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Cerezyme® (imiglucerase) 2-Year Gaucher Registry Analysis


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Cerezyme demonstrated long-term efficacy in non-CNS manifestations in patients with Gaucher disease type 3.1

The 2-year ICGG Gaucher Registry analysis

Study description1

The 2-year International Collaborative Gaucher Group (ICGG) Gaucher Registry study was an observational analysis of adult and pediatric patients (7 weeks to 54 years old) with Gaucher disease type 3 who were treated with Cerezyme.

Patients were included in the analysis if they had clinical data at baseline and follow-up assessments for one or more of the following:

  • Spleen volume
  • Liver volume
  • Hemoglobin level
  • Platelet count
  • Height Z-score

Information is voluntary and not all the data on every parameter are available for every patient in the registry. The ICGG Gaucher Registry includes patients with a variable range of disease status and management.

Cerezyme demonstrated improvements in visceral, hematologic, and growth parameters in patients with Gaucher disease type 31

An observational study of patients with Gaucher disease type 3 treated with Cerezyme over 2 yearsa

Visceral parameters

Improvements in mean spleen volume from baseline

Improvements in mean liver volume from baseline

Hematologic parameters

Hemoglobin icon

Improvement in mean hemoglobin levels
Baseline: 10 g/dL 
Mean change after 2 years: +1.8 g/dL (n=118)

Improvements in mean platelet count
Baseline: 149 × 103/mm3 
Mean change after 2 years: +105 × 103/mm3 (n=116)

Pediatric growth

Bone icon

Improvements in mean height Z-score from baseline

MN=multiples of normal.
aThe 2-year summaries include measurements within 1-3 years after treatment initiation due to the lack of predefined data collection timepoints within the registry.1

Cerezyme demonstrated improvements in visceral, hematologic, and growth parameters over 2 years in patients with Gaucher disease type 3.1

Bone icon

Bone Studies

See the effect of Cerezyme on key bone manifestations in Gaucher disease type 1

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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

Reference: 1. Cerezyme (imiglucerase). Prescribing information. Genzyme Corporation, Cambridge, MA.

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