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Omalizumab

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Omalizumab, rhuMAb-E25, Xolair

  • See Also
  1. Asthma Biologic
  2. Asthma Management
  3. Severe Asthma
  • Indications (all required)
  1. Asthma (all criteria required)
    1. See Severe Asthma
    2. Refractory moderate to Severe Persistent Asthma not controlled on Inhaled Corticosteroids
    3. Positive Allergy Testing for perennial inhaled allergen (e.g. mold, pollen, animal dander)
    4. Patients must be age 6 years or older
  2. Food Allergy
    1. Prophylaxis of serious Food Allergy reactions from accidental exposure (egg, milk, peanuts, tree nuts)
    2. Indicated in high risk patients (e.g. Anaphylaxis to food allergan) OR dual indications (e.g. Asthma and Food Allergy)
    3. FDA approved indication in 2024
    4. (2024) Presc Lett 31(5): 28
  • Mechanism
  1. Recombinant humanized Monoclonal Antibody (rhu-MAB)
  2. Blocks IgE binding to Mast Cells and Basophils
    1. Prevents release of Allergic Reaction mediators
  • Dosing
  1. Approved for age >=6 years old
  2. Dose determined by serum IgE level and body weight
  3. Usually 75 to 375 mg SQ every 2 to 4 weeks
  4. Must be given in clinical setting with observation (risk of Anaphylaxis)
  • Adverse Effects
  1. Serious and life-threatening
    1. May predispose to malignancy
    2. Anaphylaxis
      1. Requires administration in clinical setting
      2. Reaction may occur >2 hours after injection
      3. Highest risk with first 3 doses
  2. Other reactions
    1. Injection site reaction
    2. Upper Respiratory Infections (including Sinusitis, Pharyngitis)
    3. Headache
    4. Alopecia
    5. Musculoskeletal (Arthralgias, myalgias, limb pain)
  • Efficacy
  1. Reduces Asthma Exacerbations, hospitalizations and Inhaled Corticosteroid dosing in Allergic Asthma
    1. Normansell (2014) Cochrane Database Syst Rev (1):CD003559 +PMID:24414989 [PubMed]
  • Safety
  1. Pregnancy Category B
  2. Unknown safety in Lactation
  • Resources
  1. Omalizumab (DailyMed)
    1. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f6a2191-adfb-48b9-9bfa-0d9920479f0d
  • References
  1. (2020) Drugs for Asthma, Med Lett Drug Ther 62: 193-200
  2. Finn (2003) J Allergy Clin Immunol 111:278-84 [PubMed]
  3. Raymond (2023) Am Fam Physician 107(4): 358-68 [PubMed]