Omalizumab
XOLAIR
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.
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 | Target | Max |
|---|---|---|---|---|
| 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
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
⚠ BOXED WARNING
- Anaphylaxis
Classes and tags
Clinical profile
Mechanism of action: Omalizumab ballicule
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