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    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

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    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

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    Clinical Trials

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

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    Additional Resources

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

    Connect with a Medical Science Liaison

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    • 9HPT
      9-hole peg test

    • AAAAI
      American Academy of Allergy Asthma & Immunology

    • AAN
      American Academy of Neurology

    • ABC
      activated B-cell–like subtype

    • 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

    • AUC
      area under the serum concentration–time curve

    • CALs
      chronic active lesions

    • CAR
      Chimeric antigen receptor

    • cCDP
      composite clinical disease progression

    • CCOD
      clinical cut-off date

    • 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

    • CDA
      confirmed disability accumulation

    • CDC
      Centers for Disease Control and Prevention

    • CDP
      clinical disease progression

    • CI
      Confidence Interval

    • CIS
      clinically isolated syndrome

    • Cmax
      maximum serum concentration

    • COVID-19
      Coronavirus disease of 2019

    • CNS
      central nervous system

    • CPAP
      Continuous positive airway pressure

    • CR
      Complete response

    • CRP
      C-reactive protein

    • CRS
      Cytokine release syndrome

    • CSF
      cerebrospinal fluid

    • 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

    • EFSefficacy
      event-free survival for efficacy causes (time from randomization to the earliest occurrence of disease progression/relapse, death due to any cause, initiation of any non-protocol specified anti-lymphoma treatment, or biopsy-confirmed residual disease after treatment completion)

    • EMA
      European Medicines Association

    • EOT
      end of treatment

    • EPIC
      expression/genomics, proteomics, imaging, and clinical

    • FAERS
      FDA Adverse Event Reporting System

    • FDA
      Food and Drug Administration

    • FDA
      US Food and Drug Administration

    • FL
      Follicular lymphoma

    • GCB
      germinal-center B-cell–like subtype

    • Gd
      gadolinium-enhanced

    • Gd+
      gadolinium-enhancing

    • GFAP
      glial fibrillary acidic protein

    • GMR
      geometric mean ratio

    • HCP
      Health Care Provider

    • HGBCL
      High-grade B-cell lymphoma

    • HGBL
      high-grade B-cell lymphoma

    • HHV8
      human herpesvirus 8

    • HLA
      human leukocyte antigen

    • HLH
      Hemophagocytic lymphohistiocytosis

    • HR
      hazard ratio

    • ICANS
      Immune effector cell-associated neurotoxicity syndrome

    • ICU
      Intensive care unit

    • Ig
      Immunoglobulin

    • IgE
      Immunoglobulin E

    • IgG1
      Immunoglobulin G1

    • INR
      International normalized ratio

    • IPI
      International Prognostic Index

    • IR
      injection reaction

    • IRC
      Independent Review Committee

    • IRR
      Infusion-related reaction

    • ITIM
      Immunoreceptor tyrosine-based inhibitory motif

    • ITT
      intention-to-treat

    • IV
      intravenous

    • LLN
      Lower limit of normal

    • LLOQ
      lower limit of quantification

    • LMP
      last menstrual cycle

    • LMP
      Last menstrual period

    • MAS
      Macrophage activation syndrome

    • MBP
      myelin basic protein

    • MCA
      Major congenital anomalies

    • MedDRA
      Medical Dictionary for Regulatory Activities

    • MHC
      Major histocompatibility complex

    • min
      minutes

    • MRI
      magnetic resonance imaging

    • MS
      Multiple sclerosis

    • MSFC
      Multiple Sclerosis Functional Composite

    • MSKCC
      Memorial Sloan Kettering Cancer Center

    • N/E
      new/enlarging

    • NfH
      neurofilament heavy chain

    • NfL
      neurofilament light chain

    • NK
      Natural killer

    • NO
      Nitric oxide

    • NOS
      Not otherwise specified

    • OB/Gyn
      Obstetrics and Gynecology

    • OCR
      ocrelizumab

    • OCR
      OCREVUS (ocrelizumab)

    • OCT
      optical coherence tomography

    • OR
      Odds ratio

    • ORR
      Objective response rate

    • OS
      overall survival

    • PD
      pharmacodynamic

    • PD-1
      Programmed cell death protein 1

    • PD-L1
      Programmed death-ligand 1

    • PET
      Positron emission tomography

    • PDR
      protocol-defined relapse

    • PFS
      Progression-free survival

    • PIRA
      progression independent of relapse activity

    • PK
      pharmacokinetics

    • PMBCL
      Primary mediastinal B-cell lymphoma

    • PML
      progressive multifocal leukoencephalopathy

    • Pola-R-CHP
      polatuzumab plus rituximab, cyclophosphamide, doxorubicin, prednisone

    • PPMS
      Primary progressive multiple sclerosis

    • PRLs
      paramagnetic rim lesions

    • PRO
      patient reported outcome

    • PTT
      Partial thromboplastin time

    • PVR
      Poliovirus receptor

    • R-CHOP
      rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone

    • R-CHP
      rituximab plus cyclophosphamide, doxorubicin, prednisone

    • RADIEMS
      Reserve Against Disability in Early MS

    • RAN
      rapid automatized naming

    • RAW
      relapse-associated worsening

    • rHuPH20
      recombinant human hyaluronidase PH20

    • RID
      Relative infant dose

    • RMS
      relapsing forms of multiple sclerosis

    • RMS
      Relapsing multiple sclerosis

    • RRMS
      Relapsing-remitting multiple sclerosis

    • SAE
      Serious adverse event

    • SC
      subcutaneous

    • SELs
      slowly expanding lesions

    • SPMS
      secondary progressive multiple sclerosis

    • T
      Trimester

    • T25FW
      Timed 25-Foot Walk

    • 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

    • h
      hour