What is the dosing for Zolair (omalizumab) in asthma?

From the Guidelines

Xolair (omalizumab) dosing for asthma should be based on body weight and pre-treatment serum IgE levels, with doses ranging from 150 mg to 375 mg given by subcutaneous injection every 2 or 4 weeks, as determined by dosing tables considering both weight and baseline IgE levels 1. The dosing of Xolair is crucial for managing moderate to severe persistent allergic asthma that is inadequately controlled with inhaled corticosteroids.

• Key factors influencing the dose include:
  • Body weight in kilograms
  • Baseline IgE levels in IU/mL
• Administration should occur in a healthcare setting due to the risk of anaphylaxis, with appropriate observation post-injection.
• Xolair works by binding to IgE antibodies, preventing them from attaching to mast cells and basophils, thereby inhibiting the allergic inflammatory cascade that contributes to asthma symptoms.
• Improvement in asthma control may take several weeks to become apparent, and therapy is typically continued long-term for those who respond, as supported by guidelines that consider omalizumab for patients with allergies 1.
• The specific dose is determined using dosing tables that consider both weight (in kg) and baseline IgE levels (in IU/mL), for example, a patient weighing 70 kg with an IgE level of 200 IU/mL would typically receive 300 mg every 4 weeks.

From the FDA Drug Label

2 DOSAGE AND ADMINISTRATION

1. 1 Overview 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.

2. 2 Recommended 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)

The recommended dosing for asthma is XOLAIR 75 mg to 375 mg by subcutaneous injection every 2 or 4 weeks, based on serum total IgE level and body weight.

• Adult and adolescent patients 12 years of age and older: dosing is initiated according to Table 1.
• Pediatric patients 6 to <12 years of age: dosing is initiated according to Table 2. The need for continued therapy should be periodically reassessed based on the patient's disease severity and level of asthma control 2.

From the Research

Zolair Dosing for Asthma

• Zolair, also known as omalizumab, is an anti-IgE antibody used to treat moderate-to-severe persistent asthma 3, 4, 5, 6, 7.
• The dosing of omalizumab is based on the patient's body weight and baseline IgE levels, with adjustments made according to recommended dosing tables 4, 6.
• Studies have shown that omalizumab is effective in reducing asthma exacerbations and improving lung function in patients with moderate-to-severe persistent asthma, regardless of whether their IgE levels and body weight fall within the recommended dosing table or not 4, 6.
• The treatment with omalizumab has been shown to be well-tolerated, with no new safety signals reported in patients with IgE levels above 1500 IU/mL 4.
• Predictors of non-response to omalizumab treatment include higher BMI, admissions to ICU, and high count of severe adverse events before biologic treatment, while predictors of clinical remission include high FEV1% and high ACT score before biologic treatment 5.

Dosing Regimens

• Omalizumab can be administered subcutaneously every 2 or 4 weeks, based on the patient's serum IgE level and body weight 3, 7.
• The effectiveness of omalizumab has been assessed across different dosing regimens, with results showing improved asthma outcomes and quality of life in patients with moderate-to-severe allergic asthma 6.
• Patients who fall outside the recommended dosing table due to baseline IgE and/or weight may still benefit from omalizumab treatment, although the optimal treatment approach should be determined on a case-by-case basis 4, 6.

Efficacy and Safety

• Omalizumab has been shown to significantly reduce the rate of asthma exacerbations and emergency medical visits in patients with severe persistent asthma 7.
• The treatment has been found to be effective in a wide range of patients with moderate-to-severe allergic asthma, with improvements in asthma outcomes and quality of life reported in several studies 3, 4, 6, 7.
• The safety profile of omalizumab has been established, with no trend toward an increase in incidence of adverse events with increase in duration of treatment reported in long-term studies 3.