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Medication Guide - Xolair® (omalizumab)

IMPORTANT: XOLAIR SHOULD ALWAYS BE INJECTED IN YOUR DOCTOR’S OFFICE

What is the most important information I should know about Xolair?

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 so get 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

Get emergency medical treatment right away if you have signs or symptoms of anaphylaxis after receiving Xolair.

Anaphylaxis from Xolair can happen:

• Right after receiving a Xolair injection or hours later
• After any Xolair injection. Anaphylaxis has occurred after the first Xolair injection or after many Xolair injections.

Your healthcare provider should watch you for some time in the office for signs of symptoms of anaphylaxis after injecting Xolair. If you have signs or symptoms of anaphylaxis, tell your healthcare provider right away.

Your healthcare provider should instruct you about getting emergency medical treatment and further medical care if you have signs or symptoms of anaphylaxis after leaving the doctor’s office.

What is Xolair?

Xolair is an injectable medicine for patients ages 12 and older with moderate to severe persistent allergic asthma whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is done to see if you have allergic asthma.

What else should I know about Xolair?

• You should not receive Xolair if you have ever had an allergic reaction to a Xolair injection.
• Do not change or stop taking any of your other asthma medicines unless your healthcare provider tell you to do so.
• There are other possible side effects with Xolair. Talk to your doctor for more information. You can also got www.xolair.com or call 1-866-4XOLAIR (1-866-497-5427)

This Medication Guide has been approved by the U.S. Food and Drug Administration