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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Related Studies

Ontology: Daclizumab (C0663182)

Definition (NCI) A recombinant monoclonal antibody interleukin-2 receptor antagonist. Daclizumab binds specifically to the alpha subunit of the human interleukin-2 (IL-2) receptor expressed on the surface of activated lymphocytes in vivo, thereby inhibiting IL-2 binding and IL-2-mediated lymphocyte activation, a critical cellular immune response pathway.
Definition (NCI_NCI-GLOSS) A monoclonal antibody that is being studied in the treatment of adult T-cell leukemia and in the treatment of cytopenia (low blood cell count).
Definition (PDQ) A recombinant monoclonal antibody interleukin-2 receptor antagonist. Daclizumab binds specifically to the alpha subunit of the human interleukin-2 (IL-2) receptor expressed on the surface of activated lymphocytes in vivo, thereby inhibiting IL-2 binding and IL-2-mediated lymphocyte activation, a critical cellular immune response pathway. Check for "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=42006&idtype=1" active clinical trials or "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=42006&idtype=1&closed=1" closed clinical trials using this agent. ("http://nciterms.nci.nih.gov:80/NCIBrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C1569" NCI Thesaurus)
Concepts Pharmacologic Substance (T121) , Amino Acid, Peptide, or Protein (T116)
MSH C096001
SnomedCT 109133001, 386977009
English Dacliximab, Anti-Tac Humanized Monoclonal Antibody, humanized anti-Tac monoclonal antibody, monoclonal antibody anti-Tac, monoclonal antibody humanized anti-Tac, Daclizumab, daclizumab, daclizumab [Chemical/Ingredient], anti-tac, Immunoglobulin G 1, (human-mouse monoclonal 1H4 gamma-chain, anti-human interleukin 2 receptor), disulfide with human-mouse monoclonal clone 1H4 light chain, dimer, dacliximab, Daclizumab (product), Daclizumab (substance), anti-Tac, anti-Tac monoclonal antibody, MOAB anti-Tac, Humanized Anti-Tac Monoclonal Antibody, Monoclonal Antibody Anti-Tac, Anti-Tac Monoclonal Antibody, Anti-Tac, DACLIZUMAB
Spanish daclizumab (producto), daclizumab (sustancia), daclizumab

Ontology: basiliximab (C0676831)

Definition (NCI) A recombinant, chimeric, human-murine monoclonal antibody directed against the alpha subunit of the interleukin-2 receptor (IL-2R alpha) with immunosuppressant activity. Basiliximab selectively binds to and blocks IL-2R alpha, expressed on the surface of activated T-lymphocytes, thereby preventing interleukin-2 binding and inhibiting the interleukin-2-mediated activation of lymphocytes.
Definition (PDQ) A recombinant, chimeric, human-murine monoclonal antibody directed against the alpha subunit of the interleukin-2 receptor (IL-2R alpha) with immunosuppressant activity. Basiliximab selectively binds to and blocks IL-2R alpha, expressed on the surface of activated T-lymphocytes, thereby preventing interleukin-2 binding and inhibiting the interleukin-2-mediated activation of lymphocytes. Check for "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=459956&idtype=1" active clinical trials or "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=459956&idtype=1&closed=1" closed clinical trials using this agent. ("http://nciterms.nci.nih.gov:80/NCIBrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C52186" NCI Thesaurus)
Concepts Immunologic Factor (T129) , Pharmacologic Substance (T121) , Amino Acid, Peptide, or Protein (T116)
MSH C113157
SnomedCT 109135008, 386978004
English basiliximab, basiliximab (Simulect), basiliximab (medication), BASILIXIMAB, basiliximab [Chemical/Ingredient], Basiliximab, Basiliximab (product), Basiliximab (substance), Basilixumab
Spanish basilixmab (producto), basilixmab (sustancia), basilixmab

Ontology: Interleukin 2 Receptor, Alpha (C1101536)

