Experts say about 8% of children1 in the United States have a food allergy. Milk, eggs and nuts are among the most common triggers, according to the Centers for Disease Control and Prevention (CDC). While many allergic symptoms are mild, some people have life-threatening reactions when exposed to these allergens.
The U.S. Food and Drug Administration (FDA) approved Xolair (omalizumab)2, a monoclonal antibody, as a regular injection to help prevent and minimize dangerous allergic reactions to foods, including peanuts, milk, eggs and cashews. The drug was originally approved in 20033 for the treatment of moderate to severe asthma, then later for chronic hives and nasal polyps in adults.4 Now, it’s being used as a newly approved preventative5 measure for patients with food allergies.
The idea is that you—or your child over the age of one year—would receive an injection of Xolair every two to four weeks. You would continue to avoid your allergy triggers, but then, if you ingested small amounts of the food, it should not trigger a dangerous reaction. For example, if you had a bite of cake before you knew it contained nuts, most people would be protected from the most severe types of allergic reactions. However, 17% of the people in the study didn’t get any protective benefit from the drugs. For that reason, the drug manufacturers recommend continuing to avoid those foods you are allergic to. Even if you are protected from an accidental small amount of the allergan, you are not safe from eating or drinking large quantities of foods that contain your allergens, so you should not finish the slice of cake.
Xolair will not stop allergy symptoms once they’ve started. It is not intended for use in patients while they are having an allergic reaction. That’s why Xolair is considered a prevention drug.
Here’s what you need to know about the possible side effects of Xolair and how well it works.
What Does Xolair Do?
Xolair is a monoclonal antibody.2 That means it’s an antibody, a protein your body makes to respond to a specific antigen such as a virus, made in the lab and injected most often into your thigh or abdomen as a treatment for allergy prevention. Your doctor can show you how to inject yourself,6 so you can have fewer in-office appointments. It stops another antibody in your body, immunoglobulin E (IgE), from binding to receptors that trigger cells to release a chemical called histamine. Histamine7 is responsible for many of the symptoms of allergic reactions, from itching and rashes to watery eyes and nose to swollen airways and other tissues. By preventing your cells from releasing histamine, the monoclonal antibody makes it less likely that you’ll experience severe allergy symptoms.
Does Xolair Work to Prevent Food Allergies?
In the clinical trial8 to determine the safety and effectiveness of the drug, the 177 participants were aged one to 17 years old who had responded well in preliminary9 studies10) received an injection of Xolair or a placebo once every two to four weeks for 16 to 20 weeks. The doses used were based on the participant’s weight and IgE levels. Of those participants who got the drug, 67% were able to consume a small quantity of peanut protein without having a severe allergic reaction, compared to 7% of those who had the placebo.
In addition to a peanut allergy, participants also had an allergy to either cashews, milk or eggs. The drug appeared to have a similar ability to prevent severe reactions to milk or egg ingestion as it did for peanuts, though it was slightly less effective for cashew allergies (41% of participants were able to consume a small amount of cashew after taking the drug compared to 3% who did not take the drug.) Continuing the treatment for up to 44 weeks helped a small number of patients tolerate a little bit more of the substance they were allergic to, but the authors state that the improvement was limited at this point. Future studies will evaluate how long this protection lasts, and if treatments need to continue longer or even a lifetime.
It’s important to keep in mind that the drug does not allow you to consume full servings of the foods you are allergic to. Instead, when effective, it protects you against small, accidental exposures such as peanuts in a bite of a brownie.
Who Should Take Xolair to Prevent Food Allergies?
Xolair is approved to be used for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy.11 The FDA previously has approved Xolair for moderate to severe persistent allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP).
When you discuss this drug with your doctor, keep in mind that the study that the FDA based its approval on had only 177 people in it, no adults. Additionally, the study authors pointed out that the racial diversity of the study skewed non-hispanic white, and did not represent the true diversity of the general population.6
People who are different ages and races or have additional health conditions than those studied may have more side effects, different side effects and the medicine might be more effective or less. Until subgroups are studied, we won’t know.
Does Xolair Contain Steroids?
No. Steroids are often used to dampen your immune response12 after it has already been triggered and you’ve developed symptoms. But the monoclonal antibody in Xolair is designed to prevent your immune system from reacting to an allergen that you might be exposed to in the future.
Xolair Side Effects
In the clinical Xolair trial conducted for the FDA, the main adverse effect reported was injection site reactions.
However, since Xolair has been on the market and used for other conditions for several years, many other side effects have been reported, including some more serious events.
Side effects of Xolair listed on the FDA prescribing information include the following5:
- Anaphylaxis, a life-threatening allergic reaction
- Joint pain
- Rash
- Itching
- Fever
- Swollen lymph nodes
- An overactive immune response, leading to rash, worsening respiratory symptoms, cardiac complications or nerve pain or numbness
- Hair loss
- Low platelet count (thrombocytopenia)
- Infection
- Fatigue
- Bone fracture
- Ear pain
- Headache
- Ear infection
- Abdominal pain
- Nosebleed
- Dizziness
A cancer risk is indicated by data from combined early trials that found 0.5% of patients who took Xolair developed cancer within a year (there were a variety of cancers included), compared to 0.2% of patients taking a control. However, another study14 that followed patients for five years did not find a difference in the incidence of cancer diagnosis between people who took Xolair for asthma and those who didn’t.
Five patients reported their experiences with Xolair to AskAPatient.com. They had been treated for the older indications: asthma, hives and nasal polyps. The users, who are in no way a scientific sample of users and self-report their findings voluntarily, had mostly positive things to say about their experiences.
One patient said she experienced a rash after her last injection. Another said she experienced a “mild headache directly after treatment. High Blood pressure. Aches and pains in joints for about three days after treatment.” Both had commented that the side effects were worth it. One person with chronic hives wrote that she receives monthly injections and can tell when the treatment is starting to wear off near the end of the month because she starts to get itchy again.
Can Xolair Cause Liver Damage?
One 12-month-old in the study had to drop out because of elevated liver enzymes, which is a sign of liver damage. Liver damage appears to be rare, as there were no reports as of 202015 of patients who used the treatment for conditions other than food allergies having had liver problems following use.
Does Xolair Make You Gain Weight?
Steroids, another treatment for allergic reactions, are known to cause weight gain for some patients, but Xolair works differently, and clinical trials so far haven’t shown weight gain as a side effect of treatment with Xolair.
Questions to Ask Your Healthcare Provider Before Starting Xolair for Food Allergies
Before you begin any new treatment, it is best to discuss it thoroughly with your doctor and have all of your questions answered. Some things to consider might include the following:
- How long will treatment last?
- What expectations should I have regarding how this drug will work for me?
- Will the protection wear off over time?
- What side effects have people like me had?
- What symptoms should prompt a call to you? Are there any symptoms for which I should go straight to the emergency room?
- Would carrying an Epipen be sufficient to prevent a reaction from becoming deadly?
- What are the other treatment options for my allergies?
- Is there anything I should avoid doing or taking while I am being treated with Xolair?
- What if I become pregnant during the treatment?
