Natalizumab (natalizumab-sztn)

Para qué se usa Natalizumab

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.

TYRUKO is an integrin receptor antagonist indicated for treatment of: Multiple Sclerosis (MS) TYRUKO is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Natalizumab products increase the risk of PML […]. …

— Etiqueta de la FDA: Tyruko, Sandoz Inc, vigente desde el 31 de octubre de 2025. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (injection, intravenous), Tyruko, Sandoz Inc; abarca 1 producto del directorio NDC de la FDA. Las citas sobre efectos secundarios, interacciones, dosis y embarazo de abajo vienen de esta misma etiqueta.

Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.

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.

Esta etiqueta tiene una advertencia en recuadro. Su título: WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY. Leerla en la etiqueta completa →

Natalizumab: lo que dice la advertencia en recuadro

Cita de la advertencia en recuadro (Boxed Warning) de la etiqueta aprobada por la FDA. Se muestra en inglés.

WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Natalizumab products increase the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants.

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These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYRUKO [see Warnings and Precautions (5.1)]. - Healthcare professionals should monitor patients on TYRUKO for any new sign or symptom that may be suggestive of PML. TYRUKO dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation that includes a gadolinium-enhanced magnetic resonance imaging (MRI) scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended [see Contraindications (4), Warnings and Precautions (5.1)]. - Because of the risk of PML, TYRUKO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TYRUKO REMS Program [see Warnings and Precautions (5.2)]. WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning

• Natalizumab products increase the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability (5.1).
• Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYRUKO (5.1).
• Monitor patients, and withhold TYRUKO immediately at the first sign or symptom suggestive of PML (4, 5.1).
• Because of the risk of PML, TYRUKO is available only through a restricted distribution program called the TYRUKO REMS Program (5.1, 5.2).

— Etiqueta de la FDA: Tyruko, Sandoz Inc, vigente desde el 31 de octubre de 2025. Leer la etiqueta completa en DailyMed →

Efectos secundarios de Natalizumab

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 serious adverse reactions are described below and elsewhere in the labeling:

• Progressive Multifocal Leukoencephalopathy (PML) [see Warnings and Precautions (5.1)]
• Herpes Infections [see Warnings and Precautions (5.3)]
• Hepatotoxicity [see Warnings and Precautions (5.4)]
• Hypersensitivity/Antibody Formation [see Warnings and Precautions (5.5)]
• Immunosuppression/Infections [see Warnings and Precautions (5.6)]
• Hematological Abnormalities [see Warnings …

— Etiqueta de la FDA: Tyruko, Sandoz Inc, vigente desde el 31 de octubre de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Interacciones de Natalizumab

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.

Because of the potential for increased risk of PML and other infections, Crohn’s disease patients receiving natalizumab products should not be treated with concomitant immunosuppressants (e.g., 6‑ mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α, and corticosteroids should be tapered in those patients with Crohn’s disease who are on chronic corticosteroids when they start TYRUKO therapy [see Indications and Usage (1.2) and Warnings and Precautions (5.1, 5.6)].

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Ordinarily, MS patients receiving chronic immunosuppressant or immunomodulatory therapy should not be treated with TYRUKO [see Indications and Usage (1.1) and Warnings and Precautions (5.1, 5.6)].

— Etiqueta de la FDA: Tyruko, Sandoz Inc, vigente desde el 31 de octubre de 2025. Leer la etiqueta completa en DailyMed →

Dosis de Natalizumab

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.

• 300 mg infused intravenously over one hour, every four weeks. Do not give as an intravenous push or bolus. (2.1, 2.2)
• TYRUKO solution must be administered within 4 hours of preparation. (2.3)
• Observe patients during all infusions. Post-infusion, for the first 12 infusions, observe patients for one hour after the infusion is complete.

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For patients who have received 12 infusions without evidence of a hypersensitivity reaction, observe patients post-infusion for the 13th and subsequent infusions according to clinical judgment. (2.4)

• In CD, discontinue in patients that have not experienced therapeutic benefit by 12 weeks of induction therapy, and in patients that cannot discontinue chronic concomitant steroids within six months of starting therapy. (2.2) 2.1 Multiple Sclerosis (MS) Only prescribers registered in the MS TYRUKO REMS Program may prescribe TYRUKO for multiple sclerosis [see Warnings and Precautions (5.2)]. The recommended dose of TYRUKO for multiple sclerosis is 300 mg intravenous infusion over one hour every four weeks. 2.2 Crohn's Disease (CD) Only prescribers registered in the CD TYRUKO REMS Program may prescribe TYRUKO for Crohn’s disease [see Warnings and Precautions (5.2)]. The recommended dose of TYRUKO for Crohn’s disease is 300 mg intravenous infusion over one hour every four weeks. TYRUKO should not be used with concomitant immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or concomitant inhibitors of TNF-α. Aminosalicylates may be continued during treatment with TYRUKO. If the patient with Crohn’s disease has not experienced therapeutic benefit by 12 weeks of induction therapy, discontinue TYRUKO. For patients with Crohn’s disease who start TYRUKO while on chronic oral corticosteroids, commence steroid tapering as soon as a therapeutic benefit of TYRUKO has occurred; if the patient with Crohn’s disease cannot be tapered off of oral corticosteroids within six months of starting TYRUKO, discontinue TYRUKO. Other than the initial six-month taper, prescribers should consider discontinuing TYRUKO for patients who require additional steroid use that exceeds three months in a calendar year to control their Crohn’s disease. 2.3 Dilution Instructions 1. Use aseptic technique when preparing TYRUKO solution for intravenous infusion. Each vial is intended for single use only. Discard any unused portion. 2. TYRUKO is a colorless and clear to slightly opalescent solution. Inspect the TYRUKO vial for particulate material and discoloration prior to dilution and administration. If visible particulates are observed and/or the liquid in the vial is discolored, the vial must not be used. 3. To prepare the diluted solution, withdraw 15 mL of TYRUKO from the vial using a sterile needle and syringe. Inject TYRUKO into 100 mL of 0.9% Sodium Chloride Injection, USP. No other intravenous diluents may be used to prepare the TYRUKO diluted solution. 4. Gently invert the TYRUKO diluted solution to mix completely. Do not shake. Inspect the solution visually for particulate material prior to administration. 5.

