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.
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
- 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. 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.
Talk to your doctor for more information and if you have any questions about your treatment.
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 to 1-866-4XOLAIR (1-866-496-5247), Option 3.