Full Prescribing Information, Including Boxed WARNINGS
Medication Guide (PDF)

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 a person has 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.

• 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.

Status The U.S. Food and Drug Administration (FDA) approved Xolair in June 2003.

Xolair is being jointly developed under an agreement with Novartis Pharma AG and is co-marketed in the United States with Novartis Pharmaceuticals Corporation. In addition to approval in the United States, Xolair has also received marketing license across the European Union and is available in more than 30 countries worldwide.

Important Safety Information

XOLAIR should always be injected in a doctor’s office. Patients 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. Patients must 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

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.

A patient’s healthcare provider should watch the patient for some time in the office for signs or symptoms of anaphylaxis after injecting XOLAIR.  If patients have signs or symptoms of anaphylaxis, they must tell their healthcare provider right away.

Patients must not receive XOLAIR if they have ever had an allergic reaction to a XOLAIR injection. Patients should not use XOLAIR if they are allergic to any of its ingredients.      

In clinical studies, a variety of cancer types, including breast, skin, prostate, and parotid (a type of salivary gland), were reported in more patients who received XOLAIR than in patients who did not receive XOLAIR.

XOLAIR is not a rescue medicine and should not be used to treat sudden asthma attacks.

XOLAIR is not a substitute for the medicines patients are already taking.  Patients must not change or stop taking any of their other asthma medicines unless their doctor tells them to do so.

Some patients on XOLAIR may have an abnormal increase in eosinophils (a type of white blood cell) in the blood or tissues, sometimes causing an inflammation of blood vessels which can lead to rash, worsening of respiratory symptoms, heart trouble, and/or nerve pain and weakness. 

Joint inflammation or pain, rash, fever, and swollen lymph nodes have been seen in some patients taking XOLAIR after the first or subsequent injections.  Patients should talk to their doctor if they have experienced any of these signs and symptoms. 

The most commonly seen side effects occurring more frequently in patients receiving XOLAIR than in patients who received placebo (an injection with no active medicine) were joint pain, pain (general), leg pain, tiredness (fatigue), dizziness, fracture, arm pain, itching, inflammation of the skin, and earache. 

In asthma studies, the most common side effects in patients, who either needed to stop XOLAIR or needed medical attention, were injection site reaction, viral infections, upper respiratory tract infection, sinusitis, headache, and sore throat.  These side effects were seen at similar rates in XOLAIR-treated patients as in patients that did not receive XOLAIR.   

There are other possible side effects with XOLAIR.  Patients should talk to their doctor for more information and if they have any questions about their treatment.

XOLAIR has not been studied in pregnant women.  Pregnant women exposed to XOLAIR are encouraged to enroll in the XOLAIR Pregnancy Exposure Registry.  Patients can get more information by calling 1-866-4XOLAIR (1-866-496-5247) or by speaking with their doctor.

Please visit www.xolair.com for the full Prescribing Information, including Boxed WARNINGS and Medication Guide for additional important safety information.

Mechanism of Action The Xolair mechanism of action differs from standard treatments for persistent asthma. Xolair inhibits the binding of IgE to the high-affinity IgE receptor (FcåRI) on the surface of mast cells and basophils. Reduction in surface-bound IgE on FcåRI-bearing cells limits the degree of release of mediators of the allergic response. Treatment with Xolair also reduces the number of FcåRI receptors on basophils in atopic patients.