Aldurazyme Patient Counseling Information

Anaphylaxis, Hypersensitivity and Infusion Reactions: Inform the patient or caregiver that hypersensitivity reactions, including life-threatening anaphylaxis and infusion reactions may occur with ALDURAZYME treatment. Advise the patient or caregiver to report immediately to a healthcare provider if signs or symptoms of a hypersensitivity or infusion reaction occur during infusion of ALDURAZYME. Hypersensitivity reactions may also occur up to 3 hours following an infusion of ALDURAZYME (see Warnings and Precautions).
Cardiac and Respiratory Adverse Reactions: Advise the patient or caregiver to report immediately to a healthcare provider if signs or symptoms of cardiac or respiratory decompensation occur during or following an infusion (see Precautions). Inform patients using supplemental oxygen or continuous positive airway pressure (CPAP) during sleep to have these treatments readily available during infusion or extreme drowsiness/sleep induced by antihistamine use.
Registry: Patients should be informed that a registry for MPS I patients has been established in order to better understand the MPS I disease, and to track clinical outcomes of patients with MPS I over time. The MPS I Registry also monitors the effect of Aldurazyme on pregnant women, lactating women, and their infants. Patients should be encouraged to participate and advised that their participation is voluntary and may involve long-term follow-up. Information regarding the registry program may be found at www.registrynxt.com or email at: Med.SAMS@sanofi.com