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