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What you need to know about Xolair and food allergies

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The Food and Drug Administration approved a drug this month reduces the risk of serious reactions in children and adults exposed to trace amounts of peanuts, tree nuts, milk, dairy and other food allergens – a move that could dramatically improve the quality of life for people dealing with these risks. Clinical trial results supporting the decision were published on Sunday.

Although the drug,

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 chance that people with severe food allergies will develop acute reactions if they ingest small amounts of allergens, such as peanuts or eggs in prepared foods, or are otherwise exposed to trace amounts.

People must take the drug continuously to benefit from its protection. Even then, the drug does not completely eliminate the risk.

Xolair is a synthetic antibody that works by binding to immunoglobulin E, a part of the immune system, preventing it from arming key immune cells responsible for causing allergic reactions.

Xolair helps protect against most serious allergic reactions, especially those caused by immunoglobulin E. The drug may be most beneficial for people who are allergic to multiple foods and must continually avoid them all, which can be challenging, and for those who eat a lot of foods prepared by others (such as students on meal plans).

It is approved for adults and for children from 1 year of age. (Infants under 1 year old were not included in the clinical trial.)

Xolair reduces, but does not eliminate, the risk of a serious reaction to certain foods. People with these allergies should remain vigilant and avoid the foods they are allergic to; they should read food labels and inform others about their allergies. They or their caregivers should continue to carry epinephrine at all times, a medication that can reverse the symptoms of anaphylaxis.

A disadvantage of the drug is that it must be given by injection, usually in the arm. The injections are given every two to four weeks, with dosing intervals tailored to the patient.

Participants in the clinical trial were found to have benefited after 16 to 20 weeks of treatment. But protection against severe reactions appears to last only as long as patients continue treatment.

Although the drug has only recently been shown to reduce the risks of food allergies, it has been on the market for two decades for other uses, including asthma caused by allergies and chronic hives. The safety profile is therefore reasonably well known.

The most common side effects experienced by participants in the recent study were injection site reactions and fever. In rare cases, the drug itself can cause life-threatening anaphylaxis: according to the FDA, this has been shown to occur after the first dose of Xolair, as well as a year or more after starting treatment.

Therefore, Xolair should be administered in a healthcare setting equipped to manage anaphylaxis. The label also warns of rare side effects such as joint pain, rashes and parasitic infections.

Although Xolair has been used for other conditions since 2003 and the National Institutes of Health helped fund the new trial, Xolair has a hefty list price: According to Genentech, it costs about $2,900 per month for children with food allergies and about $5,000 for adults. , the manufacturer.

But now that it’s approved for severe food allergies, insurance plans are expected to at least partially cover it. Patient assistance programs are available through Genentech Access Solutions.

For eligible patients who have commercial health insurance, Genentech also offers the Xolair Co-Pay Programwhich can help cover the cost of treatment.

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