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EMRELIS Telisotuzumab Vedotin 20 mg/mL Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 00074-1044-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

EMRELIS Telisotuzumab Vedotin 20 mg/mL Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 0074-1044-01 (Billing 00074-1044-01)

by AbbVie Inc. · 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE

This is a package of 1 vial of EMRELIS Telisotuzumab Vedotin 20 mg/mL Injection, Powder, Lyophilized, For Solution from AbbVie Inc., marketed since May 2025 and currently FDA-listed. It is this product's only package size.

NDC 00074-1044-01
🏷️ FDA NDC (as labeled) 0074-1044-01 billing pads the labeler 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 0074-1044-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0074 labeler · 1044 product · 01 package
Package marketed since
May 14, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
1 EA per package
Barcode (UPC-A, from the NDC)
3 0074104401 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0074-1044-01
Product NDC 0074-1044
11-digit billing NDC 00074104401
NCPDP billing unit EA — each (per item)
RxCUI 2714245, 2714251, 2714253, 2714255
UNII 976X9VXC3Z
Application # BLA761384
SPL Set ID bc04f980-3957-4e35-ab81-8ec2ffe87215
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-14
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance TELISOTUZUMAB VEDOTIN
Biologic (Purple Book) 351(a)

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

GPI-14 21355580602120
GCN Seq No 087734
GCN 57744
HICL code 050574
Ingredient (HICL) Telisotuzumab Vedotin-Tllv
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 EMRELIS 20 MG VIAL
FDB brand name Emrelis
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087734
  • GCN: 57744
  • GPI-14 (Medi-Span): 21355580602120
  • HICL (First Databank): 050574
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2714245
Why two NDCs? The FDA registers this code as 0074-1044-01 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00074-1044-01. 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.

Clinical

Label name EMRELIS 20 MG VIAL Ingredient Telisotuzumab Vedotin-Tllv
📖 What it is MedlinePlus · NLM

Telisotuzumab vedotin-tllv injection is used a certain type of lung cancer (non-small cell lung cancer; NSCLC). Telisotuzumab vedotin-tllv is in a class of medications called antibody-drug conjugates. It works by killing 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 No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9326 $146.060 / J9326 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)0074-1044-01
11-digit billing NDC00074-1044-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ9326
Descriptor1 MG
Billing units / pkg20 units
How the units are derivedThis package is 1; the HCPCS unit is 1 MG, so one package = 20 billing units.
Medicare Part B spend (2026 (Q1))$7,180,334 · 358 claims · $20,056.80 per claim (all NDCs under J9326)
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
00074-1044-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE 2025-05-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Emrelis 20 mg/mLthis 00074-1044-01 AbbVie 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

🏛️
2025
First FDA approval
May 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2037
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 May 2037. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved May 14, 2025 ⏳ ~10.6 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
Emrelistelisotuzumab vedotin-tllv
🔒 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
2025 2027 2029 2031 2033 2035 2037
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 dateMay 14, 2037
Common questions
Is there a biosimilar for EMRELIS 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.

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.

  • 2.33 mg / 1 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.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 0.10 mg / 1 mL UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 70.0 mg / 1 mL 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 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

LabelerAbbVie Inc.
FDA applicationBLA761384 (BLA)
Labeler code00074
First marketedMay 2025
Product typeHuman Prescription Drug
Portfolio129 products on file

More NDCs from AbbVie Inc. labeler code 00074

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.
🎯 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 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 199 words ▾

1 INDICATIONS AND USAGE EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration ( 2.1 )] , who have received a prior systemic therapy . This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies ( 14 )] .

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy. ( 1 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR).

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For intravenous infusion only. ( 2.5 ) The recommended dosage of EMRELIS is 1.9 mg/kg administered intravenously every 2 weeks until disease progression or unacceptable toxicity. ( 2.2 ) Reconstitute and further dilute EMRELIS prior to intravenous infusion. ( 2.5 )

2.1Patient Selection Select patients for treatment with EMRELIS based on the presence of high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining] in patients with non-squamous NSCLC [see Indications and Usage ( 1 ) and Clinical Studies ( 14 )] . Information on FDA-approved tests for the detection of high c-Met protein overexpression is available at: http://www.fda.gov/CompanionDiagnostics.

2.2Recommended Dosage The recommended dosage of EMRELIS is 1.9 mg/kg (up to a maximum of 190 mg for patients greater than or equal to 100 kg) administered as an intravenous infusion over 30 minutes every 2 weeks until disease progression or unacceptable toxicity.

2.3Dosage Modifications for Adverse Reactions The recommended dose reductions for adverse reactions are provided in Table 1. Table 1. Recommended Dose Reductions Dose Reduction Recommended Dosage First 1.6 mg/kg every 2 weeks Second 1.3 mg/kg every 2 weeks Third 1 mg/kg every 2 weeks Permanently discontinue EMRELIS in patients who are unable to tolerate 1 mg/kg.

The recommended dosage modifications of EMRELIS for adverse reactions are provided in Table 2. Table 2. EMRELIS Dosage Modifications and Management for Adverse Reactions Adverse Reaction Severity a Dosage Modification Peripheral Neuropathy [see Warnings and Precautions ( 5.1 )] Grade 2 or 3 Withhold EMRELIS until recovery to Grade ≤1.

