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 is available in more than 30 countries worldwide.

Important Safety Information

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 always be injected in a doctor's office. You should read the Medication Guide before starting Xolair treatment and before each and every treatment.

A severe allergic reaction called anaphylaxis has happened in some patients after they received Xolair. Anaphylaxis is a life-threatening condition. Seek emergency medical treatment right away if symptoms occur. Signs and symptoms of anaphylaxis include:

• Wheezing, shortness of breath, cough, chest tightness, or trouble breathing
• Low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of "impending doom"
• Flushing, itching, hives, or feeling warm
• Swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

You should not receive Xolair if you have ever had an allergic reaction to a Xolair injection. Do not use Xolair if you are allergic to any of its ingredients.

In clinical studies 0.5% of patients receiving Xolair developed cancer, compared to 0.2% of patients receiving placebo injections.

In clinical studies, the most common side effects in patients receiving Xolair included injection-site reactions (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and sore throat (11%).

Do not change or stop taking any of your other asthma medicines unless your healthcare provider tells you to do so. You may not see an immediate improvement in your asthma when beginning Xolair therapy.

Talk to your doctor for more information and if you have any questions about your treatment.

Mechanism of Action The Xolair mechanism of action differs completely from standard treatments for persistent asthma. Xolair inhibits the binding of IgE to the high-affinity IgE receptor (FcåRI) on the surface of mast cells and basophils. Reduction in surface-bound IgE on FcåRI-bearing cells limits the degree of release of mediators of the allergic response. Treatment with Xolair also reduces the number of FcåRI receptors on basophils in atopic patients.