Drug Information for ELAPRASE™ (idursulfase) Solution for intravenous infusionInitial U.S. Approval: 2006 (Shire US Manufacturing Inc.): WARNING: Risk of Anaphylaxis

  • Life-threatening anaphylactic reactions have been observed in some patients during ELAPRASE infusions. Therefore, appropriate medical support should be readily available when ELAPRASE is administered. Biphasic anaphylactic reactions have also been observed after ELAPRASE administration and patients who have experienced anaphylactic reactions may require prolonged observation. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to infusion reactions, and require additional monitoring.

  • Drug Information Provided by National Library of Medicine (NLM).