Drug Information for ELAPRASE™ (idursulfase) Solution for intravenous infusionInitial U.S. Approval: 2006 (Shire US Manufacturing Inc.): 17. PATIENT COUNSELING INFORMATION

  • See FDA-Approved Patient Labeling (17.2)

  • 17.1 Information for Patients

  • A Hunter Outcome Survey has been established in order to understand better the variability and progression of Hunter syndrome (MPS II) in the population as a whole, and to monitor and evaluate long-term treatment effects of ELAPRASE. Patients and their physicians are encouraged to participate in this program. For more information, visit www.ELAPRASE.com or call OnePathSM at 1-866-888-0660.

    Physicians are advised to discuss the following issues with patients for whom they prescribe ELAPRASE:

  • Risk of anaphylaxis

    Potentially life-threatening anaphylactic reactions have been observed in some patients during ELAPRASE infusions. Reactions have included respiratory distress, hypoxia, hypotension, seizure, loss of consciousness, urticaria and/or angioedema of the throat or tongue. [see WARNINGS AND PRECAUTIONS (5.1)]

  • Biphasic anaphylactic reactions

    Biphasic anaphylactic reactions have also been reported to occur after administration of ELAPRASE approximately 24 hours after treatment and recovery from an initial anaphylactic reaction that occurred during ELAPRASE infusion. A biphasic anaphylactic reaction is a term used to describe a situation where a patient experiences an initial reaction at the time of contact with a drug, and then experiences, approximately 24 hours later, a usually milder occurrence of the same symptoms. [see WARNINGS AND PRECAUTIONS (5.1)]

  • Compromised respiratory function or acute respiratory disease

    Patients with compromised respiratory function or acute respiratory disease may be at higher risk of life-threatening complications from infusion reactions. Consider delaying the ELAPRASE infusion in patients with concomitant acute respiratory and/or febrile illness. [see WARNINGS AND PRECAUTIONS (5.1)]

  • Pregnancy and Nursing Mothers

    It is not known whether ELAPRASE can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. ELAPRASE should be given to pregnant women only if clearly needed. [see Pregnancy (8.1)]

    It is not known whether this product is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ELAPRASE is administered to a nursing woman. [see Nursing Mothers (8.3)]

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