— Etiqueta de la FDA: Tyruko, Sandoz Inc, vigente desde el 31 de octubre de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Natalizumab 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 There are no adequate data on the risk of major birth defects, miscarriage, or other adverse maternal outcomes associated with the use of natalizumab products in pregnant women. Adverse fetal outcomes of neonatal thrombocytopenia and anemia have been reported (see Clinical Considerations).

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In animal studies, administration of natalizumab during pregnancy produced fetal immunologic and hematologic effects in monkeys at doses similar to the human dose and reduced offspring survival in guinea pigs at doses greater than the human dose. These doses were not maternally toxic but produced the expected pharmacological effects in maternal animals (see Data). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations Fetal/Neonatal Adverse Reactions Cases of neonatal thrombocytopenia and anemia in infants born to women exposed to natalizumab products during pregnancy were reported in the post-marketing setting [see Warnings and Precautions (5.8)]. Therefore, a CBC should be obtained in neonates who were exposed to TYRUKO in utero. Data Animal Data In developmental toxicity studies conducted in guinea pigs and monkeys, at natalizumab doses up to 30 mg/kg (7 times the recommended human dose based on body weight [mg/kg]), transplacental transfer and in utero exposure of the embryo/fetus was demonstrated in both species. In a study in which pregnant guinea pigs were administered natalizumab (0, 3, 10, or 30 mg/kg) by intravenous (IV) infusion on alternate days throughout organogenesis (gestation days [GD] 4‑30), no effects on embryofetal development were observed. When pregnant monkeys were administered natalizumab (0, 3, 10, or 30 mg/kg) by IV infusion on alternative days throughout organogenesis (GDs 20-70), serum levels in fetuses at delivery were approximately 35% of maternal serum natalizumab levels. There were no effects on embryofetal development; however, natalizumab-related immunological and hematologic changes were observed in the fetuses at the two highest doses. These changes included decreases in lymphocytes (CD3+ and CD20+), changes in lymphocyte subpopulation percentages, mild anemia, reduced platelet count, increased spleen weights, and reduced liver and thymus weights associated with increased splenic extramedullary hematopoiesis, thymic atrophy, and decreased hepatic hematopoiesis. In a study in which monkeys were exposed to natalizumab during pregnancy (IV infusion of 30 mg/kg) on alternate days from GD20 to GD70 or GD20 to term, abortions were increased approximately 2-fold compared to controls. In offspring born to mothers administered natalizumab on alternate days from GD20 until delivery, hematologic effects (decreased lymphocyte and platelet counts) were also observed. These effects were reversed upon clearance of natalizumab. There was no evidence of anemia in these offspring.

— Etiqueta de la FDA: Tyruko, Sandoz Inc, vigente desde el 31 de octubre de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Natalizumab

Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.

• TYRUKO is contraindicated in patients who have or have had progressive multifocal leukoencephalopathy (PML) [see Warnings and Precautions (5.1)].
• TYRUKO is contraindicated in patients who have had a hypersensitivity reaction to natalizumab products or any of the ingredients in TYRUKO. Observed reactions range from urticaria to anaphylaxis [see Warnings and Precautions (5.5)].

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• Patients who have or have had PML (4)
• Patients who have had a hypersensitivity reaction to natalizumab products (4, 5.3)

— Etiqueta de la FDA: Tyruko, Sandoz Inc, vigente desde el 31 de octubre de 2025. Leer la etiqueta completa en DailyMed →

Sobredosis de Natalizumab

Cita de la sección «Overdosage» (sobredosis) de la etiqueta aprobada por la FDA. Se muestra en inglés. Si alguien pudo haber tomado demasiado, llame a Poison Help al 1-800-222-1222 (o al 911 en una emergencia).

Safety of doses higher than 300 mg has not been adequately evaluated. The maximum amount of natalizumab products that can be safely administered has not been determined.

— Etiqueta de la FDA: Tyruko, Sandoz Inc, vigente desde el 31 de octubre 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.

• Sandoz Inc1 producto
• Biogen Inc.1 producto

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

La lista de escasez de la FDA no incluye estos productos.

Base de datos de escasez de medicamentos de la FDA →

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

• Encuentre una farmacia cerca de ustedPregunte qué precio le corresponde y si su producto está afectado por un retiro
• Últimos retiros de medicamentos de la FDATodos los medicamentos, los más recientes primero
• TyrukoPágina de marca: productos, fabricante y precio
• TysabriPágina de marca: productos, fabricante y precio
• Esclerosis múltipleEnfermedad que menciona la etiqueta: hospitales que la tratan
• Enfermedad de CrohnEnfermedad que menciona la etiqueta: hospitales que la tratan
• Sandoz IncFabricante o distribuidor
• Biogen 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) — Tyruko, Sandoz Inc, vigente desde el 31 de octubre 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
6. Nombre en español: RxNorm (Biblioteca Nacional de Medicina de EE. UU.) y Wikidata, vinculados por el identificador RxNorm (RxCUI) del principio activo, sin coincidencias aproximadas.

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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