XOLAIR® (Omalizumab) for Subcutaneous Use Frequently Asked Questions
1. What is XOLAIR?
XOLAIR is a humanized monoclonal antibody and the only therapy which blocks immunoglobin E (IgE), an underlying cause of allergic asthma. XOLAIR was approved by the U.S. Food and Drug Administration in June 2003. XOLAIR is a prescription medicine given by injection for people who are 12 years of age and above who have moderate-to-severe allergic asthma that is triggered by year-round allergens in the air. A simple skin or blood test will confirm that a patient has 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
2. How is XOLAIR unique compared to other therapies?
XOLAIR represents a number of treatment firsts:
- First Biotechnology Derived Treatment of Asthma
XOLAIR is the first humanized monoclonal antibody used in the treatment of moderate-to-severe allergic asthma. - First Treatment Specifically Designed for Allergic Asthma
XOLAIR is the first therapy designed to specifically block IgE, an underlying cause of allergic asthma. Approximately six in 10 asthma patients make IgE when exposed to allergic triggers such as dust mites, mold, cockroaches and pet dander. By blocking IgE, XOLAIR helps to prevent asthma attacks and symptoms. - First Asthma Medication Administered Every Two or Four Weeks
XOLAIR, administered by subcutaneous injection (under the skin), is the first asthma product to be administered to patients every two or four weeks, unlike other asthma medications that must be taken once or twice daily.
3. How does XOLAIR work?
XOLAIR is unique in that it is the only medication designed to specifically block IgE, an underlying cause of allergic asthma.
IgE occurs naturally in the body in small amounts. People with allergic asthma produce IgE when exposed to allergic triggers. When exposed to allergic triggers, the IgE can bind to inflammatory cells called mast cells and cause a series of reactions known as the allergic-inflammatory process in allergic asthma. This reaction can lead to asthma attacks and symptoms (e.g., wheezing, coughing, bronchoconstriction, shortness of breath and chest tightness).
By blocking IgE, XOLAIR helps to reduce the amount of free-floating IgE in the bloodstream, thereby helping to prevent asthma attacks and symptoms. Adding XOLAIR to an existing program using inhaled corticosteroids has been clinically proven to help reduce the number of exacerbations, subsequent steroid bursts and asthma symptoms patients experience.
4. Who should use XOLAIR?
XOLAIR is approved for adults and adolescents 12 years of age and older with moderate-to-severe persistent asthma and who remain symptomatic despite the use of inhaled corticosteroids. The safety and efficacy of XOLAIR have not been established in patients with other allergic conditions.
Patients with moderate-to-severe persistent asthma may experience one or more of the following:
- Asthma symptoms every day
- Daily need for a rescue inhaler
- Asthma attacks two or more times a week
- Asthma that occurs while they sleep, causing them to wake up one or more nights a week
- A below-normal reading (less than 80%) of peak expiratory flow or forced expiratory volume in one second (FEV1) which are measures of how the lungs are functioning
Allergic asthma is a specific type of asthma that is triggered by year-round allergens. Diagnosis of allergic asthma can be confirmed by a doctor using a simple skin or blood test, called an IgE test. Only an asthma specialist can determine if a patient has allergic asthma.
5. What are the benefits of XOLAIR?
In clinical trials, the addition of XOLAIR to inhaled corticosteroid therapy (ICS) significantly reduced asthma exacerbations and related symptoms even as ICS use was reduced.
Uncontrolled asthma carries a tremendous burden to both patients and society. According to the American Lung Association and the Centers for Disease Control and Prevention, on an annual basis, asthma accounts for approximately:
- 12.8 million missed school days
- 10.1 million missed work days
- 1.9 million emergency room visits
- $16.1 billion in medical expenses and indirect costs
6. How is XOLAIR administered?
XOLAIR is given through subcutaneous injection, which means it is injected just under the skin. XOLAIR is administered every two or four weeks, depending on a patient's body weight and baseline IgE level. XOLAIR should always be injected in a doctor's office.
7. Who can prescribe XOLAIR? Where is XOLAIR available?
XOLAIR is available to patients through the allergy and pulmonology medical community.
As part of a preferred distribution network, four specialty pharmacies serve as the primary distributors of XOLAIR: Accredo Nova Factor, Inc. CaremarkRx, Inc., Option Care, Inc. and CuraScript Pharmacy, Inc. Each offers patient compliance programs, monitoring, education, reimbursement support and overnight drug delivery. XOLAIR is also available via select pharmaceutical benefit managers and wholesale channels for certain customer segments not serviced by the primary preferred specialty pharmacy network.
8. What is the important safety information allergic asthma patients should know about XOLAIR?
The most serious adverse reactions occurring in clinical studies with XOLAIR were anaphylaxis and malignancies. XOLAIR (Omalizumab) For Subcutaneous Use should always be injected in a doctor's office. The patient should be given and instructed to 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. Patients should be instructed to 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
Patients should not receive XOLAIR if they have ever had an allergic reaction to a XOLAIR injection. Patients should not receive XOLAIR if they 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 injections.
In clinical studies, the most common side effects in patients receiving XOLAIR included injection-site reactions (45%), viral infections (23%), upper respiratory tract infection (20%), sinus infection (16%), headache (15%), and sore throat (11%).
Do not change or stop taking any of your other asthma medicines unless your healthcare provider 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.
For full Prescribing Information and important safety information including Boxed WARNING and Medication Guide please visit www.XOLAIR.com or www.gene.com
9. How is XOLAIR manufactured?
Genetically engineered and humanized biologic therapies like XOLAIR are produced in living cells. The manufacturing of protein-based therapeutics – specifically humanized monoclonal antibodies – is a complex process that is more costly and difficult than the manufacturing of traditional small molecule drugs.
10. Who manufactures XOLAIR?
XOLAIR is manufactured by Novartis Pharma S.A.S. In the United States XOLAIR is co-marketed by Genentech, Inc. and Novartis Pharmaceuticals Corporation.
