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IMPORTANT SAFETY INFORMATION
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Before or even during treatment, you may have questions about XOLAIR and how it works. Listed here are some common questions about XOLAIR and answers you may find useful. If you would like more information, talk to your doctor or asthma specialist.

Who is XOLAIR for?

Who should not receive XOLAIR?

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

How does XOLAIR work?

How is XOLAIR given, and how often?

Can I take XOLAIR with my current medicines?

What will happen if I stop taking XOLAIR?

What are the signs and symptoms of anaphylaxis?

Are there any other serious side effects associated with XOLAIR?

What are the most common side effects associated with XOLAIR?

Can I use XOLAIR as a rescue medication?

How can I get more information about XOLAIR?

Q: Who is XOLAIR for?
A: 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.

Adding XOLAIR injections to an existing treatment program using inhaled steroids has been clinically proven to help reduce the number of asthma attacks a person experiences. XOLAIR has not been proven to work in other allergic conditions.
top

Q: Who should not receive XOLAIR?
A: 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. Please talk to your doctor for additional information. Xolair should not be given to children under 12 years of age.
top

Q: What is the most important information I should know about XOLAIR?
A: XOLAIR should always be injected in a doctor's office. You should read the Medication Guide before starting XOLAIR treatment and before each subsequent 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.
top

Q: How does XOLAIR work?
A: XOLAIR works by blocking the action of Immunoglobulin E (IgE), a naturally produced substance that may play a central role in the body's allergic response.

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. XOLAIR has not been proven to work in other allergic conditions. Please talk to your doctor for additional information.
top

Q: How is XOLAIR given, and how often?
A: XOLAIR is given through subcutaneous injection, which means it is injected just under the skin. XOLAIR should always be injected in a doctor's office. 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.

You will receive XOLAIR every 2 or 4 weeks. Your body weight and your IgE level, which is measured with a blood test, will determine your dose. And based on your dose, your doctor will tell you if you need 1, 2, or 3 injections per dose. If you need more than 1 injection, each injection will be given in a different place on your body. In XOLAIR studies, injection site reactions were one of the most common side effects seen in patients who needed to either stop XOLAIR or needed medical attention. The types of injection site reactions included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation.

The majority of injection site reactions occurred within 1 hour postinjection, lasted less than 8 days, and generally decreased in frequency at subsequent dosing visits.
top

Q: Can I take XOLAIR with my current medicines?
A: XOLAIR is approved for use in patients who are not controlled while taking inhaled steroids. As with all medicines, be sure to tell your doctor about any medicines you are taking for your asthma or any other condition. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. The use of Xolair and allergy immunotherapy (allergy shots) together have not been studied.
top

Q: What will happen if I stop taking XOLAIR?
A: If you stop receiving XOLAIR injections, your symptoms may return.
top

Q: What are the signs and symptoms of anaphylaxis?
A: 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

XOLAIR should always be injected in a doctor's office. You should read the Medication Guide before starting XOLAIR treatment and before each subsequent treatment.

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.

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 doctor should watch you for some time in his or her office for signs or symptoms of anaphylaxis after injecting XOLAIR. If you have signs or symptoms of anaphylaxis, tell your doctor right away.

Your doctor should also 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.
top

Q: Are there any other serious side effects associated with XOLAIR?
A: In clinical studies malignancies were seen in 0.5% of patients receiving XOLAIR, 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.
top

Q: What are the most common side effects associated with XOLAIR?
A: 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.

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

Q: Can I use XOLAIR as a rescue medication?
A: 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.
top

Q: How can I get more information about XOLAIR?
A: 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.
top

Who is XOLAIR for?

XOLAIR^® (omalizumab) for subcutaneous use is an injectable, prescription medicine for patients 12 years of age 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, so get emergency medical treatment right away if signs or symptoms of anaphylaxis occur after receiving XOLAIR.

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.

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.

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, 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 you are already taking. Do not change or stop taking any of your other asthma medicines unless your doctor tells you 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. Talk to your doctor if you've 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. Talk to your doctor for more information and if you have any questions about your treatment.

