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XOLAIR omalizumab 150 mg/1.2mL Injection, Solution, 1 vial — NDC 50242-0040-86 package photo

XOLAIR omalizumab 150 mg/1.2mL Injection, Solution, 1 vial

by Genentech, Inc. · 1 VIAL, SINGLE-USE in 1 CARTON (50242-040-86) / 1.2 mL in 1 VIAL, SINGLE-USE
NDC 50242-0040-86
🏷️ FDA NDC (as labeled) 50242-040-86 billing pads the product segment with a zero
This package
Contains1 vial Pack sizes2 compare ↓
Also priced by: Part D plans $1,518.94/unit — full pricing hub ↓
Also comes in: 1.2 mL 50242-0040-62
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🚨
Active recall for this product.
Class II · Jul 30, 2025 — CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. (Cardinal Health Inc.) · FDA recall D-0571-2025
Class II · Jul 30, 2025 — CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. (Cardinal Health Inc.) · FDA recall D-0572-2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 50242-040-86
Product NDC 50242-040
11-digit billing NDC 50242004086
NCPDP billing unit EA — each (per item)
RxCUI 1657209, 1657212, 2058943, 2058946, 2058949, 2058950, 2663917, 2663918,
UNII 2P471X1Z11
Application # BLA103976
SPL Set ID 7f6a2191-adfb-48b9-9bfa-0d9920479f0d
Established class (EPC) Anti-IgE
Mechanism of action IgE-directed Antibody Interactions
Physiologic effect Decreased IgE Activity
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2003-06-20
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance OMALIZUMAB
GCN Seq No 052758
GCN 19966
HICL code 025399
Ingredient (HICL) Omalizumab
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2L
Therapeutic class — specific (HIC3) Monoclonal Antibodies To Immunoglobulin E (Ige)
AHFS code 90:28.16.92
AHFS class Interleukin Inhibitor Agents, Misc
FDB label name XOLAIR 150 MG/1.2 ML POWDER VL
FDB brand name Xolair
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 50242-040-86 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 50242-0040-86. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anti-IgE class.

Pharmacologic class Anti-IgE
Drug family (ATC) Other systemic drugs for obstructive airway diseases
How it works IgE-directed Antibody Interactions
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerGenentech, Inc.
FDA applicationBLA103976 (BLA)
Labeler code50242
First marketedJun 2003
Product typeHuman Prescription Drug
Portfolio93 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name XOLAIR 150 MG/1.2 ML POWDER VL Ingredient Omalizumab
📗 Our plain-language guide HelloPharmacist
  • Xolair targets IgE, the antibody your immune system overproduces in response to allergens. It blocks IgE from latching onto immune cells that would otherwise trigger your allergic...
  • What exactly is Xolair doing in my body, and why does it take so long to work?
  • It's worth knowing about, but your care team will take precautions. Xolair can cause anaphylaxis — a severe allergic reaction — in a small number of patients, and it can happen aft...
  • I've heard Xolair can cause a serious allergic reaction. Should I be worried?
📖 Read our full Omalizumab Injection guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 1.3 mg / 1.2 mL UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • 2.1 mg / 1.2 mL UNII X573657P6P
    Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
  • 0.4 mg / 1.2 mL UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • 108 mg / 1.2 mL UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1,518.94 $1,822.73 / 1.2 ml
Medicare Part B allowsASP · J2357 $46.588 / J2357 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)50242-040-86
11-digit billing NDC50242-0040-86
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2357
DescriptorINJECTION, OMALIZUMAB, 5 MG
Billing units / pkg30 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Xolair 150 mg/1.2mLthis 50242-0040-86 Genentech, 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️
2003
First FDA approval
Jun 2003
📍
2026
Currently FDA-listed
23 years listed
🔓
2026
Biosimilars listed
1 FDA-licensed
🧬FDA-licensed biosimilars listed

1 interchangeable is FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)

🛡️ Latest patent/protection date listed: Biosimilars are already FDA-licensed for this product — the last listed patent runs to Jul 2043.
📅 FDA approved Jun 20, 2003

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Xolairomalizumab
Interchangeable 1
Omlycloomalizumab-igec
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
US 12,030,959 — biologic patent
US 11,987,637 — biologic patent
US 11,078,294 — biologic patent
US 10,829,732 — biologic patent
US 10,676,710 — biologic patent
US 10,034,940 — biologic patent
US 10,017,732 — biologic patent
US 8,574,869 — biologic patent
2003 2005 2007 2009 2011 2013 2015 2017 2019 2021 2023 2025 2027 2029 2031 2033 2035 2037 2039 2041 2043
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

