Medication Adverse Event Alert

July 3, 2007

ISSUE:	*New Boxed Warning, and updated WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS sections to address the risk of delayed anaphylaxis reaction with Xolair®
	*(please also refer to RxAmerica Medication Adverse Event news letter on omalizumab dated February 21, 2007)
MEDICATION:	Xolair® (omalizumab)

The following update was posted on FDA Med Watch alert website dated July 2, 2007:

"Genetech and FDA informed healthcare professionals and asthmatic patients that the prescribing information for 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 Xolair is filled or refilled at the pharmacy. Due to the risk of anaphylaxis, Xolair 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 Xolair injection."

An excerpt of the accompanying FDA news letter is provided below:

"The boxed warning emphasizes that Xolair, used to treat patients with asthma related to allergies, may cause anaphylaxis. Anaphylaxis may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat. In addition, FDA has asked Genentech to revise the Xolair label and provide a Medication Guide for patients to strengthen the existing warning for anaphylaxis. Due to the nature of continued reports in the post-marketing experience, including their lifethreatening potential, frequency, and the possibility for the delayed onset of anaphylaxis, FDA has now requested that Genentech, Inc., add the boxed warning and strengthen the existing warning. The strengthened warning includes the possibility of a patient developing anaphylaxis after any dose of Xolair, even if there was no reaction to the first dose. Also, anaphylaxis after administration of Xolair may be delayed up to 24 hours after the dose is given. Health care providers should be prepared to manage life-threatening anaphylaxis following Xolair administration and observe patients for at least two hours after an injection. Following administration of Xolair, patients should also carry and know how to initiate emergency self-treatment for anaphylaxis."

RxAmerica specialty pharmacy program notice:

The dispensing and clinical monitoring of Xolair is exclusively handled through one of these specialty pharmacy networks, Caremark Rx, CuraScript , Accredo Nova Factor, or Option Care. All questions pertaining to a specific Xolair prescription should be directed to your particular provider.