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Xolair (Omalizumab) - Summary



Xolair (Omalizumab) is a recombinant DNA-derived humanized IgG1(kappa) monoclonal antibody that selectively binds to human immunoglobulin E (IgE).

Xolair (Omalizumab) is indicated for adults and adolescents (12 years of age and above) 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. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions.

See all Xolair indications & dosage >>


Media Articles Related to Xolair (Omalizumab)

Asthma Increases Risk for Periodontitis
Source: Medscape Allergy & Clinical Immunology Headlines [2017.09.25]
People with asthma should pay particularly close attention to their oral health after research found a strong link between the condition and gum disease.
WebMD Health News

Could Pests, Dust Lower Kids' Odds for Asthma?
Source: MedicineNet Allergy Specialty [2017.09.22]
Title: Could Pests, Dust Lower Kids' Odds for Asthma?
Category: Health News
Created: 9/21/2017 12:00:00 AM
Last Editorial Review: 9/22/2017 12:00:00 AM

Asthma Drug Tied to Nightmares, Depression
Source: MedicineNet Allergy Specialty [2017.09.22]
Title: Asthma Drug Tied to Nightmares, Depression
Category: Health News
Created: 9/21/2017 12:00:00 AM
Last Editorial Review: 9/22/2017 12:00:00 AM

Kids' Colds Linked to Asthma, Lung Problems Later
Source: MedicineNet Adenoids and Tonsils Specialty [2017.09.20]
Title: Kids' Colds Linked to Asthma, Lung Problems Later
Category: Health News
Created: 9/19/2017 12:00:00 AM
Last Editorial Review: 9/20/2017 12:00:00 AM

Asthma Quiz: Test Your Medical IQ
Source: MedicineNet Asthma Complexities Specialty [2017.09.19]
Title: Asthma Quiz: Test Your Medical IQ
Category: MedicineNet Quiz
Created: 6/3/2011 4:21:00 PM
Last Editorial Review: 9/19/2017 6:36:12 PM

more news >>

Published Studies Related to Xolair (Omalizumab)

Immunologic effects of omalizumab in children with severe refractory atopic dermatitis: a randomized, placebo-controlled clinical trial. [2013]
mediated by the TSLP pathway in young patients with severe refractory AD... CONCLUSIONS: Anti-IgE therapy with omalizumab decreases levels of cytokines that

Population-based efficacy modeling of omalizumab in patients with severe allergic asthma inadequately controlled with standard therapy. [2013]
Omalizumab, a recombinant humanized monoclonal antibody, is the first approved anti-immunoglobulin E (IgE) agent for the treatment of subjects with moderate to severe persistent allergic asthma that are inadequately controlled by the standard of care... In addition, the resulting population models could be used to predict population FEV1 or FeNO response for omalizumab and/or other anti-IgE therapeutics for which PK-IgE models are constructed.

Omalizumab is effective in allergic and nonallergic patients with nasal polyps and asthma. [2013]
omalizumab in patients with nasal polyps and comorbid asthma... CONCLUSION: Omalizumab demonstrated clinical efficacy in the treatment of nasal

Omalizumab and the risk of malignancy: results from a pooled analysis. [2012]
pooled data from clinical trials of omalizumab-treated patients... CONCLUSIONS: In this pooled analysis no association was observed between

A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. [2011.09]
BACKGROUND: Proof-of-concept studies with omalizumab in patients with chronic idiopathic urticaria (CIU) have shown significant decreases in mean urticaria activity scores (UASs). OBJECTIVE: We sought to evaluate the efficacy and safety of omalizumab in patients with CIU who remain symptomatic despite concomitant H(1)-antihistamine therapy... CONCLUSION: This study demonstrated that a fixed dose of 300 or 600 mg of omalizumab provides rapid and effective treatment of CIU in patients who are symptomatic despite treatment with H(1)-antihistamines. Copyright (c) 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

more studies >>

Clinical Trials Related to Xolair (Omalizumab)

Efficacy and Safety of Omalizumab in Bullous Pemphigoid [Completed]
The primary objective is to test the safety and efficacy of Xolair in the treatment of the autoimmune blistering disease, bullous pemphigoid (BP). This is a pilot, open label case-control study. Patients treated with Xolair will be compared to patients receiving standard treatment with prednisone. The enrollment period for the study is 24 weeks: 16 weeks active treatment and 8 additional weeks of observation.

OIT and Xolair� (Omalizumab) in Cow's Milk Allergy [Active, not recruiting]
Food allergy affects up to 4% of the U. S. population and is most common in young children. Milk allergy is the most common cause of food allergy in infants and young children, and usually develops in the first year of life. There is no treatment for food allergy and the current standard of care for milk-allergic individuals is the avoidance of milk-containing products. Research is underway to identify potential therapeutic strategies to reduce or eliminate the adverse effects experienced by milk-allergic individuals when they consume milk-containing products. Several studies have suggested that milk-allergic children who receive milk protein oral immunotherapy (OIT) may become desensitized to milk, resulting in short term protection against accidental ingestion of milk products. However, these children did not develop "tolerance," which is long term protection even after milk immunotherapy is stopped. A potential strategy to induce tolerance to milk uses milk in combination with Xolair® (omalizumab). Xolair consists of anti-IgE molecules that attach to IgE, the major antibody involved in allergic reactions. The goal of this clinical trial is to see whether Xolair® in combination with milk protein OIT is safer and more effective than OIT alone in inducing tolerance to milk and milk products. Participants will be administered a double blind, placebo controlled milk challenge at various time points in the study. If desensitization is achieved participants will be tested for tolerance at a certain time point after stopping treatment.

Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair [Completed]
The purpose of this study is to study the effects of Xolair using non-invasive techniques from the expired gas of patients with moderate to severe allergic asthma.

The Effect of Xolair (Omalizumab) on Allergy Blood Cells [Completed]
We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood tests will be done in a test tube to see if they react differently before and after treatment. The blood cells will be mixed with to whatever the person is allergic.

A Study of Omalizumab (Xolair) in Subjects With Moderate to Severe Persistent Asthma (EXTRA) [Completed]
This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose inhaled corticosteroids (ICS)+ long-acting beta-agonists (LABA) with or without additional controller therapy.

more trials >>

Reports of Suspected Xolair (Omalizumab) Side Effects

Asthma (543)Dyspnoea (439)Cough (369)Nasopharyngitis (333)Fatigue (306)Wheezing (250)Malaise (230)Pneumonia (186)Blood Pressure Increased (178)Headache (169)more >>

Page last updated: 2017-09-25

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