Part B spend (2026 (Q1))$4,801,458 · 203 claims · $23,652.50 per claim (all NDCs under J9273)
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
51144-0003-01 You're viewing this Main listing 1 VIAL in 1 CARTON / 4 mL in 1 VIAL 2021-09-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tivdak 40 mg/4mLthis 51144-0003-01 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

🏛️
2021
First FDA approval
Sep 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2033
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 Sep 2033. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 20, 2021 ⏳ ~7 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
Tivdaktisotumab vedotin-tftv
🔒 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
2021 2023 2025 2027 2029 2031 2033
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 dateSep 20, 2033
Common questions
Is there a biosimilar for TIVDAK 40 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.

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 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.
  • 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.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

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 applicationBLA761208 (BLA)
Labeler code51144
First marketedSep 2021
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 🔄 Drug / Laboratory Test Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: OCULAR TOXICITY • TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss, and corneal ulceration. [see Warnings and Precautions (5.1) ]. • Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ] . • Adhere to the required premedication and eye care before, during, and after infusion. [see Dosage and Administration (2.2) ]. • Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ].

WARNING: OCULAR TOXICITY See full prescribing information for complete boxed warning. • TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss and corneal ulceration. ( 5.1 ) • Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. ( 2.2 , 5.1 ) • Adhere to the required premedication and eye care before, during, and after infusion.

( 2.2 ) • Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity. ( 2.3 , 5.1 )

🎯 Indications and Usage 60 words ▾

1 INDICATIONS AND USAGE TIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • For intravenous infusion only. Do not administer TIVDAK as an intravenous push or bolus. Do not mix with, or administer as an infusion with, other medicinal products. ( 2.4 ) • The recommended dose of TIVDAK is 2 mg/kg (up to a maximum of 200 mg) given as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. ( 2.1 )

2.1Recommended Dosage The recommended dose of TIVDAK is 2 mg/kg (up to a maximum of 200 mg for patients ≥100 kg) administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

2.2Premedication and Required Eye Care Adhere to the following recommendations to reduce the risk of ocular adverse reactions [see Warnings and Precautions (5.1) ]. • Ophthalmic exam by eye care provider: Conduct an ophthalmic exam prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. The ophthalmic exam should include visual acuity, slit lamp exam of the anterior segment of the eye, and an assessment of normal eye movement. • Topical corticosteroid eye drops: Instruct patients to administer one drop in each eye prior to each infusion and to continue to administer eye drops in each eye three times daily for 72 hours after each infusion.

The initial prescription and all renewals of any corticosteroid medication should be made only after examination with a slit lamp. • Topical ocular vasoconstrictor drops: Administer in each eye immediately prior to each infusion of TIVDAK. • Cold packs: Use cooling eye pads during each infusion of TIVDAK. • Topical lubricating eye drops: Instruct patients to administer for the duration of therapy and for 30 days after the last dose of TIVDAK. • Contact lenses: Advise patients to avoid wearing contact lenses for the entire duration of therapy unless advised by their eye care provider.

2.3Dosage Modifications for Adverse Reactions The recommended TIVDAK dose reduction schedule is provided in Table 1 . Table 1: Dosage Reduction Schedule TIVDAK Dose Level Starting dose 2 mg/kg (up to a maximum of 200 mg for patients ≥100 kg) First dose reduction 1.3 mg/kg (up to a maximum of 130 mg for patients ≥100 kg) Second dose reduction 0.9 mg/kg Permanently discontinue in patients who cannot tolerate 0.9 mg/kg (up to a maximum of 90 mg for patients ≥100 kg) The recommended dose modifications for adverse reactions are provided in Table 2 .

Table 2: Dosage Modifications for Adverse Reactions Adverse Reaction Severity Occurrence TIVDAK Dose Modification Keratitis Refer patients to an eye care provider promptly for an assessment of new or worsening ocular symptoms. [see Warnings and Precautions (5.1) ] Nonconfluent superficial keratitis Any Monitor. Confluent superficial keratitis, a corneal epithelial defect, or a 3 line or more loss in best corrected visual acuity First occurrence Withhold dose until resolution, or improvement to nonconfluent superficial keratitis, then resume treatment at the next lower dose level.

Second occurrence Permanently discontinue. Ulcerative keratitis or perforation Any Permanently discontinue. Conjunctival or corneal scarring or symblepharon [see Warnings and Precautions (5.1) ] Any scarring or symblepharon Any Permanently discontinue.

Conjunctivitis and other ocular adverse reactions [see Warnings and Precautions (5.1) ] Nonconfluent superficial punctate conjunctival defects, mild vasodilation Any Monitor. Confluent superficial punctate conjunctival defects, moderate to severe vasodilation First occurrence Withhold dose until resolution or improvement to nonconfluent superficial punctate conjunctival defects, mild vasodilation, then resume treatment at the same dose. Second occurrence Withhold dose until resolution or improvement to nonconfluent superficial punctate conjunctival defects, mild vasodilation, then resume treatment at the next lower dose level.

If no resolution or improvement to nonconfluen… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 46 words ▾

3 DOSAGE FORMS AND STRENGTHS For Injection: 40 mg of tisotumab vedotin-tftv as a white to off-white lyophilized cake or powder in a single-dose vial for reconstitution. For Injection: 40 mg as a lyophilized cake or 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 • Peripheral neuropathy: Monitor patients for new or worsening peripheral neuropathy. Withhold, reduce the dose, or permanently discontinue TIVDAK based on severity. ( 2.3 , 5.2 ) • Hemorrhage: Monitor patients for signs and symptoms of hemorrhage.

