Omalizumab (Xolair, Genentech) injection is approved to treat moderate-to-severe persistent asthma in adults and adolescents 12 years of age and older who have a positive skin test or reactivity in vitro to a perennial aeroallergen and who have not responded adequately to inhaled corticosteroids.
The FDA mandated the revised label because some patients receiving Xolair can experience anaphylaxis. This life-threatening reaction can occur at any dose and up to 24 hours later—even if the patient had no reaction to the first dose.
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A boxed warning, as well as updated warnings, precautions, and adverse reactions, have been added. A medication guide about the risk of anaphylaxis must be distributed to patients with each dose of omalizumab.