INDICATIONS AND USAGE（适应症）

Asthma

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.

XOLAIR is not indicated for treatment of other allergic conditions.

Nasal Polyps

XOLAIR is indicated for add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

Chronic Spontaneous Urticaria (CSU)

XOLAIR is indicated for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.

Limitations of Use:

XOLAIR is not indicated for treatment of other forms of urticaria.

DOSAGE（服用剂量）

Recommended Dosage for Asthma

The recommended dosage for treatment of 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).

Recommended Dosage for Nasal Polyps

Administer XOLAIR 75 mg to 600 mg by subcutaneous injection every 2 or 4 weeks based on serum total IgE level (IU/mL) measure before the start of treatment and by body weight (kg).

Recommended Dosage for Chronic Spontaneous Urticaria (CSU)

Administer XOLAIR 150 mg or 300 mg by subcutaneous injection every 4 weeks. Dosing of XOLAIR in CSU patients is not dependent on serum IgE (free or total) level or body weight.

ADVERSE REACTIONS（不良反应）

Anaphylaxis

Malignancies

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/7f6a2191-adfb-48b9-9bfa-0d9920479f0d/spl-doc?hl=Omalizumab

Xolairinformation