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

Dosing and Administration

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

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Recommended Cerezyme dosing and administration

Cerezyme is administered as an intravenous infusion over 1 to 2 hours1

Cerezyme is administered as an intravenous infusion over 1 to 2 hours

60 U/kg every 2 weeks is the dosage for which the most data are available

  • Disease severity may dictate that treatment be initiated at a relatively high dose or relatively frequent administration
  • Dosage should be individualized to each patient. Initial dosages range from 2.5 U/kg of body weight 3 times a week to 60 U/kg once every 2 weeks.
  • Dosage adjustments should be made on an individual basis and may increase or decrease based on achievement of therapeutic goals, as assessed by routine comprehensive evaluations of clinical manifestations

How to prepare and administer Cerezyme1

Use aseptic technique during preparation

After reconstitution, Cerezyme should be inspected visually before use. Because this is a protein solution, slight flocculation (described as thin, translucent fibers) occurs occasionally after dilution. The diluted solution may be filtered through an in-line, low–protein binding, 0.2-μm filter during administration

The appropriate amount of Cerezyme for each patient is diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of 100–200 mL

Cerezyme is administered by intravenous infusion over 1-2 hours

Since Cerezyme does not contain any preservative, after reconstitution, vials should be promptly diluted and not stored for subsequent use

Cerezyme, after reconstitution, has been shown to be stable for up to 12 hours when stored at room temperature (25°C) and at 2°C–8°C

Cerezyme, when diluted, has been shown to be stable for up to 24 hours when stored at 2°C–8°C

Download the Cerezyme Reconstitution & Administration Guide for detailed guidance on preparation and administration.

Storing Cerezyme1

  • Cerezyme is supplied as a sterile, nonpyrogenic, lyophilized product
  • Cerezyme vials should be stored at 2°C–8°C (36°F–46°F)
  • Any vials exhibiting opaque particles or discoloration should not be used
  • DO NOT USE Cerezyme after the expiration date on the vial
    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.
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An established ERT for children

Studied in the largest reported group of pediatric patients

Access pediatric data
When an ERT is needed, choose the longest standing therapy
Gaucher disease is manageable once diagnosed

When an ERT is needed, choose the longest-approved therapy

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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).