Full Prescribing Information
Xolair Dear Healthcare Provider Letter (316K/PDF)

Xolair is the first humanized therapeutic antibody for the treatment of moderate to severe persistent allergic asthma and the first approved therapy designed to target the antibody IgE, a key underlying cause of the symptoms of allergy related asthma.

Status The U.S. Food and Drug Administration (FDA) approved Xolair in June 2003.

Xolair is indicated for adults and adolescents (12 years of age and above) 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. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions.

Xolair is being jointly developed under an agreement with Novartis Pharma AG and is co-marketed in the United States with Novartis Pharmaceuticals Corporation. In addition to approval in the United States, Xolair has also received marketing license across the European Union and from health authorities in Australia, Brazil, Canada, Dominican Republic, Guatemala, Israel, New Zealand and Venezuela.

Safety

WARNING: Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of Xolair. Anaphylaxis has occurred as early as after the first dose of Xolair, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, patients should be closely observed for an appropriate period of time after Xolair administration, and health care providers administering Xolair should be prepared to manage anaphylaxis that can be life-threatening. Patients should also be informed of the signs and symptoms of anaphylaxis and instructed to seek immediate medical care should symptoms occur (see WARNINGS, and PRECAUTIONS, Information for Patients).

Xolair should only be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis that can be life-threatening.

Xolair should not be administered to patients who have experienced a severe hypersensitivity reaction to Xolair (see Boxed WARNING). Xolair should be discontinued in patients who experience a severe hypersensitivity reaction.

Malignant neoplasms were observed in 20 of 4127 (0.5%) Xolair-treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of asthma and other allergic disorders.

Patients should be given and instructed to read the accompanying Medication Guide before starting treatment and before each subsequent treatment.

Patients receiving Xolair should be told not to decrease the dose of, or stop taking any other asthma medications unless otherwise instructed by their physician.

The adverse reactions most commonly observed among patients treated with Xolair in clinical studies included injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These events were observed at similar rates in Xolair-treated patients and control patients.

Please refer to the full prescribing information for additional important safety information.

Mechanism of Action The Xolair mechanism of action differs completely from standard treatments for persistent asthma. Xolair is designed to bind to the circulating IgE antibodies in the blood, decreasing the amount of IgE antibodies available to bind mast cells. With Xolair, fewer IgE antibodies can bind to mast cells, making IgE cross-linking less likely and inhibiting the mast cell's release of those chemicals that can cause inflammatory responses in the body.