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Cerezyme® (imiglucerase) Mechanism of Action

Cerezyme addresses the underlying cause of Gaucher disease type 1 by replacing the deficient activity of enzyme β-glucosidase to break down GL-11

How Cerezyme works

Gaucher disease type 1 is a rare, genetic disorder that causes the accumulation of glucosylceramide, also known as glucocerebroside (GL-1), in cells of the monocyte/macrophage lineage, resulting in progressive, multiorgan dysfunction. Clinical manifestations of Gaucher disease type 1 include anemia, thrombocytopenia, hepatosplenomegaly, and skeletal disease.1,2

Cerezyme is an analog of the human enzyme β-glucocerebrosidase (also called acid β-glucosidase). Cerezyme reduces the accumulation of GL-1 by cleaving the substrate into glucose and ceramide.1,2

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Established safety

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Indication

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

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 access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue CEREZYME and immediately 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 lgG antibody formation.

Consider risks and benefits of readministering Cerezyme to individual patients following a severe reaction. 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.

Infusion-Associated Reactions:
Infusion associated reactions (IARs) have been observed in patients treated with Cerezyme. If an IAR occurs, decreasing the infusion rate, temporarily stopping the infusion and/or administering antihistamines and/or antipyretics may ameliorate the symptoms. Closely monitor patients who have experienced IARs when re-administering Cerezyme.

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.

Please see full Prescribing Information, including Boxed WARNING.

Indication

Important Safety Information

References: 1. Cerezyme (imiglucerase). Prescribing information. Genzyme Corporation, Cambridge, MA. 2. Deegan PB, Cox TM. Drug Des Devel Ther. 2012;6:81-106. 

© 2025 Sanofi. All rights reserved. Cerezyme and Sanofi are registered trademarks of Sanofi or an affiliate. MAT-US-2015553-v3.0-08/2025

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