Skip To Main Content

Xolair (omalizumab)

Prescribing Information
Medication Guide

Safety Data Sheets:

XOLAIR® PFS (300 mg/2 ml)
XOLAIR® PFS (150 mg)
XOLAIR® PFS (75 mg)
XOLAIR® Vials (150 mg)

Healthcare Provider Letters:

June 2021 - Important Prescribing Information
April 2020 - Important Prescribing Information: Self-administration during the COVID-19 pandemic
Product-Related Information Publications and Congresses Clinical Trials Additional Resources
Document with patient profile icon

Product-Related Information

Omalizumab: IgE-Mediated Food Allergy

Disease Prevalence
OUtMATCH Study Design
Primary and Secondary Outcomes
Dosing and Safety
Extrapolation in Adult Populations
Important Safety Information
Summary
Abbreviations

For FDA-approved products, please consult the full prescribing information for a complete discussion of risks and benefits of Xolair for its approved indications.

Indication and Limitations of Use

Omalizumab is indicated for the reduction of allergic reactions ​(Type I), 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.1 Omalizumab is to be used in conjunction with food allergen avoidance.​

Omalizumab is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

Please see full Prescribing Information, including Black Box Warning, for additional Important Safety Information.

  1. XOLAIR Prescribing Information. Genentech, Inc. and Novartis Pharmaceuticals

Omalizumab: IgE-Mediated Food Allergy

Disease Prevalence

Food Allergy Is Common Among Adults, With Higher Rates ​in Women1,a

Food Allergy Prevalence in All Adults, by Sex

Food Allergy Prevalence in Adults, by Ethnicity

  1. Based on data from the 2021 National Health Interview Survey conducted by the National Center for Health Statistics and analyzed by the US Centers for Disease Control and Prevention.​
  1. Ng AE, Boersma P. NCHS Data Brief, no 460. Hyattsville, MD: National Center for Health Statistics. 2023.​

OUtMATCH Study Design

A Phase 3, NIH-Led Study in IgE-Mediated Food Allergy1

Study Rationale: To determine if treatment with omalizumab can increase oral food challenge reactivity thresholds for both children and adults with multiple IgE-mediated food allergies

Screening and DBPCFCa​
4 oral food challenges ​(≤4 weeks)​
  • Placebo​
  • Peanut​
  • 2 other food allergensb
 2-3 additional oral food challenges (≤2-3 weeks)​
  • Placebo​
  • 1-2 other food allergensb
  1. Participants who experienced dose-limiting symptoms in response to a single dose of ≤100 mg of peanut protein and ≤300 mg of protein for each of the other participant-specific foods during DBPCFC moved on to Stage 1 of the trial.
  2. Additional food proteins tested included milk, egg, cashew, hazelnut, walnut, and wheat.​

OUtMATCH Pre-Specified Interim Analysis1

FDA approval of omalizumab for IgE-mediated food allergy was based on data from the interim analysis in 165 pediatric and adolescent participants.

The Data Safety Monitoring Board determined the pre-specified thresholds for significance were met and recommended that enrollment in Stage 1 of the study be halted prior to the study reaching the target enrollment of 225 participants

  1. Wood RA, et al. J Allergy Clin Immunol Glob. 2022;1(4):225-232.

Primary and Secondary Outcomes

Primary Endpoint

Proportion of participants who successfully consume a single dose ≥600 mg of peanut protein without dose-limiting symptoms during the Stage 1 DBPCFC​.1,a

  • XOLAIR should not be used for the acute treatment of allergic reactions, including anaphylaxis.
  • In studies to evaluate actual use, patients and caregivers have erroneously selected XOLAIR for the treatment of allergic reactions, including anaphylaxis.
  • The safety and effectiveness of XOLAIR for treatment of allergic reactions, including anaphylaxis, have not been established.
  • Instruct patients that XOLAIR is for maintenance use to reduce allergic reactions, including anaphylaxis, while avoiding food allergens.

A greater proportion of pediatric patients receiving omalizumab were able to consume ​peanut protein without dose-limiting symptoms compared with placebo​

  1. Subjects without an exit DBPCFC or evaluable exit DBPCFC were counted as non-responders; P-values from two-sided Fisher’s exact tests were <0.0001 for all the food challenge doses.
  2. Response defined as consumption of a single dose of the specified amount of food without dose-limiting symptoms.​

Key Secondary Endpoints1,a

Number of participants who successfully consume a single dose of ≥1000 mg of cashew, and/or milk, and/or egg protein without dose-limiting symptoms.​

  1. Proportion of pediatric patients without dose-limiting symptoms during the DBPCFC at the end of OUtMATCH Stage 1 (16-20 weeks). Subjects without an exit DBPCFC or evaluable exit DBPCFC were counted as non-responders; P-values from two-sided Fisher’s exact tests were <0.0001 for all the food challenge doses.
  2. Response defined as consumption of a single dose of the specified amount of food without dose-limiting symptoms.
  3. Consumption of a single dose of ≥1000 mg of peanut protein was an additional secondary endpoint. The key secondary efficacy endpoints were the percentage of patients who were able to consume a single dose of ≥1000 mg of cashew, milk, or egg protein.
  1. XOLAIR Prescribing Information. Genentech, Inc. and Novartis Pharmaceuticals

