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 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.
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 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 go to www.XOLAIR.com 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 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 | |||||||||||||||||
|
|||||||||||||||||
| 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: | |||||||||||||||||
|
|||||||||||||||||
| 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. | |||||||||||||||||
This Web site is a service of Genentech and Novartis Pharmaceuticals Corporation
and is intended for U.S. residents only.
9117002
