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.

Associated with Route of Administration (IV) Suggestive of Hypersensitivity Additional Events
Discomfort
Pruritus
Burning
Swelling
Sterile abscess at the site of venipuncture
Anaphylactoid reaction
Pruritus
Flushing
Urticaria
Angioedema
Chest discomfort
Dyspnea
Coughing
Cyanosis
Hypotension
Nausea
Abdominal pain
Vomiting
Diarrhea
Rash
Fatigue
Headache
Fever
Dizziness
Chills
Backache
Tachycardia

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 to Cerezyme during the first year of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity, and these patients have a higher risk of hypersensitivity. It is suggested that patients be monitored periodically for IgG antibody formation during the first year of treatment.

Hypersensitivity has also been observed in patients without detectable IgG antibodies. Symptoms suggestive of hypersensitivity have been noted in approximately 6.6% of all patients, and anaphylactoid reactions in less than 1%. Treatment with Cerezyme should be approached with caution in patients who have exhibited hypersensitivity symptoms such as pruritus, flushing, urticarial, angioedema, chest discomfort, dyspnea, coughing, cyanosis, and hypotension. Pre-treatment with antihistamines and/or corticosteroids and a reduced rate of infusion may allow continued treatment in most patients.

In less than 1% of patients, pulmonary hypertension and pneumonia have been observed during treatment with Cerezyme. These are known complications of Gaucher disease regardless of treatment. Patients with respiratory symptoms in the absence of fever should be evaluated for the presence of pulmonary hypertension.

Approximately 13.8% of patients have experienced adverse events related to treatment with Cerezyme. Some of these are injection site reactions such as discomfort, pruritus, burning, swelling or sterile abscess at the site at the site of venipuncture. Additional adverse reactions that have been reported include nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Transient peripheral edema has also been reported for this therapeutic class of drug.

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).

References

  1. Starzyk K, Richards S, Yee J, Smith SE, Kingma W. The long-term international safety experience of imiglucerase therapy for Gaucher disease. Mol Genet Metab. 2007;90(2):157-163.
Cerezyme has been demonstrated for over 17 years to be an effective treatment for Type 1 Gaucher disease in adults and children.