SHARE THIS ARTICLE
Xolair
Xolair Injection Indications – Clinical Applications Summarized
Apr 24, 2025
Chronic allergic conditions affect millions of patients worldwide, often requiring more than just standard antihistamines or decongestants. Xolair (omalizumab), a monoclonal antibody therapy, offers a targeted approach by binding to immunoglobulin E (IgE), the antibody responsible for triggering allergic inflammation. By neutralizing IgE, Xolair helps prevent the cascade of immune responses that lead to persistent allergy symptoms.
Xolair currently has FDA approval for several key indications. These include moderate to severe persistent allergic asthma in patients aged six years and older, chronic spontaneous urticaria (CSU) in individuals aged twelve and above who remain symptomatic despite H1-antihistamine therapy, and chronic rhinosinusitis with nasal polyps (CRSwNP) in adults whose symptoms are inadequately controlled with nasal corticosteroids. More recently, Xolair has also received approval as an add-on therapy for IgE-mediated food allergies in both children and adults.
As its clinical relevance continues to grow, this article provides a concise overview of Xolair’s approved indications, its real-world applications in allergy management, and how it compares to traditional therapies to support informed decision-making in clinical practice.
Key Takeaways
- Xolair (omalizumab) has FDA approval for allergic asthma, chronic spontaneous urticaria (CSU), nasal polyps, and as an add-on for IgE-mediated food allergies.
- It targets immunoglobulin E (IgE) to block the allergic response at its source.
- Injection dosage depends on the indication, with weight and IgE levels guiding treatment in asthma and nasal polyps, while CSU uses a fixed-dose regimen.
- Typical dosing ranges from 75 mg to 600 mg, administered subcutaneously every 2 to 4 weeks.
- Xolair can reduce symptoms, improve quality of life, and decrease the need for steroids or surgery in approved conditions.
- Research is ongoing for its use in food allergy desensitization, atopic dermatitis, eosinophilic esophagitis, and anaphylaxis prevention.
- Practitioners must closely monitor their patients for rare side effects such as anaphylaxis and treat them according to established safety protocols.
About: Trusted by over 2,000+ global clients since 2014, Maylips has become a leading supplier of cosmetic, skincare, and orthopedic products for medical and aesthetic professionals. Maylips offers a wide range of authentic brand-name products at competitive wholesale prices, sourced from around the world. If you’re looking to buy Xolair online, contact our sales team for guidance.
Overview of Xolair Injection’s Approved Indications
Xolair (omalizumab) acts as a monoclonal antibody therapy approved by the FDA for several chronic allergic conditions. Its primary mechanism involves binding to free IgE antibodies, preventing them from triggering inflammatory responses. This targeted approach makes Xolair especially effective for conditions where traditional therapies offer limited relief.
Currently, Xolair is approved for:
- Moderate to severe allergic asthma (ages 6 and up)
- Chronic spontaneous urticaria (CSU) (ages 12 and up)
- Chronic rhinosinusitis with nasal polyps (CRSwNP) (adults 18+)
- IgE-mediated food allergies (as add-on therapy for both children and adults)
The healthcare provider determines the injection dosage based on the patient’s body weight and baseline IgE level, except in CSU, where fixed dosing applies. They administer the injection subcutaneously every 2 to 4 weeks.
Clinical Criteria for Xolair Injection Use in Allergic Asthma
Xolair plays a crucial role in managing moderate to severe persistent allergic asthma, particularly in patients whose symptoms remain uncontrolled despite conventional therapy. Key eligibility criteria include:
- Age 6 years or older
- Documented IgE level between 30 and 700 IU/mL
- Positive test for perennial aeroallergens
- Poor symptom control despite high-dose ICS/LABA therapy
Before initiating therapy, the healthcare provider measures a baseline serum IgE level, which, in combination with body weight, determines the Xolair injection dosage. Depending on the calculated dose, the injection is administered subcutaneously every 2 or 4 weeks.
Clinical benefits of Xolair include a reduction in asthma exacerbations, improved lung function, and a decrease in corticosteroid dependence. Providers must closely monitor patients for rare but serious side effects like anaphylaxis, which can occur even after multiple doses.
Xolair Injection’s Role in Treating Chronic Spontaneous Urticaria
For CSU, healthcare providers recommend Xolair for patients who experience chronic hives for 6 weeks or more without a known cause and do not respond to maximum doses of H1-antihistamines. Unlike asthma, CSU dosing does not depend on IgE levels or weight.
