POTENTIAL SIDE EFFECTS

What are the possible side effects of Aldurazyme?

ALDURAZYME may cause serious side effects, including:

Anaphylaxis, Hypersensitivity, and Infusion-Associated Reactions (IARs)

Inform the patient or caregiver that hypersensitivity reactions, including life-threatening, allergic-type reactions known as anaphylaxis, and infusion reactions may occur with ALDURAZYME treatment. Advise the patient or caregiver to report immediately to an HCP if signs or symptoms of a hypersensitivity or IARs occur during or following the infusion of ALDURAZYME.

Cardiac and Respiratory Adverse Reactions

Advise the patient or caregiver to report immediately to an HCP if signs or symptoms of severe cardiac or respiratory failure occur during or following an infusion. Inform patients of 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.

Most common adverse reactions of ALDURAZYME (≥10%) in patients:

• 6 months of age and older are infusion reactions [fever (pyrexia), chills, blood pressure increased, increased heart rate (tachycardia), and less oxygen in the blood (oxygen saturation decreased)]
• 6 years and older are rash, upper respiratory tract infection, injection site reaction, overactive bodily reflexes (hyperreflexia), “pin-and-needles sensation” (paresthesia), flushing, and poor venous access

Tell your HCP if you get new or worsening signs or symptoms during or following treatment with ALDURAZYME.

These are not all of the possible side effects of ALDURAZYME. If you experience any side effects, it’s important to tell your HCP right away. You can also report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.