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Food Allergy Awareness Kit

Xolair Treatment for Food Allergy

The Food and Drug Administration (FDA) approved omalizumab – known under the brand name Xolair® – as a treatment for food allergies. The approval came as the result of the OUtMATCH study funded by the National Institutes of Health (NIH) and Genentech.

Here are some common questions and answers about Xolair for the treatment of food allergies.

​How Does Xolair Prevent Food Allergy Reactions?

Xolair is a treatment that works by attaching itself to the IgE antibodies to help prevent an allergic reaction. It is an anti-IgE medicine. It reduces your child’s chance of having a food allergy reaction, including anaphylaxis, if your child accidentally eats one of their food allergens. By binding to the IgE, the IgE cannot bind to the cell that helps cause an allergic reaction.

The medicine is an injection given every 2 to 4 weeks, depending on the person’s weight and total IgE level. Your doctor may request a blood draw to check for an up-to-date total IgE level. Per the FDA, the first 3 shots have to be received in the doctor’s office, due to a very small risk of anaphylaxis (2 cases per 1000 or 0.2%). After that, you can give the injection at home if you are comfortable.

While on Xolair, your child will still need to avoid their food allergens and carry epinephrine, a medicine used to treat anaphylaxis.  Xolair reduces the risk of an accidental allergic reaction but may not prevent this in all children. Xolair is not a treatment for an acute allergic reaction, including anaphylaxis.

Who Can Use Xolair Treatment for Food Allergy?

This treatment is approved for ages 1 and up.

People who are allergic to omalizumab or any of the ingredients in Xolair can’t use this treatment.

Does Xolair Work for Multiple Food Allergies?

Yes. In the OUtMATCH study, several people were able to eat at least 2 or 3 of the foods they were allergic to without dose-limiting symptoms. Dose-limiting means the side effects of a treatment are serious enough to prevent an increase in dose or level of that treatment. Xolair showed it can reduce allergic reactions in people with multiple food allergies.

What Are the Side Effects of Xolair?

Some people may get fever, muscle aches, rash, or infections. Injection site reactions are common. No severe adverse events were seen, nor were any cases of anaphylaxis to Xolair injections observed during the OUtMATCH study

Very rarely, a person may have a severe allergic reaction (anaphylaxis) when they receive Xolair. This can happen after the first dose, or later doses, but is most likely to happen in the first three doses.

From asthma studies, there are data that suggest that in older individuals (e.g., mid-40s and older), Xolair may be associated with a small increased rate of certain heart and circulation problems, but there are no data to support that Xolair use causes such issues. There is no association with an increased risk of cancer. There is insufficient data to support use in pregnancy, but this is being studied.

Talk with your doctor about the benefits and risks of using Xolair treatment.

Xolair Has a Black Box Warning. What Does That Mean?

Omalizumab has a black box warning for anaphylaxis. A black box warning is a safety warning from the FDA. This alerts you to be aware of a drug’s side effects or important instructions for safe use of the drug. We encourage you to speak with your health care provider before, during, and after the start of any new medicine. If your doctor recommends Xolair, talk with them about possible risks and concerns. When Xolair was first approved in 2003 for asthma, in the clinical trials and early post-marketing data, about 2 in every 1000 patients receiving Xolair reported anaphylaxis to the drug. While this is a very rare occurrence, the FDA has placed this warning on the box. This is why the first 3 doses are observed by your doctor.

Is Xolair Approved to Be Used with Oral Immunotherapy?

No. The treatment is only approved by the FDA to be used alone and not with oral immunotherapy (OIT).

How Much Does Xolair Cost?

The overall cost will depend on if you have insurance and what kind of insurance coverage you have.

Most insurance companies require prior authorization for biologic medicines before you can fill the prescription. This means the insurance company has to approve coverage for the medicine. They may also require that you order it from a specialty pharmacy. The criteria for insurance approval are evolving in real time.

Check with your insurance company to find out the process for specialty medicines. Ask your doctor if they have a biologics coordinator who can help you with the process.

Genentech, one of the makers of Xolair, has programs to help with the cost. If your child has been prescribed Xolair, you can sign up for their Support for You program. The program offers information on getting started, treatment information, an education session, and a review of financial support options.

If you are unable to access this treatment because your insurance plan denies it or requires strict criteria, please contact us to let us know. We are gathering patient stories and monitoring for coverage issues. We will continue to advocate for patients to have access to treatments that may improve or save their lives.

How Do I Know If Xolair Is Right for My Child?

Your doctor can help you decide if Xolair is the right treatment for your child. They may do a physical exam and allergy testing before starting the treatment, even if your child has done these before. Certain insurance plans may require a food challenge as well.

Several factors will be involved in deciding if Xolair is right for your child. These may include what type of food allergy you have, your ability to follow the shot schedule, and if you are comfortable with giving the injection.

Medical Review: May 2024 by Matthew Greenhawt, MD

Your Guide to Managing Your Child's Food Allergies