Important Safety Information: Warnings and Precautions: Hypersensitivity and Infusion-Associated Reactions: Hypersensitivity reactions, some of which are serious and include anaphylaxis have been reported. Hypersensitivity and other infusion-associated reactions have been reported during or shortly after infusion and include pruritus, flushing, urticaria, angioedema, chest discomfort... 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 20 years and has been prescribed for over 25 years.1-3

View Indication and Usage

Cerezyme efficacy & safety studies overview

Cerezyme was proven to be safe and effective in 2 prospective clinical trials and was evaluated in multiple studies from the International Collaborative Gaucher Group (ICGG) Gaucher Registry. The long-term safety of Cerezyme was shown in an international monitoring database.3-7

Explore the findings of 6 studies evaluating the safety and efficacy of Cerezyme in visceral, hematologic, and certain bone parameters in adult and pediatric populations with Gaucher disease type 1.1,3-7

Visceral &
Hematologic Data		 Bone Data Pediatric Data

6-Month Pivotal Trial1

Parameters assessed: visceral and hematologic parameters

48-Month, Long-term Prospective Study4

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

8-Year, Long-term Registry Study7*

Parameters assessed: visceral, hematologic and bone parameters

20-Year, Long-term Registry Study3*

Parameters assessed: visceral, hematologic, and bone parameters

4-year, Long-term Registry Study6

Parameters assessed: bone pain and bone crises

8-Year, Long-term Registry Study5

Parameters assessed: BMD
Visceral &
Hematologic Data

6-month Pivotal Trial1

Parameters assessed: visceral and hematologic parameters

20-Year, Long-term Registry Study3*

Parameters assessed: visceral, hematologic, and bone parameters
Bone Data

48-Month, Long-term Prospective Study4

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

4-year, Long-term Registry Study6

Parameters assessed: bone pain and bone crises

8-Year, Long-term Registry Study5

Parameters assessed: BMD
Pediatric Data

8-Year, Long-term Registry Study7*

Parameters assessed: visceral, hematologic and bone parameters

  • The Cerezyme treatment group from the ICGG Gaucher Registry analyses represents patients with Gaucher disease type 1 who received either alglucerase or imiglucerase.

The International Collaborative Gaucher Group (ICGG) Gaucher Registry

The ICGG Gaucher Registry is the world’s largest cooperative, observational database on Gaucher disease. The ICGG Gaucher Registry is sponsored by Sanofi and directed by the ICGG, a group of physicians who are experts in the management of Gaucher disease.8

  • The ICGG Gaucher Registry provides observational data in more than 6000 patients with Gaucher disease worldwide3
10-year safety analysis supports the safety profile of Cerezyme
Choose the longest-studied ERT

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
See how Cerezyme works

Designed to reduce accumulation of the lipid GL-1

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Indication and Usage

Cerezyme® (imiglucerase) for injection is indicated for treatment of adults and pediatric patients 2 years of age and older with Type 1 Gaucher disease that results in one or more of the following conditions:

  • anemia
  • thrombocytopenia
  • bone disease
  • hepatomegaly or splenomegaly
Important Safety Information

Warnings and Precautions:

Hypersensitivity and Infusion-Associated Reactions:
Hypersensitivity reactions, some of which are serious and include anaphylaxis have been reported. Hypersensitivity and other infusion-associated reactions have been reported during or shortly after infusion and include pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, cough, cyanosis, tachycardia, and hypotension. Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions. Not all patients with symptoms of hypersensitivity have detectable IgG antibody. Consider periodic monitoring during the first year of treatment for IgG antibody formation.

If a severe hypersensitivity reaction occurs, discontinue Cerezyme treatment and initiate appropriate medical treatment. Consider the risks and benefits of readministering Cerezyme to individual patients following a severe reaction. If Cerezyme is readministered, consider reducing the rate of infusion, pretreat with antihistamines and/or corticosteroids, and monitor patients for new signs and symptoms of a severe hypersensitivity reaction.

Adverse Reactions:
Adverse reactions reported in adults include back pain, chills, dizziness, fatigue, headache, hypersensitivity reactions, nausea, pyrexia, and vomiting.

Adverse reactions reported in pediatric patients 2 years of age and older are similar to adults.

Immunogenicity:
Approximately 15% of patients treated and tested to date have developed IgG antibody to Cerezyme during the first year of therapy. Patients who developed IgG antibody did so largely 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 higher risk of hypersensitivity reaction.

Please see Full Prescribing Information (PDF).

To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Medical Information at 1-800-745-4447, Option 2.