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

• XOLAIR should always be injected in a doctor's office
• 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

What are the signs and symptoms of anaphylaxis?

• 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 or 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.

Are there any other serious side effects associated with XOLAIR?

• In clinical studies, cancer was seen in a small number of patients receiving XOLAIR as well as those receiving placebo injections
• The rate was higher in patients treated with XOLAIR than with placebo (0.5% vs 0.2%)
• Several different types were seen
• Please discuss this information with your doctor

Please speak with your doctor about this information. Only your doctor can help you decide if XOLAIR is right for you.

Who should not receive XOLAIR?

Do not take XOLAIR if you are allergic to any of its ingredients or have had an allergic reaction to XOLAIR.

What are the most common side effects of XOLAIR?

The most common side effects in patients who received XOLAIR in clinical studies are listed below. This is not a complete list of all side effects reported with XOLAIR.

Injection-site reaction (45%)

Viral infections (23%)

Upper respiratory tract infection (20%)

Sinusitis (16%)

Headache (15%)

Sore throat (11%)

These side effects were about as common in patients receiving placebo injections.

What other important safety information should I know about?
Never suddenly stop taking, or change the dose of, your inhaled steroids or any other asthma medicine you are taking unless your doctor tells you to do so.

Medication Guide

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 or 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 tells you to do so.
• There are other possible side effects with XOLAIR. Talk to your doctor for more information. You can also see Important Safety Information or call 1-866-4XOLAIR (1-866-496-5247).

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

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.