Important Safety Information: Warnings and Precautions: Hypersensitivity and Infusion-Associated Reactions: Hypersensitivity reactions, some of which are serious and include anaphylaxis have been reported. Hypersensitivity and other infusion-associated reactions have been reported during or shortly after infusion and include pruritus, flushing, urticaria, angioedema, chest discomfort... View more

6-Month Pivotal Study

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 25 years.1-3

View Indication and Usage

Pivotal, phase 3 study

Cerezyme was proven to be safe and effective, as shown in a pivotal, phase 3 study that studied visceral, hematologic, and bone parameters in adult and pediatric patients with Gaucher disease type 1.1

Study design1

Cerezyme proven safe and effective in a pivotal phase 3 study
Cerezyme proven safe and effective in a pivotal phase 3 study
View the full study design for complete details, including inclusion criteria and outcome measures

Cerezyme showed similar reductions in visceral parameters at 6 months vs alglucerase1

Chart showing the reduction in spleen volume from baseline

The mean baseline spleen volume was 2369 mL for Cerezyme patients and 2603 mL for alglucerase patients.

The absolute change from baseline was -902 mL for Cerezyme and -874 mL for alglucerase. Difference of absolute change was -28 mL (95% CI: -652, 596).


Chart showing the reduction in liver volume from baseline

The mean baseline liver volume was 2521 mL for Cerezyme patients and
2788 mL for alglucerase patients.

The absolute change from baseline was -310 mL for Cerezyme and -307 mL for alglucerase. Difference of absolute change was -3 mL (95% CI: -246, 240).

* Confidence intervals were calculated using the t distribution (appropriate for small sample sizes) and the standard error of the difference in sample means (ie, the pooled estimate of the common standard deviation, computed as the weighted average of the standard deviations in the 2 treatment groups); there was no evidence that the assumption of equal variances between the groups was violated.

Cerezyme showed similar improvements in hematologic parameters at 6 months vs alglucerase1

Chart showing the improvement in hemoglobin level from baseline

The mean baseline hemoglobin level was 10.7 g/dL for Cerezyme patients and 10.9 g/dL for alglucerase patients.


Chart showing the improvement in platelet count from baseline

The mean baseline platelet count level was 68.5 x 103/mL3 for Cerezyme patients and 74.2 x 103/mL3 for alglucerase patients.

Bone x-rays showed improvements in cortical thickness and lucencies
in 7 of 11 Cerezyme-treated patients

* Confidence intervals were calculated using the t distribution (appropriate for small sample sizes) and the standard error of the difference in sample means (ie, the pooled estimate of the common standard deviation, computed as the weighted average of the standard deviations in the 2 treatment groups); there was no evidence that the assumption of equal variances between the groups was violated.
Established long-term safety data
Established long-term data

Statistically significant improvements evaluated over 20 years

See results
Get started with Cerezyme
Get started with Cerezyme

Thinking about prescribing Cerezyme?

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    References:
  1. Cerezyme [prescribing information]. Cambridge, MA: Genzyme Corporation; 2021.
  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. 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.
  6. 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.
  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. Weinreb NJ, Kaplan P. The history and accomplishments of the ICGG Gaucher registry. Am J Hematol. 2015;90(suppl 1):s2-s5.
  9. 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.
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

Warnings and Precautions:

Hypersensitivity and Infusion-Associated Reactions:
Hypersensitivity reactions, some of which are serious and include anaphylaxis have been reported. Hypersensitivity and other infusion-associated reactions have been reported during or shortly after infusion and include pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, cough, cyanosis, tachycardia, and hypotension. Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions. Not all patients with symptoms of hypersensitivity have detectable IgG antibody. Consider periodic monitoring during the first year of treatment for IgG antibody formation.

If a severe hypersensitivity reaction occurs, discontinue Cerezyme treatment and initiate appropriate medical treatment. Consider the risks and benefits of readministering Cerezyme to individual patients following a severe reaction. If Cerezyme is readministered, 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.

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.

Immunogenicity:
Approximately 15% of patients treated and tested to date have developed IgG antibody to Cerezyme during the first year of therapy. Patients who developed IgG antibody did so largely within 6 months of treatment and rarely developed antibodies to Cerezyme after 12 months of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity. Patients with antibody to Cerezyme have higher risk of hypersensitivity reaction.

Please see Full Prescribing Information (PDF).

To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Medical Information at 1-800-745-4447, Option 2.