Allergens: Particles or substances that can cause or "trigger" asthma symptoms and attacks in people with allergic asthma. Examples of year-round allergens include cockroaches, dust mites, and dander from dogs or cats.

Allergic asthma: A type of asthma in which an allergic trigger can lead to asthma symptoms and attacks. This type of asthma is confirmed by a skin or blood test.

Anaphylaxis: A rare but severe, potentially life-threatening allergic reaction that can rapidly cause symptoms such as rash, itching, swelling of the tongue and throat, and breathing difficulties.

Asthma attack: Worsening of asthma-related coughing, wheezing, and breathlessness that can happen quickly or gradually over time.

Asthma symptoms: Coughing, wheezing, difficulty breathing, and tightening of the chest are common examples of symptoms caused by asthma.

Cancer: A group of abnormal cells that grow out of control (also called a malignancy). Cancer cells that originate in one area of the body have the ability to spread to other parts of the body.

Constriction of the airways: Tightening of the muscles that surround the airways of the lungs, making it hard to breathe.

IgE (Immunoglobulin E): A naturally occurring substance in the body that, in some people, can cause a series of chemical reactions that may lead to asthma symptoms and attacks.

Inflammation of the airways: Swelling of the tissue in the airways of the lungs. This process narrows the airways, making it hard to breathe.

Inhaled steroids: Asthma medicines that help reduce inflammation of the airways; they are taken through the mouth using an inhaler or spacer.

IU: International unit.

Moderate to severe persistent asthma: Asthma in which patients experience one or more of the following: daily symptoms; daily need for a rescue inhaler; 2 or more asthma attacks a week; asthma that occurs during sleep, causing an individual to wake up one or more nights a week; and a below-normal peak flow.

Peak flow meter: A tool that measures how well the lungs work. A person with asthma blows quickly and forcefully into the meter, which gives a reading that tells how open the airways are.

Pulmonologist: An individual skilled in pulmonology.

Pulmonology: The science concerned with the anatomy, physiology, and pathology of the lungs.

Specialty Pharmacies: The select group of highly specialized pharmacies that can help you while you are on XOLAIR treatment.

Subcutaneous: Beneath the skin.

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).
Joint inflammation or pain, rash, fever, and swollen lymph nodes have been seen in patients taking XOLAIR. Talk to your doctor if you’ve experienced any of these signs and symptoms.
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 and Medication Guide for additional important safety information.