Risk of Anaphylaxis

• Life-threatening anaphylactic reactions have occurred in some patients during and up to 24 hours after ELAPRASE infusions.
• Anaphylaxis, presenting as respiratory distress, hypoxia, hypotension, urticaria and/or angioedema of throat or tongue have been reported to occur during and after ELAPRASE infusions, regardless of duration of the course of treatment.
• Closely observe patients during and after ELAPRASE administration and be prepared to manage anaphylaxis.
• Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions, and require additional monitoring