Healthcare Provider Information (U.S. ONLY)

Now Enrolling

Data collection is a critical component of evaluating patient responses to drug therapy, yet there are no adequate and well-controlled studies of XOLAIR in pregnant women. Right now, your patients who are taking or have taken XOLAIR may qualify to enroll in the EXPECT XOLAIR^® Pregnancy Registry.

The primary objective of the EXPECT Registry is to evaluate pregnancy outcomes in women who have received XOLAIR prior to conception or at any time during pregnancy. To be eligible for participation, your patients must:

Be pregnant
Have taken at least 1 dose of XOLAIR within 8 weeks prior to conception or during pregnancy

Your patients will be asked to participate in a telephone interview each trimester, at the time of delivery, and every 6 months until their baby is 1 year old. No clinic visits are required.

To refer a patient for the EXPECT Registry, call us at 1-(866)-4XOLAIR (1-866-496-5247), Option 3 or click here and complete the form and a member of the EXPECT team will contact you with additional information.

About EXPECT

The following is designed to help answer your questions about the EXPECT XOLAIR^® Pregnancy Registry.

What is the primary objective of the study?
To evaluate pregnancy outcomes in women who have received XOLAIR within 8 weeks prior to conception or at any time during pregnancy.

What are the requirements for participation?
Pregnant women who have received at least 1 dose of XOLAIR within 8 weeks prior to conception or during pregnancy may be included in this registry. Patients do not need to be on XOLAIR currently to enroll.

What is the patient compensation for enrollment in the study?
Patients enrolled in the registry will be compensated for each telephone survey they complete.

What does the EXPECT Registry involve?
A woman participating in the study will be followed to the completion of her pregnancy and continue until her baby is 1 year old. She will be asked to answer questions regarding her health and her infant’s health during a telephone interview at each trimester, at the time of delivery, and every 6 months until the infant is 1 year old. If the woman continues XOLAIR treatment while breastfeeding, she will be asked to participate in one additional phone interview when the infant is 18 months old. No clinic visits are required.

The Registry Coordinator will obtain the woman’s verbal consent to participate in the study and then will assess her eligibility. If she qualifies and agrees to provide verbal informed consent, she will be sent a signed copy of the Patient Information Sheet. The Registry Coordinator also will complete a Request for Medical Release of Information and send a copy to you. Note: For participants who qualify as minors, enrollment into the registry will only be granted after a signed written informed consent is received at the XOLAIR Pregnancy Registry Center. Once the above process is completed, all relevant healthcare providers (obstetrician, asthma specialist, pediatrician and/or other physician) will be contacted via telephone to confirm necessary healthcare information.

How is data collected by the registry then analyzed and reported?
The data is collected through the XOLAIR Pregnancy Registry Center by telephone and managed by Genentech and a Contract Research Organization called PPD. No study site visits are required. 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.

How can healthcare providers help?
If you have patients taking XOLAIR who meet initial eligibility requirements, please have them call the toll-free number at 1-(866)-4XOLAIR (1-866-496-5247), Option 3. Patients must enroll themselves. However, healthcare providers are encouraged to direct eligible patients to the registry and to call the toll-free phone number if they have any questions.

How long will the study last?
The registry will be active for a minimum of 5 years or until 250 women are enrolled.

Why is the registry important?
There are no adequate and well-controlled studies of XOLAIR in pregnant women. Data collected in the XOLAIR Pregnancy Registry may be used to assist physicians and patients in weighing the risks of XOLAIR exposure in pregnancy. The Pregnancy Registry is an essential component of ongoing efforts to understand the effects of XOLAIR during gestation and lactation. Participation in the registry will provide important information to physicians and patients regarding the use of XOLAIR during pregnancy. This registry is the primary source for collecting and evaluating exposure to XOLAIR during pregnancy. The success of the registry relies on participation of patients and healthcare providers.

XOLAIR should be used during pregnancy only if clearly needed. While XOLAIR presence in human milk has not been studied, IgG is excreted in human milk and, therefore, it is expected that XOLAIR will be present in human milk. The potential for XOLAIR absorption or harm to the infant is unknown: caution should be exercised when administering XOLAIR to a nursing woman.

INDICATION

XOLAIR^® (omalizumab) for subcutaneous use IS INDICATED FOR adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

XOLAIR has been shown to decrease the incidence of asthma exacerbations in these patients.

Important Limitations of Use

XOLAIR is not indicated for treatment of other allergic conditions
XOLAIR is not indicated for the relief of acute bronchospasm or status asthmaticus
XOLAIR is not indicated for use in pediatric patients less that 12 years of age

IMPORTANT SAFETY INFORMATION

WARNING: Anaphylaxis

Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, observe patients closely for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur (see Warnings and Precautions: Anaphylaxis).

XOLAIR should only be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis that can be life-threatening.
XOLAIR should not be administered to patients who have experienced a severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR (see Warnings and Precautions). XOLAIR should be discontinued in patients who experience a severe hypersensitivity reaction.
Malignant neoplasms were observed in 20 of 4127 (0.5%) XOLAIR-treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of asthma and other allergic disorders.
XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use XOLAIR to treat acute bronchospasm or status asthmaticus.
A constellation of signs and symptoms including arthritis/arthralgia, rash (urticaria or other forms), fever and lymphadenopathy similar to serum sickness have been reported in post-approval use of XOLAIR in some patients. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms.
Patients should be given and instructed to read the accompanying Medication Guide before starting treatment and before each subsequent treatment.
Do not abruptly discontinue corticosteroid use upon initiation of XOLAIR therapy. Decrease corticosteroids gradually under the direct supervision of a physician.
In patients ≥12 years of age, the most commonly observed adverse reactions (≥1% more frequent in XOLAIR-treated patients) from 4 placebo-controlled asthma studies were arthralgia (8%), pain (general) (7%), leg pain (4%), fatigue (3%), dizziness (3%), fracture (2%), arm pain (2%), pruritus (2%), dermatitis (2%), and earache (2%).

The adverse events most frequently resulting in clinical intervention (e.g., discontinuation of XOLAIR, or the need for concomitant medication to treat an adverse event), in either placebo-controlled or other controlled asthma studies, were injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These events were observed at similar rates in XOLAIR-treated patients and control patients.

Please see accompanying full Prescribing Information, including Boxed WARNING and Medication Guide, for additional important safety information.

To refer a patient for the EXPECT Registry, call us at 1-(866)-4XOLAIR (1-866-496-5247), Option 3 or click here and complete the form and a member of the EXPECT team will contact you with additional information.