Special Alerts:

[UPDATE 07/02/2007] Genetech and FDA informed healthcare professionals and asthmatic patients that the prescribing information for omalizumab (Xolair) was revised to include a new BOXED WARNING, and updated WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections that address the risk of anaphylaxis (the onset of action can be delayed for 24 hours or more) when taking this medication. In addition, a new MEDICATION GUIDE was developed and will be provided to patients when a prescription for omalizumab is filled or refilled at the pharmacy. Due to the risk of anaphylaxis, omalizumab should only be administered to patients in a healthcare setting under direct medical supervision. Patients should be observed for an appropriate period of time following each omalizumab injection. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Xolair , http://www.fda.gov/cder/drug/InfoSheets/HCP/omalizumabHCP.htm, http://www.fda.gov/cder/foi/label/2007/103976s5102lbl.pdf and http://www.fda.gov/cder/foi/label/2007/103976s5102mg.pdf.

[Posted 02/21/2007] FDA notified asthmatic patients and healthcare professionals of new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with omalizumab (Xolair). Usually these reactions occur within two hours of receiving a omalizumab subcutaneous injection. However, these new reports include patients who had delayed anaphylaxis—with onset two to 24 hours or even longer—after receiving omalizumab treatment. Anaphylaxis may occur after any dose of omalizumab (including the first dose), even if the patient had no allergic reaction to the first dose. Health care professionals who administer omalizumab should be prepared to manage life-threatening anaphylaxis and should observe their omalizumab-treated patients for at least two hours after omalizumab is given. Patients under treatment with omalizumab should be fully informed about the signs and symptoms of anaphylaxis, their chance of developing delayed anaphylaxis following omalizumab treatment, and how to treat it when it occurs. FDA has requested Genentech add a boxed warning to the product label and to revise the omalizumab label and provide a Medication Guide for patients to strengthen the existing warning for anaphylaxis. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Xolair, http://www.fda.gov/cder/drug/infopage/omalizumab/default.htm and http://www.fda.gov/bbs/topics/NEWS/2007/NEW01567.html.