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

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

A A A For Healthcare Professionals Important Safety Information Full Prescribing Information Share Text size SEARCH You are leaving XOLAIR.com The information contained in this section of the site is intended for U.S healthcare professionals only. Are you a U.S. healthcare professional? Please note XOLAIR is not affiliated with this website and is not responsible for its content. Browser Upgrade Required To view XOLAIR.com, you'll need Internet Explorer version 8. Simply click OK to download it now.
	Print this page >> Advanced Search IMPORTANT SAFETY INFORMATION SCROLL FOR MORE NEXT: Patient Stories and Support Before or even during treatment, you may have questions about XOLAIR and how it works. Listed here are some common questions about XOLAIR and answers you may find useful. If you would like more information, talk to your doctor or asthma specialist. Who is XOLAIR for? Who should not receive XOLAIR? What is the most important information I should know about XOLAIR? How does XOLAIR work? How is XOLAIR given, and how often? Can I take XOLAIR with my current medicines? What will happen if I stop taking XOLAIR? What are the signs and symptoms of anaphylaxis? Are there any other serious side effects associated with XOLAIR? What are the most common side effects associated with XOLAIR? Can I use XOLAIR as a rescue medication? How can I get more information about XOLAIR? Q: Who is XOLAIR for? A: 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. Adding XOLAIR injections to an existing treatment program using inhaled steroids has been clinically proven to help reduce the number of asthma attacks a person experiences. XOLAIR has not been proven to work in other allergic conditions. top Q: Who should not receive XOLAIR? A: 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. Please talk to your doctor for additional information. Xolair should not be given to children under 12 years of age. top Q: What is the most important information I should know about XOLAIR? A: XOLAIR should always be injected in a doctor's office. You should read the Medication Guide before starting XOLAIR treatment and before each subsequent 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. top Q: How does XOLAIR work? A: XOLAIR works by blocking the action of Immunoglobulin E (IgE), a naturally produced substance that may play a central role in the body's allergic response. 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. XOLAIR has not been proven to work in other allergic conditions. Please talk to your doctor for additional information. top Q: How is XOLAIR given, and how often? A: XOLAIR is given through subcutaneous injection, which means it is injected just under the skin. XOLAIR should always be injected in a doctor's office. 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. You will receive XOLAIR every 2 or 4 weeks. Your body weight and your IgE level, which is measured with a blood test, will determine your dose. And based on your dose, your doctor will tell you if you need 1, 2, or 3 injections per dose. If you need more than 1 injection, each injection will be given in a different place on your body. In XOLAIR studies, injection site reactions were one of the most common side effects seen in patients who needed to either stop XOLAIR or needed medical attention. The types of injection site reactions included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation. The majority of injection site reactions occurred within 1 hour postinjection, lasted less than 8 days, and generally decreased in frequency at subsequent dosing visits. top Q: Can I take XOLAIR with my current medicines? A: XOLAIR is approved for use in patients who are not controlled while taking inhaled steroids. As with all medicines, be sure to tell your doctor about any medicines you are taking for your asthma or any other condition. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. The use of Xolair and allergy immunotherapy (allergy shots) together have not been studied. top Q: What will happen if I stop taking XOLAIR? A: If you stop receiving XOLAIR injections, your symptoms may return. top Q: What are the signs and symptoms of anaphylaxis? A: 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 XOLAIR should always be injected in a doctor's office. You should read the Medication Guide before starting XOLAIR treatment and before each subsequent treatment. 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. 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 doctor should watch you for some time in his or her office for signs or symptoms of anaphylaxis after injecting XOLAIR. If you have signs or symptoms of anaphylaxis, tell your doctor right away. Your doctor should also 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. top Q: Are there any other serious side effects associated with XOLAIR? A: In clinical studies malignancies were seen in 0.5% of patients receiving XOLAIR, 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. top Q: What are the most common side effects associated with XOLAIR? A: 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. Please discuss this information with your doctor. Only your doctor can help you decide if XOLAIR is right for you. top Q: Can I use XOLAIR as a rescue medication? A: 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. top Q: How can I get more information about XOLAIR? A: 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. top Who is XOLAIR for? XOLAIR^® (omalizumab) for subcutaneous use is an injectable, prescription medicine for patients 12 years of age 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, so get emergency medical treatment right away if signs or symptoms of anaphylaxis occur after receiving XOLAIR. 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. 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. 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, 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 you are already taking. Do not change or stop taking any of your other asthma medicines unless your doctor tells you 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. Talk to your doctor if you've 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. Talk to your doctor for more information and if you have any questions about your treatment. XOLAIR has not been studied in pregnant women. Pregnant women exposed to XOLAIR are encouraged to enroll in the XOLAIR Pregnancy Exposure Registry. You can get more information by calling 1-866-4XOLAIR (1-866-496-5247) or by speaking with your doctor. Please see full Prescribing Information, including Medication Guide for additional important safety information. Privacy Policy Terms and Conditions Site Map Glossary Contact Us ©2011 Genentech USA, Inc. and Novartis Pharmaceuticals Corporation. All rights reserved. This website is a service of Genentech USA, Inc. and Novartis Pharmaceuticals Corporation and is intended for US residents only. XOL0000302502