FAQs About EXPECT
The following is designed to help answer your questions about the EXPECT Pregnancy Registry.
What is a Pregnancy Registry?
A Pregnancy Registry is an observational study that involves participants who have taken or are taking an approved medication and who agree to be followed and contacted periodically by study staff for the purpose of collecting additional health information.
Why should I participate in EXPECT?
Your participation in the EXPECT Registry will provide doctors and future patients with valuable information about the effects of XOLAIR on newborns. There are no adequate and well-controlled studies of XOLAIR in pregnant women. XOLAIR should be used during pregnancy only if clearly needed. While XOLAIR presence in human milk has not been studied, the Immunoglobulin G (IgG) protein is excreted in human milk. Since XOLAIR is a clone or copy of the IgG protein, it is expected that XOLAIR will be present in human milk. The potential for XOLAIR absorption or harm to the infant is unknown. Consult with your doctor about the use of XOLAIR while nursing.
What are the requirements for participation?
Study doctors are looking for pregnant women who have received XOLAIR before or during pregnancy. You do not have to be on XOLAIR currently to enroll in the registry.
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 Pregnancy Registry Center. If you decide to participate by providing verbal informed consent and are found eligible, you will be sent a copy of the signed Patient Information Sheet confirming your willingness to participate. The registry representative will also complete a Medical Release of Information to gather relevant healthcare information about you from your healthcare providers. If you qualify as a minor (17 or 18 years of age depending on the laws of your state), an Informed Consent Form will be mailed to you. If you agree to participate by signing and returning the Consent Form, you will be enrolled into the study. You may contact the Pregnancy Registry Center at 1-(866)-4XOLAIR (1-866-496-5247), Option 3, for any questions you may have about your participation in this registry.
How many times will I have to visit the clinic?
No clinic visits are required. If you are chosen for the registry, you will be asked to participate in telephone interviews where a study representative will ask about your health and the health of your baby at each trimester, at the time of delivery, and every 6 months until your baby turns 1 year old. 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.
Will I receive compensation for my time?
Yes. For each telephone survey you complete, you will be financially compensated.
How can I qualify for the EXPECT Registry?
To see if you may qualify, call 1-(866)-4XOLAIR (1-866-496-5247), Option 3. A registry representative will discuss the study with you, explain registry expectations, as well as ask you a few eligibility questions to determine if you qualify.
How do researchers determine who will be a good candidate for study participation?
The factors that allow someone to participate in an observational study are called inclusion criteria and those that restrict someone from participating are called exclusion criteria. These criteria are based on factors such as age, gender, previous treatments, medical conditions, and medications.
Some observational studies seek participants with specific illnesses or conditions, while others need healthy participants. It is important to note that inclusion and exclusion criteria help identify the right participants and ensure reliable results.
If you are found to be eligible and decide to participate, a copy of the Patient Information Sheet or Informed Consent Form if you are a minor will be sent to you. You may contact us at any time for an explanation of the content or if you have any other study-related questions.
How is study information collected, analyzed and reported?
The information you provide will be collected by telephone interviews and managed by Genentech and a Contract Research Organization called PPD. A scientific advisory board was formed to oversee registry conduct, analysis and presentation of results. The board comprises specialists in neonatology, teratology, pediatrics, allergy, asthma, epidemiology, obstetrics, and gynecology.
XOLAIR should be used during pregnancy only if clearly needed. While XOLAIR presence in human milk has not been studied, the Immunoglobulin G (IgG) protein is excreted in human milk. The potential for XOLAIR absorption or harm to the infant is unknown. Consult with your doctor about the use of XOLAIR while nursing.
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.
CLICK HERE for more information about XOLAIR.