- Full Prescribing Information including boxed WARNINGS
Last updated March 21st, 2014
Side Effect Reporting
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.
What it Treats
XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with:
- moderate to severe persistent allergic asthma who have had a skin or blood test that is positive for allergic asthma and whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids.
- 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 allergic conditions, other forms of urticaria (hives), acute bronchospasm (serious and sudden breathing problems) or status asthmaticus (acute, severe prolonged asthma attack that can be life-threatening).
XOLAIR is not for use in children less than 12 years of age.
Important Safety Information
A severe allergic reaction called anaphylaxis can happen when a patient receives 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. Patients must go to the nearest emergency room right away if they have any of these symptoms of an allergic reaction:
- 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
The patient’s healthcare provider will monitor the patient closely for symptoms of an allergic reaction while they are receiving XOLAIR and for a period of time after the patient’s injection. The patient’s healthcare provider should talk to the patient about getting medical treatment if they have symptoms of an allergic reaction after leaving the healthcare provider’s office or treatment center.
Patients must not receive XOLAIR if they are allergic to omalizumab or any of the ingredients in XOLAIR.
Before receiving XOLAIR, patients must tell their healthcare provider about all of their medical conditions, including if they:
- have any other allergies (such as food allergy or seasonal allergies)
- have sudden breathing problems (bronchospasm)
- have or have had low white blood cell count (patients should ask their doctor if they are not sure)
- have or have had a parasitic infection
- have or have had cancer
- are pregnant or plan to become pregnant. It is not known if XOLAIR may harm a patient’s unborn baby.
- if a patient becomes pregnant while taking XOLAIR, they should talk to their healthcare provider about registering with the XOLAIR Pregnancy Registry. Patients can get more information and register by calling 866 4XOLAIR (866-496-5247) or visit www.XOLAIRpregnancyregistry.com.
- are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into breast milk.
Patients must tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.
- Xolair should be given by a healthcare provider in a healthcare setting.
- Xolair is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks.
- The patient’s healthcare provider may do certain tests and change the patient’s Xolair dose as needed.
- Patients must not stop taking any of their other asthma or hive medicine unless their healthcare providers tell them to.
- Patients may not see improvement in their symptoms right away after Xolair treatment.
Possible side effects of XOLAIR:
XOLAIR may cause serious side effects, including:
- See “What is the most important information I should know about XOLAIR?” in the Xolair Medication Guide at www.xolair.com.
- Cancer. People who receive treatment with XOLAIR may have a higher chance for getting certain types of cancer.
- Fever, muscle aches, and rash. Some people who take XOLAIR get these symptoms 1 to 5 days after receiving a XOLAIR injection. If a patient has any of these symptoms, they must tell their healthcare provider.
- Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR. The patient’s healthcare provider can test the patient’s stool to check if they have a parasite infection.
- High blood levels of a certain antibody (Serum total IgE)
The most common side effects of XOLAIR:
- In people with allergic asthma: pain especially in the arms and legs, dizziness, feeling tired, skin rash, bone fractures, and pain or discomfort of the ears.
- In people with chronic idiopathic urticaria: nausea, headaches, swelling of the inside of the nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.
These are not all the possible side effects of XOLAIR. Patients should call their doctor for medical advice about side effects.
Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.
Please see full Prescribing Information, including Medication Guide for additional important safety information at www.xolair.com.