Resume EMRELIS at the next lower dose level. Grade 4 Permanently discontinue EMRELIS. Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions ( 5.2 )] Grade 1 Withhold EMRELIS and consider corticosteroids as soon as ILD/pneumonitis is suspected.

Resume EMRELIS upon radiographic resolution. Grade ≥2 Permanently discontinue EMRELIS. Keratitis [see Warnings and Precautions ( 5.3 )] Grade 2 Withhold EMRELIS.

Refer patients to an eye care professional for an ophthalmic examination and treatment (e.g., lubricating and/or steroidal eye drops). Resume EMRELIS at the same dose at the discretion of the healthcare provider. Grade 3 or 4 Refer patients to an eye care professional for an ophthalmic examination and treatment (e.g., lubricating and/or steroidal eye drops).

Permanently discontinue EMRELIS. Infusion-Related Reactions (IRR) [see Warnings and Precautions ( 5.4 )] Grade 1-3 Interrupt EMRELIS infusion and administer supportive treatment. Resume the infusion at a 50% rate reduction.

Increase infusion rate as tolerated for subsequent doses. For patients who experience an IRR, administer premedications prior to all future doses (see Table 3 ). Grade 4 Permanently discontinue EMRELIS.

Administer supportive treatment. Peripheral Edema [see Adverse Reactions ( 6.1 )] Grade ≥2 First occurrence Withhold EMRELIS until recovery to Grade ≤1. Resume EMRELIS at the same dose level.

Subsequent occurrence Withhold EMRELIS until recovery to Grade ≤1. Resume EMRELIS at the next lower dose level. Other Adverse Reactions [see Adverse Reactions ( 6.1 )] Grade 3 First occurrence Withhold EMRELIS until recovery to Grade ≤1.

Resume EMRELIS at the same dose. Subsequent occurrence Withhold EMRELIS until recovery to Grade ≤1. Resume EMRELIS at the next lower dose level.

Grade 4 Permanently discontinue EMRELIS. a Adverse reactions were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 2. 4 Recommended Premedications for Patients Who Experience Infusion-Related Reactions Table 3 contains the recommended premedications for patients who experience infusion-related reactions to EMRELIS, for subsequent infusions. Table 3: Recommended Premedications for Patients Who Experience Infusion-Related Reactions Medication Class E xamples or equi… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 52 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 20 mg or 100 mg of telisotuzumab vedotin-tllv as a white to off-white, lyophilized powder in a single-dose vial for reconstitution and further dilution. For injection: 20 mg or 100 mg of telisotuzumab vedotin-tllv as a lyophilized powder in a single-dose vial. ( 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 EMRELIS based on the severity. ( 5.1 ) I nterstitial Lung Disease (ILD)/ Pneumonitis : Severe, life-threatening or fatal ILD/pneumonitis may occur.

Withhold or permanently discontinue EMRELIS based on the severity. ( 5.2 ) Ocular Surface Disorders : Monitor patients for signs or symptoms of ocular surface disorders, including vision changes. Withhold or permanently discontinue EMRELIS based on the severity.

( 5.3 ) Infusion - Related Reactions (IRR) : Monitor patients for IRR. Withhold, reduce the rate of infusion, or permanently discontinue EMRELIS based on the severity. For patients who experience IRR, administer premedications prior to subsequent infusions.

( 5.4 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients about the potential risk to a fetus and to use effective contraception. ( 5.5 )

5.1Peripheral Neuropathy EMRELIS can cause peripheral neuropathy, including peripheral sensory neuropathy and peripheral motor neuropathy. In the safety population [see Adverse Reactions ( 6.1 )], peripheral neuropathy occurred in 51% of patients treated with EMRELIS, including Grade 3 in 11%. These adverse reactions included peripheral sensory neuropathy in 45% of patients and peripheral motor neuropathy in 9%.

The median time to onset of peripheral neuropathy was 105 days (range: 1 to 472 days). Peripheral neuropathy led to permanent discontinuation of EMRELIS in 13% of patients. The median time to onset of peripheral neuropathy leading to treatment discontinuation was 249 days (range: 57 to 519 days).

Of the 7 patients with motor neuropathy ongoing as of their last dose of EMRELIS, 6 had persistent Grade 1 or 2 symptoms 30 days after their last dose. Monitor patients for signs and symptoms of new or worsening peripheral neuropathy such as hypoesthesia, hyperesthesia, paresthesia, a burning sensation, neuropathic pain, or muscle weakness. Withhold, reduce the dose or permanently discontinue EMRELIS based on severity [see Dosage and Administration ( 2.3 )].

5.2Interstitial Lung Disease /Pneumonitis EMRELIS can cause severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis. In the safety population [see Adverse Reactions ( 6.1 )], ILD/pneumonitis occurred in 10% of patients treated with EMRELIS, including Grade 3 in 3% and Grade 4 in 0.6%. There were 3 fatal cases of ILD/pneumonitis in patients who received EMRELIS.

The median time to onset of ILD/pneumonitis was 48 days (range: 23 to 85 days). ILD/pneumonitis led to permanent discontinuation of EMRELIS in 7% of patients. The median time to onset of ILD/pneumonitis leading to treatment discontinuation was 46 days (range: 23 to 85 days).

Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD/pneumonitis. Withhold or permanently discontinue EMRELIS based on severity [see Dosage and Administration ( 2.3 )].

5.3Ocular Surface Disorders EMRELIS can cause ocular surface disorders including blurred vision, visual impairment, keratitis, and dry eye. In the safety population [see Adverse Reactions ( 6.1 )], ocular surface disorders occurred in 25% of patients treated with EMRELIS. The most common ocular surface disorders were blurred vision (15%), keratitis (11%), and dry eye (5%).

Grade 3 ocular surface disorders occurred in 1.2% of patients [blurred vision (1.2%), and keratitis (0.6%)]. The median time to onset of ocular surface disorders was 47 days (range: 1 to 319 days). Monitor patients for ocular surface disorders during treatment with EMRELIS.

Withhold EMRELIS and refer patients to an eye care professional for an ophthalmic examination and treatment for patients who develop Grade ≥2 ocular toxicity. Withhold or permanently discontinue EMRELIS based on severity [see Dosage and Administra… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Peripheral Neuropathy [see Warnings and Precautions ( 5.1 )] Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions ( 5.2 )] Ocular Surface Disorders [see Warnings and Precautions ( 5.3 )] Infusion-Related Reactions (IRR) [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥20%) were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. ( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, increased glucose, increased alanine aminotransferase, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin and decreased calcium.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. LUMINOSITY The safety population described in WARNINGS AND PRECAUTIONS and below reflects exposure to EMRELIS in 168 patients with locally advanced or metastatic EGFR wild-type non-squamous NSCLC with c-Met protein overexpression who received EMRELIS as a single agent administered at 1.9 mg/kg intravenously every 2 weeks in the LUMINOSITY study [see Clinical Studies ( 14 )].

Among patients who received EMRELIS, 42% were exposed for 6 months or longer and 11% were exposed for greater than one year. The median age of patients who received EMRELIS was 64.5 years (range: 33 to 83 years); 70% were male; 65% were White; 1.8% were Black or African American, 33% were Asian; and 0.6% were of Hispanic or Latino ethnicity. Serious adverse reactions occurred in 35% of patients.

Serious adverse reactions occurring in ≥2% of patients included ILD/pneumonitis (5%), pneumonia (5%), peripheral neuropathy (3.6%), and pleural effusion (2.4%). Fatal adverse reactions occurred in 5% of patients who received EMRELIS, including ILD/pneumonitis (1.8%), pneumonia (1.2%), sudden death (1.2%), noninfectious endocarditis (0.6%) and myocardial infarction (0.6%). Permanent discontinuations of EMRELIS due to adverse reactions occurred in 30% of patients.

Adverse reactions which resulted in permanent discontinuation of EMRELIS in ≥2% included peripheral neuropathy and ILD/pneumonitis. Dosage interruptions due to adverse reactions occurred in 44% of patients. Adverse reactions which required dosage interruption in ≥2% of patients included peripheral neuropathy, fatigue, pneumonia, increased ALT, blurred vision, COVID-19, ILD/pneumonitis, and keratitis.

Dose reductions due to adverse reactions occurred in 28% of patients. Adverse reactions which required dose reductions in ≥2% of patients included peripheral neuropathy, fatigue, and keratitis. The most common adverse reactions (≥20%) were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema.

The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, increased glucose, increased ALT, increased gamma glutamyl transferase, decreased phosphorus, decreased sodium, decreased hemoglobin and decreased calcium. Table 5 summarizes the adverse reactions in LUMINOSITY. Table 5.

Adverse Reactions (≥10%) in Patients with EGFR Wild-Type Non-squamous NSCLC with c-Met Protein Overexpression in LUMINOSITY Adverse Reaction EMRELIS (N=168) All Grades 1 % Grade 3 or 4 1 % Nervous system disorders Peripheral neuropathy 2 51 11 General disorders and administration site conditions Fatigue 2 29

3.6 Peripheral edema 2 22

1.8 Metabolism and nutrition disorders Decreased appetite 22

0.6 Gastrointestinal disorders Nausea 15 0 Constipation 14

0.6 Vomiting 10

0.6Eye disorders Blurred vision 3… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 83 words ▾

7 DRUG INTERACTIONS S trong CYP3A I nhibitors : concomitant use with EMRELIS may increase the AUC of MMAE. Monitor for increased risk of adverse reactions to EMRELIS. ( 7.1 )

7.1Effect of Other Drugs on EMRELIS Strong CYP3A Inhibitors Concomitant use with strong CYP3A inhibitors may increase unconjugated MMAE AUC [see Clinical Pharmacology ( 12.3 ) ] , which may increase the risk of EMRELIS adverse reactions. Monitor patients for adverse reactions when EMRELIS is given concomitantly with strong CYP3A inhibitors.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Severe or Moderate Hepatic I mpairment : Avoid use of EMRELIS. ( 8.6 ) Lactation : Advise not to breastfeed. ( 8.2 ) Infertility : May impair fertility. ( 8.3 )

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

Advise patients of the potential risks to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data No embryo-fetal development studies in animals have been performed with telisotuzumab vedotin-tllv.

