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Ustekinumab

AEMPS

Biologic – interleukin-12 and -23 inhibitor

ATC code: L04AC05

Brand names: Stelara, Pyzchiva, Wezenla

Updated · Methodology

Indications

A

Crohn's disease

Second line

Second-line for moderate-to-severe Crohn's disease per 2024 after anti-TNFα (infliximab, adalimumab) failure or intolerance. IV induction by body weight (260–520 mg), then 90 mg subcutaneously every 8 weeks. UNITI showed 30% reduction in relapse risk over 44 weeks.

Sources

  1. AEMPS: Ficha técnica de Ustekinumab (2024)
  2. N Engl J Med: Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. (2016)
  3. Cochrane Database Syst Rev: Anti-IL-12/23p40 antibodies for maintenance of remission in Crohn's disease. (2019)
  4. Journal of Crohn's and Colitis: ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment (2019)

ICD-10: K50.9 · ICD-11: DD70

A

Psoriasis

Second line

Second-line for moderate-to-severe plaque psoriasis per AEDV 2024 and EuroGuiderm after failure or intolerance of systemic therapies (methotrexate, cyclosporine). Starting dose 45 mg (or 90 mg if over 100 kg) subcutaneously at weeks 0 and 4, then every 12 weeks. Sbidian 2022 meta-analysis: ustekinumab underperforms anti-IL-17 and anti-IL-23 agents (secukinumab, ixekizumab, guselkumab, risankizumab) on PASI 90.

Sources

  1. AEMPS: Ficha técnica de Ustekinumab (2024)
  2. AEDV: Documento de consenso sobre alopecia androgenética (2022)

ICD-10: L40 · ICD-11: EA90

A

Ulcerative colitis

Second line

Second-line for moderate-to-severe ulcerative colitis per 2024. IV induction by weight, then 90 mg subcutaneously every 8–12 weeks.

Sources

  1. AEMPS: Ficha técnica de Ustekinumab (2024)
  2. N Engl J Med: Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. (2019)
  3. ECCO: ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment (2022)
  4. Gut: Efficacy of biological therapies and small molecules in moderate to severe ulcerative colitis: systematic review and network meta-analysis. (2021)

ICD-10: K51 · ICD-11: DD71

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Anti-aging and longevity

Not recommended

Ustekinumab is a monoclonal antibody against interleukins 12 and 23 (IL-12/23). It is prescribed for moderate-to-severe psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis ( 2020, 2024, 2023 guidelines). In anti-aging circles, ustekinumab is promoted as a biological against aging-related inflammation and autoimmune background in healthy people. In healthy adults, no clinical studies of prophylactic use exist. The drug has serious risks: severe infections (including opportunistic), reactivation of tuberculosis (requires screening before start), increased malignancy risk on long-term use, and hypersensitivity reactions. If ustekinumab was recommended to suppress aging-related inflammation in a healthy person, seek a second opinion immediately.

Sources

  1. AEMPS: Ficha técnica de Ustekinumab (2024)
  2. Cochrane: Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases (2012)
How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

A fully human IgG1κ monoclonal antibody binding the shared p40 subunit of IL-12 and IL-23. Blocks binding to IL-12Rβ1 on T-cells, NK cells, and antigen-presenting cells. Suppresses Th1 and Th17 differentiation – key cells in psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Half-life 15–32 days – infrequent injections every 8–12 weeks.

Safety

Contraindications

  • Ustekinumab hypersensitivity
  • Active tuberculosis or other severe infections
  • Severe sepsis in the prior year
  • Age under 6 (most indications)

Serious adverse effects

  • Serious infections including opportunistic (tuberculosis, invasive fungal)
  • Hepatitis B reactivation
  • Malignancies (theoretical, not confirmed)
  • Reversible posterior leukoencephalopathy syndrome (RPLS)
  • Allergic reactions
  • Non-infectious pneumonitis

Common adverse effects

  • Injection site reactions
  • Upper respiratory infections
  • Nasopharyngitis
  • Headache
  • Fatigue

Pregnancy: can you take Ustekinumab?