Definition (NCI) Interleukin-2 receptor alpha chain (272 aa, 31 kD) is a cell fate protein that is encoded by the human IL2RA gene and has roles in immune response, cell proliferation, apoptosis and signal transduction.
Definition (MSH) A low affinity interleukin-2 receptor subunit that combines with the INTERLEUKIN-2 RECEPTOR BETA SUBUNIT and the INTERLEUKIN RECEPTOR COMMON GAMMA-CHAIN to form a high affinity receptor for INTERLEUKIN-2.
Concepts Receptor (T192) , Amino Acid, Peptide, or Protein (T116) , Immunologic Factor (T129)
MSH D053645
English Antigens, CD25, CD25 Antigens, Tac P55 Peptide, CD25 Antigen, IL-2Ralpha, Antigen, CD25, IL 2Ralpha, Interleukin 2 Receptor alpha Chain, Interleukin 2 Receptor alpha Subunit, Interleukin 2 Receptor alpha, Interleukin 2 Receptors alpha, Interleukin 2Ralpha, Interleukin-2 Receptor alpha Chain, Interleukin-2 Receptor alpha Subunit, Interleukin-2 Receptor alpha, Interleukin-2 Receptors alpha, Interleukin-2Ralpha, Receptor alpha, Interleukin-2, Receptors alpha, Interleukin-2, alpha-subunit, Receptor, Interleukin-2, TAC PEPTIDE P 055, INTERLEUKIN 002 RECEPTOR ALPHA SUBUNIT, CD 025 ANTIGENS, ANTIGENS CD 025, INTERLEUKIN 002 RECEPTORS ALPHA, Interleukin-2 Receptor Alpha Chain, Interleukin-2 Receptor alpha Subunit [Chemical/Ingredient], Interleukin 2 Receptor, Alpha, IL-2 Receptor, Interleukin 2 Receptor, CD25, IL-2R, IL2R, IL2RA, Low Affinity Interleukin 2 Receptor
Portuguese Receptores de Interleucina-2, Subunidade alfa, Subunidade alfa de Receptor de Interleucina-2, Peptídeo Tac P55, Antígenos CD25, Subunidade alfa de Receptor da Interleucina-2, Subunidade alfa do Receptor da Interleucina-2, Subunidade alfa de Receptores da Interleucina-2, Receptores alfa de Interleucina-2
Spanish Subunidad alfa del Receptor de Interleucina-2, Receptores de Interleucina-2, Subunidad alfa, Antígenos CD25, Péptido Tac P55, Receptores alfa de Interleucina-2
Russian TAC P55 ПЕПТИД, ИНТЕРЛЕЙКИНА-2 РЕЦЕПТОРЫ АЛЬФА, ИНТЕРЛЕЙКИНА-2 РЕЦЕПТОРА АЛЬФА-СУБЪЕДИНИЦА, АНТИГЕНЫ CD25, РЕЦЕПТОРЫ АЛЬФА ИНТЕРЛЕЙКИНА-2, TAC P55 PEPTID, INTERLEIKINA-2 RETSEPTORA AL'FA-SUB"EDINITSA, INTERLEIKINA-2 RETSEPTORY AL'FA, RETSEPTORY AL'FA INTERLEIKINA-2, ANTIGENY CD25
German Interleukin-2-Rezeptor-alpha, Interleukin-2-Rezeptor, alpha-Untereinheit, CD25-Antigen, Interleukin-2-Rezeptoren, alpha, IL-2Ralpha, Interleukin-2Ralpha, CD25-Antigene, Interleukin-2-Rezeptor, alpha-Kette, Interleukin-2-Rezeptor, alpha-chain, Tac-P55, Peptide
French Peptide Tac, Chaîne alpha du récepteur à l'interleukine-2, Chaîne alpha du récepteur de l'interleukine-2, Antigène CD25, Chaîne alpha du récepteur à l'IL-2, Sous-unité alpha du récepteur à l'IL2, Sous-unité alpha du récepteur à l'IL-2, Peptide p55, Sous-unité alpha du récepteur à l'interleukine-2, IL-2-R alpha, Sous-unité alpha du récepteur de l'interleukine-2, Antigènes CD25, CD25
Finnish Interleukiini-2-reseptorin alfa-alayksikkö
Czech IL-2Ralfa, antigen CD25, antigeny CD25, peptid Tac P55, receptor pro interleukin-2 - alfa-podjednotka, interleukin-2 - receptor alfa, receptor interleukinu-2 - alfa-podjednotka
Italian Sottounità alfa del recettore per l'interleuchina-2
Swedish Interleukin-2 Receptor alpha Subunit
Polish Podjednostka alfa receptora interleukiny 2
Japanese インターロイキン2受容体アルファサブユニット, インターロイキン2受容体αサブユニット, インターロイキン2受容体アルファ, 抗原-CD25, TACペプチド, Tac抗原, インターロイキン-2受容体アルファ, TAC p55ペプチド, CD25抗原

Ontology: Anti-CD25 Monoclonal Antibody (C2698127)

Definition (NCI) Any monoclonal antibody directed against the alpha subunit of the human interleukin 2 receptor.
Concepts Amino Acid, Peptide, or Protein (T116) , Immunologic Factor (T129) , Pharmacologic Substance (T121)
English Anti-CD25 Monoclonal Antibody