Anaphylaxis and Allergic Reactions (see BOXED WARNING)

Life-threatening anaphylactic reactions have been observed in some patients during or up to three hours after ALDURAZYME infusions. Reactions have included respiratory failure, respiratory distress, stridor, tachypnea, bronchospasm, airway obstruction, hypoxia, hypotension, bradycardia, and urticaria. Interventions have included resuscitation, mechanical ventilatory support, emergency tracheotomy, hospitalization, and treatment with inhaled beta-adrenergic agonists, epinephrine, and intravenous corticosteroids.

In clinical trials and post-marketing 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. Due to the potential for severe allergic reactions, appropriate medical support should be readily available when ALDURAZYME is administered. Because of the potential for recurrent reactions, some patients who experience initial severe reactions may require prolonged observation.

Patients with an acute illness at the time of ALDURAZYME infusion appear to be at greater risk for infusion-related reactions. Careful consideration should be given to the patient's clinical status prior to administration of ALDURAZYME. One patient with acute bronchitis and hypoxia experienced increased tachypnea during the first ALDURAZYME infusion that resolved without intervention. The patient's respiratory symptoms returned within 30 minutes of completing the infusion and responded to bronchodilator therapy. Approximately six hours after the infusion, the patient experienced coughing, then respiratory arrest, and died.

Patients should receive antipyretics and/or antihistamines prior to infusion (see ADVERSE REACTIONS). If an infusion reaction occurs, regardless of pre-treatment, decreasing the infusion rate, temporarily stopping the infusion, and/or administration of additional antipyretics and/or antihistamines may ameliorate the symptoms (see ADVERSE REACTIONS).

If anaphylactic or other severe allergic reactions occur, immediately discontinue the infusion of ALDURAZYME and initiate appropriate 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.

The risks and benefits of re-administering ALDURAZYME following an anaphylactic or severe allergic reaction should be considered. Extreme care should be exercised, with appropriate resuscitation measures available, if the decision is made to re-administer the product.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies to assess the mutagenic and carcinogenic potential of ALDURAZYME have not been conducted.

Reproductive studies in rats have not demonstrated impairment of fertility (see PRECAUTIONS:Pregnancy).

Pregnancy: Category B

Reproduction studies have been performed in male and female rats at doses up to 6.2 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ALDURAZYME. However, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ALDURAZYME should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ALDURAZYME is administered to a nursing woman (see PRECAUTIONS: Information for Patients regarding a registry program. Nursing women are encouraged to participate in this program.).

Pediatric Use

Patients younger than 5 were not included in the clinical studies because of inability to comply with efficacy outcome assessments. It is not known if children younger than 5 respond differently from older children.

Geriatric Use

Clinical studies of ALDURAZYME did not include patients aged 65 and over. It is not known whether they respond differently from younger patients.

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