XOLAIR (Omalizumab) For Subcutaneous Use

WHO IS XOLAIR FOR?
XOLAIR^® (Omalizumab) For Subcutaneous Use is a prescription medicine given by injection for people who are 12 years of age and above who have moderate to severe persistent asthma that is triggered by year-round allergens in the air. A simple skin or blood test will confirm that you have this kind of asthma. This is known as allergic asthma. 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. XOLAIR has not been proven to work in other allergic conditions.

Important Safety Information

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.

Please see full Prescribing Information and the Medication Guide for additional important information.