Latebreakers: Xolair anaphylaxis risk added to label

July 23, 2007

A boxed warning label has been added for omalizumab (Xolair, Genentech),

A boxed warning label has been added for omalizumab (Xolair, Genentech), and the Warnings, Precautions, and Adverse Reactions sections of the prescribing information have been modified to indicate the risk of anaphylaxis following administration of the asthma therapy. In all, three cases of anaphylaxis were reported during clinical trials and 124 case reports were made since the drug's approval. According to the FDA, 39% of the anaphylaxis cases occurred after the first dose of omalizumab, 19% followed the second dose, and 10% resulted from the third dose. One case occurred after 29 doses. Therefore, omalizumab should be administered to patients only in a healthcare setting under direct medical supervision. An updated Medication Guide has also been developed and should be distributed with each new prescription and refill. Xolair is approved to treat adults and adolescents (12 years and older) with moderate to severe persistent asthma whose symptoms are inadequately controlled with inhaled corticosteroids.