XOLAIR (omalizumab) for subcutaneous use Indications and Important Safety Information

Who is XOLAIR for?
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 you have 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.

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 and can lead to death. 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 (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 you are already taking. Do not change or stop taking any of your other asthma medicines unless your doctor tells you to do so. You may not see an immediate improvement in your asthma when beginning XOLAIR therapy.

You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch, or by calling 1-800-FDA-1088. You may also report any side effects at 1-866-4XOLAIR (1-866-496-5247).

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

Please see full Prescribing Information, including Medication Guide for additional important safety information.

XOLAIR^® and its logo are registered trademarks of Novartis Pharmaceuticals Corporation.
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