Meds & supplements › Omalizumab
Medicine · Anti-IgE
Omalizumab
XOLAIR is an anti-IgE antibody
Selected manufacturer label information, organised into consistent sections by Sofidex. Read the full label at DailyMed ↗
Boxed warning
WARNING: ANAPHYLAXIS Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis. WARNING: ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred after the first dose of XOLAIR but also has occurred beyond 1 year after beginning treatment. Initiate XOLAIR therapy in a healthcare setting, closely observe patients for an appropriate period of time after XOLAIR administration and be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur.
Drug facts
- Used for
- Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment IgE-mediated food allergy in adult and pediatric patients aged 1 year and older
- for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment Limitations of Use : Not indicated for acute bronchospasm or status asthmaticus. ( 1.1 , 5.3 ) Not indicated for the emergency treatment of allergic reactions, including anaphylaxis Not indicated for other forms of urticaria. 1.1 Asthma 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. 1.2 Chronic Rhinosinusitis with Nasal Polyps 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. 1.3 IgE-Mediated Food Allergy XOLAIR is indicated
What it is used for
XOLAIR is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods.
To be used in conjunction with food allergen avoidance Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment Limitations of Use: Not indicated for acute bronchospasm or status asthmaticus. ( 1.1, 5.3 ) Not indicated for the emergency treatment of allergic reactions, including anaphylaxis Not indicated for other forms of urticaria.
1.1 Asthma 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.
1.2 Chronic Rhinosinusitis with Nasal Polyps 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. 1.3 IgE-Mediated Food Allergy 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. 1.4 Chronic Spontaneous Urticaria 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.
More about this medicine
Storage
XOLAIR prefilled syringe and autoinjector should be shipped and stored under refrigerated conditions 2°C to 8°C (36°F to 46°F) in the original carton. Protect from direct sunlight. XOLAIR prefilled syringe and autoinjector can be removed from and placed back in the refrigerator if needed. The total combined time out of the refrigerator may not be more than 2 days. Do not use if prefilled syringe or autoinjector is left at temperatures above 25°C (77°F).
Do not freeze. Do not use if the prefilled syringe or autoinjector has been frozen.
Storage
XOLAIR should be shipped at controlled ambient temperature (≤30°C [≤86°F]). Store XOLAIR under refrigerated conditions 2°C to 8°C (36°F to 46°F) in the original carton. Do not use beyond the expiration date stamped on carton.
Cite this page
- NLM
sofidex [Internet]. Daloreum; c2026. Omalizumab; [reviewed 2026 Aug 2; cited 2026 Nov 10]. Available from: https://sofidex.com/patients/medicines/omalizumab
- APA 7th
sofidex. (2026, August 2). Omalizumab. Daloreum. Retrieved November 10, 2026, from https://sofidex.com/patients/medicines/omalizumab
- AMA 11th
Omalizumab. sofidex. Reviewed August 2, 2026. Accessed November 10, 2026. https://sofidex.com/patients/medicines/omalizumab
The cited date is today’s, because a citation records when you read the page. The reviewed date is when a clinician last checked it.