EMA summary of product characteristics (section 4.6): there are not enough data on ustekinumab use in pregnant women. Animal studies show no direct or indirect harmful effects on pregnancy, embryonic or fetal development, delivery or postnatal development. As a precaution, it is preferable to avoid ustekinumab during pregnancy. Women of childbearing potential use effective contraception during treatment and for at least 15 weeks after it.

Breastfeeding: can you take Ustekinumab?

Low milk concentrations, minimal infant GI absorption. Compatible with breastfeeding.

Calculate RIDFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Before start and every 6 months screen for latent tuberculosis (QuantiFERON or Mantoux, chest X-ray) and hepatitis B/C. Live vaccines are contraindicated during therapy and for one year after discontinuation. Remove pen or syringe from fridge 30 minutes before injection to reduce pain.
Label mentions9 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • Minorcorticosteroidesclass named in the label
    «Tratamiento inmunosupresor concomitante: En los estudios de psoriasis, no se ha evaluado la seguridad ni la eficacia de STELARA en combinación con inmunosupresores, incluidos los biológicos, o con…»

    AEMPS, section 4.4 · Open on CIMA

  • Acetylsalicylic acid
    «No se han realizado estudios de interacciones en humanos. En el análisis de farmacocinética poblacional de los ensayos en fase 3 se investigó el efecto de los medicamentos concomitantes más…»

    AEMPS, section 4.5 · Open on CIMA

  • AINEclass named in the label
    «No se han realizado estudios de interacciones en humanos. En el análisis de farmacocinética poblacional de los ensayos en fase 3 se investigó el efecto de los medicamentos concomitantes más…»

    AEMPS, section 4.5 · Open on CIMA

  • Atorvastatin
    «No se han realizado estudios de interacciones en humanos. En el análisis de farmacocinética poblacional de los ensayos en fase 3 se investigó el efecto de los medicamentos concomitantes más…»

    AEMPS, section 4.5 · Open on CIMA

  • Azathioprine
    «No se han realizado estudios de interacciones en humanos. En el análisis de farmacocinética poblacional de los ensayos en fase 3 se investigó el efecto de los medicamentos concomitantes más…»

    AEMPS, section 4.5 · Open on CIMA

  • corticosteroidsclass named in the label
    «Concomitant Therapies: In trials in subjects with plaque psoriasis the safety of Ustekinumab in combination with immunosuppressive agents or phototherapy has not been evaluated. In trials in subjects…»

    FDA, section 7 · Open on DailyMed

  • Ibuprofen
    «No se han realizado estudios de interacciones en humanos. En el análisis de farmacocinética poblacional de los ensayos en fase 3 se investigó el efecto de los medicamentos concomitantes más…»

    AEMPS, section 4.5 · Open on CIMA

  • Metformin
    «No se han realizado estudios de interacciones en humanos. En el análisis de farmacocinética poblacional de los ensayos en fase 3 se investigó el efecto de los medicamentos concomitantes más…»

    AEMPS, section 4.5 · Open on CIMA

  • Paracetamol
    «No se han realizado estudios de interacciones en humanos. En el análisis de farmacocinética poblacional de los ensayos en fase 3 se investigó el efecto de los medicamentos concomitantes más…»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Ustekinumab used for?

Ustekinumab is evaluated for the following indications with varying evidence strength: Ulcerative colitis (evidence tier A), Crohn's disease (evidence tier A), Psoriasis (evidence tier A). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Ustekinumab?

Common side effects of Ustekinumab (≥ 1 in 100): Injection site reactions, Upper respiratory infections, Nasopharyngitis, Headache, Fatigue. See the Safety section for uncommon and serious reactions.

Is Ustekinumab safe during pregnancy?

EMA summary of product characteristics (section 4.6): there are not enough data on ustekinumab use in pregnant women. Animal studies show no direct or indirect harmful effects on pregnancy, embryonic or fetal development, delivery or postnatal development. As a precaution, it is preferable to avoid ustekinumab during pregnancy. Women of childbearing potential use effective contraception during treatment and for at least 15 weeks after it.

Is Ustekinumab compatible with breastfeeding?

Low milk concentrations, minimal infant GI absorption. Compatible with breastfeeding.

Who should not take Ustekinumab?

Ustekinumab is contraindicated in: Ustekinumab hypersensitivity; Active tuberculosis or other severe infections; Severe sepsis in the prior year; Age under 6 (most indications). Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

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