II. Indications (all required)

  1. See Severe Asthma
  2. Refractory moderate to Severe Persistent Asthma
  3. Positive Allergy Testing for perennial inhaled allergen
  4. Patients must be age 6 years or older

III. Mechanism

  1. Recombinant humanized Monoclonal Antibody (rhu-MAB)
  2. Blocks IgE binding to Mast Cells and Basophils
    1. Prevents release of Allergic Reaction mediators

IV. Adverse effects

  1. Serious and life-threatening
    1. May predispose to malignancy
    2. Anaphylaxis
      1. Requires administration in clinical setting
      2. Reaction may occur within 2 hours of injection
  2. Other reactions
    1. Injection site reaction
    2. Upper Respiratory Infections (including Sinusitis, Pharyngitis)
    3. Headache

VI. Cost

  1. Dose dependent
  2. Varies from $500 to over $3000 for one month supply

VII. Dosing

  1. Dose determined by serum IgE level
  2. Usually 150 to 375 mg SQ every 2-4 weeks
  3. Must be given in clinical setting with observation

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Ontology: omalizumab (C0966225)

Definition (NCI) A humanized monoclonal antibody directed against the C-epsilon 3 domain of immunoglobulin E. Olizumab binds to this IgE domain, thereby preventing IgE from binding to its high-affinity mast-cell receptor. (NCI04)
Concepts Immunologic Factor (T129) , Amino Acid, Peptide, or Protein (T116) , Pharmacologic Substance (T121)
MSH C426106
SnomedCT 406442003, 406443008
English omalizumab (medication), OMALIZUMAB, Olizumab, omalizumab [Chemical/Ingredient], Immunoglobulin G, anti-(human immunoglobulin E Fc region)(human-mouse monoclonal E25 clone pSVIE26 gamma-chain), disulfide with human-mouse monoclonal E25 clone pSVIE26 kappa-chain, dimer, omalizumab, Omalizumab, Omalizumab (product), Omalizumab (substance)
Spanish omalizumab (producto), omalizumab (sustancia), omalizumab