II. Indications

  1. Severe Plaque Psoriasis
  2. Psoriatic Arthritis
  3. Moderate to Severe Crohn's Disease

III. Contraindications

  1. Serious infection
  2. High risk of malignancy

IV. Mechanism

  1. Humanized Monoclonal Antibody against the Interleukins IL-12 and IL-23 (at P40 Protein subunit)
  2. Immunomodulating activity, inhibiting CD4 positive T cells from differentiating into Th1 and Th17 cells
  3. Results in specifically reduced Th1 and Th17 specific immune function and associated Cytokine release
    1. May prevent Graft Versus Host Disease (GVHD)

V. Precautions

  1. Prepare for Monoclonal Antibody use with infection screening (e.g. Tuberculosis) and Immunizations
    1. See Monoclonal Antibody

VI. Dosing

  1. Severe Plaque Psoriasis or Psoriatic Arthritis (adults or age >12 years)
    1. Weight <100 kg
      1. Induction: Inject 45 mg SQ at 0 and 4 weeks
      2. Maintenance: 45 mg SQ every 12 weeks
    2. Weight >100 kg
      1. Induction: Inject 90 mg SQ at 0 and 4 weeks
      2. Maintenance: 90 mg SQ every 12 weeks
  2. Moderate to Severe Crohns Disease
    1. Induction
      1. Weight <=55 kg: Infuse 260 mg IV over 1 hour via inline Protein binding filter
      2. Weight 56 to 85 kg: infuse 390 mg IV over 1 hour via inline Protein binding filter
      3. Weight >85 kg: Infuse 520 mg IV over 1 hour via inline Protein binding filter
    2. Maintenance
      1. Inject 90 mg SQ every 8 weeks (starting 8 weeks after IV ibfusion)

VII. Safety

  1. Pregnancy Category B
  2. Unknown safety in Lactation

VIII. Adverse Effects

  1. Serious infection
  2. Hypersensitivity
  3. Malignancy exacerbation (e.g. Skin Cancer)
  4. Reversible Posterior Leukoencephalopathy

X. References

  1. (2023) Biologics for Crohn's Disease, Presc Lett, #390826
  2. (2023) Drugs for Inflammatory Bowel Disease, Med Lett Drug Ther 65: 105-12

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Cost: Medications

stelara (on 7/19/2023 at Medicaid.Gov Survey of pharmacy drug pricing)
STELARA 45 MG/0.5 ML SYRINGE $25,519.96 per ml
STELARA 90 MG/ML SYRINGE $24,599.06 per ml