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Warnings and Precautions

Anaphylaxis and Hypersensitivity Reactions

• Anaphylaxis and serious hypersensitivity reactions have been observed in patients during or up to 3 hours after ALDURAZYME infusions. Some of these reactions were life-threatening and included respiratory failure, respiratory distress, stridor, tachypnea, bronchospasm, obstructive airways disorder, hypoxia, hypotension, bradycardia, and urticaria.
  • If anaphylactic or other serious hypersensitivity reactions occur, immediately discontinue the infusion of ALDURAZYME and initiate appropriate medical treatment.
  • Caution should be exercised if epinephrine is being considered for use in patients with MPS I due to the increased prevalence of coronary artery disease in these patients.
  • Interventions have included resuscitation, mechanical ventilatory support, emergency tracheotomy, hospitalization, and treatment with inhaled beta-adrenergic agonists, epinephrine, and IV corticosteroids.
• In clinical studies and postmarketing safety experience with ALDURAZYME, approximately 1% of patients experienced severe or serious allergic reactions. In patients with MPS I, pre-existing upper airway obstruction may have contributed to the severity of some reactions. Because of the potential for recurrent reactions, some patients who experience initial severe reactions may require prolonged observation.
• The risks and benefits of re-administering ALDURAZYME following an anaphylactic or severe hypersensitivity reaction should be considered. Extreme care should be exercised, with appropriate resuscitation measures available, if the decision is made to re-administer the product.

Acute Respiratory Complications Associated with Administration

• Patients with an acute febrile or respiratory illness at the time of ALDURAZYME infusion may be at greater risk for infusion reactions. Careful consideration should be given to the patient’s clinical status prior to administration of ALDURAZYME and consider delaying ALDURAZYME infusion.
• Sleep apnea is common in MPS I patients. Evaluation of airway patency should be considered prior to initiation of treatment with 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.

Risk of Acute Cardiorespiratory Failure

• Caution should be exercised when administering ALDURAZYME to patients susceptible to fluid overload or patients with an acute underlying respiratory illness or compromised cardiac and/or respiratory function for whom fluid restriction is indicated. These patients may be at risk of serious exacerbation of their cardiac or respiratory status during infusions.
• Appropriate medical support and monitoring measures should be readily available during ALDURAZYME infusion, and some patients may require prolonged observation times that should be based on the individual needs of the patient.

Infusion Reactions

• Because of the potential for infusion reactions, patients should receive antipyretics and/or antihistamines prior to infusion. If an infusion-related reaction occurs, regardless of pre-treatment, decreasing the infusion rate, temporarily stopping the infusion, or administering additional antipyretics and/or antihistamines may ameliorate the symptoms.

Adverse Reactions

Patients 6 years of age and older

• The most common adverse reactions reported in >10% of patients were infusion reactions (32%).  These included rash (36%), flushing (23%), injection site reaction (18%), and paresthesia (14%).  Other common adverse reactions included upper respiratory infection (32%), hyperreflexia (14%), and poor venous access (14%).

Patients 6 months of age and older

• The most common serious adverse events were otitis media (20%) and central venous catheterization required for ALDURAZYME infusion (15%).  The most common adverse reactions reported in >10% of patients were infusion reactions (35%).  These included pyrexia (30%), chills (20%), blood pressure increased (10%), tachycardia (10%), and oxygen saturation decreased (10%).

Please see Full Prescribing Information including Boxed WARNING for Aldurazyme.