In February 2024, the U.S. Food and Drug Administration (FDA) approved Xolair (Omalizumab) for patients 1 year of age and older at risk for immunoglobulin E (IgE)-mediated food allergic reactions after accidental exposure.
Xolair has been on the market for 20 years, and at Schreiber Allergy, we have extensive experience using Xolair for our patients. Initially, Xolair was approved for the treatment of moderate to severe persistent asthma, as well as urticaria (hives) and chronic rhinosinusitis with nasal polyps. In February 2024, it was approved for the food allergy indication described above.
What is Xolair, and how does it work?
Xolair is in the class of medications called biologics. More specifically, Xolair is a monoclonal antibody that binds to IgE, the antibody type that triggers allergic reactions. When used for patients with food allergy, Xolair binds to IgE which prevents IgE from triggering an allergic reaction in most cases of accidental exposures.
How is Xolair taken?
Xolair is an injection given every 2-4 weeks. The dose and frequency of injections are determined by the patient’s weight and total IgE levels (the IgE level is obtained through blood testing).
Can Xolair be used in patients with allergies to more than one food?
Yes! In fact, Xolair is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure.
Is Xolair a cure for food allergies?
No, Xolair does not eliminate food allergies or allow patients to consume food allergens freely in most cases. Patients who take Xolair must continue to avoid foods they are allergic to and carry their epinephrine autoinjectors.
Does Xolair replace epinephrine autoinjectors such as EpiPen or Auvi-Q?
No, patients who take Xolair must continue to carry an up-to-date epinephrine autoinjector for treatment of anaphylaxis. Xolair is used once every 2-4 weeks to reduce the ongoing risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.
What are the side effects and risks of Xolair?
The most common side effects of Xolair included injection site reactions and fever. Xolair comes with certain warnings and precautions, such as anaphylaxis, cancer/malignancy, fever, joint pain, rash, parasitic (worm) infection, cardiovascular and clotting events, and abnormal laboratory tests.
Anaphylaxis has occurred after the first dose of Xolair but also has occurred beyond one year after beginning treatment. Xolair should only be started in a healthcare setting equipped to treat anaphylaxis.
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While the approval of Xolair is a major step forward for our patients with food allergies and their families, there are certainly some questions that still exist for patients and providers alike.
How long does a patient need to be on Xolair?
Since Xolair does not cure food allergies, it may be a lifelong therapy for some patients. Alternatively, some patients with food allergy may outgrow their food allergies on their own. As of right now, we do not have guidelines or testing to determine when and how to stop Xolair in patients who may have outgrown their food allergy.
17% of patients with food allergy do not respond to Xolair
In the major clinical study for use of Xolair in food allergies, 17% of subjects with peanut allergy receiving Xolair had no significant change in the amount of peanut protein they were able to tolerate. As of right now, we do not have guidelines or testing to determine which patients will respond or not respond to Xolair.
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Although Xolair may be a good option for patients with food allergies, much information is needed to determine how best to use this therapy. In addition, not all food allergy patients are good candidates for this therapy. If you or a family member has food allergies and are interested in learning more about Xolair, please call our office to schedule an appointment.