Withhold, reduce the dose, or permanently discontinue TIVDAK based on severity. ( 2.3 , 5.3 ) • Pneumonitis: Severe, life-threatening, or fatal pneumonitis may occur. Withhold TIVDAK for persistent or recurrent Grade 2 pneumonitis and consider dose reduction.

Permanently discontinue TIVDAK for Grade 3 or 4 pneumonitis. ( 2.3 , 5.4 ) • Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions, including events of fatal or life-threatening Stevens-Johnson syndrome (SJS), can occur in patients treated with TIVDAK. Immediately withhold TIVDAK for suspected severe cutaneous adverse reactions, including SJS.

Permanently discontinue TIVDAK for confirmed Grade 3 or 4 severe cutaneous adverse reactions, including SJS. ( 2.3 , 5.5 ) • Embryo-fetal toxicity: TIVDAK can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception.

( 5.6 , 8.1 , 8.3 )

5.1Ocular Adverse Reactions TIVDAK can cause severe ocular adverse reactions, including conjunctivitis, keratopathy (keratitis, punctate keratitis, and ulcerative keratitis), and dry eye (increased lacrimation, eye pain, eye discharge, pruritus, irritation, and foreign body sensation), that may lead to changes in vision and/or corneal ulceration. Ocular adverse reactions occurred in 55% of patients with cervical cancer treated with TIVDAK across clinical trials. The most common ocular adverse reactions were conjunctivitis (32%), dry eye (24%), keratopathy (17%), and blepharitis (5%).

Grade 3 ocular adverse reactions occurred in 3.3% of patients, including severe ulcerative keratitis in 1.2% of patients. Nine patients (2.1%) experienced ulcerative keratitis (including one with perforation requiring corneal transplantation), six (1.4%) conjunctival ulcer, four (0.9%) corneal erosion, two (0.5%) conjunctival erosion, and two (0.5%) symblepharon. The median time to onset of the first ocular adverse reaction was 1.2 months (range, 0-17.1).

Of the patients who experienced ocular events, 59% had complete resolution and 31% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade) at last follow up. Ocular adverse reactions led to permanent discontinuation of TIVDAK in 6% of patients with cervical cancer. In innovaTV 301, 8 (3.2%) patients experienced delayed ocular adverse reactions occurring more than 30 days after discontinuation of TIVDAK.

These adverse reactions included 3 patients with ulcerative keratitis, and one patient (each) with keratitis, punctate keratitis and corneal erosion, blepharitis and conjunctival hyperemia, conjunctival scar, and conjunctivitis and xerophthalmia. Refer patients to an eye care provider to conduct an ophthalmic exam prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. The exam should include visual acuity, slit lamp exam of the anterior segment of the eye, and an assessment of normal eye movement and ocular signs or symptoms which include dry or irritated eyes, eye secretions or blurry vision.

Adhere to the required premedication and eye care before, during, and after infusion to reduce the risk of ocular adverse reactions [see Dosage and Administration (2.2) ]. Monitor for ocular toxicity and promptly refer patients to an eye care provider for any new or worsening ocular signs and symptoms. Withhold, reduce, or permanently discontinue TIVDAK based on the severity or persistence of the ocular adverse reaction [see Dosage and Administration (2.3) ].

5.2Peripheral Neuropathy Peripheral neuropathy occurred in 39% of patients with cervical cancer treated with TIVDAK across clinical trials; 6% of patients experienced Grade 3 peripheral neuropathy. Perip… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Ocular Adverse Reactions [see Boxed Warning , Warnings and Precautions (5.1) ] • Peripheral Neuropathy [see Warnings and Precautions (5.2) ] • Hemorrhage [see Warnings and Precautions (5.3) ] • Pneumonitis [see Warnings and Precautions (5.4) ] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] The most common (≥25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased, peripheral neuropathy, conjunctival adverse reactions, nausea, fatigue, aspartate aminotransferase increased, epistaxis, alopecia, alanine aminotransferase increased, and hemorrhage.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Seagen Inc. at 1-855-4SEAGEN 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 data in the WARNINGS AND PRECAUTIONS section reflect exposure to TIVDAK in 425 patients with recurrent or metastatic cervical cancer who received at least one dose of TIVDAK at 2 mg/kg intravenously every 3 weeks in innovaTV 301, innovaTV 204, innovaTV 201 (NCT02001623), innovaTV 202 (NCT02552121), innovaTV 203 (NCT03245736), and innovaTV 206 (NCT03913741).

The median duration of treatment with TIVDAK was 3.7 months (range: 0.4-40.2). In this pooled safety population, the most common (≥25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased (45%), peripheral neuropathy (39%), conjunctival adverse reactions (38%), nausea (37%), fatigue (36%), aspartate aminotransferase increased (33%), epistaxis (33%), alopecia (31%), alanine aminotransferase increased (30%), and hemorrhage (28%). The data described in this section reflect exposure to TIVDAK from innovaTV 301 and innovaTV 204. innovaTV 301 The safety of TIVDAK was evaluated in an open-label, randomized study in patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy [see Clinical Studies (14.1) ].

