Nemolizumab-ilto

Para qué se usa Nemolizumab-ilto

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.

NEMLUVIO is an interleukin-31 receptor antagonist indicated for: Prurigo Nodularis The treatment of adults with prurigo nodularis. Atopic Dermatitis The treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription …

— Etiqueta de la FDA: Nemluvio, Galderma Laboratories, L.P., vigente desde el 26 de junio de 2025. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (injection, powder, lyophilized, for solution, subcutaneous), Nemluvio, Galderma Laboratories, L.P.; 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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Advertencia en recuadro

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Efectos secundarios de Nemolizumab-ilto

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 in greater details elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1)] Most common adverse reactions are: Prurigo Nodularis (incidence ≥1%): headache, dermatitis atopic, eczema, and eczema nummular. (6.1) Atopic Dermatitis (incidence ≥1%): headache (including migraine), arthralgia, urticaria, and myalgia.

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(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 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. Prurigo Nodularis A total of 508 adult subjects with prurigo nodularis were treated with NEMLUVIO in two placebo-controlled trials and an open label long-term extension trial. Of these, 375 subjects were exposed for at least 1 year in the drug development program for prurigo nodularis. The safety of NEMLUVIO in adult subjects with prurigo nodularis was evaluated in two randomized, doubleblind, placebo-controlled, multicenter trials (OLYMPIA 1 and OLYMPIA 2). Subjects were treated for up to 24 weeks in OLYMPIA 1 and up to 16 weeks in OLYMPIA 2. In these 2 trials, 370 subjects were treated with subcutaneous injections of NEMLUVIO, and 186 subjects received placebo [see Clinical Studies (14.1)]. Subjects weighing less than 90 kg in the NEMLUVIO group received an initial NEMLUVIO dose of 60 mg or placebo at Week 0, followed by a NEMLUVIO dose of 30 mg or placebo every 4 weeks. Subjects weighing 90 kg or more in the NEMLUVIO group received an initial NEMLUVIO dose of 60 mg or placebo at Week 0 followed by a NEMLUVIO dose of 60 mg or placebo every 4 weeks. During the treatment period in Trials OLYMPIA 1 and OLYMPIA 2, the proportion of subjects who discontinued treatment because of adverse reactions was 4% in the NEMLUVIO group versus 3% in the placebo group. Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% in the NEMLUVIO group, and for which the rate exceeds the rate in the placebo group through Week 16. Table 1: Adverse Reactions Occurring in ≥1% of Adult Subjects with Prurigo Nodularis in the NEMLUVIO Group and Greater than Placebo in the OLYMPIA 1 and OLYMPIA 2 Trials through Week 16. *includes: headache and tension headache Adverse Reaction NEMLUVIO N= 370 n (%) Placebo (N= 186) n (%) Headache* 23 (6) 6 (3) Dermatitis atopic 16 (4) 1 (0.5) Eczema 14 (4) 3 (2) Eczema nummular 11 (3) 0 Specific Adverse Reactions Hypersensitivity reactions Type 1 hypersensitivity reactions (Ig-E mediated reactions), including one report of discrete facial (peri-ocular) angioedema, were reported in subjects treated with NEMLUVIO [see Contraindications (4)].

— Etiqueta de la FDA: Nemluvio, Galderma Laboratories, L.P., vigente desde el 26 de junio de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Dosis de Nemolizumab-ilto

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.

Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO. (2.1) Prurigo Nodularis: Adult Patients Weighing Less Than 90kg: The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks.

