The purpose of the Expect Pregnancy Registry is to monitor pregnancy outcomes in women receiving XOLAIR (omalizumab) during pregnancy. Registries are observational, which means they are conducted to gather data. The information collected will provide doctors with a better understanding of the effect of XOLAIR exposure during pregnancy.
The EXPECT Pregnancy Registry seeks participants who:
You do not have to be taking XOLAIR now to be eligible.
If eligible, you will be asked to participate in a telephone interview each trimester, postpartum, and every 6 months until your baby is 1 year old. No study site visits are required to participate. After your baby is born, if you continue to take XOLAIR while breastfeeding, you will be asked to participate in one more telephone interview when your baby is 18 months old. Talk to your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive XOLAIR. Eligible participants will be compensated for each telephone interview.
To see if you may qualify for the EXPECT Registry, call us at 1-(866)-4XOLAIR (1-866-496-5247), Option 3 or click here.
What is XOLAIR?
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 asthma whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens.
XOLAIR is not used to treat other allergic conditions, acute bronchospasm or status asthmaticus.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about XOLAIR?
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.