Listed patents (8)
PatentTypeUse codeExpires
US 12,030,959 ↗ Biologic patent — Jul 20, 2043
US 11,987,637 ↗ Biologic patent — Jul 8, 2028
US 11,078,294 ↗ Biologic patent — Jul 8, 2028
US 10,829,732 ↗ Biologic patent — Mar 14, 2034
US 10,676,710 ↗ Biologic patent — Mar 14, 2034
US 10,034,940 ↗ Biologic patent — Nov 4, 2025
US 10,017,732 ↗ Biologic patent — Mar 14, 2034
US 8,574,869 ↗ Biologic patent — Jul 8, 2028
Common questions
Is there a biosimilar for XOLAIR 150 MG/1.2 ML POWDER VL?
Yes — at least one FDA-licensed biosimilar is listed for this biologic. See the Purple Book family above for the available products.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial50242-0040-62 11,037 Rx · $22,868,765
1 vial this page50242-0040-86 No Medicaid data
Drug total (last 4 qtrs): 11,037 Rx · 20,730 units · $22,868,765 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Xolair — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Xolair. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$132.06M
Claims incl. refills
36.3K
Beneficiaries
12.7K
Spend / beneficiary
$10,399.59
Spend / claim
$3,635.74
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Xolair (this brand).

Top reported reactions

Asthma11,940
Urticaria10,606
Dyspnoea10,248
Cough7,047
Pruritus6,150
Fatigue6,022
Malaise5,659

Age at onset

Neonate66
Infant32
Child591
Adolescent798
Adult13,165
Elderly4,161

Reporter sex

80,446 reports
Male · 26%
Female · 73%
Unknown · 0%

Serious outcomes

Hospitalization15,430
Death2,401
Life-threatening2,036
Disabling867
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 11,944 3,900
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50242-0040-62 1 VIAL, SINGLE-USE in 1 CARTON (50242-040-62) / 1.2 mL in 1 VIAL, SINGLE-USE 2003-06-20 Active
50242-0040-86 You're viewing this 1 VIAL, SINGLE-USE in 1 CARTON (50242-040-86) / 1.2 mL in 1 VIAL, SINGLE-USE 2013-12-20 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 50242-0040-86?
NDC 50242-0040-86 contains 1 vial — 1 vial, single-use in 1 carton / 1.2 ml in 1 vial, single-use.
What is the difference between NDC 50242-0040-86 and NDC 50242-0040-62?
Both are XOLAIR omalizumab 150 mg/1.2mL Injection, Solution — the drug itself is identical. NDC 50242-0040-86 is the 1 vial package, while NDC 50242-0040-62 is the 1 vial package.
What NDC number is used to bill for this package of XOLAIR omalizumab 150 mg/1.2mL Injection, Solution?
Bill NDC 50242-0040-86 — the 11-digit billing format is 50242004086. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 50242-040-86, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50242-0040-86, written without dashes as 50242004086. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 50242-0040-86, the first segment (50242) is the labeler code FDA assigned to Genentech, Inc.; the middle segment (0040) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (86) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Genentech, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (50242-0040-62). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Genentech, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2357 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: ANAPHYLAXIS 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 as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration.

Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to 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 [see Dosage and Administration (2.6) , Warnings and Precautions (5.1) and Adverse Reactions (6.1 , 6.2) ] .

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.

( 2.6 , 5.1 , 6.1 , 6.2 )

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE XOLAIR is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids ( 1.1 ) Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment ( 1.2 ) IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods.

To be used in conjunction with food allergen avoidance ( 1.3 ) Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment ( 1.4 ) Limitations of Use : Not indicated for acute bronchospasm or status asthmaticus. ( 1.1 , 5.3 ) Not indicated for the emergency treatment of allergic reactions, including anaphylaxis ( 1.3 ) Not indicated for other forms of urticaria. ( 1.4 )

1.1Asthma XOLAIR is indicated for adults and pediatric patients 6 years of age and older 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. Limitations of Use: XOLAIR is not indicated for the relief of acute bronchospasm or status asthmaticus.

1.2Chronic Rhinosinusitis with Nasal Polyps XOLAIR is indicated for add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

1.3IgE-Mediated Food Allergy XOLAIR 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. XOLAIR is to be used in conjunction with food allergen avoidance. Limitations of Use: XOLAIR is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

1.4Chronic Spontaneous Urticaria XOLAIR is indicated for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: XOLAIR is not indicated for treatment of other forms of urticaria.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For subcutaneous (SC) administration only. ( 2.2 , 2.3 , 2.4 , 2.5 ) See full prescribing information for administration instructions ( 2.6 , 2.7 , 2.8 ). Asthma : XOLAIR 75 to 375 mg SC every 2 or 4 weeks.

Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts. ( 2.2 ) Chronic Rhinosinusitis with Nasal Polyps : XOLAIR 75 to 600 mg SC every 2 or 4 weeks.

Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts. ( 2.3 ) IgE-Mediated Food Allergy : XOLAIR 75 mg to 600 mg SC every 2 or 4 weeks.

Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination chart. ( 2.4 ) Chronic Spontaneous Urticaria : XOLAIR 150 or 300 mg SC every 4 weeks.

Dosing in CSU is not dependent on serum IgE level or body weight. ( 2.5 )

2.1Overview of Dosage Determination Asthma, and Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy Determine dosage of XOLAIR by serum total IgE level (IU/mL) measured before the start of treatment, and by body weight (kg). For patients with asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergy, dosage determination should be based on the primary diagnosis for which XOLAIR is being prescribed. Adjust doses for significant changes in body weight during treatment.

Refer to Tables 1 and 2 for the recommended dosage for treatment of asthma, Table 3 for treatment of CRSwNP, and Table 4 for treatment of IgE-mediated food allergy. Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during XOLAIR treatment cannot be used as a guide for dose determination.

Interruptions lasting less than one year: Dose based on serum IgE levels obtained at the initial dose determination. Interruptions lasting one year or more: Re-test total serum IgE levels for dose determination ( Table 1 or 2 for treatment of asthma, based on the patient's age, Table 3 for treatment of CRSwNP, and Table 4 for treatment of IgE-mediated food allergy). Chronic Spontaneous Urticaria Dosage of XOLAIR in patients with chronic spontaneous urticaria (CSU) is not dependent on serum IgE (free or total) level or body weight [see Dosage and Administration (2.5) ] .

2.2Recommended Dosage for Asthma The recommended dosage for asthma is XOLAIR 75 mg to 375 mg by subcutaneous injection every 2 or 4 weeks based on serum total IgE level (IU/mL) measured before the start of treatment and by body weight (kg) [see Dosage and Administration (2.1) ] . Adult and adolescent patients 12 years of age and older: Initiate dosing according to Table 1 . Pediatric patients 6 to <12 years of age: Initiate dosing according to Table 2 .

Table 1. Subcutaneous XOLAIR Doses Every 2 or 4 Weeks* for Patients 12 Years of Age and Older with Asthma Table 2. Subcutaneous XOLAIR Doses Every 2 or 4 Weeks* for Pediatric Patients with Asthma Who Begin XOLAIR Between the Ages of 6 to <12 Years Duration of Therapy Periodically reassess the need for continued therapy based upon the patient's disease severity and level of asthma control.

Table 1 Table 2

2.3Recommended Dosage for Chronic Rhinosinusitis with Nasal Polyps The recommended dosage for chronic rhinosinusitis with nasal polyps (CRSwNP) is XOLAIR 75 mg to 600 mg by subcutaneous injection every 2 or 4 weeks based on serum total IgE level (IU/mL) measured before the start of treatment and by body weight (kg) [see Dosage and Administration (2.1) ] . Refer to Table 3 for recommended dosage based on serum total IgE level and body weight for patients with CRSwNP. Table 3.

Subcutaneous XOLAIR Doses Every 2 or 4 Weeks* for Adult Patients with C…

💊 Dosage Forms and Strengths 133 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: a clear to slightly opalescent and colorless to pale brownish-yellow solution available in the following: 75 mg/0.5 mL single-dose prefilled syringe with needle shield 75 mg/0.5 mL single-dose prefilled autoinjector 150 mg/mL single-dose prefilled syringe with needle shield 150 mg/mL single-dose prefilled autoinjector 300 mg/2 mL (150 mg/mL) single-dose prefilled syringe with needle shield 300 mg/2 mL single-dose prefilled autoinjector For injection: 150 mg white lyophilized powder in a single-dose vial for reconstitution Injection: 75 mg/0.5 mL, 150 mg/mL, and 300 mg/2 mL (150 mg/mL) solution in a single-dose prefilled syringe.

( 3 ) 75 mg/0.5 mL, 150 mg/mL and 300 mg/2 mL solution in a single-dose prefilled autoinjector. ( 3 ) For Injection: 150 mg lyophilized powder in a single-dose vial for reconstitution. ( 3 )

⛔ Contraindications 40 words ▾

4 CONTRAINDICATIONS XOLAIR is contraindicated in patients with severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR [see Warnings and Precautions (5.1) ] . Severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR ( 4 , 5.1 )

⚠️ Warnings and Cautions ~3 min read ▾

5 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. ( 5.1 ) Malignancy: Malignancies have been observed in clinical studies. ( 5.2 ) Acute Asthma Symptoms: Do not use for the treatment of acute bronchospasm or status asthmaticus.

( 5.3 ) Corticosteroid Reduction: Do not abruptly discontinue corticosteroids upon initiation of XOLAIR therapy. ( 5.4 ) Eosinophilic Conditions: Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids. ( 5.5 ) Fever, Arthralgia, and Rash: Stop XOLAIR if patients develop signs and symptoms similar to serum sickness.

