XOLAIR Dosing for IgE-Mediated Food Allergy
For IgE-mediated food allergy, XOLAIR (omalizumab) is dosed at 75 mg to 600 mg subcutaneously every 2 or 4 weeks, with the specific dose and frequency determined by the patient's baseline serum total IgE level (IU/mL) and body weight (kg). 1
Dose Determination Algorithm
The dosing for food allergy follows a weight- and IgE-based table (Table 4 in the FDA label) that applies to patients aged 1 year and older 1:
- Measure baseline serum total IgE before initiating treatment 1
- Obtain current body weight in kilograms 1
- Refer to the FDA dosing table (Table 4) which stratifies doses based on these two parameters 1
- Administer every 2 or 4 weeks depending on the dose required by the table 1
Important: Total IgE levels remain elevated during treatment and for up to one year after discontinuation, so re-testing IgE during therapy cannot guide dose adjustments 1. If treatment is interrupted for less than one year, continue using the original IgE level for dosing; if interrupted for one year or more, re-test IgE levels 1.
Administration Requirements
Initial Dosing Safety Protocol
XOLAIR must be initiated in a healthcare setting due to the risk of anaphylaxis, which can be life-threatening 1:
- Observe patients for 2 hours after the first 3 injections 2
- Observe for 30 minutes after subsequent injections 2
- Healthcare providers must be prepared to manage anaphylaxis with immediate access to epinephrine and resuscitation equipment 2, 1
The anaphylaxis risk with omalizumab is approximately 0.09-0.2% of patients, with reactions occurring both early (within 30 minutes) and delayed (up to beyond 12 hours, even after multiple doses) 2.
Patient Selection for Self-Administration
For food allergy patients specifically, self-administration may be considered only after meeting these criteria 1:
- No prior history of anaphylaxis to XOLAIR or other agents (except foods) such as drugs or biologics 1
- Received at least 3 doses under healthcare supervision without hypersensitivity reactions 1
- Patient/caregiver can recognize anaphylaxis symptoms and treat appropriately 1
- Patient/caregiver demonstrates proper injection technique 1
Clinical Context and Evidence
The FDA approval for food allergy is based on the OUtMATCH trial, which demonstrated that 67% of omalizumab-treated patients (vs. 7% placebo) could tolerate at least 600 mg of peanut protein after 16-20 weeks of treatment 3. Similar improvements were seen for cashew (41% vs. 3%), milk (66% vs. 10%), and egg (67% vs. 0%) 3.
Critical limitation: XOLAIR is not indicated for emergency treatment of allergic reactions or anaphylaxis 1. It is used for prophylaxis to reduce the risk of reactions from accidental exposure and must be combined with continued food allergen avoidance 1.
Duration of Therapy
The optimal duration of XOLAIR therapy for food allergy has not been established 1. Periodically reassess the need for continued treatment based on the patient's clinical status and risk of accidental exposure 1.
Common Adverse Effects
The most common adverse reactions (≥3% of patients) in food allergy trials were injection site reactions and fever 1. The safety profile is otherwise similar to other indications, with no dose-dependent increase in serious adverse events 3.