Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Genes that may be involved
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names


Austria: Stelara; Belgium: Stelara; Bulgaria: Stelara; Czech Republic: Stelara; Denmark: Stelara; Estonia: Stelara; Finland: Stelara; France: Stelara; Germany: Stelara; Greece: Stelara; Hungary: Stelara; Ireland: Stelara; Italy: Stelara; Latvia: Stelara; Lithuania: Stelara; Luxembourg: Stelara; Malta: Stelara; Netherlands: Stelara; Poland: Stelara; Portugal: Stelara; Romania: Stelara; Slovakia: Stelara; Slovenia: Stelara; Spain: Stelara; Sweden: Stelara; UK: Stelara.

North America

Canada: Stelara; USA: Stelara.

Drug combinations


Ustekinumab: C~6482~H~10004~N~1712~O~2016~S~46~. Mw: 148.08-149.69. Human IgG1~κ~ monoclonal antibody against the p40 subunit of the IL-12 and IL-23 cytokines. Comprised of 1326 aa. CAS-815610-63-0.

Pharmacologic Category

Immunosuppressive Agents; Interleukin-12 Inhibitor; Interleukin-23 Inhibitor, Monoclonal Antibody. Antipsoriatic Agents. (ATC-Code: L04AC05).

Mechanism of action

Ustekinumab is a human IgG~1~ monoclonal antibody that binds with high affinity and specificity to the p40 protein subunit used by both the interleukin IL-12 and IL-23 cytokines. IL-12 and IL-23 are naturally-occurring cytokines involved in inflammatory and immune responses, such as natural killer cell activation and CD4^+^ T-cell differentiation and activation. Ustekinumab also interferes with the expression of monocyte chemotactic protein-1 (MCP-1), tumor necrosis factor-alpha (TNF-α), interferon-inducible protein-10 (IP-10), and interleukin-8 (IL-8). In in vitro models, ustekinumab was shown to disrupt IL-12- and IL-23-mediated signaling and cytokine cascades by disrupting the interaction of these cytokines with a shared cell-surface receptor chain, IL-12β1.

Therapeutic use

Treatment of moderate-to-severe plaque psoriasis.

Pregnancy and lactiation implications

Reproduction studies have not been conducted in pregnant women. Use during pregnancy only if clearly needed. Because many immunoglobulins are secreted in milk it is expected that ustekinumab will be present in breast milk. Use caution in nursing women.

Unlabeled use


Hypersensitivity to ustekinumab or any component of the formulation; severe infections such as sepsis, tuberculosis and opportunistic infections.

Warnings and precautions

Antibody formation to ustekinumab has been observed with therapy and has been associated with decreased serum levels and therapeutic response in some patients. May increase the risk of infections and reactivation of latent infections. Should not be given to patients with any clinically important active infection (caution in patients with a chronic infection or history of recurrent infection). Patients taking ustekinumab have theoretically more risk for particular infections, and appropriate diagnostic testing should be considered (individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations). Patients should be evaluated for tuberculosis infection prior to initiating treatment (patients should be monitored closely for signs and symptoms of active tuberculosis during and after treatment). Malignancies were reported among subjects who received this medical product (its safety has not been evaluated in patients with history of malignancy or who have a known malignancy). One case of reversible posterior leukoencephalopathy syndrome (RPLS) was observed (if RPLS is suspected, treatment should be discontinued). Patients being treated should not receive live vaccines (prior to initiating therapy, patients should receive all immunizations appropriate for age). Non-live vaccinations received during treatment may not elicit a sufficient immune response to prevent disease.



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