Cerezyme® (imiglucerase) For US HCPs

The only ERT with 30+ years of real-world experience treating Gaucher disease type 1. The first and only treatment approved for the non-CNS manifestations of Gaucher disease type 3.^2,3,b

^aData on file. Based on publicly available patient numbers as of September 2025.¹

Cerezyme is the ONLY ERT that demonstrates:

Efficacy

The ONLY ERT with multiple studies showing long-term outcomes^2,4-6

Proven efficacy with demonstrated improvements in visceral, hematologic, and certain bone parameters^2,5
Long-term efficacy supported by adult and pediatric data in International Collaborative Gaucher Group (ICGG) Gaucher Registry analyses^2,4,6,a
- Including a long-term ICGG Gaucher Registry analysis of patients with Gaucher disease type 3²

Experience

The ONLY ERT with 30 years of real-world experience^2,3

The ERT available for patients with Gaucher disease type 1 worldwide since 1994^2,3

Established Safety

The longest-studied ERT^2,7

Anaphylaxis has occurred during the early course and after extended duration of enzyme replacement therapy²
Adverse reactions reported in adult and pediatric patients include back pain, chills, dizziness, fatigue, headache, hypersensitivity reactions, nausea, pyrexia, and vomiting²
Supported by 10-year data from an international safety monitoring database⁷

^aThe Cerezyme treatment group from the Gaucher Registry analyses represents patients who received either alglucerase or imiglucerase.

CNS=central nervous system; ERT=enzyme replacement therapy.

Consequences of delayed diagnosis

Timely treatment is important

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Efficacy and safety demonstrated in adult and pediatric patients

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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

References: 1. Data on file. Sanofi. 2. Cerezyme (imiglucerase). Prescribing information. Genzyme Corporation, Cambridge, MA. 3. 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. 4. Weinreb NJ, Camelo JS, 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. 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. 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. 7. 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.

The only ERT with 30+ years of real-world experience treating Gaucher disease type 1. The first and only treatment approved for the non-CNS manifestations of Gaucher disease type 3.2,3,b

Cerezyme is the ONLY ERT that demonstrates:

Efficacy

Experience

Established Safety

Consequences of delayed diagnosis

Consider Cerezyme

Indication

Important Safety Information

Warnings and Precautions:

Indication

Important Safety Information

The only ERT with 30+ years of real-world experience treating Gaucher disease type 1. The first and only treatment approved for the non-CNS manifestations of Gaucher disease type 3.^2,3,b