( 5.6 ) Potential Medication Error Related to Emergency Treatment of Anaphylaxis: XOLAIR should not be used for emergency treatment of allergic reactions, including anaphylaxis. ( 5.9 )

5.1Anaphylaxis Anaphylaxis has been reported to occur after administration of XOLAIR in premarketing clinical trials and in postmarketing spontaneous reports [see Boxed Warning and Adverse Reactions (6.2) ] . Signs and symptoms in these reported cases have included bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue. Some of these events have been life-threatening.

In premarketing clinical trials in patients with asthma, anaphylaxis was reported in 3 of 3507 (0.1%) patients. Anaphylaxis occurred with the first dose of XOLAIR in two patients and with the fourth dose in one patient. The time to onset of anaphylaxis was 90 minutes after administration in two patients and 2 hours after administration in one patient.

A case-control study in asthma patients showed that, among XOLAIR users, patients with a history of anaphylaxis to foods, medications, or other causes were at increased risk of anaphylaxis associated with XOLAIR, compared to those with no prior history of anaphylaxis [see Adverse Reactions (6.1) ] . In postmarketing spontaneous reports, the frequency of anaphylaxis attributed to XOLAIR use was estimated to be at least 0.2% of patients based on an estimated exposure of about 57,300 patients from June 2003 through December 2006.

Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond one year after beginning regularly scheduled treatment. Approximately 60% to 70% of anaphylaxis cases have been reported to occur within the first three doses of XOLAIR, with additional cases occurring sporadically beyond the third dose. Initiate XOLAIR only in a healthcare setting equipped to manage anaphylaxis, which can be life-threatening.

Observe patients closely for an appropriate period of time after administration of XOLAIR, taking into account the time to onset of anaphylaxis seen in premarketing clinical trials and postmarketing spontaneous reports [see Adverse Reactions (6.1 , 6.2) ] . Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs or symptoms occur. Once XOLAIR therapy has been established, administration of XOLAIR prefilled syringe or autoinjector outside of a healthcare setting by a patient or a caregiver may be appropriate for selected patients.

Patient selection, determined by the healthcare provider in consultation with the patient, should take into account the pattern of anaphylaxis events seen in premarketing clinical trials and postmarketing spontaneous reports, as well as individual patient risk factors (e.g., prior history of anaphylaxis), ability to recognize signs and symptoms of anaphylaxis, and ability to perform subcutaneous injections with XOLAIR prefilled syringe or autoinjector with proper technique according to the prescribed dosing regimen and Instructions for Use [see Dosage and Administration (2.6) , Adverse Reactions (6.1 , 6.2) ].

Discontinue XOLAIR in patien…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis [see Boxed Warning and Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] 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.

( 6.1 ) 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. ( 6.1 ) IgE-Mediated Food Allergy : The most common adverse reactions (≥3% of patients) were injection site reactions and pyrexia. ( 6.1 ) 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.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions from Clinical Studies in Adult and Adolescent Patients 12 Years of Age and Older with Asthma The data described below reflect XOLAIR exposure for 2076 adult and adolescent patients ages 12 and older, including 1687 patients exposed for six months and 555 exposed for one year or more, in either placebo-controlled or other controlled asthma studies.

The mean age of patients receiving XOLAIR was 42 years, with 134 patients 65 years of age or older; 60% were women, and 85% Caucasian. Patients received XOLAIR 150 mg to 375 mg every 2 or 4 weeks or, for patients assigned to control groups, standard therapy with or without a placebo. The adverse reactions most frequently resulting in clinical intervention (e.g., discontinuation of XOLAIR, or the need for concomitant medication to treat an adverse reaction) were injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%).

These reactions were observed at similar rates in XOLAIR-treated patients and control patients. Table 7 shows adverse reactions from four placebo-controlled asthma trials that occurred ≥1% and more frequently in adult and adolescent patients 12 years of age and older receiving XOLAIR than in those receiving placebo. Adverse reactions were classified using preferred terms from the International Medical Nomenclature (IMN) dictionary.

Injection site reactions were recorded separately from the reporting of other adverse reactions. Table 7. Adverse Reactions ≥1% More Frequent in XOLAIR-Treated Adult or Adolescent Patients 12 years of Age and Older in Four Placebo-controlled Asthma Trials Adverse reaction XOLAIR n=738 Placebo n=717 Body as a whole Pain 7% 5% Fatigue 3% 2% Musculoskeletal system Arthralgia 8% 6% Fracture 2% 1% Leg pain 4% 2% Arm pain 2% 1% Nervous system Dizziness 3% 2% Skin and appendages Pruritus 2% 1% Dermatitis 2% 1% Special senses Earache 2% 1% There were no differences in the incidence of adverse reactions based on age (among patients under 65), gender or race.