Dosing and Safety

Omalizumab Dosing for Patients with IgE-Mediated Food Allergy1,a

Refer to the table for recommended dosage and dosing frequency based on serum IgE level and body weight for patients with IgE-mediated food allergy.​

  1. Based on covariate analyses to evaluate the effects of demographic characteristics and other factors on omalizumab exposure and clinical responses. These analyses demonstrated that no omalizumab dose adjustments are necessary for age (1 year and older), race, ethnicity, or gender.​

Adverse Reactions Occurring in ≥3% of Omalizumab-Treated Pediatric Patients 1 Year of Age and Older and More Frequently Than in Patients Treated With Placebo in Food Allergy Trial1

  Omalizumab
(n=110)		 Placebo
(n=55)
Injection site reactionsa 17 (15.5)​ 6 (10.9)
Pyrexia 7 (6.4) 2 (3.6)
  1. Injection site reactions terms: "injection site reaction," "injection site urticaria," "injection site discomfort," "injection site erythema," "injection site pain" and "injection site rash." All injection site reactions were mild to moderate severity and none resulted in study discontinuation.
  1. XOLAIR Prescribing Information. Genentech, Inc. and Novartis Pharmaceuticals​

Extrapolation in Adult Populations

The Effectiveness of Omalizumab in Adults is Supported by 3 Pillars of Data1-4

Disease similarity:

  • IgE-mediated food allergy is the most common type of food allergy and is responsible for the majority of acute food reactions and anaphylaxis2​
  • In food allergen-sensitized individuals, subsequent exposure to the food allergen triggers IgE-mediated degranulation of immune effector cells, resulting in the rapid manifestation of symptoms4
  • While the molecular and cellular mechanisms of food allergy are complex, the final immunological pathways of IgE-mediated food allergy are identical from infancy through adulthood, supporting the concept that IgE-mediated food allergy is one disease across the lifespan2​

Treatment response:

  • Treatment response to omalizumab is similar between children, adolescents (age 16 and older) and adults with food allergy2​

Similarity in dosing:

  • No dose adjustments are necessary for age, race, ethnicity, or gender1

Post-Hoc Analysis4,a,d

Efficacy of Omalizumab in Post-Pubertal Patients

  1. Proportion of pediatric patients without dose-limiting symptoms during the DBPCFC at the end of OUtMATCH Stage 1 (16-20 weeks). Subjects without an exit DBPCFC or evaluable exit DBPCFC were counted as non-responders; P-values from two-sided Fisher’s exact tests were <0.0001 for all the food challenge doses.
  2. Response defined as consumption of a single dose of the specified amount of food without dose-limiting symptoms.
  3. Consumption of a single dose of ≥1000 mg of peanut protein was an additional secondary endpoint. The key secondary efficacy endpoints were the percentage of patients who were able to consume a single dose of ≥1000 mg of cashew, milk, or egg protein.
  4. Post-pubertal was defined as ≥16 years.
  1. XOLAIR Prescribing Information. Genentech, Inc. and Novartis Pharmaceuticals
  2. Data on file, Genentech, Inc.
  3. FDA Draft Guidance on Pediatric Extrapolation (E11A). Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e11a-pediatric-extrapolation
  4. Renz H, et al. Nat Rev Dis Primers. 2018;4:17098

Important Safety Information

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.​

In the food allergy clinical trial, the most common adverse events were injection site reaction and fever.1

Please consult the full prescribing information for a complete discussion of risks and benefits of XOLAIR for its approved indication(s).

  1. XOLAIR Prescribing Information. Genentech, Inc. and Novartis Pharmaceuticals

Summary

The effectiveness of omalizumab in adults is supported by the adequate and well-controlled trial of omalizumab in pediatric patients, disease similarity in pediatric and adult patients, and pharmacokinetic similarity.1

Adult and child icon

Disease similarity in pediatrics and adults​

Hand holding first aid kit icon

Treatment benefit ​was generally consistent between adults and children​

Two curving pharmacokinetic lines icon

Consistency of pharmacodynamics effect in children and adults​

  1. XOLAIR Prescribing Information. Genentech, Inc. and Novartis Pharmaceuticals

Looking for more information?

Reach out to a Genentech Medical Science Liaison near you, or connect with the contact center.

Connect with an MSL
Submit a Request

Call Us: 1-800-821-8590 Hours: Monday-Friday, 5am-5pm PT

TOP
Publications icon

Publications and Congresses

The information in this section may include content beyond what is in the FDA-approved label. Because the FDA has not approved such content, no conclusions regarding safety or efficacy may be made. Providing this information should not be construed as recommendation for use of a Genentech product for unapproved uses. For FDA-approved products please consult the product’s full prescribing information for a complete discussion of risks and benefits of the product(s) for its approved indication(s).

