II. Indications

  1. Renal Transplant Rejection Prophylaxis
    1. Basiliximab (Simulect)
      1. Used in combination with Cyclosporine and Corticosteroids
    2. Daclizumab (off-market, see below)
  2. Multiple Sclerosis
    1. Daclizumab (off-market, marginal efficacy, see below)

III. Mechanism

  1. Interleukin-2 Receptor Alpha (IL-2Ra, CD25)
    1. Interleukin 2 binds IL-2Ra on Leukocyte surface, triggering immune response
      1. IL-2Ra binding is involved in cell signaling, immune response, cell proliferation and apoptosis
    2. IL-2Ra (CD25) is expressed on the surface of Leukocytes, esp. activated T Cells and Regulatory T Cells (Tregs)
    3. Alpha subunit combines with 2 other subunits (beta and gamma chain) to form a high affinity Interleukin 2 receptor
  2. CD25 Monoclonal Antibody
    1. Chimeric monoclonal antibodies bind CD25 receptor alpha on Leukocytes (esp. activated T Cells)
    2. Blocks Interleukin-2 binding, thereby reducing IL-2 mediated immune response

IV. Dosing

  1. See other references for disease specific dosing protocols
  2. Prescribers are typically specialists knowledgeable about the risks and monitoring of Voclosporin

V. Medications

  1. Basiliximab (Simulect)
  2. Daclizumab (Zinbryta, off-market)
    1. https://www.fda.gov/drugs/drug-safety-and-availability/fda-working-manufacturers-withdraw-zinbryta-market-united-states
    2. Voluntarily removed from market 2018 after association with autoimmune Encephalitis, and risk of hepatotoxicity

VII. Safety: Basiliximab

  1. Unknown safety in Lactation
  2. Unknown safety in pregnancy (although labeled as Pregnancy Category B)
    1. Use only in pregnancy if benefit outweighs risk

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