The FDA has approved Xolair for use in individuals aged 12 years and older, and these patients do not need IgE level measurement for dosing. The typical regimen involves a fixed dose of 150 mg or 300 mg administered every 4 weeks. Healthcare providers determine the appropriate dose based on the severity of symptoms and the patient’s response to treatment.
Most patients start on 300 mg, with many experiencing symptom improvement within a few weeks, although some may require up to three months for full efficacy. In addition to reducing the frequency of outbreaks, Xolair improves sleep, daily function, and overall quality of life for CSU patients.
Continued assessment helps determine whether the dosage should remain the same, decrease, or stop. Discontinuation may be appropriate if there is no clinical benefit after six months.
Application of Xolair Injection in Nasal Polyps Management
Nasal polyps are benign growths in the nasal passages that result from chronic allergic inflammation. Xolair is approved for adults who have:
- Confirmed nasal polyps via endoscopy or imaging
- Persistent symptoms despite intranasal corticosteroids
- Chronic sinus issues, including congestion or loss of smell
Dosing for nasal polyps follows a similar structure to asthma, based on the patient’s IgE levels and body weight, with injections given every 2 to 4 weeks. Healthcare providers use Xolair as an adjunct to intranasal corticosteroids, but do not replace corticosteroids with Xolair.
Clinical trials have shown that Xolair can lead to significant reductions in polyp size, improved nasal airflow, restored sense of smell, and fewer sinus infections. It also decreases the need for surgical interventions, making it a valuable part of long-term management for select patients.
Emerging Indications and Research on Xolair Injection
Beyond its current FDA-approved uses, Xolair is under investigation for additional allergic and immunologic disorders. Clinical trials are ongoing for conditions such as IgE-mediated food allergies (e.g., peanut, egg, milk), atopic dermatitis, eosinophilic esophagitis, allergic rhinitis, and prevention of anaphylaxis from accidental allergen exposure.
Early results suggest that Xolair may reduce allergic sensitivity, raise reaction thresholds, and improve patient tolerance when used alongside therapies like oral immunotherapy (OIT) for food allergy desensitization. These findings are especially promising for children and adults with life-threatening allergies who have limited treatment options.
While these applications remain off-label, they highlight the potential of Xolair to become a broad-spectrum allergy biologic. Until formal approval occurs, providers limit use of Xolair in these areas to clinical trials or specialist-supervised compassionate use settings.
Conclusion
Xolair injection has emerged as a highly targeted and well-tolerated therapy for patients with severe allergic asthma, chronic spontaneous urticaria, and nasal polyps. Its precision in blocking IgE-mediated pathways allows it to address the underlying mechanisms of these conditions, offering relief where traditional treatments fall short.
Although not a first-line treatment, Xolair fills a critical gap for patients with persistent symptoms and poor quality of life despite standard care. Ongoing research continues to explore its utility across a wider range of allergic diseases, signaling its growing importance in personalized medicine.
For clinicians, understanding Xolair’s indications, appropriate injection dosage, and monitoring protocols is essential for ensuring safe, effective use in both current and future applications.
FAQs
1. What is Xolair and how does it work?
Xolair (omalizumab) is a monoclonal antibody that blocks immunoglobulin E (IgE), a key player in allergic reactions. By targeting IgE, it helps reduce inflammation and allergy symptoms.
2. What conditions is Xolair approved to treat?
Xolair is approved for moderate-to-severe allergic asthma, chronic spontaneous urticaria (CSU), and nasal polyps in patients who don’t respond well to standard therapies.
3. How is Xolair administered?
Xolair is given as a subcutaneous (under the skin) injection every 2 to 4 weeks, depending on the condition and dosage.
4. Who should not use Xolair?
Xolair is not for use in acute asthma attacks or as a rescue medication. It’s also not recommended for patients with a known allergy to omalizumab.
5. Are there any serious side effects?
Yes. Although rare, Xolair may cause anaphylaxis, which is a severe allergic reaction. Patients are usually monitored after the first few injections.
6. How soon can I expect to see results?
Many patients begin to see symptom improvement within 12 to 16 weeks, though it can vary based on the condition and individual response.
7. Can I take other medications while on Xolair?
Yes, Xolair is often used with other medications. However, always inform your healthcare provider about all drugs you’re taking to avoid interactions.
References
UpToDate. Uptodate.com. Published 2024. https://www.uptodate.com/contents/whats-new-in-allergy-and-immunology
Levine H. Allergy Medicines to Avoid. AARP. Published April 20, 2022. Accessed April 25, 2025. https://www.aarp.org/health/drugs-supplements/allergy-medicine-side-effects/