A total of 250 patients received TIVDAK 2 mg/kg every 3 weeks until disease progression or unacceptable toxicity. The median duration of treatment with TIVDAK was 3.7 months (range: 0.4-19). Serious adverse reactions occurred in 33% of patients receiving TIVDAK.

The most common (≥2%) serious adverse reactions were urinary tract infection (4.8%), small intestinal obstruction (2.4%), sepsis (2%), abdominal pain (2%), and hemorrhage (2%). Fatal adverse reactions occurred in 1.6% of patients who received TIVDAK, including acute kidney injury (0.4%), pneumonia (0.4%), sepsis (0.4%) and Stevens-Johnson syndrome (0.4%). Adverse reactions leading to permanent discontinuation occurred in 15% of patients receiving TIVDAK; the most common (≥3%) adverse reactions leading to permanent discontinuation were peripheral neuropathy (6%) and ocular adverse reactions (6%).

Adverse reactions leading to dose interruption occurred in 39% of patients receiving TIVDAK; the most common (≥3%) adverse reactions leading to dose interruption were ocular adverse reactions (16%) and peripheral neuropathy (6%). Adverse reactions leading to dose reduction occurred in 30% of patients receiving TIVDAK; the most common (≥3%) adverse reactions leading to dose reduction were peripheral neuropathy (10%) and ocular adverse reactions (10%). The ocular adverse reactions included conjunctival disorders (4.8%), keratopathy (4%), and dry eye (0.8%).

The most common (≥25%) adverse reactions, including laboratory abnormalities, in patients receiving TIVDAK were hemoglobin decreased, peripheral neuropathy, conjunctival adverse reactions, aspartate aminotransferase increased, nausea, alanine aminotransferase increased, fatigue, sod… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 73 words ▾

7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors: Closely monitor for TIVDAK adverse reactions. ( 7.1 )

7.1Effects of Other Drugs on TIVDAK Strong CYP3A4 Inhibitors MMAE is a CYP3A4 substrate. Concomitant use of TIVDAK with strong CYP3A4 inhibitors may increase unconjugated MMAE exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of TIVDAK adverse reactions. Closely monitor patients for adverse reactions of TIVDAK when used concomitantly with strong CYP3A4 inhibitors.

🔄 Drug / Laboratory Test Interactions 58 words ▾

7.1Effects of Other Drugs on TIVDAK Strong CYP3A4 Inhibitors MMAE is a CYP3A4 substrate. Concomitant use of TIVDAK with strong CYP3A4 inhibitors may increase unconjugated MMAE exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of TIVDAK adverse reactions. Closely monitor patients for adverse reactions of TIVDAK when used concomitantly with strong CYP3A4 inhibitors.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Moderate or severe hepatic impairment: Exposure to MMAE and adverse reactions are increased. Avoid use. ( 8.6 ) • Lactation: Advise women not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on the mechanism of action and findings in animals, TIVDAK can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available human data on TIVDAK use in pregnant women to inform a drug-associated risk. In an animal reproduction study, administration of the small molecule component of TIVDAK, MMAE, to pregnant rats during organogenesis caused embryo-fetal mortality and structural abnormalities at exposures below the clinical exposure at the recommended dose (see Data ) .

Advise patients of the potential risk to a 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 No embryo-fetal development studies in animals have been performed with tisotumab vedotin-tftv. In an embryo-fetal development study in pregnant rats, administration of two intravenous doses of MMAE, the small molecule component of TIVDAK, on gestational days 6 and 13 caused embryo-fetal mortality and structural abnormalities, including protruding tongue, malrotated limbs, gastroschisis, and agnathia compared to controls at a dose of 0.2 mg/kg (approximately 0.5-fold the human area under the curve [AUC] at the recommended dose).

8.2Lactation Risk Summary There are no data on the presence of tisotumab vedotin-tftv 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 TIVDAK and for 3 weeks after the last dose.

8.3Females and Males of Reproductive Potential TIVDAK can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ]. Pregnancy testing Verify pregnancy status in females of reproductive potential prior to initiating TIVDAK treatment. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with TIVDAK 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 TIVDAK and for 4 months after the last dose. Infertility Females Based on findings in animal studies with MMAE-containing antibody-drug conjugates (ADCs), TIVDAK may impair female fertility. The effect on fertility is reversible [see Nonclinical Toxicology (13.1) ].

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

8.4Pediatric Use Safety and effectiveness of TIVDAK in pediatric patients have not been established. Nonclinical studies of tisotumab vedotin-tftv suggest a lack of anti-tumor activity and penetrance to brain based on limited in vivo data from tissue factor (TF)-expressing subcutaneous or orthotopic pediatric models of high‑grade gliomas/glioblastomas (HGG/GBM) and diffuse intrinsic pontine glioma (DIPG).

8.5Geriatric Use Of the 425 patients with cervical cancer treated with TIVDAK across clinical trials, 14% were ≥65 years of age and 2.4% were ≥75 years of age. Grade ≥3 adverse reactions occurred in 60% of patients ≥65 years and in 55% of patients <65 years. Drug was discontinued due to an adverse reaction in 25% of patients ≥65 years and in 13% of patients <65 years.

Clinical studies of TIVDAK did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients.