In an embryo-fetal development study in pregnant rats, administration of two intravenous doses of MMAE, the small molecule component of EMRELIS, on gestational days 6 and 13 caused embryo-fetal mortality and structural abnormalities, including protruding tongue, agnathia, malrotated limbs, and gastroschisis compared to controls at a dose of 0.2 mg/kg (approximately 2 times the human area under the curve [AUC] at the recommended dose).

8.2Lactation Risk Summary There are no data on the presence of telisotuzumab vedotin-tllv or MMAE 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 EMRELIS and for 1 month after the last dose.

8.3Females and Males of Reproductive Potential EMRELIS 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 EMRELIS treatment. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with EMRELIS and for 2 months after the last dose.

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

Males Based on findings from animal studies, EMRELIS may impair male fertility. The reversibility of this effect is unknown [see Nonclinical Toxicology ( 13.1 )] .

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

8.5Geriatric Use Of the 168 patients with previously treated EGFR wild-type non-squamous NSCLC with c-Met protein overexpression treated with EMRELIS in LUMINOSITY, 50% were ≥65 years of age and 12% were ≥75 years of age. No overall differences in safety or effectiveness were observed between older and younger patients.

8.6Hepatic Impairment Avoid use of EMRELIS in patients with moderate or severe hepatic impairment (total bilirubin >1.5 x ULN and any AST). Patients with moderate or severe hepatic impairment are likely to have increased exposure to MMAE, which may increase the risk of adverse reactions. EMRELIS has not been studied in patients with moderate or severe hepatic impairment.

No dosage adjustment is recommended for patients with mild hepatic impairment (total bilirubin ≤ULN and AST >ULN or total bilirubin >ULN and ≤1.5 x ULN and any AST) [see Clinical Pharmacology ( 12.3 ) ] .

🤰 Pregnancy 206 words ▾

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

Advise patients of the potential risks to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data No embryo-fetal development studies in animals have been performed with telisotuzumab vedotin-tllv.

In an embryo-fetal development study in pregnant rats, administration of two intravenous doses of MMAE, the small molecule component of EMRELIS, on gestational days 6 and 13 caused embryo-fetal mortality and structural abnormalities, including protruding tongue, agnathia, malrotated limbs, and gastroschisis compared to controls at a dose of 0.2 mg/kg (approximately 2 times the human area under the curve [AUC] at the recommended dose).

🧒 Pediatric Use 15 words ▾

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

🧓 Geriatric Use 50 words ▾

8.5Geriatric Use Of the 168 patients with previously treated EGFR wild-type non-squamous NSCLC with c-Met protein overexpression treated with EMRELIS in LUMINOSITY, 50% were ≥65 years of age and 12% were ≥75 years of age. No overall differences in safety or effectiveness were observed between older and younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Telisotuzumab vedotin-tllv is a c-Met-directed antibody drug conjugate (ADC). The antibody is a humanized IgG1κ directed against c-Met, the cell surface receptor for hepatocyte growth factor. The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease cleavable linker.

Following binding to c-Met-expressing cells, telisotuzumab vedotin-tllv undergoes internalization and intracellular cleavage of MMAE. MMAE disrupts the microtubule network of actively dividing cells, subsequently inducing cell cycle arrest and apoptotic cell death. Telisotuzumab vedotin-tllv exhibited antitumor activity in xenograft models of NSCLC.

12.2Pharmacodynamics Exposure Response Relationships Exposure-response relationships for efficacy and time course of pharmacodynamic response have not been fully characterized. Higher telisotuzumab vedotin-tllv exposure was associated with increased rates of Grade 3 peripheral neuropathy, and Grades 2 and 3 ocular surface disorders. Higher unconjugated MMAE exposure was associated with increased rates of Grade ≥3 adverse reactions and fatal adverse reactions.

Cardiac Electrophysiology There is insufficient information to characterize the effect of telisotuzumab vedotin-tllv on the QT interval.

12.3Pharmacokinetics The exposure parameters of telisotuzumab vedotin-tllv (ADC) and unconjugated MMAE (cytotoxic component of EMRELIS) are summarized in Table 7. The plasma exposure of the ADC and unconjugated MMAE increased proportionally over a dose range of 1.2 to 3.3 mg/kg (0.64 to 1.7 times the approved recommended dose). ADC time to maximum plasma concentrations (Tmax) occurs at the end of intravenous infusion while MMAE Tmax occurs approximately 5 days after EMRELIS administration.

Minimal accumulation of the ADC or MMAE occurs. Table 7. Exposure Parameters of Telisotuzumab Vedotin-tllv (ADC) and Unconjugated MMAE at EMRELIS 1.9 mg/kg Every 2 Weeks ADC Unconjugated MMAE C max 29 (43) µg/mL 2.2 (53) ng/mL AUC 0- tau 2,130 (55) µg∙hr/mL 405 (64) ng∙hr/mL C max = maximum concentration AUC 0- tau = area under the concentration-time curve from time zero to 14 days (2 weeks) Distribution The estimated volume of distribution is

3.4L (16.5%CV) for telisotuzumab vedotin-tllv. MMAE plasma protein binding ranges from 68% to 82% in vitro . Elimination The elimination half-life is approximately 3 days for the ADC and approximately 4 days for MMAE. The estimated clearance (CL) is

1.3L/day (31.5%CV) for the ADC and 76 L/day (52.1%CV) for MMAE. Metabolism Telisotuzumab vedotin-tllv catabolism 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. MMAE is metabolized primarily by CYP3A4.