Publications: The list of publications is not an exhaustive list of published materials on the product. The list of references by data topics is selected per evidence-based medicine criteria. To browse a full listing of published scientific literature:

Visit PubMed

Congresses: The list of congresses is a subset of Roche/Genentech posters and oral presentations for the product with data presented at scientific meetings in the recent 24 months. To browse full Roche/Genentech congress presentations and posters:

Visit Medically

Filters

Disease State

Omalizumab Data Topics

Reset filters

Showing 68 out of 68 results

No results

Try resetting the filters or selecting another category.

Looking for more information?

Reach out to a Genentech Medical Science Liaison near you, or connect with the contact center.

Connect with an MSL
Submit a Request

Call Us: 1-800-821-8590 Hours: Monday-Friday, 5am-5pm PT

TOP
Clinical trials icon

Clinical Trials

Find information about active clinical research for XOLAIR at ClinicalTrials.gov and information about our research at Genentech Clinical Trials.

Additional resources icon

Additional Resources

For additional information or assistance regarding Xolair® use the links below.

Connect with a Medical Science Liaison

Browse the Genentech Medical Information Library

  • AAAAI
    American Academy of Allergy Asthma & Immunology

  • AE
    Adverse event

  • Ang2
    Angiopoietin-2

  • ARR
    Annualized Relapse Rate

  • ART
    Assisted Reproductive Technology

  • ASTCT
    American Society for Transplantation and Cellular Therapy

  • ATG
    Anti-thymocyte globulin

  • CAR
    Chimeric antigen receptor

  • CD3
    Cluster of differentiation 3

  • CD4
    Cluster of differentiation 4

  • CD8
    Cluster of differentiation 8

  • CD19
    Cluster of differentiation 19

  • CD20
    Cluster of differentiation 20

  • CD226
    Cluster of differentiation 226

  • CDC
    Centers for Disease Control and Prevention

  • CI
    Confidence Interval

  • COVID-19
    Coronavirus disease of 2019

  • CPAP
    Continuous positive airway pressure

  • CR
    Complete response

  • CRP
    C-reactive protein

  • CRS
    Cytokine release syndrome

  • CT
    Computed tomography

  • CTCAE
    Common Terminology Criteria for Adverse Events

  • DIC
    Disseminated intravascular coagulation

  • DLBCL
    Diffuse large B-cell lymphoma

  • DMT
    Disease-modifying therapy

  • DMT
    Disease-modifying treatment

  • DoCR
    Duration of complete response

  • DoR
    Duration of response

  • DBPCFC
    Double-blind, placebo-controlled food challenge

  • ECOG PS
    Eastern Cooperative Oncology Group performance status

  • ECTRIMS
    European Committee for Treatment and Research in Multiple Sclerosis

  • EDSS
    Expanded Disability Status Scale

  • EMA
    European Medicines Association

  • FAERS
    FDA Adverse Event Reporting System

  • FDA
    Food and Drug Administration

  • FDA
    US Food and Drug Administration

  • FL
    Follicular lymphoma

  • HCP
    Health Care Provider

  • HGBCL
    High-grade B-cell lymphoma

  • HLH
    Hemophagocytic lymphohistiocytosis

  • ICANS
    Immune effector cell-associated neurotoxicity syndrome

  • ICU
    Intensive care unit

  • Ig
    Immunoglobulin

  • IgE
    Immunoglobulin E

  • IgG1
    Immunoglobulin G1

  • INR
    International normalized ratio

  • IRC
    Independent Review Committee

  • IRR
    Infusion-related reaction

  • ITIM
    Immunoreceptor tyrosine-based inhibitory motif

  • LLN
    Lower limit of normal

  • LMP
    last menstrual cycle

  • LMP
    Last menstrual period

  • MAS
    Macrophage activation syndrome

  • MCA
    Major congenital anomalies

  • MHC
    Major histocompatibility complex

  • MS
    Multiple sclerosis

  • MSKCC
    Memorial Sloan Kettering Cancer Center

  • NK
    Natural killer

  • NO
    Nitric oxide

  • NOS
    Not otherwise specified

  • OB/Gyn
    Obstetrics and Gynecology

  • OCR
    OCREVUS (ocrelizumab)

  • OR
    Odds ratio

  • ORR
    Objective response rate

  • PD-1
    Programmed cell death protein 1

  • PD-L1
    Programmed death-ligand 1

  • PET
    Positron emission tomography

  • PFS
    Progression-free survival

  • PMBCL
    Primary mediastinal B-cell lymphoma

  • PML
    progressive multifocal leukoencephalopathy

  • PPMS
    Primary progressive multiple sclerosis

  • PTT
    Partial thromboplastin time

  • PVR
    Poliovirus receptor

  • RID
    Relative infant dose

  • RMS
    Relapsing multiple sclerosis

  • RRMS
    Relapsing-remitting multiple sclerosis

  • SAE
    Serious adverse event

  • T
    Trimester

  • TCR
    T-cell receptor

  • TIGIT
    T cell immunoreceptor with Ig and ITIM domains

  • UCSF
    University of California San Francisco

  • USPI
    United States Prescribing Information

  • URTI
    Upper respiratory tract infection

  • UTI
    Urinary tract infection

  • VWF
    von Wilebrand factor

  • NIH
    National Institutes of Health