8.6Hepatic Impairment Avoid use of TIVDAK in patients with moderate or severe hepatic impairment [aspartate amin… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 213 words ▾

8.1Pregnancy Risk Summary Based on the mechanism of action and findings in animals, TIVDAK can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available human data on TIVDAK use in pregnant women to inform a drug-associated risk. In an animal reproduction study, administration of the small molecule component of TIVDAK, MMAE, to pregnant rats during organogenesis caused embryo-fetal mortality and structural abnormalities at exposures below the clinical exposure at the recommended dose (see Data ) .

Advise patients of the potential risk to a 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 No embryo-fetal development studies in animals have been performed with tisotumab vedotin-tftv. In an embryo-fetal development study in pregnant rats, administration of two intravenous doses of MMAE, the small molecule component of TIVDAK, on gestational days 6 and 13 caused embryo-fetal mortality and structural abnormalities, including protruding tongue, malrotated limbs, gastroschisis, and agnathia compared to controls at a dose of 0.2 mg/kg (approximately 0.5-fold the human area under the curve [AUC] at the recommended dose).

🧒 Pediatric Use 55 words ▾

8.4Pediatric Use Safety and effectiveness of TIVDAK in pediatric patients have not been established. Nonclinical studies of tisotumab vedotin-tftv suggest a lack of anti-tumor activity and penetrance to brain based on limited in vivo data from tissue factor (TF)-expressing subcutaneous or orthotopic pediatric models of high‑grade gliomas/glioblastomas (HGG/GBM) and diffuse intrinsic pontine glioma (DIPG).

🧓 Geriatric Use 94 words ▾

8.5Geriatric Use Of the 425 patients with cervical cancer treated with TIVDAK across clinical trials, 14% were ≥65 years of age and 2.4% were ≥75 years of age. Grade ≥3 adverse reactions occurred in 60% of patients ≥65 years and in 55% of patients <65 years. Drug was discontinued due to an adverse reaction in 25% of patients ≥65 years and in 13% of patients <65 years.

Clinical studies of TIVDAK did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tisotumab vedotin-tftv is a tissue factor (TF)-directed antibody drug conjugate (ADC). The antibody is a human IgG1 directed against cell surface TF. TF is the primary initiator of the extrinsic blood coagulation cascade.

The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease-cleavable linker. Nonclinical data suggests that the anticancer activity of tisotumab vedotin-tftv is due to the binding of the ADC to TF expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death.

In vitro, tisotumab vedotin-tftv also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

12.2Pharmacodynamics Tisotumab vedotin-tftv exposure-response relationships and the time course of pharmacodynamics response have not been fully characterized. Cardiac Electrophysiology At the recommended dose, tisotumab vedotin-tftv had no large mean effect on QTc prolongation (>20 msec).

12.3Pharmacokinetics Table 8 summarizes the exposure parameters of tisotumab vedotin-tftv and unconjugated MMAE (the cytotoxic component of tisotumab vedotin-tftv) following administration of one 3-week cycle of tisotumab vedotin-tftv 2 mg/kg to patients. Tisotumab vedotin-tftv concentrations peaked near the end of the infusion, while unconjugated MMAE concentrations peaked approximately 2 to 3 days after tisotumab vedotin-tftv dosing. Tisotumab vedotin-tftv C max increased proportionally, while AUC0-last increased in a more than dose-proportional manner, after a single dose ranging from 0.3–2.2 mg/kg (0.15 to 1.1 times the approved recommended dose).

There was no accumulation of tisotumab vedotin-tftv and unconjugated MMAE. Steady-state concentrations of tisotumab vedotin-tftv and unconjugated MMAE were reached after 1 treatment cycle. Table 8.

Exposure Parameters of Tisotumab Vedotin-tftv and Unconjugated MMAE C max =maximum concentration, AUC = area under the concentration-time curve from time 0 to 21 days (3 weeks) Tisotumab Vedotin-tftv Mean (± SD) Unconjugated MMAE Mean (± SD) C max 40.8 (8.12) μg/mL 5.91 (4.2) ng/mL AUC 57.5 (13.4) day*μg/mL 50 (35.8) day*ng/mL Distribution The tisotumab vedotin-tftv steady state volume of distribution is 7.83 (%CV: 19.1) L. Plasma protein binding of MMAE ranged from 68% to 82%, in vitro. Elimination The median terminal half-life of tisotumab vedotin-tftv and unconjugated MMAE is 4.04 (range: 2.26-7.25) days and 2.56 (range: 1.81-4.10) days, respectively.

The linear clearance of tisotumab vedotin-tftv and unconjugated MMAE was 1.54 (%CV: 28.8) L/day and 45.9 (%CV: 61.1) L/day, respectively. Elimination of MMAE appeared to be limited by its rate of release from tisotumab vedotin-tftv. Metabolism Tisotumab vedotin-tftv is expected to undergo catabolism to small peptides, amino acids, unconjugated MMAE, and unconjugated MMAE-related catabolites.

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

A similar excretion profile of MMAE is expected after tisotumab vedotin-tftv administration. Specific Populations No clinically significant differences in the pharmacokinetics of tisotumab vedotin-tftv were observed based on age (21 to 81 years), sex, race (white vs non-white) or ethnicity (Hispanic or Latino vs non-Hispanic or non-Latino). No clinically significant differences in exposures of tisotumab vedotin-tftv and unconjugated MMAE were observed in patients with mild to moderate renal im… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 121 words ▾

12.1Mechanism of Action Tisotumab vedotin-tftv is a tissue factor (TF)-directed antibody drug conjugate (ADC). The antibody is a human IgG1 directed against cell surface TF. TF is the primary initiator of the extrinsic blood coagulation cascade.

