Key takeaways:
Xolair (omalizumab) is an injectable medication that targets antibodies called immunoglobulin E (IgE) that drive allergic reactions. It’s now FDA approved to lower the risk of allergic reactions to foods, such as peanuts and eggs, after accidental exposure.
Xolair is approved for adults and children ages 1 year and older. You’ll administer a dose every 2 to 4 weeks, depending on your body weight and blood IgE levels.
You’ll still need to avoid foods you’re allergic to while receiving Xolair. And if you develop a severe allergic reaction, Xolair won’t take the place of injectable epinephrine.
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Your child is happily enjoying lunch in the bustling cafeteria at school. Suddenly, after taking a bite of their sandwich, a look of distress crosses their face as the telltale symptoms of an allergic reaction begin to appear. Swiftly, a teacher springs into action, retrieving a trusty EpiPen — a crucial tool for moments like these when accidental exposures occur.
Whether they’re due to peanuts, dairy, or eggs, allergic reactions to foods can quickly become a life-threatening situation. Epinephrine injections, such as an EpiPen, can lessen a reaction as it’s occurring. But what if you could lower the risk of these reactions from happening in the first place? Now you can with Xolair (omalizumab).
Now, more than 20 years after its initial U.S. debut, Xolair is approved to lower the risk of allergic reactions to multiple foods after accidental exposure. If you or your child is living with a food allergy, Xolair may be an option to consider. Here’s five Xolair facts you need to know.
1. Xolair works by targeting an antibody that triggers allergic reactions
Many food allergies are driven by an antibody in your body called immunoglobulin E (IgE). When you’re exposed to an allergen, such as peanut proteins, IgE antibodies bind to certain immune cells to set off an allergic reaction. Xolair is a lab-made antibody that stops this from happening by binding to IgE and preventing it from attaching to its normal target.
Xolair is administered as an under-the-skin injection every 2 to 4 weeks. The dose and injection frequency is based on body weight and blood IgE levels. That way, there’s enough Xolair available to bind up the free IgE in the blood. In general, the higher your body weight and IgE levels, the higher and more frequent your Xolair dose. Your allergist will determine what your blood IgE levels are.
2. Xolair isn’t the only medication for food allergies, but it covers the most types of food
In January 2020, Palforzia became the first FDA-approved treatment for peanut allergies. It works by exposing you to small amounts of peanut protein to make you less sensitive to it (called oral immunotherapy, or OIT). Xolair can also lower the risk of allergic reactions to peanuts. But because of how it works, it covers a wider variety of foods.
Each allergen — whether it’s peanut, egg, or milk protein — has specific IgE antibodies your immune system makes to recognize it. Xolair binds to IgE broadly, no matter the allergen it targets. During clinical trials, Xolair was studied in people who are allergic to peanuts and at least two of the following foods:
Cashew
Hazelnut
Walnut
Milk
Egg
Wheat
In addition to offering support against more foods than Palforzia, Xolair is approved for use in a wider range of ages. Palforzia is only approved for children ages 4 to 17 years old, while Xolair is approved for adults and children ages 1 year and older
3. You still need to avoid foods that you’re allergic to while taking Xolair
Xolair is meant to be paired with food allergen avoidance, meaning that you or your child still need to avoid foods you’re allergic to while receiving it. Xolair is meant to help make small, accidental exposures less likely to cause serious problems.
After 16 to 20 weeks of treatment in initial studies, 68% of people receiving Xolair were able to eat a single dose of peanut protein (about 2.5 peanuts) without developing moderate-to-severe allergic symptoms. The percentage for milk and egg protein were similar, with 66% and 67% of participants able to eat a single dose, respectively. Cashew protein was slightly lower at 42%.
Clinical trials for Xolair’s use in allergic reactions are ongoing. Researchers plan to see if Xolair treatment beyond 20 weeks stops or reduces allergic reactions even more. One of the questions they hope to answer is if people will be able to eat triggering foods after stopping Xolair (when used on its own or in combination with OIT).
Until more information is available, your prescriber will work with you to determine how long you or your child should continue receiving Xolair.
4. Xolair has side effects and risks to consider
The most common Xolair side effects from food allergy trials were injection site reactions and fever. These side effects usually resolve on their own within a few days. Other potential side effects may include:
Joint pain
Rash
Increased risk of parasitic infections
Abnormal laboratory tests
While rare, some people may experience a severe allergic reaction (anaphylaxis) to Xolair itself. For this reason, Xolair has a boxed warning — the FDA’s strongest medication warning — for anaphylaxis.
Most anaphylaxis cases happen within the first three Xolair doses. Because of this, these initial doses are usually administered by a healthcare professional in a medical setting. If an allergic reaction occurs, emergency treatment will be readily available. After these initial doses, you may be able to administer Xolair injections at home. But you’ll still need to monitor for anaphylaxis.
Xolair also has a warning about an increased risk of cancer. This is because there were more cancer cases seen during clinical studies in people who received Xolair compared to those who didn’t. However, additional research hasn’t found an increased cancer risk with Xolair. More research is needed to confirm.
5. Xolair shouldn’t be used as emergency treatment for an allergic reaction
Xolair helps proactively lower the risk of an allergic reaction to certain foods. If a severe reaction happens, Xolair doesn’t take the place of your usual emergency treatment — an epinephrine injection like EpiPen or Auvi-Q. So you should still keep one on hand and call 911 after administering it.
Once an allergic reaction has started, this means that IgE has already triggered the chain of events with other immune cells. These immune cells release chemicals that cause symptoms including hives, reduced blood pressure, and shortness of breath. Epinephrine helps reverse some of these effects, such as bringing blood pressure back up and opening the airways.
The bottom line
Xolair (omalizumab) is an injectable medication that can lower the risk of allergic reactions to multiple foods after accidental exposure in people ages 1 year and older. It’s administered every 2 to 4 weeks, depending on body weight and blood immunoglobulin E (IgE) levels.
Xolair is meant to be paired with food allergen avoidance, meaning that you still need to avoid foods you’re allergic to during treatment. It doesn’t take the place of injectable epinephrine, which should still be kept on hand in case a serious allergic reaction occurs.
If you or your child is living with a food allergy, it’s a good idea to understand your options. Talk to your prescriber if you’re interested in learning more about Xolair.
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References
Aimmune Therapeutics. (2023). Palforzia initial dose escalation- peanut kit [package insert]. DailyMed.
American Academy of Allergy, Asthma & Immunology. (n.d.). Oral immunotherapy defined.
Anvari, S., et al. (2018). IgE-mediated food allergy. Clinical Reviews in Allergy & Immunology.
Bagnasco, D., et al. (2022). Omalizumab and cancer risk: Current evidence in allergic asthma, chronic urticaria, and chronic rhinosinusitis with nasal polyps. The World Allergy Organization Journal.
Children’s Hospital of Philadelphia. (n.d.). IgE-mediated food allergies.
ClinicalTrials.gov. (2023). Omalizumab as monotherapy and as adjunct therapy to multi-allergen OIT in food allergic participants (OUtMATCH).
Genentech. (2024). FDA approves Xolair as first and only medicine for children and adults with one or more food allergies.
Genentech, Inc. (2024). Xolair [package insert].
U.S. Food and Drug Administration. (2020). FDA approves first drug for treatment of peanut allergy for children.
U.S. Food and Drug Administration. (2024). FDA approves first medication to help reduce allergic reactions to multiple foods after accidental exposure.
