Safety

Immunologic Adverse Events

Approximately 15% of patients treated and tested to date have developed IgG antibody to Cerezyme during the first year of therapy:¹

• Largely within first 6 months, rarely after 12 months of therapy

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

• 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity
• Not all patients with symptoms of hypersensitivity have detectable IgG antibodies

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

Periodic monitoring for IgG antibody formation during the first year of treatment is suggested.

Common Adverse Events

Approximately 13.8% of patients have experienced adverse events. Each occurred in <1.5% of the total patient population.

Safety Monitoring

The 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 Information at 800-745-4447, option 2. Please see full prescribing information.

Indication & Usage

Cerezyme^® (imiglucerase for injection) is indicated for long-term enzyme replacement therapy for pediatric and adult patients with a confirmed diagnosis of Type 1 Gaucher disease that results in one or more of the following conditions:

1. anemia
2. thrombocytopenia
3. bone disease
4. hepatomegaly or splenomegaly

Important Safety Information

Approximately 15% of patients have developed IgG antibodies, and these patients have a higher risk of hypersensitivity reaction. Therefore periodic monitoring is suggested; caution should be exercised in patients with antibodies or prior symptoms of hypersensitivity. Symptoms suggestive of hypersensitivity occurred in 6.6% of patients, and include anaphylactoid reaction, pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, coughing, cyanosis and hypotension.

Reactions related to Cerezyme administration have been reported in less than 15% of patients. Each of the following events occurred in less than 2% of the total patient population. Reported adverse events include nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Adverse events associated with the route of administration include discomfort, pruritus, burning, swelling or sterile abscess at the site at the site of injection.

To report suspected adverse reactions, contact Genzyme at 800-745-4447, option 2 or FDA at 800-FDA-1088 or http://www.fda.gov/Safety/MedWatch

Please see Full Prescribing Information (PDF).