The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease-cleavable linker. Nonclinical data suggests that the anticancer activity of tisotumab vedotin-tftv is due to the binding of the ADC to TF expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death.

In vitro, tisotumab vedotin-tftv also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.

📦 How Supplied / Storage and Handling 129 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied TIVDAK (tisotumab vedotin-tftv) is supplied as a white to off-white lyophilized cake or powder in a 40 mg single-dose vial for reconstitution. TIVDAK vials are available in the following packages: • Carton of one 40 mg single-dose vial [NDC 51144-003-01] Storage Store TIVDAK vials refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light. Do not freeze.

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

1

How Supplied TIVDAK (tisotumab vedotin-tftv) is supplied as a white to off-white lyophilized cake or powder in a 40 mg single-dose vial for reconstitution. TIVDAK vials are available in the following packages: • Carton of one 40 mg single-dose vial [NDC 51144-003-01]

📋 Description 177 words ▾

11 DESCRIPTION Tisotumab vedotin-tftv is a Tissue Factor (TF) directed antibody drug conjugate (ADC) comprised of a human anti-TF IgG1-kappa antibody conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a protease-cleavable vc (valine-citrulline) linker. The monoclonal antibody is produced in a mammalian cell line (Chinese hamster ovary). MMAE and the linker are produced by chemical synthesis.

Each monoclonal antibody molecule carries an average of 4 MMAE molecules. Tisotumab vedotin-tftv has an approximate molecular weight of 153 kDa. The chemical structure is as follows: Figure 1.

Structural Formula TIVDAK (tisotumab vedotin-tftv) for injection, is provided as a sterile, preservative-free, white to off-white lyophilized cake or powder in a single-dose vial for infusion after dilution. Following reconstitution with 4 mL of Sterile Water for Injection, a clear to slightly opalescent, colorless to brownish-yellow solution containing 10 mg/mL tisotumab vedotin-tftv is produced [see Dosage and Administration (2.3) ]. Each mL of reconstituted solution contains 10 mg of tisotumab vedotin-tftv, d-mannitol (30 mg), l-histidine (2.11 mg), l-histidine monohydrochloride (3.44 mg), and sucrose (30 mg), at pH 6.0.

Structural Formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Ocular Adverse Reactions • Inform patients about the eye exam they will receive with an eye care provider before starting TIVDAK, before each of the first nine cycles and as clinically indicated [see Warnings and Precautions (5.1) ] . • Inform patients about the ocular signs or symptoms the eye care provider will review before each cycle [see Warnings and Precautions (5.1) ] . • Inform patients that ocular adverse reactions may occur during treatment with TIVDAK and to contact their healthcare provider if they experience new or worsening ocular signs and symptoms [see Warnings and Precautions (5.1) ] . • Instruct patients to bring their eye drops to each infusion and advise on how to administer the eye drops throughout treatment [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ]. • Inform patients to avoid wearing contact lenses during treatment unless directed by an eye care provider [see Dosage and Administration (2.2) ].

Peripheral Neuropathy • Advise patients to report to their healthcare provider any numbness and tingling of the hands or feet or muscle weakness [see Warnings and Precautions (5.2) ]. Hemorrhage • Instruct patients to contact their healthcare provider to seek immediate medical attention for signs or symptoms of unusual severe bleeding or hemorrhage [see Warnings and Precautions (5.3) ]. Pneumonitis • Advise patients to immediately report new or worsening respiratory symptoms [see Warnings and Precautions (5.4) ].

Severe Cutaneous Adverse Reactions • Inform patients of the signs and symptoms of severe cutaneous adverse reactions, including life-threatening and potentially fatal SJS, which include target lesions, worsening skin reactions, blistering or peeling of the skin, painful sores in mouth, nose, throat, or genital area, fever or flu-like symptoms, and swollen lymph nodes [see Warnings and Precautions (5.5) ]. • Instruct patients to contact their healthcare provider to seek immediate medical attention for signs or symptoms of severe cutaneous adverse reactions, including SJS [see Warnings and Precautions (5.5) ].

Embryo-Fetal Toxicity • Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients to inform their healthcare providers of a known or suspected pregnancy [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1) ]. • Advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose [see Use in Specific Populations (8.1 , 8.3) ].

Lactation • Advise women not to breastfeed during treatment with TIVDAK and for 3 weeks after the last dose [see Use in Specific Populations (8.2) ] . Manufactured by: Seagen Inc. Bothell, WA 98021 1-855-4SEAGEN Marketed by: Seagen Inc.

Bothell, WA 98021 and Genmab US, Inc. Plainsboro, NJ 08536 U.S. License 2257 TIVDAK ® is a trademark owned by Seagen Inc. ©2025 Seagen Inc. and Genmab US, Inc.

LAB-1596-1.0

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 11/2025 MEDICATION GUIDE TIVDAK (TIV-dack) (tisotumab vedotin-tftv) for injection, for intravenous use What is the most important information I should know about TIVDAK?

TIVDAK can cause serious side effects, including: Eye problems . Eye problems are common with TIVDAK, and can also be severe. TIVDAK can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss.

