Cerezyme® (imiglucerase) for injection logo


When an ERT is needed for Gaucher disease type 1, choose Cerezyme® (imiglucerase)

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 30 years.1-3

Indication

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

Cerezyme is the ONLY ERT that demonstrates:

Experience

With over 30 years of real-world experience1,2

  • The ERT available for patients with Gaucher disease type 1 worldwide since 19941,2

Efficacy

With multiple studies showing long-term outcomes1,3-5

  • Proven efficacy with demonstrated improvements in visceral, hematologic, and certain bone parameters1,4
  • Long-term efficacy supported by adult and pediatric data in International Collaborative Gaucher Group (ICGG) Gaucher Registry analyses3,5,a

Established Safety

As the longest-studied ERT1,6

  • Adverse reactions reported in adults include back pain, chills, dizziness, fatigue, headache, hypersensitivity reactions, nausea, pyrexia, and vomiting1
  • Adverse reactions reported in pediatric patients 2 years of age and older are similar to adults1
  • Supported by 10-year data from an international safety monitoring database6

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

Consequences of delayed diagnosis

Timely treatment is important

Consider Cerezyme

Efficacy and safety demonstrated in adult and pediatric patients with Gaucher disease type 1

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. 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, 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. 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. 6. 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.

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