II. Indications (all required)

  1. Refractory moderate to Severe Persistent Asthma
  2. Positive Allergy Testing for perennial inhaled allergen
  3. Patients must be age 12 years or over

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

V. Efficacy

  1. Appears to be very effective in first year of use

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