Tell your healthcare provider if you develop new or worsening vision changes or eye problems during treatment with TIVDAK. • Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with TIVDAK, before each infusion for your first 9 infusions of TIVDAK, and as needed for any new or worsening signs or symptoms of eye problems. • Your healthcare provider will ask if you have any signs or symptoms of eye problems before each infusion. You will be referred to an eye specialist for any new or worsening signs or symptoms of eye problems. • Your healthcare provider will prescribe 3 different types of eye drops before you start treatment with TIVDAK.

Bring the eye drops with you to each infusion and use them as directed by your healthcare provider to reduce your risk of eye problems: o Use 1 drop of steroid eye drops in each eye before each infusion and continue to use your eye drops 3 times a day for 3 days after each infusion. o Use vasoconstrictor eye drops right before each infusion. o Use lubricating eye drops throughout treatment and for 30 days after your last dose of TIVDAK. • Do not wear contact lenses throughout your treatment with TIVDAK unless you are told to use them by your eye specialist.

See “ What are the possible side effects of TIVDAK? ” for more information about side effects. What is TIVDAK? TIVDAK is a prescription medicine used to treat adults with cervical cancer: • that has returned or has spread to other parts of the body, and • who have received chemotherapy that did not work or is no longer working.

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

Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TIVDAK. Females who are able to become pregnant: o Your healthcare provider should do a pregnancy test before you start treatment with TIVDAK. o You should use an effective birth control during treatment and for 2 months after your last dose of TIVDAK. Males with female partners who are able to become pregnant: o You should use an effective birth control during treatment and for 4 months after your last dose of TIVDAK. • are breastfeeding or plan to breastfeed.

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

Taking TIVDAK with certain other medicines may cause side effects. How will I receive TIVDAK? • TIVDAK will be given to you by intravenous (IV) infusion into your vein over 30 minutes. • TIVDAK is usually given every 3 weeks. • Your healthcare provider will decide how many infusions you need. • Your healthcare provider will put cold packs on your eyes during each infusion. • Your healthcare provider may decrease your dose, temporarily stop, or completely stop treatment with TIVDAK if you have side effects. What are the possible side effects of TIVDAK?

TIVDAK can cause s… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Table 8 summarizes the exposure parameters of tisotumab vedotin-tftv and unconjugated MMAE (the cytotoxic component of tisotumab vedotin-tftv) following administration of one 3-week cycle of tisotumab vedotin-tftv 2 mg/kg to patients. Tisotumab vedotin-tftv concentrations peaked near the end of the infusion, while unconjugated MMAE concentrations peaked approximately 2 to 3 days after tisotumab vedotin-tftv dosing. Tisotumab vedotin-tftv C max increased proportionally, while AUC0-last increased in a more than dose-proportional manner, after a single dose ranging from 0.3–2.2 mg/kg (0.15 to 1.1 times the approved recommended dose).

There was no accumulation of tisotumab vedotin-tftv and unconjugated MMAE. Steady-state concentrations of tisotumab vedotin-tftv and unconjugated MMAE were reached after 1 treatment cycle. Table 8.

Exposure Parameters of Tisotumab Vedotin-tftv and Unconjugated MMAE C max =maximum concentration, AUC = area under the concentration-time curve from time 0 to 21 days (3 weeks) Tisotumab Vedotin-tftv Mean (± SD) Unconjugated MMAE Mean (± SD) C max 40.8 (8.12) μg/mL 5.91 (4.2) ng/mL AUC 57.5 (13.4) day*μg/mL 50 (35.8) day*ng/mL Distribution The tisotumab vedotin-tftv steady state volume of distribution is 7.83 (%CV: 19.1) L. Plasma protein binding of MMAE ranged from 68% to 82%, in vitro. Elimination The median terminal half-life of tisotumab vedotin-tftv and unconjugated MMAE is 4.04 (range: 2.26-7.25) days and 2.56 (range: 1.81-4.10) days, respectively.

The linear clearance of tisotumab vedotin-tftv and unconjugated MMAE was 1.54 (%CV: 28.8) L/day and 45.9 (%CV: 61.1) L/day, respectively. Elimination of MMAE appeared to be limited by its rate of release from tisotumab vedotin-tftv. Metabolism Tisotumab vedotin-tftv is expected to undergo catabolism to small peptides, amino acids, unconjugated MMAE, and unconjugated MMAE-related catabolites.

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

A similar excretion profile of MMAE is expected after tisotumab vedotin-tftv administration. Specific Populations No clinically significant differences in the pharmacokinetics of tisotumab vedotin-tftv were observed based on age (21 to 81 years), sex, race (white vs non-white) or ethnicity (Hispanic or Latino vs non-Hispanic or non-Latino). No clinically significant differences in exposures of tisotumab vedotin-tftv and unconjugated MMAE were observed in patients with mild to moderate renal impairment (CLcr 30 to < 90 mL/min using the Cockcroft-Gault equation) compared to patients with normal renal function.

The effect of severe renal impairment (CLcr 15 to < 30 mL/min) or end-stage renal disease with or without dialysis on pharmacokinetics of tisotumab vedotin-tftv and unconjugated MMAE is unknown. Patients with Hepatic Impairment Unconjugated MMAE exposures were 37% higher, but there were no clinically significant differences in exposures of tisotumab vedotin-tftv in patients with mild hepatic impairment compared to patients with normal hepatic function. The effect of moderate or severe hepatic impairment or liver transplantation on the pharmacokinetics of tisotumab vedotin-tftv or unconjugated MMAE is unknown.

