Prescribing Information Change To Asthma Med

July 17, 2007

The full prescribing information for omalizumab (Xolair) injection has been revised to include a new Boxed Warning and updated Warnings, Precautions, and Adverse Reactions sections to address the risk of anaphylaxis (the onset of action can be delayed for 24 hours or more) when taking this medication [more].

The full prescribing information for omalizumab (Xolair) injection has been revised to include a new Boxed Warning and updated Warnings, Precautions, and Adverse Reactions sections to address the risk of anaphylaxis (the onset of action can be delayed for 24 hours or more) when taking this medication. A new Medication Guide was also developed and will be provided to patients when a prescription for the drug is filled or refilled at the pharmacy. Due to the risk of anaphylaxis, omalizumab should only be administered to patients in a health care setting under direct medical supervision. Patients should be observed for an appropriate period of time following each injection.

Earlier this year, the FDA notified asthmatic patients and health care professionals of new reports of serious and life-threatening allergic reactions in patients after treatment with omalizumab. Typically the reactions occurred within two hours of receiving a subcutaneous injection. However, these new reports included patients who had delayed anaphylaxis-with onset two to 24 hours, or even longer-after receiving an injection. Anaphylaxis may occur after any dose of omalizumab (including the first dose), even if the patient had no allergic reaction to the first dose.

Omalizumab is prescribed for the treatment of adults and adolescents (12 years of age and older) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen, and whose symptoms are inadequately controlled with inhaled corticosteroids. To report an adverse event associated with this drug, contact the FDA’s Medwatch program online at www.fda.gov/medwatch/index.html, or by telephone at 800-FDA-1088.