Approximately 15% of patients treated and tested to date have developed IgG antibody to Cerezyme ® (imiglucerase for injection) during the first year of therapy. Patients who developed IgG antibody largely did so 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 hypersentivity reaction. Conversely, not all patients with symptoms of hypersensitivity have detectable IgG antibody. It is suggested that patients be monitored periodically for IgG antibody formation during the first 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 less than 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.

General

In less than 1% of the patient population, pulmonary hypertension has also been observed during treatment with Cerezyme ®. Pulmonary hypertension is a known complication of Gaucher disease, and has been observed both in patients receiving and not receiving Cerezyme ®. No causal relationship with Cerezyme ® has been established. Patients with respiratory symptoms should be evaluated for the presence of pulmonary hypertension.

Therapy with Cerezyme ® (imiglucerase for injection) should be directed by physicians knowledgeable in the management of patients with Gaucher disease.

Caution may be advisable in administration of Cerezyme ® to patients previously treated with Ceredase® and who have developed antibody to Ceredase® or who have exhibited symptoms of hypersensitivity to Ceredase®.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been conducted in either animals or humans to assess the potential effects of Cerezyme ® (imiglucerase for injection) on carcinogenesis, mutagenesis, or impairment of fertility.

Teratogenic Effects: Pregnancy Category C

Animal reproduction studies have not been conducted with Cerezyme ® (imiglucerase for injection). It is also not known whether Cerezyme ® can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Cerezyme ® should not be administered during pregnancy except when the indication and need are clear and the potential benefit is judged by the physician to substantially justify the risk.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cerezyme ® (imiglucerase for injection) is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Cerezyme® (imiglucerase for injection) have been established in patients between 2 and 16 years of age. Use of Cerezyme® in this age group is supported by evidence from adequate and well-controlled studies of Cerezyme® and Ceredase® (alglucerase injection) in adults and pediatric patients, with additional data obtained from the medical literature and from long-term postmarketing experience. Cerezyme® has been administered to patients younger than 2 years of age, however the safety and effectiveness in patients younger than 2 have not been established.

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