It used to be that the only way for people with food allergies to prevent a serious allergic reaction (like anaphylaxis) was to avoid that food completely. Unfortunately, even when a person does their best to avoid a specific food, it is still possible to eat that food by accident. For people with allergies to multiple foods, it is even harder to avoid an accidental reaction.
In 2024, Xolair became the first medicine approved to help make accidental allergic reactions to multiple foods less serious. Even though it is still important for people to avoid the foods they are allergic to, Xolair may make it less stressful and less dangerous to have serious food allergies.
How Does Xolair Work for Managing Food Allergies?
Allergic reactions happen when the body’s immune system overreacts to a specific substance. The substance that causes this reaction is called an allergen. There are many different types of allergens. Some of the more common allergens are foods, drugs, pollen, and animals.
When it comes to food allergies, allergic reactions can be very serious. Serious allergic reactions, called anaphylaxis, can be life-threatening. These reactions can include the following symptoms:
- A sense that something bad is about to happen
- Dizziness or fainting
- Itchy skin reactions, such as a rash or hives
- Stomach pain, nausea, and/or vomiting
- Swelling of the lips, tongue, or throat, which can make it difficult to breathe
- Very low blood pressure
The best way to prevent an allergic reaction is to avoid the allergen. If you have a food allergy, you should review all ingredients on food labels. When eating in a restaurant or accepting homemade food items, you should ask how the food is prepared and whether it may have been exposed to any allergens.
Sometimes, though, you may still accidentally eat something that contains the food you are allergic to. This is why it is important for anyone with a serious food allergy to have an emergency medicine, called epinephrine, with them at all times. This emergency medicine can reduce the swelling (inflammation) that causes many of the symptoms of a serious allergic reaction while you are waiting for medical help.
The active ingredient in Xolair is a medicine called omalizumab, which works by blocking a substance in the body called immunoglobulin E (IgE). The body produces large amounts of IgE when it senses an allergen. For people with food allergies, blocking IgE can decrease the body’s reaction to allergens. Even though it is still important to avoid food allergens, Xolair may make serious allergic reactions (like anaphylaxis) happen less often.
How Was Xolair Studied for Managing Food Allergies?
One clinical study was done to find out if Xolair was safe and could help to prevent serious allergic reactions (anaphylaxis) to foods. This study included children who were at least 1 year old and adults who were no more than 55 years old. The average age was 7 years. A little more than half (56%) of the people in the study were male. Most of the people in the study were White (62%), about 14% were Asian, and about 7% were Black. Everyone was from the United States.
Every person in this study had a serious allergy to peanuts and couldn’t eat more than half a peanut without having symptoms. Everyone in this study also had a serious allergy to at least two other specific foods. Here are the other food allergies that people had, and how many people had them:
- Cashews (56%)
- Egg (40%)
- Milk (35%)
- Walnuts (44%)
- Hazelnuts (13%)
- Wheat (11%)
Everyone in this study had high IgE levels in their blood due to their allergies. Many of them also had other allergic conditions, such as asthma and atopic dermatitis, which is a type of eczema.
Xolair was compared with a placebo. The people in the study did not know whether they were receiving the medicine or the placebo. People were told to continue avoiding all of the foods they were allergic to throughout the study.
Efficacy was measured by the number of people who were able to eat about two-and-a-half peanuts (or about a half-teaspoon of peanut butter) without having symptoms of an allergic reaction.
What Benefits Were Seen in These Clinical Studies?
Serious allergic reactions to peanuts. At the beginning of the study, no one (0%) was able to eat more than half a peanut without having symptoms of an allergic reaction. After 4-5 months in the study, about two-thirds of people who used Xolair (67%) were able to eat about two-and-a-half peanuts without having symptoms of a serious allergic reaction. Only 7% of the people who used the placebo were able to do this.
