Infliximab (infliximab-dyyb)

Para qué se usa Infliximab

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.

ZYMFENTRA is a tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. moderately to severely active Crohn’s disease following with an infliximab products administered intraneously. ZYMFENTRA is indicated in adults for maintenance treatment of …

— Etiqueta de la FDA: Zymfentra, CELLTRION USA Inc., vigente desde el 18 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (injection, subcutaneous), Zymfentra, CELLTRION USA 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.

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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.

Esta etiqueta tiene una advertencia en recuadro. Leerla en la etiqueta completa →

Infliximab: 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: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as hitoplasmosis) and infections due to ohter opportunistic pathogens. (5.1) Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis.

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(5.1) Perform test for latent TB; if positive, start treatment for TB prior to starting ZYMFENTRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. (5.1) Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. (5.2) Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males. (5.2) SERIOUS INFECTIONS Patients treated with TNF blockers, inculding ZYMFENTRA, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1), Adverse Reactions (6.1)]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patientsfor latent tuberculosis before ZYMFENTRA use and during therapy. Initiate treatment for latent infection prior to ZYMFENTRA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with ZYMFENTRA prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symtoms of infection during and after treatment with ZYMFENTRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

— Etiqueta de la FDA: Zymfentra, CELLTRION USA Inc., vigente desde el 18 de agosto de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Efectos secundarios de Infliximab

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: Serious infections [see Warnings and Precautions (5.1)] Malignancies [see Warnings and Precautions (5.2)] Hepatitis B virus reactivation [see Warnings and Precautions (5.3)] Hepatotoxicity [see Warning and Precautions (5.4)] Congestive heart failure [see Warnings and Precautions (5.5)] Hematologic reactions [see Warnings and Precautions (5.6)] Hypersensitivity and other administration reactions [see Warnings and Precautions (5.7)] Neruologic reactions [see Warnings and Precautions (5.8)] Autoimmunity [see Warnings and Precautions (5.11)] Most common adverse reactions (>3%) are: Ulcerative Colitis: COVID-19, anemia, arthralgia, injection site reaction, increased alanine aminotransferase, and abdominal pain.

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(6.1) Crohn's Disease: COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness, and leukopenia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact CELLTRION USA, Inc. at 1-800-560-9414 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to ZYMFENTRA in 518 adult subjects in two 54-weekrandomized, double-blind, placebo-controlled trials in subjects with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD) (UC Trial I an CD Trial I). Subject who achieved clinical response following three induction doses of infliximab-dyyb administered as an intravenous infusion at Week 0, 2 and 6 were randomized 2:1 to ZYMFENTRA 120 mg or placebo as a subcutaneous injection every two weeks at Week 10 [see Clinical Studies (14.1 and 14.2)]. Ulcerative Colitis The most common adverse reactions reported in ≥3% of subjects and at a higher rate than Placebo in UC Trial I are shown in Table 1. Table 1 Adverse Reactions a in the Maintenance Phase of a Randomized, Double-Blind 54-Week Study of Subjects with UC (UC Tral I) ZYMFENTRA 120 mg Subcutaneous Injection b N=296 (%) Placebo N=140 (%) COVID-19 10 6 Anemia d 5 4 Arthralgia 4 1 Injection site reaction # 3 2 Increased alanine aminotransferase 3 1 Abominal pain f 3 1 a reported in at least 3% of ZYMFENTRA-treated subjects and at a higher than placebo b ZYMFENTRA 120 mg as a subcutaneous injection every two weeks starting Week 10 following 3 intravenous induction doses of inflixiab-dyyb c Includes: COVID-19 and COVID-19 pneumonia d Includes: anemia and iron deficiency anemia # Some subjects had multiple occurences of injection site reactions. In this table, injection site reactions are counted only once per subject. Symptoms in individual subjects included one or more of injection site bruising, edema, erythema, induration, pain, pruritus and swelling. f Includes: abdominal pain, upper abdominal pain, lower abdominal pain, and abdominal discomfort Crohn's Disease The most common adverse reactions reported in ≥3% of subjects and at a higher rate than placebo in CD Trial I are shown in Table 2.

— Etiqueta de la FDA: Zymfentra, CELLTRION USA Inc., vigente desde el 18 de agosto de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Interacciones de Infliximab

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.

Other Biological Products Used to Treat UC and CD The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended [see Warnings and Precautions (5.9)].

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Consier the half-life and mode of action of prior biologial products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA [see Warnings and Precautions (5.10)]. 7.2 Cytochrome P450 Substrates The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (e.g., TNFα, IL-1, IL-6, IL-10, IFN) during chronic inflammation. Therefore, ZYMFENTRA, an antagonist of TNFα, could normalize the formation of CYP450 enzymes potentially resulting in a decrease in exposure of CYP450 substrates. Upon initiation or discontinuation of TNF blockers, including ZYMFENTRA, in patients being treated with CYP450 substrates requiring therapeutic drug monitoring, monitor therpeutic parameters (e.g., INR for warfarin) or drug concentration (e.g., cyclosporine or theophylline). Dosage adjustment may be needed to maintain drug concentrations or parameters within the therapeutic range. See prescribing information for specific drugs. 7.3 Live Vaccines/Therapeutic Infectious Agents It is recommended that live vaccines not be given concurrently with ZYMFENTRA. It is also recommended that live vaccines not be given to infants after in utero exposure to infliximab products for 6 months following birth [see Warnings and Precautions (5.12)]. It is recommended that therapeutic infectious agents not be given concurrently with ZYMFENTRA [see Warnings and Precautions (5.12)].

— Etiqueta de la FDA: Zymfentra, CELLTRION USA Inc., vigente desde el 18 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Dosis de Infliximab

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.

