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
Cerezyme does not contain preservatives
Reconstitute each 400-unit vial of Cerezyme by slowly injecting 10.2 mL of Sterile Water for Injection, USP, down the inside wall of each vial
Roll and tilt the vial to allow the powder to dissolve completely. Each vial will yield a concentration of Cerezyme after reconstitution of 40 units/mL. Visually inspect the solution after reconstitution for particulate matter and discoloration. Discard if opaque particles or discoloration are observed
Withdraw up to 10 mL per vial. Discard unused portion
Dilute the Cerezyme solution promptly with 0.9% Sodium Chloride Injection, USP, to a final volume of 100 to 200 mL
For patients weighing less than 18 kg, dilute Cerezyme to a final volume of 100 mL. Gently invert infusion bag to mix the solution, avoiding vigorous shaking and agitation. Visually inspect the solution prior to administration of the final product for particulate matter and discoloration. Slight flocculation of protein particles (described as thin translucent fibers) may occur after dilution and does not affect the quality of the product
The diluted solution may be filtered through an in-line low protein-binding 0.2 μm filter during administration
If the reconstituted Cerezyme vial is not used immediately, store at room temperature at 68 °F to 77 °F (20 °C to 25 °C) or refrigerated at 36 °F to 46 °F (2 °C to 8 °C) for up to 12 hours
After dilution, Cerezyme is stable for up to 24 hours when stored refrigerated at 36 °F to 46 °F (2 °C to 8 °C)
Download the Cerezyme Reconstitution & Administration Guide for detailed guidance on preparation and administration.
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:
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 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.
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.