According to estimates from the American Academy of Allergy, Asthma & Immunology, at least 50% of Americans with asthma have allergic asthma. For these individuals, an asthma attack can be caused by an inhaled allergen such as dust, mold, pollen, or smoke. Generally, the allergen causes the body to make excessive amounts of immunoglobulin E (IgE), a substance normally produced by the immune system to fight infections. An allergic response occurs after IgE binds to receptors (specialized places on cells that recognize and attract specific substances) on certain white blood cells. Two results are inflammation and tightening of the muscles in the airways.

Presently, omalizumab (Xolair) is the only monoclonal antibody approved for treating asthma. It is mainly for individuals who have moderate-to-severe persistent allergic asthma that no longer responds well to treatment with other asthma medications. Omalizumab prevents the allergic reaction by keeping IgE from binding to receptors. Treatment with omalizumab also reduces the number of IgE receptors on some of the white blood cells responsible for the reaction.

Drugs in this Class
Omalizumab Solution for Injection (Omalizumab (Hamster) Solution for Injection, Xolair Solution for Injection)

Summarizing the Evidence

• Currently, omalizumab is used as a second-line controller agent for patients with moderate-to-severe persistent allergic asthma that standard asthma therapy does not control.
• Omalizumab should not be used for the treatment of acute asthma exacerbations (attacks).
• Clinical trials evaluated omalizumab's effectiveness for preventing asthma symptoms, reducing the number of asthma attacks, and decreasing the need to use corticosteroids. Omalizumab relieved allergic asthma symptoms better than placebo (inactive injections) when it was combined with inhaled and/or oral corticosteroids.
• Patients who required high doses of corticosteroids, needed frequent emergency asthma treatments, or had poor lung function benefited most from omalizumab in clinical studies.
• Corticosteroids should not be discontinued abruptly if treatment with omalizumab is started. Decreases in corticosteroids should be performed gradually under the direct supervision of a physician.
• The cost-effectiveness of omalizumab therapy must be evaluated on a patient-by-patient basis. Generally, however, the selection of add-on asthma therapy typically depends on the doctor's preference, the patient's experience with previous treatment, and other medications the patient may be taking (to avoid potential drug interactions).
• Anaphylactic (severe allergic) reactions have occurred in about one out of 1,000 individuals using omalizumab. Symptoms of an anaphylactic reaction may be life-threatening. They can include fainting, difficult breathing, chest tightness, and swelling of the tongue and/or throat. Once thought to occur with an hour or two of the injection, anaphylactic reactions are now known to happen 24 hours or more after a dose of omalizumab. In 2007, the U.S. Food and Drug Administration required a warning about anaphylactic reactions to be placed on the omalizumab label.
• Injection-site reactions, including bruising, burning, hives, inflammation, itching, pain, redness, and stinging, may occur with omalizumab. In a clinical trial, over 40 percent of the participants in both the omalizumab-treated group and placebo-treated group had injection-site reactions. Most injection-site reactions occurred within an hour, lasted less than 8 days, and decreased after several injections.
• In clinical trials, 0.5% of patients receiving omalizumab developed various forms of cancer as compared to 0.2% in the placebo group. The exact reason for the increase is not known. Although these results suggests that omalizumab may slightly increase the risk of cancer, more studies are needed to determine the role, if any, of omalizumab in causing cancer.

Dosage and Administration

• The U.S. Food and Drug Administration (FDA) has approved omalizumab for treating moderate-to-severe persistent asthma in individuals who are at least 12 years of age, who have a positive skin test for a perennial airborne allergen, and who have asthma symptoms that are not controlled by inhaled corticosteroids.
• Omalizumab injections are given in a doctor's office or clinic.
• Doses and dosing frequency for omalizumab are determined by measuring the patient's weight and the amount of IgE in the blood.
• Recommended doses for omalizumab range from 150 mg to 375 mg given as one injection to three injections subcutaneously (under the skin) every two weeks or four weeks. Doses over 150 mg are given in more than one injection to lessen the risk of injection-site reactions.
• Because the solution is relatively thick, the injections may take as much as 10 seconds to administer.

Generic Availability

• Omalizumab is not available as a generic.

Drug Interactions

Some interactions between medications can be more severe than others. The best way for you to avoid harmful interactions is to tell your doctor and/or pharmacist what medications you are currently taking, including any over-the-counter products, vitamins, and herbals. For specific information on how the drugs interact and the severity of the interaction, please use our Drug Interactions Checker.

Side Effects

To view specific side effect information, please use our Side Effect Checker.

Additional Information

References

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Last Updated: September 2008

Note: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking any medication.

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