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... View more

Overview of Studies

Cerezyme is the ONLY ERT (enzyme replacement therapy) that has shown long-term efficacy and safety in multiple studies over 10 years and has been prescribed for over 20 years.1-3

View Indications and Usage

Cerezyme efficacy & safety studies overview

Cerezyme was proven to be safe and effective in clinical trials, and efficacy has also been shown in multiple studies from the International Collaborative Gaucher Group (ICGG) Registry. The long-term safety of Cerezyme was shown in an international monitoring database.3-8

Explore the findings of 6 studies demonstrating the efficacy of Cerezyme in visceral, hematologic, and certain bone parameters in adult and pediatric populations.3-8

Visceral &
Hematologic Data
Bone Data Pediatric Data

9-Month Pivotal Trial4

Parameters assessed: visceral & hematologic parameters

48-Month, Long-Term Prospective Study5

Parameters assessed: bone mineral density (BMD) & bone crises

8-Year, Long-Term Registry Study8*

Parameters assessed: visceral, hematologic & bone parameters

10-Year, Long-Term Registry Study3*

Parameters assessed: visceral, hematologic & bone parameters

4-year, Long-Term Registry Study7

Parameters assessed: bone pain & bone crises

8-Year, Long-Term Registry Study6

Parameters assessed: BMD

Visceral &
Hematologic Data

9-Month Pivotal Trial4

Parameters assessed: visceral & hematologic parameters

10-Year, Long-Term Registry Study3*

Parameters assessed: visceral, hematologic & bone parameters

Bone Data

48-Month, Long-Term Prospective Study5

Parameters assessed: bone mineral density (BMD) & bone crises

4-year Long-Term Registry Study6

Parameters assessed: bone pain & bone crises

8-Year, Long-Term Registry Study7

Parameters assessed: BMD

Pediatric Data

8-Year, Long-Term Registry Study8*

Parameters assessed: visceral, hematologic & bone parameters

*The Cerezyme treatment group from the ICGG Gaucher Registry analyses represents patients who received either alglucerase or imiglucerase.

The Gaucher Registry

The ICGG Registry is the world’s largest cooperative, observational database on Gaucher disease. The Gaucher Registry is sponsored by Sanofi Genzyme and directed by the ICGG, a group of physicians who are experts in the management of Gaucher disease.9

  • The ICGG Gaucher Registry provides observational data in more than 6000 patients with Gaucher disease worldwide3
    References:
  1. Cerezyme [prescribing information]. Cambridge, MA: Genzyme Corporation; 2018.
  2. Weinreb N, Taylor J, Cox T, Yee J, vom Dahl S. A benchmark analysis of the achievement of therapeutic goals for type 1 Gaucher disease patients treated with imiglucerase. Am J Hematol. 2008;83(12):890-895.
  3. Weinreb NJ, Goldblatt J, Villalobos J, et al. Long-term clinical outcomes in type 1 Gaucher disease following 10 years of imiglucerase treatment. J Inherit Metab Dis. 2013;36(3):543-553.
  4. Grabowski GA, Barton NW, Pastores G, et al. Enzyme therapy in type 1. Gaucher disease: comparative efficacy of mannose-terminated glucocerebrosidase from natural and recombinant sources. Ann Intern Med. 1995;122(1):33-39.
  5. Sims KB, Pastores GM, Weinreb NJ, et al. Improvement of bone disease by imiglucerase (Cerezyme) therapy in patients with skeletal manifestations of type 1 Gaucher disease: results of a 48-month longitudinal cohort study. Clin Genet. 2008;73(5):430-440.
  6. Wenstrup RJ, Kacena KA, Kaplan P, et al. Effect of enzyme replacement therapy with imiglucerase on BMD in type 1 Gaucher disease. J Bone Miner Res. 2007;22(1):119-126.
  7. Charrow J, Dulisse B, Grabowski GA, Weinreb NJ. The effect of enzyme replacement therapy on bone crisis and bone pain in patients with type 1 Gaucher disease. Clin Genet. 2007;71(3):205-211.
  8. Andersson H, Kaplan P, Kacena K, Yee J. Eight-year clinical outcomes of long-term enzyme replacement therapy for 884 children with Gaucher disease type 1. Pediatrics. 2008;122(6):1182-1190.
  9. Weinreb NJ, Kaplan P. The history and accomplishments of the ICGG Gaucher registry. Am J Hematol. 2015;90(suppl 1):s2-s5.
  10. 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.
10-year safety analysis supports the safety profile of Cerezyme
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Supported by 10-year safety data from an international monitoring database

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A proven ERT designed to reduce accumulation of the lipid GL-1
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Designed to reduce accumulation of the lipid GL-1

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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:

  • anemia
  • thrombocytopenia
  • bone disease
  • 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 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 Sanofi Genzyme Medical Information at 1-800-745-4447, Option 2.

Please see Full Prescribing Information (PDF).