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Cerezyme® (imiglucerase) Studies Overview


The ONLY ERT (enzyme replacement therapy) with over 30 years of real-world experience treating Gaucher disease type 1. The first and only treatment approved for non-CNS manifestations Gaucher disease type 3.1,2

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.1,3-7 The long-term safety of Cerezyme was shown in an international monitoring database.8

Explore the findings of several 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 or type 3.1,3,4-7

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Visceral &
Hematologic Data

6-Month Pivotal Trial1

Parameters assessed: Visceral and hematologic

2-Year, Long-Term Registry Study1

Parameters assessed: Visceral, hematologic, and pediatric growth

20-Year, Long-Term Registry Study3,a

Parameters assessed: Visceral, hematologic, bone pain, and bone crises

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Bone Data

48-Month, Long-Term Prospective Study4

Parameters assessed: Bone mineral density (BMD), bone pain, and bone crises

4-year, Long-Term Registry Study5

Parameters assessed: Bone pain and bone crises

8-Year, Long-Term Registry Study6

Parameters assessed: BMD

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Pediatric Data

8-Year, Long-Term Registry Study7,a

Parameters assessed: Visceral, hematologic, and BMD

aThe Cerezyme treatment group from these 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 experts in the management of Gaucher disease.9

  • The ICGG Gaucher Registry provides observational data on >7000 patients with Gaucher disease worldwide10
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Choose the longest-studied ERT

Supported by 10-year safety data from an international monitoring database

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See how Cerezyme works

Designed to reduce accumulation of the lipid GL-1

Indication

Cerezyme® (imiglucerase) for injection is indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adult and pediatric patients. 

Important Safety Information

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS
Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate CEREZYME in a healthcare setting with appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue CEREZYME immediately, and initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis, and to seek immediate medical care should symptoms occur.

Warnings and Precautions:

Hypersensitivity Reactions Including Anaphylaxis: See Boxed WARNING.
Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions. Consider periodic monitoring during the first year of treatment for IgG antibody formation.

Consider risks and benefits of readministering Cerezyme to individual patients following a severe reaction. If a mild or moderate hypersensitivity reaction occurs, consider reducing the rate of infusion, pretreat with antihistamines and/or corticosteroids, and monitor patients for new signs and symptoms of a hypersensitivity reaction. 

Infusion-Associated Reactions:
Infusion associated reactions (IARs) have been observed in patients treated with Cerezyme. If a severe IAR occurs, discontinue CEREZYME and immediately initiate appropriate medical treatment. Consider the risks and benefits of re-administering CEREZYME following a severe IAR. If a mild or moderate IAR occurs, consider decreasing the infusion rate, temporarily stopping the infusion, and/or administering antihistamines, antipyretics, and/or corticosteroids.

Adverse Reactions:

  • Adverse reactions reported in adults and pediatric patients include back pain, chills, dizziness, fatigue, headache, hypersensitivity reactions, nausea, pyrexia, and vomiting. 

Please see accompanying Full Prescribing Information, including Boxed WARNING.

Indication

Important Safety Information

References: 1. Cerezyme (imiglucerase). Prescribing information. Genzyme Corporation, Cambridge, MA. 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, Camelo JS Jr, Charrow J, et al. Gaucher disease type 1 patients from the ICGG Gaucher Registry sustain initial clinical improvements during twenty years of imiglucerase treatment. Mol Genet Metab. 2021;132(2):100-111. 4. 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. 5. 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. 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. 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. 8. 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. 9. National Gaucher Foundation. Should your medical history be in the International Gaucher Registry? Accessed November 17, 2025. https://www.gaucherdisease.org/blog/medical-history-international-gaucher-registry/ 10. Mistry PK, Balwani M, Charrow J, et al. Long-term effectiveness of eliglustat treatment: a real-world analysis from the International Collaborative Gaucher Group Gaucher Registry. Am J Hematol. 2024;99(8):1500-1510.

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