Serious allergic reactions to other foods. Everyone in this study was allergic to peanuts, so peanuts were the main focus of the study. But each person in the study was also allergic to at least two other foods. The people who were able to eat two-and-a-half peanuts at the end of the study without having symptoms of an allergic reaction were tested to see if they could eat more of the other foods that they were allergic to as well. On average, the people who used Xolair were able to eat larger amounts of cashews, eggs, and milk than they could before the study started, without having symptoms of an allergic reaction.
Each person’s response to Xolair may be different, and anyone who is using Xolair should continue to avoid exposure to their food allergens. The amounts of each food tolerated in this study were still much smaller than what would be found in a normal serving size.
How Quickly Will Xolair Work to Help Manage Food Allergies?
Xolair may make it possible for you to accidentally eat small amounts of the foods you are allergic to without having a serious allergic reaction. You will only be able to tell if it is working if you accidentally eat a food you are allergic to. If Xolair works for you, it should start working within about 4 months after you start taking it.
Do not stop using Xolair or any other medicines that you are taking for allergies without talking to your health care provider first. You should also not lower the dose of any of your other allergy medicines without talking to your health care provider first.
Is There Anything I Should Know Before Using Xolair for Food Allergies?
It is very important that you continue to avoid the foods you are allergic to even when you are using Xolair. Xolair does not completely prevent allergic reactions. Instead, it may make those reactions less serious. But it can only do this for very small amounts of food. Xolair does not make it possible to eat large amounts of foods you are allergic to or to eat those foods on a regular basis.
After you start using Xolair, you should still keep an emergency medicine like epinephrine with you at all times. If you have a serious allergic reaction, use your emergency medicine and get medical help right away. Xolair should be used on a regular schedule, as prescribed by your health care provider. It should not be used when a quick response to an allergic reaction is needed.
How Do I Use It?
Xolair is a liquid that is injected under the skin every 2-4 weeks. Your health care provider will decide whether you should receive it every 2 weeks or every 4 weeks. This will depend on your weight and the amount of IgE in your blood. It can be injected into the thigh, stomach, or outer area of the upper arm.
The first few times that you use Xolair, your health care provider will give you the dose in a health care setting. This will allow them to monitor you for any type of reaction to the dose. After the first few doses, you may continue to receive the dose in a health care setting. If you meet certain criteria, your health care provider may allow you to give yourself the dose at home.
The drug comes in two forms. The most common form is a pre-filled device called an autoinjector. This device is ready to inject the drug under the skin, so you do not need to learn how to use a syringe and needle. The other form is a pre-filled syringe with a needle, which is most often used in very young children. The pre-filled syringe contains latex, but the autoinjector does not contain latex. Let your health care provider know if you have an allergy to latex so they can prescribe the right form of Xolair.
If you and your health care provider decide that you will start giving your own doses at home, they will teach you how to inject the drug before you use it the first time. It is important to inject the drug properly so that you get the right dose. Your prescription should also come with “Instructions for Use,” which explains how to prepare and give a dose.
What Happens When the Medicine Is Stopped?
If you stop using Xolair, your food allergies will likely become as serious as they were before you used Xolair. The effects of the medicine will start to wear off around the time that your next dose would have been due.
How Can I Prevent or Manage Side Effects?
In rare cases, some people may have a serious allergic reaction (anaphylaxis) after their first dose of Xolair. Your first dose of Xolair will always be given in a health care setting, where you will be monitored for an allergic reaction. If anything happens, trained professionals will be there to manage any side effects.
These are not all of the possible side effects of Xolair. Talk with your health care provider if you are having symptoms that bother you. If you experience anything that you think may be caused by Xolair, you can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
Are There Any Interactions With Other Medicines?
There are no known interactions between Xolair and other medicines. But it is still important for your health care provider to be aware of all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken.
Are There Any Special Steps Required to Get Xolair?
Xolair is a type of medicine called a “specialty” medicine. This means that you can only get it from a specialty pharmacy and that it may require prior authorization from your insurance company. Your first dose of Xolair will always be given by a health care provider in a health care setting.
Is There a Coupon Card Available?
There is a savings coupon available from the drugmaker that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance, and what type of insurance you have. You can find out more at https://www.xolaircopay.com/.