Specific Populations No clinically significant differences in the pharmacokinetics of the ADC or unconjugated MMAE were observed based on age (30 to 87 years), sex, race (65% White, 32% Asian, and 3% Black), body weight (34 to 144 kg), mild or moderate renal impairment (CLcr 30 to 89 mL/min, estimated by Cockcroft-Gault), or mild hepatic impairment (total bilirubin ≤ULN and AST >ULN or total bilirubin >ULN and ≤1.5 x ULN and any AST). The effect of severe renal impairment (CLcr <30 mL/min), end-stage renal disease with or without dialysis, or moderate to severe hepatic impairment (total bilirubin >1.5 × ULN and any AST) on the pharmacokinetics of telisotuzumab vedotin-tllv or unconjugated MMAE is unknown.

Drug Interaction Studies Clinical Studies and Model-Informed Approaches: No clinical studies have evaluated the potential for drug-drug interactions. Strong CYP3A4 Inhibitor: MMAE AUC is predicted to increase by 1.4-fold following concomitant administration of EMRELIS with ketoconazole (a strong CYP3A inhibitor). Strong CYP3A4 Inducer: MMAE AUC is predicted to decrease by 70% following concomitant administration of EMRELIS with rifampicin (a st… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 89 words ▾

12.1Mechanism of Action Telisotuzumab vedotin-tllv is a c-Met-directed antibody drug conjugate (ADC). The antibody is a humanized IgG1κ directed against c-Met, the cell surface receptor for hepatocyte growth factor. The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease cleavable linker.

Following binding to c-Met-expressing cells, telisotuzumab vedotin-tllv undergoes internalization and intracellular cleavage of MMAE. MMAE disrupts the microtubule network of actively dividing cells, subsequently inducing cell cycle arrest and apoptotic cell death. Telisotuzumab vedotin-tllv exhibited antitumor activity in xenograft models of NSCLC.

📦 How Supplied / Storage and Handling 88 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied EMRELIS (telisotuzumab vedotin-tllv) for injection is a sterile, preservative-free, white to off-white lyophilized powder, supplied in a glass single-dose vial. Carton of one 20 mg/vial (NDC 0074-1044-01) Carton of one 100 mg/vial (NDC 0074-1055-01) Storage and Handling Store refrigerated at 2 o C to 8 o C (36 o F to 46 o F) in original carton to protect from light. Do not freeze.

Do not shake. Special Handling EMRELIS is a hazardous product. Follow special handling and disposal procedures.

1

📋 Description ~1 min read ▾

11 DESCRIPTION Telisotuzumab vedotin-tllv is a c-Met directed antibody-drug conjugate (ADC) comprised of a humanized immunoglobulin G1 kappa (IgG1κ) monoclonal antibody conjugated to the small molecule microtubule-disrupting agent, monomethyl auristatin E (MMAE), via a protease-cleavable valine-citrulline (vc) linker. The antibody is produced in a mammalian cell line (Chinese hamster ovary) and the drug-linker is produced by chemical synthesis. Each monoclonal antibody molecule carries an average of 3 MMAE molecules.

Telisotuzumab vedotin-tllv has an approximate molecular weight of 152 kDa. EMRELIS (telisotuzumab vedotin-tllv) for injection is a sterile, white to off-white, preservative-free, lyophilized powder in a single-dose vial for reconstitution and dilution prior to intravenous infusion. EMRELIS is supplied as 20 mg per vial or 100 mg per vial and requires reconstitution with Sterile Water for Injection, USP (1.1 mL and 5.2 mL, respectively) to obtain a concentration of 20 mg/mL [see Dosage and Administration ( 2.4 )] .

Following reconstitution, each mL delivers 20 mg of telisotuzumab vedotin-tllv, and histidine (2.33 mg), polysorbate 80 (0.10 mg), sucrose (70.0 mg), and Water for Injection. Hydrochloric acid was added to adjust the pH to 6.0. Telisotuzumab vedotin-tllv is a c-Met directed antibody-drug conjugate (ADC) comprised of a humanized immunoglobulin G1 kappa (IgG1κ) monoclonal antibody conjugated to the small molecule microtubule-disrupting agent, monomethyl auristatin E (MMAE), via a protease-cleavable valine-citrulline (vc) linker.

The antibody is produced in a mammalian cell line (Chinese hamster ovary) and the drug-linker is produced by chemical synthesis. Each monoclonal antibody molecule carries an average of 3 MMAE molecules. Telisotuzumab vedotin-tllv has an approximate molecular weight of 152 kDa.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Peripheral Neuropathy Advise patients that EMRELIS can cause peripheral neuropathy. Advise patients to report to their healthcare provider any new or worsening numbness or tingling of the hands or feet or any muscle weakness [see Warnings and Precautions ( 5.1 )].

ILD/Pneumonitis Advise patients that EMRELIS can cause ILD/pneumonitis. Advise patients to immediately report to their healthcare provider any new or worsening respiratory symptoms [see Warnings and Precautions ( 5.2 )]. Ocular Surface Disorders Advise patients that EMRELIS can cause ocular surface disorders.

