What is the use of Xolair (Omalizumab)?

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Last updated: April 27, 2025View editorial policy

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From the Guidelines

Xolair (omalizumab) is a recommended treatment for moderate to severe persistent allergic asthma, particularly for patients whose symptoms are not adequately controlled with standard treatments, as it targets the underlying allergic mechanism rather than just managing symptoms. The medication works by binding to IgE antibodies, preventing them from triggering allergic reactions in the body. According to the most recent and highest quality study 1, the typical dosage ranges from 150-375 mg administered by subcutaneous injection every 2-4 weeks, with the specific dose determined by body weight and blood IgE levels.

Some key points to consider when prescribing Xolair include:

  • The medication should be administered in a healthcare setting due to the risk of anaphylaxis, which can occur immediately or hours after injection 1
  • Common side effects include injection site reactions, viral infections, upper respiratory infections, sinusitis, headache, and sore throat 1
  • Xolair has been shown to reduce the need for both oral and inhaled steroids and to reduce the incidence of asthma exacerbations, even among patients with more severe asthma 1
  • The medication is particularly effective for patients with IgE-mediated allergic asthma, as it targets the underlying allergic mechanism rather than just managing symptoms 1

It is essential to note that Xolair should be used as additive therapy for patients 12 years and older with severe persistent asthma who have demonstrated immediate hypersensitivity to inhaled allergens, and clinicians who administer omalizumab should be prepared and equipped to identify and treat anaphylaxis that may occur 1.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Zolair (Omalizumab) Overview

  • Zolair, also known as omalizumab, is an anti-immunoglobulin E (anti-IgE) monoclonal antibody used in the treatment of moderate-to-severe allergic asthma 2.
  • It is approved for use in adults and adolescents (aged ≥12 years) with allergic asthma that is not adequately controlled with inhaled corticosteroids (ICSs) 2.

Efficacy and Safety

  • Omalizumab has been shown to significantly reduce asthma exacerbations when added to ICS therapy in patients with moderate-to-severe allergic asthma 2.
  • It has also been found to be effective in reducing asthma exacerbation rates when added to high-dose ICS + LABA therapy with or without other controller medications 2.
  • The safety profile of omalizumab has been established in several clinical trials, with no major safety concerns identified 2.

Treatment Guidelines

  • Current treatment guidelines recommend considering the addition of omalizumab for patients with allergic asthma that is not adequately controlled with high-dose ICS + LABA therapy 2, 3.
  • The Global Initiative for Asthma and the National Asthma Education and Prevention Program provide guidelines for the management of asthma, including the use of omalizumab for severe allergic asthma 3.
  • Patients with severe uncontrolled asthma despite appropriate treatment should be reassessed and considered for specialty referral, where biologic agents such as omalizumab may be considered 3, 4.

Asthma Management

  • Asthma management typically begins with inhaled corticosteroids, and additional medications or dosage increases should be added in a stepwise fashion according to guideline-directed therapy recommendations 3, 5.
  • Single maintenance and reliever therapy, which combines an inhaled corticosteroid and long-acting beta2 agonist, is preferred for adults and adolescents with asthma 3.
  • For patients with severe therapy-resistant asthma, phenotyping can help optimize responses to existing and new therapies, including biologic agents such as omalizumab 4.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Chronic Asthma Treatment: Common Questions and Answers.

American family physician, 2023

Research

Diagnosis and Management of Severe Asthma.

Seminars in respiratory and critical care medicine, 2018

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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