XOLAIR
Xolair (omalizumab) is an anti-IgE antibody indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. It is also approved for adult and pediatric patients to reduce Type I allergic reactions, including anaphylaxis, following accidental exposure to one or more food allergens. The therapy is used as a maintenance treatment for patients whose symptoms are inadequately controlled by standard therapies such as inhaled corticosteroids or H1 antihistamines. It is not intended for the relief of acute bronchospasm or the emergency treatment of anaphylactic reactions.
How XOLAIR Works
Omalizumab binds to circulating IgE, which inhibits the antibody from binding to the high-affinity IgE receptors located on mast cells, basophils, and dendritic cells. This interaction leads to a down-regulation of these receptors and a subsequent reduction in the release of inflammatory mediators. In allergic asthma, this process reduces blood and tissue eosinophils as well as cytokines including IL-4, IL-5, and IL-13. While the drug effectively lowers free IgE levels and down-regulates receptors, the exact mechanism by which these effects improve symptoms of chronic spontaneous urticaria is unknown.
Details
- Status
- Prescription
- First Approved
- 2003-06-20
- Routes
- N/A
- Dosage Forms
- VIAL, SYRINGE
XOLAIR Approval History
What XOLAIR Treats
6 indicationsXOLAIR is approved for 6 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Chronic Rhinosinusitis
- Nasal Polyps
- Food Allergy
- Anaphylaxis
- Chronic Spontaneous Urticaria
XOLAIR Boxed 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 XOLAI...
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 [see Dosage and Administration (2.6) , Warnings and Precautions (5.1) and Adverse Reactions (6.1 , 6.2) ] . 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. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis. ( 2.6 , 5.1 , 6.1 , 6.2 )
XOLAIR Target & Pathway
ProTarget
A cytokine that promotes Th2 immune responses and IgE production. IL-4 drives allergic inflammation in atopic dermatitis and asthma. Blocking IL-4 (often together with IL-13) reduces the type 2 inflammation underlying these conditions.
XOLAIR Biosimilars
1 FDA-approved1 can be substituted at the pharmacy without calling the prescriber.
What are biosimilars? Lower-cost alternatives to XOLAIR with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XOLAIR FDA Label Details
ProIndications & Usage
FDA Label (PDF)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), ...
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...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.