Warnings and Precautions
Hypersensitivity Reactions Including Anaphylaxis: See Boxed WARNING.
- Pre-existing upper airway obstruction may contribute to the severity of some reactions. Consider premedicating patients with antihistamines, with or without antipyretics. Because of the potential for recurrent reactions, some patients who experience initial severe reactions may require prolonged observation.
- Consider risks and benefits of re-administering ALDURAZYME following severe hypersensitivity reactions. Patients may be rechallenged using slower infusion rates which may be increased if tolerated to reach the recommended rate. If a mild or moderate hypersensitivity reaction occurs, consider temporarily holding the infusion or slowing the infusion rate.
Acute Respiratory Complications Associated with Administration: See Boxed WARNING.
- Patients with an acute febrile or respiratory illness may be at greater risk for infusion reactions. Consider the patient’s clinical status prior to administration of ALDURAZYME and consider delaying the infusion.
- Evaluation of airway patency should be considered prior to initiating ALDURAZYME. Patients using supplemental oxygen or continuous positive airway pressure (CPAP) during sleep should have these treatments readily available during infusion in the event of an infusion reaction or extreme drowsiness/sleep induced by antihistamine use.
Acute Cardiorespiratory Failure:
- Use caution when administering ALDURAZYME to patients susceptible to fluid overload, or with an acute underlying respiratory illness or compromised cardiac and/or respiratory function for whom fluid restriction is indicated. Consider a decreased total infusion volume and infusion rate when administering ALDURAZYME to these patients.
Infusion-Associated Reactions:
- ALDURAZYME may cause infusion-associated reactions (IARs). Consider pre-medicating with antihistamines, with or without antipyretics, however IARs may still occur in patients after receiving pre-medication. Discontinue immediately or adjust the infusion rate based on the severity of the reaction.
Adverse Reactions
Patients 6 months of age and older
- The most common adverse reactions reported in ≥10% of patients were infusion reactions, which included pyrexia, chills, blood pressure increased, tachycardia, and oxygen saturation decreased.
Patients 6 years of age and older
- The most common adverse reactions reported in ≥10% of patients were rash, upper respiratory tract infection, injection site reaction, hyperreflexia, paresthesia, flushing, and poor venous access.
Please see Full Prescribing Information including Boxed WARNING for Aldurazyme.
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