The Food and Drug Administration this month approved a drug that reduces the risk of serious reactions in children and adults exposed to traces of peanuts, tree nuts, milk, dairy products and other food allergens, a measure that could dramatically improve the quality of life of people facing these risks. Clinical trial results supporting the decision were released Sunday.
While the drug Xolair offers a new layer of protection to people who may have life-threatening reactions to common foods, and especially those who are allergic to multiple foods, its use comes with important caveats.
Does Xolair cure food allergies?
No. Xolair does not cure food allergies nor can it be used to treat acute reactions. People taking Xolair should continue to avoid foods to which they are allergic.
But Xolair can significantly reduce the chances that people with severe food allergies will develop acute reactions if they eat trace amounts of allergens, such as peanuts or eggs in prepared foods, or are exposed to trace amounts in some other way.
People must take the medication continuously to benefit from its protection. Even then, the drug does not completely eliminate the risk.
How does it work?
Xolair is a synthetic antibody that works by binding to immunoglobulin E, a component of the immune system, preventing it from assembling key immune cells that are responsible for triggering allergic reactions.
Who benefits most from taking Xolair?
Xolair helps protect against more serious allergic reactions, specifically those caused by immunoglobulin E. The medication may be most beneficial for people who have allergies to multiple foods and must constantly avoid all of them, which can be challenging, and for whom They eat a lot of foods prepared by other people (like college students with meal plans).
It is approved for adults and children 1 year and older. (Infants under 1 year of age were not included in the clinical trial.)
How well does it work?
Xolair reduces, but does not eliminate, the risk of having a serious reaction to a certain food. People with these allergies should continue to be extremely vigilant and avoid foods to which they are allergic; They should read food labels and tell others about their allergies. They or their caregivers should continue to carry epinephrine, a medication that can reverse the symptoms of anaphylaxis, at all times.
How is Xolair administered?
A disadvantage of the medication is that it must be administered by injection, usually in the arm. Injections are administered every two to four weeks, at dosing intervals tailored to the patient.
Participants in the clinical trial were found to benefit after 16 to 20 weeks of treatment. But protection against serious reactions appears to last only as long as patients continue treatment.
Does Xolair have side effects? Is it safe for long term use?
Although the drug was recently shown to reduce the risks of food allergies, it has been on the market for 20 years for other uses, including asthma caused by allergies and chronic hives. Therefore, its safety profile is quite well known.
The most common side effects experienced by participants in the recent trial were injection site reactions and fever. In rare cases, the drug itself can cause life-threatening anaphylaxis—it has been shown to occur after the first dose of Xolair, according to the FDA, as well as a year or more after starting treatment.
For this reason, Xolair should be administered in a healthcare setting equipped to treat anaphylaxis. The label also warns of rare side effects such as joint pain, rash, and parasitic infection.
How much does Xolair cost? Is it covered by insurance?
Although Xolair has been used for other conditions since 2003 and the National Institutes of Health helped fund the new trial, Xolair has a high list price: about $2,900 a month for children with food allergies and about $5,000 for adults, according to Genentech. , the manufacturer.
But now that it’s approved for severe food allergies, insurance plans are expected to cover it at least in part. Patient assistance programs are available through Genentech Access Solutions.
For eligible patients who have commercial health insurance, Genentech also offers the Xolair Copay Programwhich can help cover the cost of treatment.
