XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment.
XOLAIR is not used to treat other forms of urticaria.
What is the most important information I should know about XOLAIR?
Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:
Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after your injection. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction after leaving the healthcare provider's office or treatment center.
Do not receive XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.
Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.
How should I receive XOLAIR?
What are the possible side effects of XOLAIR?
XOLAIR may cause serious side effects, including:
The most common side effects of XOLAIR:
These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at 888-669-6682.
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