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These highlights do not include all the information needed to use XOLAIR safely and effectively. See full prescribing information for XOLAIR. XOLAIR® (omalizumab) injection, for subcutaneous use XOLAIR® (omalizumab) for injection, for subcutaneous use Initial U.S. Approval: 2003
Medication labelWhy this: Advisory · dailymed-prescription
XOLAIR is indicated for adults and pediatric patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Limitations of Use: XOLAIR is not indicated for the relief of acute bronchospasm or status asthmaticus. XOLAIR is indicated for add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. XOLAIR is indicated for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. XOLAIR is to be used in conjunction with food allergen avoidance. Limitations of Use: XOLAIR is not indicated for the emergency treatment of allergic reactions, including anaphylaxis. XOLAIR is indicated for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: XOLAIR is not indicated for treatment of other forms of urticaria.
- generic_name
- omalizumab
- product_names
- omalizumab
- ndc
- 50242-040, 50242-214, 50242-215, 50242-227, 50242-040-62, 50242-040-86, 50242-214-01, 50242-214-86, 50242-214-03, 50242-214-55, 50242-214-99, 50242-214-83, 50242-215-86, 50242-215-01, 50242-215-03, 50242-215-55, 50242-215-99, 50242-215-83, 50242-227-01, 50242-227-55, 50242-227-99, 50242-227-86
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en