Advise patients to contact their healthcare provider any new or worsening ocular problems or vision changes [see Warnings and Precautions ( 5.3 )]. Infusion -Related Reactions Advise patients that EMRELIS can cause infusion-related reactions. Advise patients to immediately contact their healthcare provider if they experience signs and symptoms of infusion reactions, including fever, chills, rash, or breathing problems [see Warnings and Precautions ( 5.4 )].

Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise female patients to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with EMRELIS [see Warnings and Precautions ( 5.5 ) and Use in Specific Populations ( 8.1 )]. Females and Males of Reproductive Potential Advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose [see Use in Specific Populations ( 8.3 )] .

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 ( 8.3 )]. Lactation Advise women not to breastfeed during treatment with EMRELIS and for 1 month after the last dose [see Use in Specific Populations ( 8.2 )]. Infertility Advise males and females of reproductive potential that EMRELIS may impair fertility [see Nonclinical Toxicology ( 13 ) ].

EMRELIS™ [telisotuzumab vedotin-tllv] Manufactured by: AbbVie Inc. North Chicago, IL 60064, U.S.A. U.S.

License No. 1889 © 2025 AbbVie. All rights reserved.

EMRELIS and its design are trademarks of AbbVie Inc. 20090524

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE EMRELIS™ (EM-rell-is) (telisotuzumab vedotin-tllv) for injection, for intravenous use What is the most important information I should know about EMRELIS? EMRELIS can cause serious side effects, including: Nerve problems in your hands or feet (peripheral neuropathy). Nerve problems are common during treatment with EMRELIS and can also be severe.

Tell your healthcare provider if you develop any new or worsening signs or symptoms of nerve problems, including: numbness tingling burning sensation pain or discomfort muscle weakness difficulty walking Lung problems. EMRELIS can cause lung problems that may be severe, life-threatening or that may lead to death. Tell your healthcare provider right away if you develop new or worsening lung symptoms, including: cough trouble breathing or shortness of breath fever wheezing Eye problems.

Your healthcare provider may send you to an eye care professional to check your eyes if you develop eye problems. Tell your healthcare provider right away if you develop any new or worsening eye problems or vision changes, including: blurred vision dry eyes sensitivity to light eye pain or swelling eye redness Infusion-related reactions. EMRELIS can cause infusion reactions that can be severe or life-threatening.

Tell your healthcare provider right away if you develop any signs and symptoms of infusion reactions, including: itching or rash shortness of breath or wheezing flushing chest discomfort fever back pain chills headache nausea or vomiting feel like passing out Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with EMRELIS and may provide treatment for your side effects. Your healthcare provider may also need to change your dose, temporarily stop, or completely stop treatment with EMRELIS if you have severe side effects.

See “What are the possible side effects of EMRELIS?” for more information about side effects. What is EMRELIS? EMRELIS is a prescription medicine used to treat adults with non-squamous non-small cell lung cancer (NSCLC): that has spread to areas near the lungs (locally advanced) or to other parts of the body (metastatic), and whose tumors have high c-Met protein overexpression, and who have received a prior treatment.

Your healthcare provider will perform a test to make sure EMRELIS is right for you. It is not known if EMRELIS is safe and effective in children. Before receiving EMRELIS, tell your healthcare provider about all of your medical conditions, including if you: have a history of nerve problems have lung or breathing problems other than your lung cancer have eye problems have liver problems are pregnant or plan to become pregnant.

EMRELIS can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with EMRELIS. You should use effective birth control (contraception) during treatment and for 2 months after your last dose of EMRELIS.

Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EMRELIS. Males with female partners who are able to become pregnant: You should use an effective birth control during treatment and for 4 months after your last dose of EMRELIS. are breastfeeding or plan to breastfeed. It is not known if EMRELIS passes into your breast milk.

Do not breastfeed during treatment with EMRELIS and for 1 month after the last dose. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking certain medicines with EMRELIS may increase your risk of side effects.

How will I receive EMRELIS? Your healthcare provider will give you EMRELIS into your vein through an intravenous (IV) line over 30 minutes. EMRELIS is given 1 time every 2 weeks.

Your healthcare provider will decide how many infusions… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics The exposure parameters of telisotuzumab vedotin-tllv (ADC) and unconjugated MMAE (cytotoxic component of EMRELIS) are summarized in Table 7. The plasma exposure of the ADC and unconjugated MMAE increased proportionally over a dose range of 1.2 to 3.3 mg/kg (0.64 to 1.7 times the approved recommended dose). ADC time to maximum plasma concentrations (Tmax) occurs at the end of intravenous infusion while MMAE Tmax occurs approximately 5 days after EMRELIS administration.

Minimal accumulation of the ADC or MMAE occurs. Table 7. Exposure Parameters of Telisotuzumab Vedotin-tllv (ADC) and Unconjugated MMAE at EMRELIS 1.9 mg/kg Every 2 Weeks ADC Unconjugated MMAE C max 29 (43) µg/mL 2.2 (53) ng/mL AUC 0- tau 2,130 (55) µg∙hr/mL 405 (64) ng∙hr/mL C max = maximum concentration AUC 0- tau = area under the concentration-time curve from time zero to 14 days (2 weeks) Distribution The estimated volume of distribution is

3.4L (16.5%CV) for telisotuzumab vedotin-tllv. MMAE plasma protein binding ranges from 68% to 82% in vitro . Elimination The elimination half-life is approximately 3 days for the ADC and approximately 4 days for MMAE. The estimated clearance (CL) is

1.3L/day (31.5%CV) for the ADC and 76 L/day (52.1%CV) for MMAE. Metabolism Telisotuzumab vedotin-tllv catabolism 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. MMAE is metabolized primarily by CYP3A4.