Anaphylaxis Case Control Study A retrospective case-control study investig…

🔄 Drug Interactions 63 words ▾

7 DRUG INTERACTIONS No formal drug interaction studies have been performed with XOLAIR. In patients with asthma, CRSwNP, and IgE-mediated food allergy the concomitant use of XOLAIR and allergen immunotherapy has not been evaluated . In patients with CSU, the use of XOLAIR in combination with immunosuppressive therapies has not been studied. No formal drug interaction studies have been performed. ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary A registry study of XOLAIR exposure during pregnancy showed no increase in the rate of major birth defects or miscarriage. There was an increased rate of low birth weight among registry infants compared to infants in the other cohorts, despite average gestational age at birth; however, women taking XOLAIR during pregnancy also had more severe asthma, which makes it difficult to determine whether the low birth weight is due to the drug or the disease severity [see Data ] . There are risks associated with poorly or moderately controlled asthma in pregnancy [see Clinical Considerations ] .

Human IgG antibodies are known to cross the placental barrier; therefore, XOLAIR may be transmitted from the mother to the developing fetus. In animal reproduction studies, no evidence of fetal harm was observed in Cynomolgus monkeys with subcutaneous doses of omalizumab up to approximately 5 times the maximum recommended human dose (MRHD) [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate.

The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. Data Human Data A prospective cohort pregnancy exposure registry study conducted in the US from 2006 to 2018, included 250 pregnant women with asthma treated with XOLAIR. Of these, 246 patients were exposed to XOLAIR in the first trimester of pregnancy, and the median exposure duration was 8.7 months.

The registry findings for applicable mother and infant subgroups were compared to age-adjusted frequencies in a disease-matched external cohort of 1,153 pregnant women with asthma (without exposure to XOLAIR) identified from healthcare databases of residents in the Canadian province of Quebec, and referred to as the Quebec External Comparator Cohort ("comparator cohort"). Among applicable registry infants, the prevalence of major congenital anomalies (8.1%) was similar to that for infants in the comparator cohort (8.9%).

Among applicable registry pregnancies, 99.1% led to live births, similar to 99.3% for the comparator cohort. There was an increased rate of low birth weight among registry infants (13.7%) as compared to the comparator cohort (9.8%); however, women taking XOLAIR during pregnancy also had more severe asthma, which makes it difficult to determine whether the low birth weight is due to the drug or the disease severity. The registry study cannot definitively establish the absence of any risk because of methodological limitations, including the observational nature of the registry, small sample size, and potential differences between the registry population and the comparator cohort.

Animal Data Reproductive studies have been performed in Cynomolgus monkeys. There was no evidence of maternal toxicity, embryotoxicity, or teratogenicity when omalizumab was administered throughout the period of organogenesis at doses that produced exposures approximately 5 times the MRHD (on a mg/kg basis with maternal subcutaneous doses up to 75 mg/kg/week). Omalizumab did not elicit adverse effects on fetal or neonatal growth when administered throughout late gestation, delivery, and nursing.

8.2Lactation Risk Summary There is no information regarding the presence of omalizumab in human milk, or the effects on milk production. However, omalizumab is…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary A registry study of XOLAIR exposure during pregnancy showed no increase in the rate of major birth defects or miscarriage. There was an increased rate of low birth weight among registry infants compared to infants in the other cohorts, despite average gestational age at birth; however, women taking XOLAIR during pregnancy also had more severe asthma, which makes it difficult to determine whether the low birth weight is due to the drug or the disease severity [see Data ] . There are risks associated with poorly or moderately controlled asthma in pregnancy [see Clinical Considerations ] .

Human IgG antibodies are known to cross the placental barrier; therefore, XOLAIR may be transmitted from the mother to the developing fetus. In animal reproduction studies, no evidence of fetal harm was observed in Cynomolgus monkeys with subcutaneous doses of omalizumab up to approximately 5 times the maximum recommended human dose (MRHD) [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate.

The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. Data Human Data A prospective cohort pregnancy exposure registry study conducted in the US from 2006 to 2018, included 250 pregnant women with asthma treated with XOLAIR. Of these, 246 patients were exposed to XOLAIR in the first trimester of pregnancy, and the median exposure duration was 8.7 months.

The registry findings for applicable mother and infant subgroups were compared to age-adjusted frequencies in a disease-matched external cohort of 1,153 pregnant women with asthma (without exposure to XOLAIR) identified from healthcare databases of residents in the Canadian province of Quebec, and referred to as the Quebec External Comparator Cohort ("comparator cohort"). Among applicable registry infants, the prevalence of major congenital anomalies (8.1%) was similar to that for infants in the comparator cohort (8.9%).

Among applicable registry pregnancies, 99.1% led to live births, similar to 99.3% for the comparator cohort. There was an increased rate of low birth weight among registry infants (13.7%) as compared to the comparator cohort (9.8%); however, women taking XOLAIR during pregnancy also had more severe asthma, which makes it difficult to determine whether the low birth weight is due to the drug or the disease severity. The registry study cannot definitively establish the absence of any risk because of methodological limitations, including the observational nature of the registry, small sample size, and potential differences between the registry population and the comparator cohort.

