Omalizumab

XOLAIR

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Pronunciation: oe-ma-lye-ZOO-mab (ZOEL-air)

Omalizumab ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Omalizumab ballicule

Omalizumab XOLAIR mascot mnemonic cartoon — Visual mnemonic: Omalizumab mascot

What it isAnti-IgE monoclonal antibody; allergic asthma, chronic urticaria, nasal polyps and food allergy.

Why this oneUnlike other asthma biologics, it also treats chronic urticaria and IgE-mediated food allergy.

What limits itAnaphylaxis requires observed initial administrations. Dosing depends on IgE level and weight.

Omalizumab molecular structure (skeletal formula) — Molecular structure: Omalizumab

FDA-approved for

Moderate-to-severe persistent allergic asthma (2003)
chronic spontaneous urticaria (2003)
nasal polyps (2003)
IgE-mediated food allergy (2003)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Anaphylaxis (presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of throat/tongue) may occur after administration — as early as the first dose or beyond 1 year of treatment; initiate in a healthcare setting, observe patients, and be prepared to manage anaphylaxis.

FDA dosing	Population	Start
Moderate-to-severe persistent asthma (perennial aeroallergen sensitivity, inadequately controlled on ICS)	Adults & peds ≥6 yr	75–375 mg SC every 2 or 4 weeks, by baseline serum total IgE and body weight
Chronic rhinosinusitis with nasal polyps (add-on maintenance, inadequate response to nasal corticosteroids)	Adults ≥18 yr	75–600 mg SC every 2 or 4 weeks, by baseline serum total IgE and body weight
IgE-mediated food allergy (reduce Type I reactions incl. anaphylaxis; with food avoidance)	Adults & peds ≥1 yr	75–600 mg SC every 2 or 4 weeks, by baseline serum total IgE and body weight
Chronic spontaneous urticaria (symptomatic despite H1 antihistamine)	Adults & adolescents ≥12 yr	150 or 300 mg SC every 4 weeks (not based on serum IgE or body weight)

Renal Undefined

Hepatic Undefined

Instructions

Subcutaneous administration only
For asthma, CRSwNP, and food allergy, determine dose by baseline serum total IgE and body weight (do not use IgE re-testing to adjust)
Initiate in a healthcare setting and observe for anaphylaxis

Available strengths

inj 75 mg/.5 mL
inj 150 mg/1.2 mL
inj 300 mg/2 mL

Contraindications

Severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR

Cautions

Anaphylaxis
Malignancy
Not for acute bronchospasm or status asthmaticus
Do not abruptly discontinue corticosteroids on initiation
Eosinophilic conditions
Fever, arthralgia, and rash (serum sickness-like)
Not for emergency treatment of allergic reactions/anaphylaxis

Adverse reactions

Asthma (adults/adolescents): arthralgia, pain, leg/arm pain, fatigue, dizziness, pruritus, dermatitis
Asthma (peds 6–<12): nasopharyngitis, headache, pyrexia, epistaxis
CRSwNP: headache, injection-site reaction, arthralgia
Food allergy: injection-site reactions, pyrexia
CSU: nausea, nasopharyngitis, sinusitis, URTI, headache

Pregnancy Registry showed no increased major birth defects/miscarriage; increased rate of low birth weight (confounded by asthma severity)

Lactation No data on presence in milk; IgG present in human milk in small amounts; infections not increased in breastfed exposed infants

Cost

Omalizumab (XOLAIR)

Strength		#/mo	CostPlus
75 mg/.5 mL	inj	per unit	not offered
150 mg/1.2 mL	inj	per unit	not offered
300 mg/2 mL	inj	per unit	not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Omalizumab is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

⚠ BOXED WARNING

Anaphylaxis

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger1 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk1 / 4

Legacy pregnancy categoryB

Defining liabilityAnaphylaxis, sometimes delayed

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