Specific Populations No clinically significant differences in the pharmacokinetics of the ADC or unconjugated MMAE were observed based on age (30 to 87 years), sex, race (65% White, 32% Asian, and 3% Black), body weight (34 to 144 kg), mild or moderate renal impairment (CLcr 30 to 89 mL/min, estimated by Cockcroft-Gault), or mild hepatic impairment (total bilirubin ≤ULN and AST >ULN or total bilirubin >ULN and ≤1.5 x ULN and any AST). The effect of severe renal impairment (CLcr <30 mL/min), end-stage renal disease with or without dialysis, or moderate to severe hepatic impairment (total bilirubin >1.5 × ULN and any AST) on the pharmacokinetics of telisotuzumab vedotin-tllv or unconjugated MMAE is unknown.

Drug Interaction Studies Clinical Studies and Model-Informed Approaches: No clinical studies have evaluated the potential for drug-drug interactions. Strong CYP3A4 Inhibitor: MMAE AUC is predicted to increase by 1.4-fold following concomitant administration of EMRELIS with ketoconazole (a strong CYP3A inhibitor). Strong CYP3A4 Inducer: MMAE AUC is predicted to decrease by 70% following concomitant administration of EMRELIS with rifampicin (a strong CYP3A inducer).

Sensitive CYP3A Substrate: No clinically significant difference in the pharmacokinetics of midazolam (a sensitive CYP3A substrate) is predicted when used concomitantly with EMRELIS. In Vitro Studies Cytochrome P450 (CYP) Enzymes: MMAE is a substrate and an inhibitor of CYP3A4/5. Transporter Systems: MMAE is a substrate of P-glycoprotein (P-gp).

🧬 Pharmacodynamics 77 words ▾

12.2Pharmacodynamics Exposure Response Relationships Exposure-response relationships for efficacy and time course of pharmacodynamic response have not been fully characterized. Higher telisotuzumab vedotin-tllv exposure was associated with increased rates of Grade 3 peripheral neuropathy, and Grades 2 and 3 ocular surface disorders. Higher unconjugated MMAE exposure was associated with increased rates of Grade ≥3 adverse reactions and fatal adverse reactions.

Cardiac Electrophysiology There is insufficient information to characterize the effect of telisotuzumab vedotin-tllv on the QT interval.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Previously Treated EGFR Wild-Type N on-squamous NSCLC with High c-Met Protein Overexpression LUMINOSITY The efficacy of EMRELIS was evaluated in the LUMINOSITY study (NCT03539536), a multicenter, open-label, single-arm, multi-cohort clinical trial. Eligible patients were required to have locally advanced or metastatic NSCLC with c-Met protein overexpression and treatment with prior systemic therapy (including no more than one line of prior chemotherapy) in the locally advanced or metastatic setting.

The study excluded patients who had received radiation therapy to the lungs <6 months prior to enrollment and patients who had a history of ILD/pneumonitis requiring treatment with steroids or ILD/pneumonitis within 3 months of the first dose. Patients received EMRELIS at 1.9 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity. The major efficacy outcome measure was overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by a blinded independent central review (BICR).

An additional efficacy outcome measure was duration of response (DOR) by BICR. The efficacy population included 84 patients with non-squamous, EGFR wild-type NSCLC with high c-Met protein overexpression who had received prior systemic therapy. High c-Met protein overexpression was defined as ≥50% of tumor cells with strong (3+) membrane staining on archival or recent tissue samples by immunohistochemistry (IHC) and was determined by prospective testing at a central laboratory prior to enrollment using the MET (SP44) clinical trial assay (CTA).

Of the 84 patients with high c-Met protein overexpression identified by central testing using the CTA, tissue samples from 38/84 (45%) patients were tested retrospectively using the VENTANA MET (SP44) RxDx assay. One sample was unevaluable. Of the 37 samples retested and evaluable, 32 (87%) samples were confirmed to have high c-Met protein overexpression, defined as ≥50% of tumor cells with strong (3+) membrane and/or cytoplasmic staining.

The median age was 64 years (range: 38 to 83 years); 75% were male; 61% were White, 1.2% were Black or African American, 38% were Asian; none were of Hispanic or Latino ethnicity. Twenty-five percent had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 and 74% had ECOG PS of 1; 19% were never smokers, 68% were former smokers, and 13% were current smokers; 99% had Stage IV disease; and 19% of patients had previously treated brain metastases. The median number of lines of prior therapies was 1 (range 1 - 3); 73% of patients had one line, 24% had two lines, and 3.6% had three lines of prior systemic therapy; 96% of patients had prior platinum therapy, 82% had prior immunotherapy (anti-PD-1/PD-L1), 6% had prior targeted therapy, and 3.6% had prior MET tyrosine kinase inhibitor therapy.