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(2.2) Adult Patients Weighing 90kg or More: The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 60 mg given every 4 weeks. (2.2) Atopic Dermatitis: The recommended subcutaneous dosage is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks. (2.3) After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a dosage of 30 mg every 8 weeks is recommended. (2.3) Use NEMLUVIO with topical corticosteroids and/or topical calcineurin inhibitors. When the disease has sufficiently improved, discontinue use of topical therapies. (2.3) Administer NEMLUVIO by subcutaneous injection. (2.5) NEMLUVIO must be reconstituted prior to administration. (2.6) 2.1 Vaccination Prior to Treatment Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to treatment with NEMLUVIO [see Warnings and Precautions (5.2)]. 2.2 Recommended Dosage for Prurigo Nodularis Adult Patients Weighing Less Than 90 kg: The recommended subcutaneous dosage of NEMLUVIO for adult patients weighing less than 90 kg is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks. Adult Patients Weighing 90 kg or More: The recommended subcutaneous dosage of NEMLUVIO for adult patients weighing 90 kg or more is an initial dose of 60 mg (two 30 mg injections), followed by 60 mg given every 4 weeks. 2.3 Recommended Dosage for Atopic Dermatitis The recommended subcutaneous dosage of NEMLUVIO in adults and pediatric patients 12 years of age and older is an initial dose of 60 mg (two 30 mg injections), followed by 30 mg given every 4 weeks. After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a subcutaneous dosage of 30 mg every 8 weeks is recommended. Concomitant Topical Therapies: Use NEMLUVIO with topical corticosteroids and/or topical calcineurin inhibitors. When the disease has sufficiently improved, discontinue use of topical therapies. 2.4 Missed Dose If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. 2.5 Important Administration Instructions NEMLUVIO is administered by subcutaneous injection. NEMLUVIO is intended for use under the guidance of a healthcare provider. Prior to the first injection, provide patients and/or caregivers with proper training on the preparation and administration of NEMLUVIO. Patients may self-inject NEMLUVIO after receiving training on subcutaneous injection techniques. In pediatric patients 12 years of age and older, administer NEMLUVIO by or under the supervision of a trained adult or caregiver. For the initial dose, administer each of the two NEMLUVIO injections at different injection sites.

— Etiqueta de la FDA: Nemluvio, Galderma Laboratories, L.P., vigente desde el 26 de junio de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Nemolizumab-ilto 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 on NEMLUVIO use in pregnant women exposed during clinical trials are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

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In an enhanced pre- and postnatal development study in cynomolgus monkeys, when nemolizumab-ilto was administered subcutaneously during organogenesis to parturition, an increase in early postnatal death was observed at a dose 36 times the maximum recommended human dose (MRHD) for PN and 50 times for AD (see Data). The clinical significance of this nonclinical finding is unknown. The background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defects, 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 Considerations Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, NEMLUVIO may be present in infants exposed in utero. The potential impact of infants being exposed in utero to NEMLUVIO should be considered. Data Animal Data In an enhanced pre- and postnatal development study, subcutaneous doses up to 25 mg/kg of nemolizumab-ilto were administered to pregnant cynomolgus monkeys once every two weeks during organogenesis to parturition. No maternal or embryofetal toxicities were observed at doses up to 25 mg/kg (36 times the MRHD for PN and 50 times for AD, based on AUC comparison). Early postnatal death occurred in the offspring of one control monkey and 3 monkeys at 25 mg/kg (36 times the MRHD for PN and 50 times for AD, based on AUC comparison). The clinical significance of this nonclinical finding is unknown. Nemolizumab-ilto was administered subcutaneously to the offspring at doses up to 25 mg/kg (122 times the MRHD for PN and 168 times for AD, based on AUC comparison), once every 2 weeks for 6 months, starting from postnatal day 35. No adverse effects were noted in the remaining offspring.

— Etiqueta de la FDA: Nemluvio, Galderma Laboratories, L.P., vigente desde el 26 de junio de 2025. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Nemolizumab-ilto

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

NEMLUVIO is contraindicated in patients who have known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO [see Warnings and Precautions (5.1)]. Known hypersensitivity to nemolizumab-ilto or to any of the excipients in NEMLUVIO. (4)

— Etiqueta de la FDA: Nemluvio, Galderma Laboratories, L.P., vigente desde el 26 de junio de 2025. Leer la etiqueta completa en DailyMed →

Sobredosis de Nemolizumab-ilto

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).

There is no specific treatment for NEMLUVIO overdosage. In the event of overdosage, contact Poison Control (1-800-222-1222) for the latest recommendations and monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.

— Etiqueta de la FDA: Nemluvio, Galderma Laboratories, L.P., vigente desde el 26 de junio de 2025. Leer la etiqueta completa en DailyMed →

Presentaciones y vía de administración

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• Galderma Laboratories, L.P.1 producto

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Fuentes

1. Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Nemluvio, Galderma Laboratories, L.P., vigente desde el 26 de junio 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

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