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*, hypertension*
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 reactions, including anaphylaxis, 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†

  TREATMENT-
RELATED AEs		 ALL AEs
Total 852 2931
General disorders and
administration site
reactions		 161 455
Pyrexia 25 80
Chills 21 55
Chest discomfort 22 44
Skin and subcutaneous
tissue disorders		 117 325
Pruritus 28 82
Rash 23 67
Urticaria 24 60
Respiratory, thoracic, and
mediastinal disorders		 88 298
Dyspnea 28 75
Cough 12 32
Throat irritation 9 11

Most of the related AEs were temporally related to the infusion of Cerezyme and typical of immune-mediated reactions.

  • These types of AEs were predominantly self-limited and effectively managed by either decreasing the rate of infusion or pretreatment with antihistamines, which generally decreased the frequency of these events
  • In patients with significant reactions, temporary modifications in dose were made in addition to lowering the infusion rate and pretreatment with antihistamines
    • Over time, most patients tolerated Cerezyme at the regular infusion rate without additional pretreatment with antihistamine
  • Only 4 patients with significant infusion reactions subsequently discontinued enzyme replacement therapy

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.

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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.