EMRELIS Telisotuzumab Vedotin 20 mg/mL Injection, Powder, Lyophilized, For Solution, 1 vial
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 system | Per mL | Per 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?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Emrelis 20 mg/mLthis 00074-1044-01 | AbbVie | 1 vial | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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.
🛈 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.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | May 14, 2037 |
Is there a biosimilar for EMRELIS 20 MG VIAL?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00074-1044-01 You're viewing this | 1 VIAL, SINGLE-DOSE in 1 CARTON (0074-1044-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2025-05-14 | Active |
🧭 About this NDC listing & data coverage
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. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Does this product have a billing J-code?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
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…
💊 Dosage Forms and Strengths ▾
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 ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
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…
🤒 Adverse Reactions ▾
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
0.6 Eye disorders Blurred vision 3…
🔄 Drug Interactions ▾
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 ▾
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 ▾
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 ▾
8.4Pediatric Use Safety and effectiveness of EMRELIS have not been established in pediatric patients.
🧓 Geriatric Use ▾
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 ▾
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…
🧬 Mechanism of Action ▾
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 ▾
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 ▾
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 ▾
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 ▾
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…