Important Dosage Information. (2.1). ZYMFENTRA is indicated as maintenance treatment only, starting at Week 10 and thereafter. ▫ All pateitns must complete an intravenous induction regiemen with an infliximab product before starting ZYMFENTRA. ZYMFENTRA is for subcutaneous use only. Recommeneded Maintenance Dosage in Ulcerative Colitis and Crohn's Direase (2.2) Week 10 and thereafter: Inject 120 mg subcutaneously once every two weeks.

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To swift patients who are responding to maintenance therapy with an infliximab product administered intravenously, administer the first subcutaneous dose of ZYMFENTRA in place of the next scheduled intravenous infusion and every two weeks thereafter. See the full prescribing information on how to administer subcutaneously. (2.3) 2.1 Important Dosage Information ZYMFENTRA is indicated as maintenance treatment only, starting at Week 10 and thereafter. ▫ All patients mush coplete an intravenous induction regimen with an infliximab product before starting ZYMFENTRA. For induction dosing information, see the corresponding full prescribing information for the chosen infliximab product. ZYMFENTRA is for subtutaneous use only. 2.2 Recommeneded Dosage for Maintenance Treatment in Ulcerative Colitis Crohn's Disease Maintenance dosage starting at Week 10 and thereafter: 120 mg subcutaneously once every two weeks. To switch patients who are responding to maintenance therapy with an infliximab product administered intravenously, administer the first subcutaneous dose of ZYMFNETRA in place of the next scheuled intravenous infusion and every two weeks thereafter. 2.3 Subcutaenous Administration Instructions ZYMFENTRA is intended for use under the guidance and supervision of a healthcare professional. If a healthcare professional determines that it is appropriate, patients may self-injection ZYMFENTRA or caregivers may injection ZYMFENTRA using either the ZYMFENTRA prefilled syringe, ZYMFENTRA prefilled syringe with needle guard, or ZYMFENTRA prefilled pen after proper training in subcutaenous injection technique. Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whether solution and container permit. ZYMFENTRA should be a clear, colorless to pale brwon solution. Do not use if particulates or discoloration is presnet. Inject into the front of the tights, the abdomen excepts for the 2 inches around the navel, or the outer area of the upper arms (caregiver only). Rotate the injectoin site each time an inejction is given. Allow at least 1.2 inches between the new injection site and the previous inejction site. Never inject into areas where the skin is red, bruised, tender, or indurated. Do not use the syringe or pen of it has been dropped or is visibly damaged. A damaged syringe may not function proprely. Do not resue or shake the syringe or pen at any time. Mixed Dose If an injection of ZYMFENTRA is missed, inject the next subcutaneous dose as soon as possible and then every two weeks thereafter.

— Etiqueta de la FDA: Zymfentra, CELLTRION USA Inc., vigente desde el 18 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Infliximab 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 Available data from reports of pregnancy in clinical trials with ZYMFENTRA are insufficient to identify a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with inflammatory bowel disease in pregnancy (see Clinical Considerations).

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Available observational data in pregnant women exposed to infliximab products administered intravenously showed no increased risk of major malformations among live births as compared to those exposed to non-biologics. Most TNF blockers, such as infliximab products, administered intravenously are transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. Infants exposed in utero should not be administered live vaccines for at least 6 months after birth (see Clinical Considerations). Because infliximab products do not cross-react with TNFα in species other than humans and chimpanzees, animal reproduction studies have not been conducted with ZYMFENTRA. The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. Clinical Consideration Disease-Associated Maternal and/or Embryo/Fetal Risk Published data suggest that there is an increased risk of adverse pregnancy outcomes in women with inflammatory bowel disease associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2.5 kg) and small for gestational age at birth. Fetal/Neonatal Adverse Reactions The risk of fetal/neonatal adverse reactions with in utero exposure to infliximab-dyyb administered subcutaneously is unknown. However, most TNF blockers, such as infliximab products, cross the placenta and have been detected in infant serum up to 6 months following birth. Consequently, infants exposed to infliximab products may be at increased risk of infection, including disseminated infection which can become fatal. At least a six-month waiting period following birth is recommended before the administration of live vaccines (e.g., BCG vaccine or other live vaccines, such as the rotavirus vaccine) to infants exposed to intravenous infliximab in utero [see Warnings and Precautions (5.12)]. Cases of agranulocytosis in infants exposed to intravenous infliximab in utero have also been reported. Therefore, ZYMFENTRA, administered during pregnancy may affect immune responses in the in utero-exposed newborn and infant [see Adverse Reactions 6.2]. Data Animal Data Because infliximab products do not cross-react with TNFα in species other than humans and chimpanzees, animal reproduction studies have not been conducted with ZYMFENTRA.

— Etiqueta de la FDA: Zymfentra, CELLTRION USA Inc., vigente desde el 18 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Infliximab

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

ZYMFENTRA is contraindicated in patients with a history of a severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients in ZYMFENTRA, or any murine proteins. Reactions have included anaphylaxis [see Warnings and Precautions (5.7)]. History of severe hypersentitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients in ZYMFENTRA or to any murine proteins. (4)

— Etiqueta de la FDA: Zymfentra, CELLTRION USA Inc., vigente desde el 18 de agosto de 2026. 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.

• CELLTRION USA, 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

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Retiros del mercado

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Identificadores oficiales

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• Últimos retiros de medicamentos de la FDATodos los medicamentos, los más recientes primero
• Colitis ulcerativaEnfermedad que menciona la etiqueta: hospitales que la tratan
• Enfermedad de CrohnEnfermedad que menciona la etiqueta: hospitales que la tratan
• CELLTRION USA, 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) — Zymfentra, CELLTRION USA Inc., vigente desde el 18 de agosto de 2026; 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.

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