Risankizumab (risankizumab-rzaa)

Para qué se usa Risankizumab

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.

SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. active psoriatic arthritis in adults and pediatric patients 6 years of age and older. moderately to severely active Crohn's disease in adults. …

— Etiqueta de la FDA: Skyrizi, AbbVie Inc., vigente desde el 15 de junio de 2026. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (injection, subcutaneous), Skyrizi, AbbVie Inc.; abarca 6 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 Risankizumab

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 adverse reactions are discussed in other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Infections [see Warnings and Precautions (5.2)] Tuberculosis [see Warnings and Precautions (5.3)] Hepatotoxicity [see Warnings and Precautions (5.4)] Most common adverse reactions are: Plaque Psoriasis and Psoriatic Arthritis (≥ 1%): upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

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(6.1) Crohn’s Disease (>3%): ◦ Induction: upper respiratory infections, headache, and arthralgia. (6.1) ◦ Maintenance: arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection. (6.1) Ulcerative Colitis (≥3%): ◦ Induction: arthralgia. (6.1) ◦ Maintenance: arthralgia, pyrexia, injection site reactions, and rash. (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 trials are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults with Plaque Psoriasis A total of 2234 subjects were treated with SKYRIZI in clinical development trials in plaque psoriasis. Of these, 1208 subjects with psoriasis were exposed to SKYRIZI for at least one year. Data from placebo- and active-controlled trials were pooled to evaluate the safety of SKYRIZI for up to 16 weeks. In total, 1306 subjects were evaluated in the SKYRIZI 150 mg group. Table 4 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the SKYRIZI group than the placebo group during the 16-week controlled period of pooled clinical trials. Table 4. Adverse Reactions Occurring in ≥ 1% of Adults with Plaque Psoriasis on SKYRIZI through Week 16 Adverse Drug Reactions SKYRIZI N = 1306 n (%) Placebo N = 300 n (%) Upper respiratory infections a 170 (13) 29 (9.7) Headache b 46 (3.5) 6 (2) Fatigue c 33 (2.5) 3 (1) Injection site reactions d 19 (1.5) 3 (1) Tinea infections e 15 (1.1) 1 (0.3) a Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis b Includes: headache, tension headache, sinus headache, cervicogenic headache c Includes: fatigue, asthenia d Includes: injection site bruising, erythema, extravasation, hematoma, hemorrhage, infection, inflammation, irritation, pain, pruritus, reaction, swelling, warmth e Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, tinea infection, onychomycosis Adverse reactions that occurred in < 1% but > 0.1% of subjects in the SKYRIZI group and at a higher rate than in the placebo group through Week 16 were folliculitis and urticaria.

— Etiqueta de la FDA: Skyrizi, AbbVie Inc., vigente desde el 15 de junio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Dosis de Risankizumab

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 the treatment of moderately to severely active Crohn’s disease and ulcerative colitis: Obtain liver enzymes and bilirubin levels prior to initiating treatment with SKYRIZI. (2.1, 5.4) Complete all age-appropriate vaccinations as recommended by current immunization guidelines (2.1, 5.5) Recommended Dosage Moderate-to-Severe Plaque Psoriasis: Adults: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.

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(2.3) Pediatric P atients 6 Years of Age and Older: Patients weighing less than 40 kg: 55 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. (2.3) Patients weighing 40 kg or greater: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. (2.3) Active Psoriatic Arthritis: Adults: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. (2.4) Pediatric Patients 6 Y ears of Age and Older: Patients weighing less than 40 kg: 55 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. (2.4) Patients weighing 40 kg or greater: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. (2.4) SKYRIZI may be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs). (2.4) Moderately to Severely Active Crohn’s Disease: The recommended induction dosage is 600 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage to maintain therapeutic response. (2.6) Moderately to Severely Active Ulcerative Colitis: The recommended induction dosage is 1,200 mg administered by intravenous infusion over at least two hours at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage to maintain therapeutic response. (2.7) 2.1 Procedures Prior to Treatment Initiation For the treatment of moderately to severely active Crohn’s disease and ulcerative colitis, obtain liver enzymes and bilirubin levels prior to initiating treatment with SKYRIZI [see Warnings and Precautions (5.4)]. Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI [see Warnings and Precautions (5.3)]. Complete all age-appropriate vaccinations as recommended by current immunization guidelines [see Warnings and Precautions (5.5)]. 2.2 General Considerations for Administration

• Visually inspect SKYRIZI for particulate matter and discoloration prior to administration.

— Etiqueta de la FDA: Skyrizi, AbbVie Inc., vigente desde el 15 de junio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Risankizumab 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.

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while treated with SKYRIZI. Patients should be encouraged to enroll by calling 1-877-302-2161 or visiting http://glowpregnancyregistry.com.

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Risk Summary Available pharmacovigilance and clinical trial data with risankizumab use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Although there are no data on risankizumab-rzaa, monoclonal antibodies can be actively transported across the placenta, and SKYRIZI may cause immunosuppression in the in utero - exposed infant. There are adverse pregnancy outcomes in women with inflammatory bowel disease (see Clinical Considerations). In an enhanced pre- and post-natal developmental toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of 5 or 50 mg/kg risankizumab-rzaa once weekly during the period of organogenesis up to parturition. Increased fetal/infant loss was noted in pregnant monkeys at the 50 mg/kg dose (see Data). The 50 mg/kg dose in pregnant monkeys resulted in approximately 5 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 32 times the exposure (AUC) to the maximum recommended maintenance dose (360 mg). No risankizumab-rzaa-related effects on functional or immunological development were observed in infant monkeys from birth through 6 months of age. The clinical significance of these findings for humans is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. 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 Considerations Disease-associated maternal and embryo/fetal risk Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth. Fetal/Neonatal adverse reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, SKYRIZI may be present in infants exposed in utero. The potential clinical impact of risankizumab exposure in infants exposed in utero should be considered. Data Animal Data An enhanced pre- and post-natal developmental toxicity study was conducted in cynomolgus monkeys. Pregnant cynomolgus monkeys were administered weekly subcutaneous doses of risankizumab-rzaa of 5 or 50 mg/kg from gestation day 20 to parturition, and the cynomolgus monkeys (mother and infants) were monitored for 6 months after delivery.

— Etiqueta de la FDA: Skyrizi, AbbVie Inc., vigente desde el 15 de junio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Risankizumab

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

SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients [see Warnings and Precautions (5.1)]. SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients (4)

— Etiqueta de la FDA: Skyrizi, AbbVie Inc., vigente desde el 15 de junio 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.

• AbbVie Inc.6 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

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
• Colitis ulcerativaEnfermedad que menciona la etiqueta: hospitales que la tratan
• Enfermedad de CrohnEnfermedad 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) — Skyrizi, AbbVie Inc., vigente desde el 15 de junio 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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