Omalizumab is a recombinant humanized IgG1κ monoclonal antibody (MW ~149 kD) that binds specifically to circulating human IgE. As a result, native IgE is inhibited from binding to the high-affinity IgE receptor (FcεRI) present on mast cells and basophils, reducing the release of allergic mediators.
Based upon pre-licensing trials in subjects with persistent asthma, omalizumab received US FDA approval in 2003 for treatment of moderate to severe IgE-mediated, persistent asthma, in adults and children over 12 years old inadequately controlled by inhaled corticosteroids. Omalizumab is also currently licensed for use in the EU, Australia, Brazil, Canada, Dominican Republic, Guatemala, Israel, New Zealand and Venezuela.
Adverse effects of omalizumab include administration-associated aphylaxis; based on pre- and post-licensing data, a black-box warning regarding this complication was added in July 2007.
moderate to severe IgE-mediated, persistent asthma (US) or severe asthma (EU), in adults and children over 12 years old, inadequately controlled by inhaled corticosteroid treatment
| Source | Link | Revision Date | Access Date |
| Omalizumab Prescribing Information | http://www.gene.com/gene/products/in...ogical/xolair/ | 2007-July | 2008-June-04 |
| Cox L, Platts-Mills TA, et al. American Academy of Allergy, Asthma & Immunology Joint Task Force Report on omalizumab-associated anaphylaxis. J Allergy Clin Immunol. 2007 Dec;120(6):1373-7 | http://www.ncbi.nlm.nih.gov/pubmed/17996286 | 2008-June-05 | |
| Plosker GL, Keam SJ. Omalizumab: a review of its use in the treatment of allergic asthma. BioDrugs. 2008;22(3):189-204 | http://www.ncbi.nlm.nih.gov/pubmed/18481901 | 2008-June-04 | |
| Buhl R, Solèr M, et al. Omalizumab provides long-term control in patients with moderate-to-severe allergic asthma. Eur Respir J. 2002 Jul;20(1):73-8 | http://erj.ersjournals.com/cgi/content/full/20/1/73 | 2008-June-05 |
NO RELIANCE FOR MEDICAL DECISIONSInformation, services and/or other features contained in this web site (including any electronic bulletin board contained therein) are being provided for general educational and informational purposes only and are not intended to be a substitute for independent medical judgment or constitute case-specific medical advice or treatment in any way. Such information, services and/or features are not intended to serve as the primary basis for making personal or professional medical decisions, nor are they intended to be a substitute for professional medical advice. Always seek the advice of your physician or other qualified health provider prior to making any treatment or diagnosis decisions and with any questions you may have regarding a medical condition or its diagnosis or treatment. You should confirm any information obtained from this site with other sources before undertaking any treatment or otherwise taking any actions relating thereto. Any reliance on any information, services or other features contained in this site is solely at your own risk. |
|
Clinical Immunology Society 555 East Wells Street, Suite 1100 Milwaukee, WI 53202-3823 USA Phone: 414/224-8095 | Fax: 414/272-6070 Email: info@clinimmsoc.org © 2001-2011 Clinical Immunology Society | Web Site Disclaimer |
