Aldurazyme Patient Counseling Information

Hypersensitivity Reactions (Including Anaphylaxis) and Infusion-Associated Reactions (IARs): Advise the patient or caregiver that reactions related to the infusion may occur during and up to 3 hours after ALDURAZYME treatment, including life-threatening hypersensitivity reactions, including anaphylaxis, and IARs. Inform the patient and caregiver of the signs and symptoms of hypersensitivity reactions and IARs and to seek medical care should signs and symptoms occur (see Warnings and Precautions).
Cardiac and Respiratory Adverse Reactions: Advise the patient and/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 Warnings and 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: Inform the patient and/or caregiver 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. Additionally, the MPS I Registry also monitors the effect of Aldurazyme on pregnant women, lactating women, and their infants. Encourage the patient and/or caregiver to contact the registry program by visiting www.registrynxt.com or email at: Med.SAMS@sanofi.com.