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Studies have shown that asthma in children that is caused by allergies to specific environmental allergens (e.g., dust; mites; pollen) can benefit from immunotherapy. The traditional way of giving immunotherapy is by an "allergy shot" where a small amount of the allergen (the substance to which the patient is allergic) is injected into the body. Allergy shots help the body to fight the allergen by producing specific antibodies which neutralize the allergen before it can set-off a severe allergic reaction. After many allergy shots, many patients build up sufficient resistance to the allergen so that their symptoms become less severe.

Immunotherapy can also be adminstered by allergy drops that are placed under the tongue - a method called sublingual allergy immunotherapy. The principle of sublingual allergy immunotherapy is similar to "allergy shots" - to boost the body's antibodies against a specific allergen to which the patient is allergic. Rather than injecting the allergen, however, the allergen is produced in the form of drops that are administered under the tongue. Although sublingual immunotherapy is used routinely in Europe, it is still considered as an investigational treatment in the United States and is, therefore, not covered by most health insurance plans. Studies have shown that both bypes of immunotherapy, allergy shots and sublingual, are effective for controlling asthma in children whose symptoms are triggered by environmental allergens.

Recently, a newer type of immunotherapy using a monoclonal antibody called omalizumab (Xolair) became available for the treatment of allergic childhood asthma. Omalizumab is administered by subcutaneous injection under the skin and works by blocking the action of an antibody called immunoglobulin E (IgE) which the underlying cause of allergic asthma. Omalizumab is approved for:

• Children 12 years of age or older
• Have moderate to severe persistent asthma
• Have asthma that is triggered by environmental allergens
• People whose symptoms cannot be adequately controlled with inhaled corticosteroids

In February 2007, the FDA notified asthmatic patients and healthcare professionals of new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair. Usually these reactions occur within two hours of receiving a Xolair subcutaneous injection. However, these new reports include patients who had delayed anaphylaxis-with onset two to 24 hours or even longer-after receiving Xolair treatment.Anaphylaxis may occur after any dose of Xolair (including the first dose), even if the patient had no allergic reaction to the first dose.

Health care professionals who administer Xolair should be prepared to manage life-threatening anaphylaxis and should observe their Xolair-treated patients for at least two hours after Xolair is given. Patients under treatment with Xolair should be fully informed about the signs and symptoms of anaphylaxis, their chance of developing delayed anaphylaxis following Xolair treatment, and how to treat it when it occurs.

The FDA has requested Genentech add a boxed warning to the product label and to revise the label and provide a Medication Guide for patients.