IgE-directed Antibody Interactions

Anti-IgE

Asthma

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-9"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">Omalizumab is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE).  The antibody has a molecular weight of approximately 149 kiloDaltons.  XOLAIR is produced by a Chinese hamster ovary cell suspension culture.</p><p>XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials.</p><div class="Section" data-sectioncode="42229-5"><a name="section-9.1"></a><p></p><p class="First"><span class="Underline">XOLAIR Injection (Prefilled Syringe or Autoinjector)</span></p><p>XOLAIR (omalizumab) injection is supplied as a sterile, preservative-free, clear to slightly opalescent and colorless to pale brownish-yellow solution for subcutaneous injection.  XOLAIR (omalizumab) injection is available as a single-dose prefilled syringe or a single-dose autoinjector.</p><p>Each 75 mg prefilled syringe or autoinjector delivers 75 mg omalizumab in 0.5 mL and contains arginine hydrochloride (21.05 mg), histidine (0.68 mg), L-histidine hydrochloride monohydrate (1.17 mg), and polysorbate 20 (0.2 mg) in Sterile Water for Injection (SWFI), USP.</p><p>Each 150 mg prefilled syringe or autoinjector delivers 150 mg omalizumab in 1 mL and contains arginine hydrochloride (42.1 mg), histidine (1.37 mg), L-histidine hydrochloride monohydrate (2.34 mg), and polysorbate 20 (0.4 mg) in SWFI, USP.</p><p>Each 300 mg prefilled syringe or autoinjector delivers 300 mg omalizumab in 2 mL and contains arginine hydrochloride (84.2 mg), histidine (2.74 mg), L-histidine hydrochloride monohydrate (4.68 mg), and polysorbate 20 (0.8 mg) in SWFI, USP.</p><p>The needle cap of the XOLAIR 75 mg/0.5 mL and 150 mg/mL prefilled syringe with 26-gauge staked needle contains a derivative of natural rubber latex which may cause allergic reactions in latex sensitive individuals <span class="Italics">[see <a href="#S16">How Supplied/Storage and Handling (16)</a>]</span>.</p><p>The XOLAIR autoinjector is not made with natural rubber latex.</p></div><div class="Section" data-sectioncode="42229-5"><a name="section-9.2"></a><p></p><p class="First"><span class="Underline">XOLAIR for Injection (Vial)</span></p><p>XOLAIR (omalizumab) for injection is a sterile, white, preservative free, lyophilized powder in a single-dose vial.  After reconstitution with 1.4 mL of Sterile Water for Injection, USP, the vial contains 150 mg of omalizumab per 1.2 mL of reconstituted solution for subcutaneous injection.  Each 1.2 mL of reconstituted solution also contains histidine (1.3 mg), L-histidine hydrochloride monohydrate (2.1 mg), polysorbate 20 (0.4 mg) and sucrose (108 mg).</p></div></section>

XOLAIR

omalizumab 150 MG Injection

omalizumab 150 MG Injection [Xolair]

1 ML omalizumab 150 MG/ML Prefilled Syringe

1 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair]

0.5 ML omalizumab 150 MG/ML Prefilled Syringe

0.5 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair]

2 ML omalizumab 150 MG/ML Prefilled Syringe

2 ML omalizumab 150 MG/ML Prefilled Syringe [Xolair]

2 ML omalizumab 150 MG/ML Auto-Injector

2 ML omalizumab 150 MG/ML Auto-Injector [Xolair]

1 ML omalizumab 150 MG/ML Auto-Injector

1 ML omalizumab 150 MG/ML Auto-Injector [Xolair]

0.5 ML omalizumab 150 MG/ML Auto-Injector

0.5 ML omalizumab 150 MG/ML Auto-Injector [Xolair]

omalizumab

Xolair

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

Hidradenitis Suppurativa (HS)

Cosentyx

Siliq

Tremfya

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Stelara

Skyrizi

Ilumya

Migraine

Cluster Headache

Migraine Prevention

Emgality

Qulipta

Acute Migraine

Ubrelvy

Nurtec ODT

Vyepti

Aimovig

Ajovy

Breast Cancer: HR+ (HER2-)

Verzenio

Ibrance

Kisqali

Atopic Dermatitis (Eczema)

Cibinqo

Eucrisa

Asthma (injectable)

Asthma OCS Dependent

Nasal Polyposis

Eosinophilic Esophagitis (EoE)

Prurigo Nodularis

Dupixent

Opzelura

Adbry

NSCLC ALK+ OR ROS1+ Disease

Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Xeljanz

Uveitis

Graft Versus Host Disease (GVHD)

Orencia

COVID-19 Treatment

Alopecia Areata

Olumiant

Multiple Sclerosis (MS)

Secondary Progressive Multiple Sclerosis

Zeposia

Rinvoq

Entyvio

Report Adverse Event 

Prescribing Information

Medication Guide 

Submit MSL Request 

Pharmacy List 

Reimbursement Information 

Online Sample Form 

How To Order Xolair 

Coding Guide: Allergic Asthma 

Coding Guide: Chronic Spontaneous Urticaria

Coding Guide: Nasal Polyps

Coverage Authorization Request 

Coverage Authorization Appeals

Letter of Medical Necessity 

Xolair Prescriber Service Form 

Patient Consent Form - English 

Patient Consent Form - Spanish 

My Patient Solutions - HCP Portal (for managing service requests)

Prescriber Service Form - Online Portal 

Genentech Patient Assistance Foundation Application: Prescriber Form 

Bridge Program 

Enroll in Patient Savings Program 

Other HCP Resources 

Progress Tracker: Allergic Asthma 

Patient Brochure: Allergic Asthma 

Doctor Discussion Guide: Allergic Asthma

Patient Brochure: Chronic Spontaneous Urticaria 

About Xolair: Allergic Asthma 

Patient Stories: Allergic Asthma 

FAQs: Allergic Asthma

Taking Xolair: Allergic Asthma 

About Xolair: Chronic Spontaneous Urticaria 

Patient Stories: Chronic Spontaneous Urticaria 

FAQs: Chronic Spontaneous Urticaria 

Taking Xoliar: Chronic Spontaneous Urticaria 

About Xolair: Nasal Polyps 

Comprehensive Support Program 

Instructions For Use: Allergic Asthma

Instructions For Use: Nasal Polyps 

Instructions For Use: Chronic Spontaneous Urticaria 