II. Indications
- Severe Plaque Psoriasis
- Psoriatic Arthritis
- Moderate to Severe Crohn's Disease
III. Contraindications
- Serious infection
- High risk of malignancy
IV. Mechanism
- Humanized Monoclonal Antibody against the Interleukins IL-12 and IL-23 (at P40 Protein subunit)
- Immunomodulating activity, inhibiting CD4 positive T cells from differentiating into Th1 and Th17 cells
- Results in specifically reduced Th1 and Th17 specific immune function and associated Cytokine release
- May prevent Graft Versus Host Disease (GVHD)
V. Precautions
- Prepare for Monoclonal Antibody use with infection screening (e.g. Tuberculosis) and Immunizations
VI. Dosing
- Severe Plaque Psoriasis or Psoriatic Arthritis (adults or age >12 years)
- Weight <100 kg
- Induction: Inject 45 mg SQ at 0 and 4 weeks
- Maintenance: 45 mg SQ every 12 weeks
- Weight >100 kg
- Induction: Inject 90 mg SQ at 0 and 4 weeks
- Maintenance: 90 mg SQ every 12 weeks
- Weight <100 kg
- Moderate to Severe Crohns Disease
- Induction
- Maintenance
- Inject 90 mg SQ every 8 weeks (starting 8 weeks after IV ibfusion)
VII. Safety
- Pregnancy Category B
- Unknown safety in Lactation
VIII. Adverse Effects
- Serious infection
- Hypersensitivity
- Malignancy exacerbation (e.g. Skin Cancer)
- Reversible Posterior Leukoencephalopathy
IX. Resources
X. References
- (2023) Biologics for Crohn's Disease, Presc Lett, #390826
- (2023) Drugs for Inflammatory Bowel Disease, Med Lett Drug Ther 65: 105-12
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Ontology: ustekinumab (C1608841)
| Definition (NCI) | An orally available, human, IgG1kappa, monoclonal antibody directed against the p40 protein subunit of both interleukin-12 (IL-12) and IL-23, with immunomodulating activity. Upon administration, ustekinumab binds to the p40 subunit of IL-12 and IL-23, blocking the binding of IL-12 and IL-23 to their interleukin receptors. This inhibits IL-12- and IL-23-mediated signaling and inhibits differentiation of CD4 positive T-cells into Th1 and Th17 cells. This prevents Th1- and Th17-mediated responses and cytokine production. This may prevent graft versus host disease (GVHD). IL-12 and IL-23, cytokines that play a key role in the regulation of the immune system, are upregulated in immune-mediated inflammatory disorders. Both Th1 and Th17 cells play a crucial role in GVHD. |
| Concepts | Pharmacologic Substance (T121) , Amino Acid, Peptide, or Protein (T116) , Immunologic Factor (T129) |
| MSH | C504320 |
| SnomedCT | 443465002, 443644001 |
| English | ustekinumab, USTEKINUMAB, Ustekinumab, Ustekinumab (product), Ustekinumab (substance), Immunoglobulin G1, Anti-(Human Interleukin-12 Subunit beta (IL-12B, CLMF p40, NKSF2)) (Human Monoclonal CNTO 1275 gamma1-chain), Disulfide with Human Monoclonal CNTO 1275 kappa-chain, Dimer |
| Spanish | ustekinumab, ustekinumab (producto), ustekinumab (sustancia) |