Efficacy results are summarized in Table 8. Table 8. Efficacy Results in LUMINOSITY for Patients with EGFR Wild-Type Non-squamous NSCLC with High c-Met Protein Overexpression Efficacy Parameter EMRELIS N = 84 Confirmed Overall Response Rate (ORR) , % (95% CI) 35 (24, 46) Complete Response, % 0 Partial Response, % 35 Duration of Response N = 29 Median, months (95% CI) 7.2 (4.2, 12) DOR ≥6 months, a % 59 DOR ≥12 months, a % 21 CI=confidence interval; DOR=duration of response a Based on observed duration of response in 29 responders.

🧪 Nonclinical Toxicology 214 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies in animals have not been performed with telisotuzumab vedotin-tllv or the small molecule MMAE. Mutagenesis 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 L5178Y TK +/- mouse lymphoma forward mutation assay.

Impairment of Fertility Fertility studies with telisotuzumab vedotin-tllv or MMAE have not been conducted. However, results of repeat-dose toxicity studies in rats and monkeys indicate the potential for telisotuzumab vedotin-tllv to impair male and female reproductive function and fertility. In a 2-week repeat-dose toxicology study in rats, telisotuzumab vedotin-tllv administered at doses ≥6 mg/kg (≥12 times the human exposure [AUC] at the recommended dose) resulted in decreased number/degeneration of germ cells in the testes largely due to loss of spermatogonia.

The reversibility of these findings was not assessed. In a 4-week repeat-dose toxicology study in sexually immature monkeys, telisotuzumab vedotin-tllv administered at doses ≥3 mg/kg (≥4 times the human exposure [AUC] at the recommended dose) resulted in degeneration of granulosa cells and decreased number of tertiary follicles in the ovaries and degeneration/necrosis of endometrial glands in the uterus. There was evidence of reversibility after an 8-week recovery period.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 211 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies in animals have not been performed with telisotuzumab vedotin-tllv or the small molecule MMAE. Mutagenesis 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 L5178Y TK +/- mouse lymphoma forward mutation assay.

Impairment of Fertility Fertility studies with telisotuzumab vedotin-tllv or MMAE have not been conducted. However, results of repeat-dose toxicity studies in rats and monkeys indicate the potential for telisotuzumab vedotin-tllv to impair male and female reproductive function and fertility. In a 2-week repeat-dose toxicology study in rats, telisotuzumab vedotin-tllv administered at doses ≥6 mg/kg (≥12 times the human exposure [AUC] at the recommended dose) resulted in decreased number/degeneration of germ cells in the testes largely due to loss of spermatogonia.

The reversibility of these findings was not assessed. In a 4-week repeat-dose toxicology study in sexually immature monkeys, telisotuzumab vedotin-tllv administered at doses ≥3 mg/kg (≥4 times the human exposure [AUC] at the recommended dose) resulted in degeneration of granulosa cells and decreased number of tertiary follicles in the ovaries and degeneration/necrosis of endometrial glands in the uterus. There was evidence of reversibility after an 8-week recovery period.

📚 References 9 words ▾

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

📄 Package Label / Principal Display Panel 156 words ▾

PRINCIPAL DISPLAY PANEL NDC 0074-1044-01 Emrelis™ (telisotuzumab vedotin-tllv) For Injection 20 mg per vial Hazardous Drug For Intravenous Infusion after reconstitution and dilution Single-Dose Vial Discard Unused Portion Dispense the enclosed Medication Guide to each patient Rx Only abbvie PRINCIPAL DISPLAY PANEL NDC 0074-1044-01 Emrelis™ (telisotuzumab vedotin-tllv) For Injection 20 mg per vial Hazardous Drug For Intravenous Infusion after reconstitution and dilution Single-Dose Vial Discard Unused Portion Dispense the enclosed Medication Guide to each patient Rx Only abbvie

PRINCIPAL DISPLAY PANEL NDC 0074-1055-01 Emrelis™ (telisotuzumab vedotin-tllv) For Injection 100 mg per vial Hazardous Drug For Intravenous Infusion after reconstitution and dilution Single-Dose Vial Discard Unused Portion Dispense the enclosed Medication Guide to each patient Rx Only abbvie PRINCIPAL DISPLAY PANEL NDC 0074-1055-01 Emrelis™ (telisotuzumab vedotin-tllv) For Injection 100 mg per vial Hazardous Drug For Intravenous Infusion after reconstitution and dilution Single-Dose Vial Discard Unused Portion Dispense the enclosed Medication Guide to each patient Rx Only abbvie

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Emrelis — 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 Emrelis. 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.
Period
Total Part D spend
$337.5K
Claims incl. refills
16
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$21,094.17
Trend by period
💵 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 Telisotuzumab Vedotin — the ingredient across all brands.

Top reported reactions

Neuropathy Peripheral6
Keratitis5
Disease Progression4
Interstitial Lung Disease4
Pneumonia4
Vision Blurred4
Death3

Reporter sex

64 reports
Male · 40%
Female · 60%

Serious outcomes

Death8
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 23 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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The 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 AbbVie Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AbbVie 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 J9326 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.
← 00074-1043-14 · AbbVie 00074-1050-01 · AbbVie →
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.