Adverse Events*

* approximately 13.8% of patients reported adverse events. Each occurred in <1.5% of the total patient population

Safety Monitoring

A worldwide voluntary adverse events database maintained since 1994

Approximately 13.8% of patients have experienced adverse events judged to be related to Cerezyme® (imiglucerase for injection) administration and which occurred with an increase in frequency

Most commonly reported adverse events:

In children (2-12 years) – dyspnea, fever, nausea, flushing, vomiting, coughing

In adolescents (>2 – 16 years) and adults (>16 years) – headache, pruritus, rash

Side effects should be reported promptly to Genzyme Medical Affairs at 800-745-4447, option 2.

Immunology

Approximately 15% of patients have developed IgG antibody to Cerezyme^® during the first year of therapy

Largely within first 6 months, rarely after 12 months

Patients with antibody to Cerezyme^® have a higher risk of hypersensitivity reaction

46% of patients with IgG experience symptoms of hypersensitivity

Not all patients with symptoms of hypersensitivity have IgG antibody

Anaphylactoid reactions have been reported in <1% of patients. Further treatment with Cerezyme^® 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

No Cerezyme^® patients tested to date have been positive for serum IgE*

Periodic monitoring is suggested

*Data on file, Genzyme Corporation