Drug Interaction Studies Clinical Studies No clinical studies evaluating the drug-drug interaction potential of tisotumab vedotin-tftv have been conducted. To characterize the drug-drug interaction potential of unconjugated MMAE, clinical studies with another ADC that contains MMAE are described below, and similar effects on tisotumab vedotin-tftv and unconjugated MMAE exposures are expected with concomitant use of TIVDAK. There were no clin… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 36 words ▾

12.2Pharmacodynamics Tisotumab vedotin-tftv exposure-response relationships and the time course of pharmacodynamics response have not been fully characterized. Cardiac Electrophysiology At the recommended dose, tisotumab vedotin-tftv had no large mean effect on QTc prolongation (>20 msec).

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Recurrent or Metastatic Cervical Cancer innovaTV 301 The efficacy of TIVDAK was evaluated in innovaTV 301 (NCT04697628), an open-label, active-controlled, multicenter, randomized trial that enrolled 502 patients with recurrent or metastatic cervical cancer who had received one or two prior systemic therapy regimens in the recurrent or metastatic setting, including chemotherapy with or without bevacizumab and/or an anti-PD-(L)1 agent. Patients were excluded if they had active ocular surface disease, any prior episode of cicatricial conjunctivitis or ocular SJS, Grade ≥2 peripheral neuropathy, or clinically significant bleeding issues or risks.

Patients were randomized (1:1) to receive either TIVDAK 2 mg/kg intravenously every 3 weeks (n=253) or investigator’s choice of chemotherapy (n=249) consisting of topotecan, vinorelbine, gemcitabine, irinotecan or pemetrexed, until unacceptable toxicity or disease progression. Randomization was stratified by prior treatment with bevacizumab (yes or no), prior anti-PD-(L)1 therapy (yes or no), region (US, Europe, or Other), and ECOG performance status (0 or 1). Patients were treated until disease progression or unacceptable toxicity.

Tumor response assessments were performed every 6 weeks for the first 30 weeks and every 12 weeks thereafter. The major efficacy outcome measure was overall survival (OS). Additional efficacy outcome measures were progression free survival (PFS) and confirmed objective response rate (ORR) as assessed by investigator using RECIST v1.1.

The median age was 50 years (range: 26 to 80); 49% were White, 36% were Asian, 10% were not reported, 3% were American Indian or Alaskan Native, and 2% were Black; 20% were Hispanic/Latino; and baseline ECOG performance status was 0 (54%) or 1 (46%). Sixty-three percent of patients had squamous cell carcinoma, 32% had adenocarcinoma, and 5% had adenosquamous histology. Ninety percent of patients had extrapelvic disease; 61% of patients had received 1 prior line of systemic therapy, and 38% had 2 prior lines of systemic therapy.

All patients received prior chemotherapy; 64% received prior bevacizumab and 27% received prior anti-PD-1 or anti-PD-L1 therapy. Patients on the control arm received gemcitabine (44%), pemetrexed (32%), topotecan (8%), vinorelbine (7%), or irinotecan (6%). Statistically significant improvements in OS, PFS, and ORR were demonstrated for TIVDAK compared with chemotherapy.

Table 9 and Figure 2 summarize the efficacy results from innovaTV 301. Table 9. Efficacy Results in innovaTV 301 CI: confidence interval Endpoint TIVDAK N=253 Chemotherapy N=249 Overall Survival Number (%) of patients with events 123 (48.6) 140 (56.2) Median in months (95% CI) 11.5 (9.8, 14.9) 9.5 (7.9, 10.7) Hazard ratio (95% CI) 0.70 (0.54, 0.89) p-value 0.0038 Based on a stratified log-rank test.

The threshold for statistical significance is 0.0226 (2-sided) Progression Free Survival Number (%) of patients with events 198 (78.3) 194 (77.9) Median in months (95% CI) 4.2 (4.0, 4.4) 2.9 (2.6, 3.1) Hazard ratio (95% CI) 0.67 (0.54, 0.82) p-value <0.0001 Based on a stratified log-rank test. The threshold for statistical significance is 0.0453 (2-sided) Confirmed Objective Response Rate (CR + PR) ORR (%) (95% CI) 17.8 (13.3, 23.1) 5.2 (2.8, 8.8) p-value <0.0001 Based on CMH test. The threshold for statistical significance is 0.05 (2-sided) Complete response rate (%) 2.4 0 Partial response rate (%) 15.4

5.2Figure 2. Kaplan Meier Plot of Overall Survival innovaTV 204 The efficacy of TIVDAK was evaluated in innovaTV 204 (NCT03438396), an open-label, multicenter, single-arm trial that treated 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen. Patients were excluded if they had active ocular surface disease, any prior episode of cicatricial conjunctivitis… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies in animals have not been performed with tisotumab vedotin-tftv or MMAE. MMAE was positive for genotoxicity in the in vivo rat bone marrow micronucleus study through an aneugenic mechanism. MMAE was not mutagenic in the bacterial reverse mutation (Ames) assay or the L5178 TK +/- mouse lymphoma forward mutation assay.

