INFORMATION FOR PATIENTS (US Only)
EXPECT is the Xolair® Pregnancy Registry: An Observational Study Of The Use and Safety Of Xolair® (Omalizumab) During Pregnancy
- What is Xolair?
- What is EXPECT Xolair Pregnancy Registry?
- Why participate in EXPECT?
- Who can take part in EXPECT?
- What does participation in EXPECT involve?
- What are my rights as a participant in EXPECT?
- Where can I get more information?
Xolair (Omalizumab) is a prescription medicine given by injection for people who are 12 years of age and above who have moderate-to-severe persistent asthma that is triggered by year-round allergens in the air. A simple skin or blood test will confirm that you have this kind of asthma. This is known as allergic asthma. 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. Xolair has not been proven to work in other allergic conditions.
What is EXPECT Xolair Pregnancy Registry?
EXPECT Xolair Pregnancy Registry is an observational study to collect health information about women who are pregnant and have been exposed to Xolair.
This patient registry will provide patients and doctors with important information on the use of Xolair in pregnant women and their babies.
There are no adequate and well-controlled studies of Xolair in pregnant women. By participating in the study, you will be contributing to important research to better understand the use of Xolair in pregnant women.
If you decide to participate in the study and are qualified to participate, you will receive $25 for each telephone survey that you complete. Depending on your eligibility, you may be asked to participate in up to eight telephone surveys.
Remember, Xolair should be used during pregnancy only if it is clearly needed. Please talk to your doctor about the use of Xolair if you are pregnant or nursing.
If you are pregnant and took Xolair within 8 weeks prior to becoming pregnant or during your pregnancy, you may be eligible to participate in this registry.
What does participation in EXPECT involve?
When you call toll-free 1 (866) 4XOLAIR (496-5247) and select Option 3, a registry representative will explain the study and ask if you would like to participate. The representative will then determine if you are eligible and will ask some enrollment questions.
If you participate in the study, you will be asked to answer questions regarding your health and your baby’s health during a telephone interview at each trimester, at the time of delivery, and every 6 months until the infant is one year old. No clinic visits are required.
If you continue to take Xolair while breastfeeding, you will be asked to participate in one more telephone interview when your child is 18 months old.
If you qualify and agree to participate, you also will be asked to provide written Informed Consent and fill out a healthcare form to protect your private healthcare information. After the registry receives these forms, a registry representative will contact your relevant healthcare providers (obstetrician, asthma specialist, pediatrician, or other doctor) by telephone to confirm necessary healthcare information.
Because information collection relies on the registry keeping in contact with you, it is crucial that you keep the registry informed of any changes to your contact information throughout your participation. Changes to your telephone number or address can be made by calling 1 (866) 4XOLAIR (496-5247), Option 3.
What are my rights as a participant in EXPECT?
Participation in this registry is entirely voluntary and you may withdraw at any time without reason. Protecting your privacy is important to the Xolair Pregnancy Registry Center. If you decide to participate and are found eligible, you will be given an Informed Consent document that provides all the details, procedures, and risks associated with the study, as well as a Healthcare Insurance Portability and Accountability Act (HIPAA) form giving your permission for the registry to gather your relevant healthcare information from your healthcare providers. You may also contact the Xolair Pregnancy Registry Center at any time for an explanation of the content of the Informed Consent form, the HIPAA form, or any other study-related questions.
Where can I get more information?
If you or someone you know is interested in getting more information or enrolling into this registry, please call toll free 1 (866) 4XOLAIR (496-5247), Option 3.
