If approved, Xolair prefilled syringe would become available for either self-administration by select patients or administration by their caregivers. A decision on approval is anticipated by Q1 2021. In the
'Due to the COVID-19 pandemic, there is an urgent need to provide self-administration of Xolair to our patients, particularly those who are considered high-risk for severe illness,' said
If approved, once Xolair therapy has been established and closely observed by a healthcare provider, self-administration of Xolair prefilled syringe outside of a healthcare setting by a patient or caregiver may be deemed appropriate by the healthcare provider for select patients. In those instances, the patient or caregiver would be trained by a healthcare provider in the correct subcutaneous injection technique and recognition of the early signs and symptoms of anaphylaxis.
Approximately 460,000 patients have been treated in the
In the
About Allergic Asthma and Chronic Idiopathic Urticaria
Asthma is a serious and chronic lung disease affecting an estimated 24 million people in the
Chronic idiopathic urticaria (CIU) is a skin condition that can cause hives and severe itch that can last many months and years. CIU is characterized by hives that spontaneously occur without an identifiable cause, and recur for six weeks or more. It is estimated that approximately 1.5 million people in the
About Xolair
Xolair is the only approved antibody designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade.
Important Safety Information
The most important information patients should know about XOLAIR is that a severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction: 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
The patient's healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after the patient's injection. The patient's healthcare provider should talk to the patient about getting medical treatment if they have symptoms of an allergic reaction after leaving the healthcare provider's office or treatment center.
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