XOLAIR® (Omalizumab) for Subcutaneous Use Fact Sheet
XOLAIR® (Omalizumab) for Subcutaneous Use is a humanized monoclonal antibody for moderate to severe allergic asthma and the only therapy which blocks IgE (Immunoglobin E), an underlying cause of allergic asthma. Approved by the FDA in June 2003, XOLAIR is the first biotechnology derived treatment for moderate to severe persistent asthma in people 12 years of age and above.
- IgE is a main cause of allergic asthma attacks and symptoms.
- IgE is produced in small amounts as part of the body's natural defense system against allergens.
- Approximately six in 10 people with asthma make IgE when exposed to allergic triggers such as dust mites, mold, cockroaches and pet dander. This is called allergic asthma.
- The IgE, when exposed to allergic triggers starts an allergic inflammatory cascade that can lead to asthma attacks and symptoms.
XOLAIR 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 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.
- XOLAIR is not a rescue medication and should not be used to treat sudden asthma attacks. XOLAIR is not a substitute for medications patients may already be taking.
- XOLAIR is administered by a healthcare provider through subcutaneous (under the skin) injection once every two or four weeks.
- The therapeutic dose is determined by a patient's IgE level, which is measured by a simple blood test, and body weight. Based on the patient's IgE level and body weight, the doctor will administer one, two or three injections per dose. If more than one injection is needed, each will be given in a different place on the body.
- The most serious adverse events reported with XOLAIR have been anaphylaxis and malignancies. XOLAIR 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 reaction (45% ), viral infections (23% ), upper respiratory tract infection (20% ), sinus infection (16% ), headache (15% ) and sore throat (11% ).
- For full Prescribing Information and important safety information including Boxed WARNING and Medication Guide please visit www.XOLAIR.com or www.gene.com
- XOLAIR is co-marketed in the United States by Genentech, Inc. and Novartis Pharmaceuticals Corporation. XOLAIR was approved by the U.S. Food and Drug Administration (FDA) in June 2003 and is available in more than 30 countries worldwide.