Animal Data Reproductive studies have been performed in Cynomolgus monkeys. There was no evidence of maternal toxicity, embryotoxicity, or teratogenicity when omalizumab was administered throughout the period of organogenesis at doses that produced exposures approximately 5 times the MRHD (on a mg/kg basis with maternal subcutaneous doses up to 75 mg/kg/week). Omalizumab did not elicit adverse effects on fetal or neonatal growth when administered throughout late gestation, delivery, and nursing.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Asthma Safety and effectiveness of XOLAIR for moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids, have been established in pediatric patients aged 6 years and older. Use of XOLAIR for this indication is supported by evidence from adequate and well-controlled studies. XOLAIR was evaluated in 2 trials in 926 (XOLAIR 624; placebo 302) pediatric patients 6 to <12 years of age with moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen.

One trial was a pivotal trial of similar design and conduct to that of adult and adolescent Asthma Trials 1 and 2. The other trial was primarily a safety study and included evaluation of efficacy as a secondary outcome. In the pivotal trial, XOLAIR-treated patients had a statistically significant reduction in the rate of exacerbations (exacerbation was defined as worsening of asthma that required treatment with systemic corticosteroids or a doubling of the baseline ICS dose) [see Clinical Studies (14.1) ] .

Safety and efficacy in pediatric patients with asthma below 6 years of age have not been established. Chronic Rhinosinusitis with Nasal Polyps Safety and effectiveness in pediatric patients with chronic rhinosinusitis with nasal polyps (CRSwNP) below 18 years of age have not been established. IgE-Mediated Food Allergy The safety and effectiveness of XOLAIR for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods have been established in pediatric patients aged 1 year and older with IgE-mediated food allergy.

Use of XOLAIR for this indication is supported by evidence from an adequate and well-controlled study that included a total of 165 pediatric patients; 61 patients aged 1 year to less than 6 years of age and 104 patients aged 6 to less than 18 years of age. A significantly greater percentage of XOLAIR-treated patients compared to placebo-treated patients was able to consume a single dose of food (peanut, cashew, milk, egg) without dose-limiting symptoms [see Clinical Studies (14.3) ]. Safety and effectiveness in pediatric patients with IgE-mediated food allergy below 1 year of age have not been established.

Chronic Spontaneous Urticaria The safety and effectiveness of XOLAIR for chronic spontaneous urticaria (CSU) in patients who remain symptomatic despite H1 antihistamine treatment have been established in pediatric patients aged 12 years and older. Use of XOLAIR in this population is supported by evidence from adequate and well-controlled studies. Adolescent patients with CSU were evaluated in 39 patients 12 to 17 years of age (XOLAIR 29, placebo 10) included in three randomized, placebo-controlled CSU trials.

A numerical decrease in weekly itch score was observed, and adverse reactions were similar to those reported in patients 18 years and older. Safety and effectiveness in pediatric patients with CSU below 12 years of age have not been established.

🧓 Geriatric Use 62 words ▾

8.5Geriatric Use In clinical studies, 134 asthma patients, 20 CRSwNP patients, 37 CSU patients and no IgE-mediated food allergy patients 65 years of age or older were treated with XOLAIR. Although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Asthma, Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and dendritic cells, resulting in FcεRI down-regulation on these cells. In allergic asthmatics, treatment with omalizumab inhibits IgE-mediated inflammation, as evidenced by reduced blood and tissue eosinophils and reduced inflammatory mediators, including IL-4, IL-5, and IL-13. Chronic Spontaneous Urticaria Omalizumab binds to IgE and lowers free IgE levels.

Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of omalizumab result in an improvement of chronic spontaneous urticaria (CSU) symptoms is unknown.

12.2Pharmacodynamics Asthma In clinical studies, serum free IgE levels were reduced in a dose-dependent manner within 1 hour following the first dose and maintained between doses. Mean serum free IgE decrease was greater than 96% using recommended doses. Serum total IgE levels (i.e., bound and unbound) increased after the first dose due to the formation of omalizumab:IgE complexes, which have a slower elimination rate compared with free IgE.

At 16 weeks after the first dose, average serum total IgE levels were five-fold higher compared with pre-treatment when using standard assays. After discontinuation of XOLAIR dosing, the XOLAIR-induced increase in total IgE and decrease in free IgE were reversible, with no observed rebound in IgE levels after drug washout. Total IgE levels did not return to pre-treatment levels for up to one year after discontinuation of XOLAIR.

