Telisotuzumab vedotin

Para qué se usa Telisotuzumab vedotin

Cita de la sección «Indications and Usage» (indicaciones y uso) de la etiqueta aprobada por la FDA. Se muestra en inglés, tal como la publica la FDA.

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 […], who have received a prior systemic therapy. …

— Etiqueta de la FDA: Emrelis, AbbVie Inc., vigente desde el 25 de mayo de 2025. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (injection, powder, lyophilized, for solution, intravenous), Emrelis, AbbVie Inc.; abarca 2 productos del directorio NDC de la FDA. Las citas sobre efectos secundarios, interacciones, dosis y embarazo de abajo vienen de esta misma etiqueta.

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Enfermedades que menciona la etiqueta

Estos nombres aparecen tal cual en la sección «Indications and Usage» de la etiqueta (según una tabla revisada). Cada página muestra los hospitales cuyos sitios web mencionan la enfermedad.

Especialidades médicas relacionadas

Advertencia en recuadro

La advertencia en recuadro («caja negra») es la advertencia más seria de la FDA en la etiqueta de un medicamento, para riesgos graves o mortales.

La etiqueta citada arriba no tiene advertencia en recuadro.

Efectos secundarios de Telisotuzumab vedotin

Cita de la sección «Adverse Reactions» (reacciones adversas) de la etiqueta aprobada por la FDA. Se muestra en inglés. Avise a su médico de cualquier efecto secundario que le preocupe.

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.

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(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. 6.1 Clinical 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.

— Etiqueta de la FDA: Emrelis, AbbVie Inc., vigente desde el 25 de mayo de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Interacciones de Telisotuzumab vedotin

Cita de la sección «Drug Interactions» (interacciones) de la etiqueta aprobada por la FDA. Se muestra en inglés. Dígale a su farmacéutico todos los medicamentos, vitaminas y productos herbales que toma.

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) 7.1 Effect 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.

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Monitor patients for adverse reactions when EMRELIS is given concomitantly with strong CYP3A inhibitors.

— Etiqueta de la FDA: Emrelis, AbbVie Inc., vigente desde el 25 de mayo de 2025. Leer la etiqueta completa en DailyMed →

Dosis de Telisotuzumab vedotin

Cita de la sección «Dosage and Administration» (dosis y administración) de la etiqueta aprobada por la FDA. Se muestra en inglés. Su dosis es la que le receta su médico: no la cambie por su cuenta.

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.

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(2.5) 2.1 Patient 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. 2.2 Recommended 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. 2.3 Dosage 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.

— Etiqueta de la FDA: Emrelis, AbbVie Inc., vigente desde el 25 de mayo de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Telisotuzumab vedotin en el embarazo

Cita de la parte sobre embarazo (Pregnancy) de la etiqueta aprobada por la FDA. Se muestra en inglés. Pregunte a su médico antes de tomar cualquier medicamento si está embarazada o planea estarlo.

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.

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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).

— Etiqueta de la FDA: Emrelis, AbbVie Inc., vigente desde el 25 de mayo de 2025. Leer la etiqueta completa en DailyMed →

Presentaciones y vía de administración

Empresas que tienen este medicamento

Empresas en el directorio NDC de la FDA: la empresa que aparece en el envase (fabricante o distribuidor), con su número de productos con receta.

• AbbVie Inc.2 productos

Historial de aprobación de la FDA

• BLA: Solicitud de licencia de productos biológicos (BLA): así se aprueba un medicamento biológico (hecho a partir de células vivas).

Escasez

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Retiros del mercado

No aparece ningún retiro vinculado a estos productos (por su código NDC) en los informes de la FDA.

Identificadores oficiales

Siguientes pasos

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• Últimos retiros de medicamentos de la FDATodos los medicamentos, los más recientes primero
• Cáncer de pulmónEnfermedad que menciona la etiqueta: hospitales que la tratan
• AbbVie Inc.Fabricante o distribuidor
• Todos los medicamentos con receta de la A a la ZBusque por nombre genérico, de marca o en español

Fuentes

1. Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Emrelis, AbbVie Inc., vigente desde el 25 de mayo de 2025; vía openFDA, datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
2. NDC Directory (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
3. Drugs@FDA (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
4. Drug recall enforcement reports (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 27 de octubre de 2026, consultados el 31 de octubre de 2026
5. Drug shortages (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026

La FDA ofrece los datos de openFDA tal cual; pueden estar incompletos. Guíese siempre por la etiqueta que viene con su medicamento. Buscador de informes de retiros de la FDA →

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