Full Prescribing Information, Including Boxed WARNINGS
Xolair Dear Healthcare Provider Letter (316K/PDF)
Medication Guide (22K/PDF)

Xolair® (omalizumab) for subcutaneous use is an injectable, prescription medicine for patients ages 12 and older. It is for patients with moderate to severe persistent allergic asthma caused by year-round allergens in the air. A skin or blood test is done to see if a person has allergic asthma. Xolair is for patients who are not controlled by asthma medicines called inhaled steroids. Xolair helps reduce the number of asthma attacks in people with allergic asthma who still have asthma symptoms even though they are taking inhaled steroids.

Important Limitations of Use

• Xolair has not been proven to work in other allergic conditions.
• Xolair is not a rescue medicine and should not be used to treat sudden asthma attacks.
• Xolair should not be used in children under 12 years of age.

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

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 Xolair should always be injected in a doctor's office. Patients 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 and can lead to death. Patients must 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

Patients should not receive Xolair if they have ever had an allergic reaction to a Xolair injection. Patients should not use Xolair if they 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 (an injection with no active medicine).

In patients ≥12 years of age, the most commonly observed side effects in asthma studies that had a ≥1% difference between Xolair and placebo were joint pain (8%), pain (general) (7%), leg pain (4%), tiredness (fatigue) (3%), dizziness (3%), fracture (2%), arm pain (2%), itching (2%), inflammation of the skin (2%), and earache (2%).

In asthma studies, the most common side effects in patients, who either needed to stop Xolair or needed medical attention, were injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and sore throat (11%). These side effects were seen at the same rates in Xolair-treated patients as in patients in the control group who received placebo.

Xolair is not a rescue medicine and should not be used to treat sudden asthma attacks.

Xolair is not a substitute for the medicines patients are already taking. Patients must not change or stop taking any of their other asthma medicines unless their doctor tells them to do so. Patients may not see an immediate improvement in their asthma when beginning Xolair therapy.

Patients should talk to their doctor for more information and if they have any questions about their treatment.

Please visit www.xolair.com for the full Prescribing Information, including Boxed WARNINGS and Medication Guide for additional important safety information.

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.