Off-Label Uses of Omalizumab

Clin Rev Allergy Immunol. 2016 Feb;50(1):84-96. doi: 10.1007/s12016-015-8490-y.


The off-label use of medicines is a common and extensive clinical practice. Omalizumab has been licensed for use in severe allergic asthma and chronic urticaria. Omalizumab dosing was based on body weight and baseline serum IgE concentration. All patients are required to have a baseline IgE between 30 and 700 IU/ml and body weight not more than 150 kg. The use of off-label drugs may lead to several problems including adverse effects and an increased risk/benefit balance. In this article, there are summarized off-label uses of omalizumab in the last recent years in diseases in which IgE maybe or certainly has a corner role such as allergic rhinitis, allergic bronchopulmonary aspergillosis, anaphylaxis, keratoconjunctivitis, food allergy, drug allergy, urticaria, angioedema, non-atopic asthma, atopic dermatitis, nasal polyps, Churg-Strauss syndrome, eosinophilic otitis media, chronic rhinosinusitis, bullous pemphigoid, contact dermatitis, and others. Use in pregnancy asthmatic women and pre-co-administration with specific immunotherapy will also be revised.

Keywords: ABPA; Anti-IgE; Atopic dermatitis; Intrinsic asthma; Off-label; Omalizumab; Xolair.

Publication types

  • Review

MeSH terms

  • Anti-Allergic Agents / administration & dosage
  • Anti-Allergic Agents / therapeutic use*
  • Combined Modality Therapy
  • Drug Hypersensitivity / drug therapy
  • Drug Hypersensitivity / prevention & control
  • Ear Diseases / drug therapy
  • Ear Diseases / prevention & control
  • Eye Diseases / drug therapy
  • Eye Diseases / prevention & control
  • Food Hypersensitivity / drug therapy
  • Food Hypersensitivity / prevention & control
  • Humans
  • Immunotherapy
  • Off-Label Use*
  • Omalizumab / administration & dosage
  • Omalizumab / therapeutic use*
  • Premedication
  • Respiratory Tract Diseases / diagnosis
  • Respiratory Tract Diseases / drug therapy
  • Respiratory Tract Diseases / prevention & control
  • Skin Diseases / drug therapy
  • Skin Diseases / prevention & control


  • Anti-Allergic Agents
  • Omalizumab