Fertility studies with tisotumab vedotin-tftv or MMAE have not been conducted. However, results of a repeat-dose toxicity study in monkeys indicate the potential for tisotumab vedotin-tftv to impair male reproductive function and fertility. In a repeat-dose toxicology study conducted in monkeys for 13 weeks, doses ≥1 mg/kg tisotumab vedotin-tftv (≥0.6 times the human exposure [AUC] at the recommended dose) resulted in decreased testicular size and seminiferous tubule atrophy, reduction or absence in sperm count, and decreased sperm motility.

Findings of sperm absence and decreased motility did not reverse by the end of the recovery period at doses ≥3 mg/kg (≥1.7 times the human exposure [AUC] at the recommended dose). 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 in animals have not been performed with tisotumab vedotin-tftv or MMAE. MMAE was positive for genotoxicity in the in vivo rat bone marrow micronucleus study through an aneugenic mechanism. MMAE was not mutagenic in the bacterial reverse mutation (Ames) assay or the L5178 TK +/- mouse lymphoma forward mutation assay.

Fertility studies with tisotumab vedotin-tftv or MMAE have not been conducted. However, results of a repeat-dose toxicity study in monkeys indicate the potential for tisotumab vedotin-tftv to impair male reproductive function and fertility. In a repeat-dose toxicology study conducted in monkeys for 13 weeks, doses ≥1 mg/kg tisotumab vedotin-tftv (≥0.6 times the human exposure [AUC] at the recommended dose) resulted in decreased testicular size and seminiferous tubule atrophy, reduction or absence in sperm count, and decreased sperm motility.

Findings of sperm absence and decreased motility did not reverse by the end of the recovery period at doses ≥3 mg/kg (≥1.7 times the human exposure [AUC] at the recommended dose). 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

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL Rx Only NDC 51144 -003 -01 tivdak ® (tisotumab vedotin-tftv) for injection 40 mg/vial CAUTION: Hazardous Agent For intravenous infusion only Must reconstitute and dilute before use One single-dose vial. Discard unused portion. Provide the enclosed Medication Guide to each patient Seagen ® Genmab Dosage: See Prescribing Information.

Storage: Store vial refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in original carton to protect from light. DO NOT FREEZE. DO NOT SHAKE.

No U.S. Standard of Potency U.S. License 2257 TIVDAK and the TIVDAK logo are US registered trademarks owned by Seagen Inc.

Seagen is US registered trademark of Seagen Inc. ©2021 Seagen Inc. and Genmab. All rights reserved. Printed in USA PRODUCT OF SWITZERLAND Each vial contains 40 mg of tisotumab vedotin-tftv.

No Preservative After reconstitution with 4 mL of Sterile Water for Injection, USP, the concentration of TIVDAK (tisotumab vedotin-tftv) is 10 mg/mL Each mL of reconstituted solution contains 10 mg of tisotumab vedotin-tftv, D-mannitol (30 mg), L-histidine (2.11 mg), L-histidine monojhydrochloride (3.44 mg), and sucrose (30mg) Mfg by: Seagen Inc. Bothell, WA 98021 For more information: 1-855-4SEAGEN GTIN 00351144003014 1401 - 02 Rx Only NDC 51144 -003 -01 tivdak ® (tisotumab vedotin-tftv) for injection 40 mg/vial For intravenous infusion only Must reconstitute and dilute before use Single-dose vial.

Discard unused portion. CAUTION: Hazardous Agent Store at 2ºC to 8ºC (36ºF to 46ºF) Protect from light. DO NOT FREEZE.

DO NOT SHAKE. Dosage: See Prescribing Information Provide the enclosed Medication Guide to each patient. Mfg by: Seagen Inc.

U.S. License 2257 PRODUCT OF SWITZERLAND Seagen ® Genmab 1400-02 logo carton 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
356
Units reimbursed last 4 qtrs
703
Gross reimbursed last 4 qtrs
$4.95M
Avg / prescription
$13,916.39
Avg / unit
$7,049.78
Latest quarter Q1 2026
55Rx
Fee-for-service vs managed care ⓘ
12% FFS 88% MCO
Fee-for-service · 41 Rx Managed care · 315 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 205 units · 1.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 41 units · 1.0 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 34 units · 0.3 per 100k residents IL Indiana: 21 units · 0.3 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 83 units · 0.2 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 34 units · 0.4 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 25 units · 0.4 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: 21 units · 2.0 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 25 units · 0.2 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 103 units · 0.3 per 100k residents TX Florida: 110 units · 0.5 per 100k residents FL
Units reimbursed · per 100k residents
0.22.0
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 Delaware 2.0 /100k
2 New York 1.0 /100k
3 Oregon 1.0 /100k
4 Florida 0.5 /100k
5 Virginia 0.4 /100k
6 Tennessee 0.4 /100k
7 Texas 0.3 /100k
8 Indiana 0.3 /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.

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Tivdak — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Tivdak. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$836.2K
Claims incl. refills
33
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$25,340.04
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 Tisotumab vedotin — the ingredient across all brands.

Top reported reactions

Neuropathy Peripheral74
Malignant Neoplasm Progression70
Nausea64
Dry Eye51
Rash44
Conjunctivitis42
Diarrhoea38

Age at onset

Adult46
Elderly7

Reporter sex

912 reports
Male · 3%
Female · 97%

Serious outcomes

Life-threatening15
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 232 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 — Not published for this NDC No photo available yet for this listing.
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 J9273 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.
← 51144-0002-12 · SEAGEN 51144-0020-01 · 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.