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

Safety

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

Safety was evaluated in clinical trials and by analyzing a long-term observational monitoring database1,9

Adverse Reactions

The following adverse reactions associated with the use of imiglucerase were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

System Organ Class Adverse Reactions
Nervous system disorders dizziness, headache
Cardiac disorders tachycardia
Vascular disorders cyanosis, * flushing, * hypotension*
Respiratory, thoracic and mediastinal disorders cough, * dyspnea, * pneumonia, pulmonary hypertension
Gastrointestinal disorders abdominal pain, diarrhea, nausea, vomiting
Immune system disorder anaphylaxis,* hypersensitivity
Skin and subcutaneous tissue disorders angioedema, * pruritus, * rash, urticaria*
Musculoskeletal and connective tissue disorders back pain
General disorders and administration site conditions chest discomfort, * chills, fatigue, infusion-site burning, infusion-site discomfort, infusion-site swelling, pyrexia
* Signs and symptoms suggestive of hypersensitivity and other infusion-associated reactions.
* Adverse reactions reported in pediatric patients 2 years of age and older were similar to adults.

10-year analysis of an international safety monitoring database by Starzyk et al9

A retrospective, observational, 10-year analysis reviewed the safety profile of Cerezyme established over 10 years after approval (1994–2004) based on worldwide postmarketing experience and data collected through immunosurveillance.*

The most frequently reported treatment-related AEs fell under 3 body systems
These AEs were non-serious, infusion-associated reactions, and most AEs showed a consistent distribution across the time intervals.

TOP 3 SYSTEM ORGAN-CLASS CATEGORIES OF RELATED AEs AND THE 3 MOST FREQUENTLY REPORTED AES FOR CEREZYME FROM 1997 to 2004

Cerezyme showed consistent rates of reported events over time

* Small-scale production limited the use of Cerezyme during the early postapproval period of 1994 to 1997, resulting in a small number of treated patients and reported AEs during this time period.
Each of these events was found to occur in <1% of the total patient population. Each event may have occurred more than once in any individual patient.

AE=adverse event.

    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.
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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.