Cerezyme Warnings

Approximately 15% of patients treated and tested to date have developed IgG antibody to Cerezyme during the 1st year of therapy. Patients who developed IgG antibody did so largely within 6 months of treatment, and rarely developed antibodies to Cerezyme after 12 months of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity.
Patients with antibody to Cerezyme have a higher risk of hypersensitivity reaction. Conversely, not all patients with symptoms of hypersensitivity have detectable IgG antibody. It is suggested that patients should be monitored periodically for IgG antibody formation during the 1st year of treatment.
Treatment with Cerezyme should be approached with caution in patients who have exhibited symptoms of hypersensitivity to the product.
Anaphylactoid reaction has been reported in <1% of the patient population. Further treatment with imiglucerase should be conducted with caution. Most patients have successfully continued therapy after a reduction in rate of infusion and pretreatment with antihistamines and/or corticosteroids.