XOLAIR (Omalizumab) Monograph – Treatment for Asthma, Food Allergies, Rhinosinusitis & More

Published: July 11, 2025

XOLAIR (omalizumab) is Genetech, Inc.’s multi-functional medication that helps people living with asthma, food allergies, rhinosinusitis, and more. The medication has been approved by the U.S. Food and Drug Administration (FDA) multiple times over the years for different treatment options for patients of all ages.

One of the latest FDA approved uses of XOLAIR is the 2024 approval for children and adults with one or more food allergies. While it’s not a treatment for an emergency allergic reaction, XOLAIR was the first FDA-approved medication that reduces allergic reactions in people who are accidentally exposed to food to which the patient is allergic. The approval was based on the findings of the OUtMATCH study that evaluated patients who were allergic to peanuts and other allergens like milk, eggs, wheat, and others.

Read on to discover even more about XOLAIR and how it can benefit patients of all ages.

Medication Overview:

Brand Name: XOLAIR
Generic Name: omalizumab
Treatment for: Asthma, Chronic Rhinosinusitis with Nasal Polyps, IgE-Mediated Food Alery
Manufacturer(s): Genetech, Inc.
FDA Approval: 2003 for moderate-to-severe asthma; 2014 for chronic idiopathic urticaria; 2016 for allergic asthma in children; 2018 as a prefilled syringe formulation; 2020 for adults with nasal polyps; 2021 for self-injection across all indications; 2024 as the first and only medicine for children and adults with one or more food allergies

Indicated Condition	Indication	Age	Date Approved
Moderate-to-Severe Asthma	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.	Patients 12 years and older	June 20, 2003
Chronic Idiopathic Urticaria	Indicated for for people 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy.	Patients 12 years and older	March 21, 2014
Allergic Asthma in Children	Indicated to treat moderate to severe persistent asthma in children six to 11 years of age who have had a positive skin test or in vitro reactivity to an airborne allergen and have symptoms that are inadequately controlled with inhaled corticosteroids.	Pediatric patients, 6–11 years old	July 7, 2016
Adults with Nasal Polyps	Indicated for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.	Adults	December 1, 2020
Children and Adults with One of More Food Allergies	Indicated for the reduction of allergic reactions, 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.	Adults/Pediatric patients 1 year and older	February 16, 2024

Warnings and Precautions:

Anaphylaxis: Initiate XOLAIR therapy in a healthcare setting prepared to manage anaphylaxis which can be life-threatening and observe patients for an appropriate period of time after administration.
Malignancy: Malignancies have been observed in clinical studies.
Acute Asthma Symptoms: Do not use it for the treatment of acute bronchospasm or status asthmaticus.
Corticosteroid Reduction: Do not abruptly discontinue corticosteroids upon initiation of XOLAIR therapy.
Eosinophilic Conditions: Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids.
Fever, Arthralgia, and Rash: Stop XOLAIR if patients develop signs and symptoms similar to serum sickness.
Potential Medication Error Related to Emergency Treatment of Anaphylaxis: XOLAIR should not be used for emergency treatment of allergic reactions, including anaphylaxis.

Dosage and Administration:

XOLAIR is for subcutaneous (SC) administration only. For administration instructions consult the full prescribing information.

For Asthma: XOLAIR 75 to 375 mg SC every two or four weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
For Chronic Rhinosinusitis with Nasal Polyps: XOLAIR 75 to 600 mg SC every two or four weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
For IgE-Mediated Food Allergy: XOLAIR 75 mg to 600 mg SC every two or four weeks. Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
For Chronic Spontaneous Urticaria: XOLAIR 150 or 300 mg SC every four weeks. Dosing in CSU is not dependent on serum IgE level or body weight.

Contraindications:

XOLAIR is contraindicated in patients with severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR.

Drug Interactions:

No formal drug interaction studies have been performed with XOLAIR.
In patients with asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy the concomitant use of XOLAIR and allergen immunotherapy has not been evaluated.
In patients with chronic spontaneous urticaria, the use of XOLAIR in combination with immunosuppressive therapies has not been studied.

Adverse Reactions:

The most clinically significant adverse reactions are anaphylaxis and malignancies.

For Asthma: The most common adverse reactions (≥ 1% of patients) in clinical studies with adult and adolescent patients ≥12 years of age were arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In clinical studies with pediatric patients 6 to <12 years of age, the most common adverse reactions (≥3% of patients) were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis.
For Chronic Rhinosinusitis with Nasal Polyps: The most common adverse reactions (≥ 3% of patients) in clinical studies with adult patients included the following: headache, injection site reaction, arthralgia, upper abdominal pain, and dizziness.
For IgE-Mediated Food Allergy: The most common adverse reactions (≥3% of patients) were injection site reactions and pyrexia.
For Chronic Spontaneous Urticaria: The most common adverse reactions (≥2% of patients) included the following: nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, arthralgia, headache, and cough.

Examples of Omalizumab in Guidelines:

Diagnosis and Management of Acute and Chronic Urticaria Guideline

Societies: ACAAI/AAAAI
"In contrast to other alternative agents for refractory CU, the therapeutic utility of omalizumab has been supported by findings from large double-blind, randomized controlled trials and is associated with a relatively low rate of clinically significant adverse effects. On the basis of this evidence, omalizumab should be considered for refractory CU if, from an individualized standpoint, a therapeutic trial of omalizumab is favorable when balancing the potential for benefit with the potential for harm/burden and cost, and the decision to proceed is consistent with the patient’s values and preferences."

Evaluation and Treatment of Severe Asthma

Societies: ATS/ERS
"In patients with severe allergic asthma the ATS and ERS suggest a therapeutic trial of omalizumab both in adults and in children."

Please note: This article is current as of July 7, 2025. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.