Chronic Rhinosinusitis with Nasal Polyps In clinical studies in chronic rhinosinusitis with nasal polyps (CRSwNP) patients, omalizumab treatment led to a reduction in serum free IgE and an increase in serum total IgE levels, similar to the observations in asthma patients. The mean total IgE concentrations at baseline were 168 IU/mL and 218 IU/mL in CRSwNP Trial 1 and 2, respectively. After repeated dosing every 2 or 4 weeks, with dosage and frequency according to Table 3 , the mean predose free IgE concentrations at Week 16 were

10.0 IU/mL in CRSwNP Trial 1 and

11.7IU/mL in CRSwNP Trial 2 and remained stable at 24 weeks of treatment. Total IgE levels in serum increased due to the formation of omalizumab-IgE complexes, which have a slower elimination rate compared with free IgE. After repeated dosing every 2 or 4 weeks, with dosage and frequency according to Table 3 , mean and median predose serum total IgE levels at Week 16 were 3- to 4- fold higher compared with pre-treatment levels, and remained stable between 16 and 24 weeks of treatment.

IgE-Mediated Food Allergy In a clinical study in patients with IgE-mediated food allergy, omalizumab treatment led to a reduction in serum free IgE and an increase in serum total IgE levels, similar to the observations in asthma patients. The mean total IgE concentration at baseline was 810 IU/mL. After repeated dosing every 2 or 4 weeks, with dosage and frequency according to Table 4 , the mean pre-dose free IgE concentration at Week 16 was

10.0IU/mL. Mean total IgE levels in serum increased about 2.4-fold due to the formation of omalizumab-IgE complexes, which have a longer half-life compared with free IgE. Chronic Spontaneous Urticaria In clinical studies in chronic spontaneous urticaria (CSU) patients, XOLAIR treatment led to a dose-dependent reduction of serum free IgE and an increase of serum total IgE levels, similar to the observations in asthma patients.

Maximum suppression of free IgE was observed 3 days following the first subcutaneous dose. After repeat dosing once every 4 weeks, predose serum free IgE levels remained stable between 12 and 24 weeks of treatment. Total IgE levels in serum increased after the first dose due to the formation of omalizumab-IgE complexes which have a slower elimination rate compared with fr…

🧬 Mechanism of Action 108 words ▾

12.1Mechanism of Action Asthma, Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and dendritic cells, resulting in FcεRI down-regulation on these cells. In allergic asthmatics, treatment with omalizumab inhibits IgE-mediated inflammation, as evidenced by reduced blood and tissue eosinophils and reduced inflammatory mediators, including IL-4, IL-5, and IL-13. Chronic Spontaneous Urticaria Omalizumab binds to IgE and lowers free IgE levels.

Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of omalizumab result in an improvement of chronic spontaneous urticaria (CSU) symptoms is unknown.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Injection (Prefilled Syringe or Autoinjector) XOLAIR (omalizumab) injection is a clear to slightly opalescent and colorless to pale brownish-yellow solution for subcutaneous use. XOLAIR injection is provided as either a single-dose prefilled syringe with staked needle, rigid needle cap, and needle shield or a single-dose prefilled autoinjector with staked needle, needle cap and needle guard. XOLAIR is available as prefilled syringe and autoinjector as described in Tables 18 and 19 .

Table 18. XOLAIR Prefilled Syringe Strengths and Package Configurations Package Configuration Strength NDC 1 prefilled syringe with a 27-gauge staked needle 75 mg/0.5 mL NDC 50242-214-03 1 prefilled syringe with a 27-gauge staked needle 150 mg/mL NDC 50242-215-03 1 prefilled syringe with a 27-gauge staked needle 300 mg/2 mL (150 mg/mL) NDC 50242-227-01 Table 19. XOLAIR Autoinjector Strengths and Package Configurations Package Configuration Strength NDC 1 autoinjector with a 27-gauge staked needle 75 mg/0.5 mL NDC 50242-214-55 1 autoinjector with a 27-gauge staked needle 150 mg/mL NDC 50242-215-55 1 autoinjector with a 27-gauge staked needle 300 mg/2 mL NDC-50242-227-55 Storage XOLAIR prefilled syringe and autoinjector should be shipped and stored under refrigerated conditions 2°C to 8°C (36°F to 46°F) in the original carton.

Protect from direct sunlight. XOLAIR prefilled syringe and autoinjector can be removed from and placed back in the refrigerator if needed. The total combined time out of the refrigerator may not be more than 2 days.

Do not use if prefilled syringe or autoinjector is left at temperatures above 25°C (77°F). Do not freeze. Do not use if the prefilled syringe or autoinjector has been frozen.

For Injection (Vial) XOLAIR is supplied as a lyophilized, white, sterile powder in a single-dose vial without preservatives. Each carton contains: one single-dose vial of XOLAIR ® (omalizumab) 150 mg for injection NDC 50242-040-62. Storage XOLAIR should be shipped at controlled ambient temperature (≤30°C [≤86°F]).

