Important Safety Information: Approximately 15% of patients have developed IgG antibodies to Cerezyme during the first year of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity, and these patients have a higher risk of hypersensitivity. It is suggested that patients be monitored periodically for IgG antibody formation during the first year of treatment... View more

Safety

Cerezyme is the ONLY ERT (enzyme replacement therapy) that has
shown long-term efficacy and safety in multiple studies over 10 years
and has been prescribed for over 20 years.1-3

View Indications and Usage

Safety was evaluated in clinical trials and a long-term observational monitoring database1,10

Adverse events (AEs)1

Approximately 13.8% of patients have experienced AEs related to Cerezyme administration. Each occurred in <1.5% of the total patient population.

ASSOCIATED WITH ROUTE
OF ADMINISTRATION (IV)
  • Discomfort
  • Pruritus
  • Burning
  • Swelling
  • Sterile abscess at the site of venipuncture
SUGGESTIVE OF HYPERSENSITIVITY
REPORTED IN APPROXIMATELY 6.6% OF PATIENTS
  • Anaphylactoid reaction
  • Pruritus
  • Flushing
  • Urticaria
  • Angioedema
  • Chest discomfort
  • Dyspnea
  • Coughing
  • Cyanosis
  • Hypotension
  • Pretreatment with antihistamines and/or
    corticosteroids and reduced rate of
    infusion have allowed continued use of
    Cerezyme in most patients.
ADDITIONAL EVENTS REPORTED IN
APPROXIMATELY 6.5% OF PATIENTS
  • Nausea
  • Abdominal pain
  • Vomiting
  • Diarrhea
  • Rash
  • Fatigue
  • Headache
  • Fever
  • Dizziness
  • Chills
  • Backache
  • Tachycardia

Reported rates of AEs are based on Sanofi Genzyme’s postmarketing database of spontaneously reported AEs and AEs discussed in the medical literature. The actual number of patients exposed to Cerezyme since 1994 is likely to be greater than estimated from these voluntary sources, and therefore, the percentages calculated for the frequencies of adverse reactions are most likely greater than the actual incidences.

Common AEs1

The most commonly reported AEs in children (defined as ages 2–12 years) included dyspnea, fever, nausea, flushing, vomiting, and coughing.
In adolescents (>12–16 years) and in adults (>16 years) the most commonly reported events included headache, pruritus, and rash.

Immunologic AEs1

Approximately 15% of patients treated and tested to date have developed IgG antibodies to Cerezyme during the first year of therapy.

  • Most occurrences were within the first 6 months, and rarely after 12 months of therapy

Patients with antibodies to Cerezyme have a higher risk of hypersensitivity reaction.

  • 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity
  • Not all patients with symptoms of hypersensitivity have detectable IgG antibodies

Antibody formation did not interfere with therapeutic efficacy or result in major immune-mediated reactions

Periodic monitoring for lgG antibody formation is recommended during the first year of treatment

Anaphylactoid reactions have been reported in <1% of patients. Further treatment with Cerezyme should be conducted with caution.

  • Most patients have successfully continued therapy after a reduction in rate of infusion and pretreatment with antihistamines and/or corticosteroids

Pulmonary hypertension and pneumonia

In less than 1% of the patient population, pulmonary hypertension and pneumonia have also been observed during treatment with Cerezyme.

  • Pulmonary hypertension and pneumonia are known complications of Gaucher disease and have been observed both in patients receiving and not receiving Cerezyme
  • No causal relationship with Cerezyme has been established
  • Patients with respiratory symptoms in the absence of fever should be evaluated for the presence of pulmonary hypertension
  • Therapy with Cerezyme should be directed by physicians knowledgeable in the management of patients with Gaucher disease

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

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 nonserious, 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 1997-2004

Cerezyme showed consistent rates of reported events over time

*Small-scale production limited the use of Cerezyme during the early postapproval period of 1994–1997, 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.

    References:
  1. Cerezyme [prescribing information]. Cambridge, MA: Genzyme Corporation; 2018.
  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, Goldblatt J, Villalobos J, et al. Long-term clinical outcomes in type 1 Gaucher disease following 10 years of imiglucerase treatment. J Inherit Metab Dis. 2013;36(3):543-553.
  4. Grabowski GA, Barton NW, Pastores G, et al. Enzyme therapy in type 1. Gaucher disease: comparative efficacy of mannose-terminated glucocerebrosidase from natural and recombinant sources. Ann Intern Med. 1995;122(1):33-39.
  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. 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.
  7. 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.
  8. 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.
  9. Weinreb NJ, Kaplan P. The history and accomplishments of the ICGG Gaucher registry. Am J Hematol. 2015;90(suppl 1):s2-s5.
  10. 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 & Usage

Cerezyme® (imiglucerase for injection) is indicated for long-term enzyme replacement therapy for pediatric and adult patients with a confirmed diagnosis of Type 1 Gaucher disease that results in one or more of the following conditions:

  • anemia
  • thrombocytopenia
  • bone disease
  • hepatomegaly or splenomegaly
Important Safety Information

Approximately 15% of patients have developed IgG antibodies to Cerezyme during the first year of therapy. Approximately 46% of patients with detectable IgG antibodies experienced symptoms of hypersensitivity, and these patients have a higher risk of hypersensitivity. It is suggested that patients be monitored periodically for IgG antibody formation during the first year of treatment.

Hypersensitivity has also been observed in patients without detectable IgG antibodies. Symptoms suggestive of hypersensitivity have been noted in approximately 6.6% of all patients, and anaphylactoid reactions in less than 1%. Treatment with Cerezyme should be approached with caution in patients who have exhibited hypersensitivity symptoms such as pruritus, flushing, urticarial, angioedema, chest discomfort, dyspnea, coughing, cyanosis, and hypotension. Pre-treatment with antihistamines and/or corticosteroids and a reduced rate of infusion may allow continued treatment in most patients.

In less than 1% of patients, pulmonary hypertension and pneumonia have been observed during treatment with Cerezyme. These are known complications of Gaucher disease regardless of treatment. Patients with respiratory symptoms in the absence of fever should be evaluated for the presence of pulmonary hypertension.

Approximately 13.8% of patients have experienced adverse events related to treatment with Cerezyme. Some of these are injection site reactions such as discomfort, pruritus, burning, swelling or sterile abscess at the site of venipuncture. Additional adverse reactions that have been reported include nausea, abdominal pain, vomiting, diarrhea, rash, fatigue, headache, fever, dizziness, chills, backache, and tachycardia. Transient peripheral edema has also been reported for this therapeutic class of drug.

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

Please see Full Prescribing Information (PDF).