Store XOLAIR under refrigerated conditions 2°C to 8°C (36°F to 46°F) in the original carton. Do not use beyond the expiration date stamped on carton.

📦 Storage and Handling 126 words ▾

Storage XOLAIR prefilled syringe and autoinjector should be shipped and stored under refrigerated conditions 2°C to 8°C (36°F to 46°F) in the original carton. Protect from direct sunlight. XOLAIR prefilled syringe and autoinjector can be removed from and placed back in the refrigerator if needed.

The total combined time out of the refrigerator may not be more than 2 days. Do not use if prefilled syringe or autoinjector is left at temperatures above 25°C (77°F). Do not freeze.

Do not use if the prefilled syringe or autoinjector has been frozen.

Storage XOLAIR should be shipped at controlled ambient temperature (≤30°C [≤86°F]). Store XOLAIR under refrigerated conditions 2°C to 8°C (36°F to 46°F) in the original carton. Do not use beyond the expiration date stamped on carton.

📋 Description ~1 min read ▾

11 DESCRIPTION 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.

XOLAIR (omalizumab) is administered as a subcutaneous (SC) injection and is available in prefilled syringe, autoinjector and in vials. XOLAIR Injection (Prefilled Syringe or Autoinjector) 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.

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. 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. 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.

XOLAIR for Injection (Vial) 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).

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Anaphylaxis Inform patients of the risk of life-threatening anaphylaxis with XOLAIR including the following points [see Boxed Warning and Warnings and Precautions (5.1) ] : There have been reports of anaphylaxis occurring up to 4 days after administration of XOLAIR Initiate XOLAIR only in a healthcare setting by healthcare providers Observe patients closely following administration Inform patients of the signs and symptoms of anaphylaxis Instruct patients to seek immediate medical care should such signs or symptoms occur Potential Medication Error Related to Emergency Treatment of Anaphylaxis Advise patients, parents, or caregivers that XOLAIR should not be used for the emergency treatment of allergic reactions, including anaphylaxis [see Warnings and Precautions (5.9) ] .

Continuation of Other Medications Instruct patients receiving XOLAIR not to decrease the dose of, or stop taking any other asthma, CRSwNP, CSU or IgE-mediated food allergy medications or allergen immunotherapy unless otherwise instructed by their physician. Inform patients that they may not see immediate improvement in their asthma, CRSwNP, CSU or IgE-mediated food allergy symptoms after beginning XOLAIR therapy. Instruction on Injection Technique If a patient or caregiver is to administer subcutaneous XOLAIR prefilled syringe or autoinjector, instruct on injection technique and assess ability to inject subcutaneously to ensure proper administration of XOLAIR.

For patients who require more than 1 injection to complete their prescribed dose, instruct patients to administer all injections consecutively and in one sitting [see Dosage and Administration (2.7) , Warnings and Precautions (5.1) , and Instructions for Use ] .

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 8/2026 MEDICATION GUIDE XOLAIR ® (ZOHL-air) (omalizumab) injection, for subcutaneous use XOLAIR ® (ZOHL-air) (omalizumab) for injection, for subcutaneous use What is the most important information I should know about XOLAIR? XOLAIR may cause serious side effects, including: Severe allergic reaction .

A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later.

Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction: wheezing, shortness of breath, cough, chest tightness, or trouble breathing low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of "impending doom" flushing, itching, hives, or feeling warm swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated.

Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction. What is XOLAIR? XOLAIR is an injectable prescription medicine used to treat: moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids.

A skin or blood test is performed to see if you have allergies to year-round allergens. It is not known if XOLAIR is safe and effective in people with asthma under 6 years of age. chronic rhinosinusitis with nasal polyps (CRSwNP) in people 18 years of age and older when medicines to treat CRSwNP called nasal corticosteroids have not worked well enough. It is not known if XOLAIR is safe and effective in people with CRSwNP under 18 years of age. food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic.

While taking XOLAIR you should continue to avoid all foods to which you are allergic. It is not known if XOLAIR is safe and effective in people with food allergy under 1 year of age. chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if XOLAIR is safe and effective in people with CSU under 12 years of age.

XOLAIR should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. XOLAIR should also not be used to treat other forms of hives, or sudden breathing problems. Who should not receive and use XOLAIR?

Do not receive and use XOLAIR if you: are allergic to omalizumab or any of the ingredients in XOLAIR. See the end of this Medication Guide for a complete list of ingredients in XOLAIR. What should I tell my healthcare provider before receiving XOLAIR?

Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you: have any allergies (such as seasonal allergies). have sudden breathing problems (bronchospasm). have ever had a severe allergic reaction called anaphylaxis. have or have had a parasitic infection. have or have had cancer. are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk.

Talk with your healthcare provider about the best way to feed your baby while you receive and use XOLAIR. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medici…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.