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

Dosing and Administration

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

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Recommended Cerezyme dosing and administration

Cerezyme is administered as an intravenous infusion1

Cerezyme is administered as an intravenous infusion over 1 to 2 hours
  • Titrate the dosage based on clinical manifestations of disease and therapeutic goals for the patient
  • For patients weighing 18 kg and greater, infuse the diluted Cerezyme solution over 1 to 2 hours. For patients weighing less than 18 kg, infuse the diluted Cerezyme solution over 2 hours
  • The recommended dosage of Cerezyme based upon disease severity ranges from 2.5 units/kg 3 times a week to 60 units/kg once every 2 weeks
  • If a severe hypersensitivity reaction occurs, discontinue Cerezyme treatment and initiate appropriate medical treatment
  • For patients who experience a hypersensitivity reaction to Cerezyme and a decision is made to readminister the product, consider reducing the rate of infusion and pretreat with antihistamines and/or corticosteroids. Monitor patients for the occurrence of new hypersensitivity reactions.

How to prepare and administer Cerezyme1

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.

Storing Cerezyme1

  • Cerezyme for injection is supplied as a white to off-white lyophilized powder in a single-dose vial: NDC 58468‑4663‑1
  • Cerezyme vials should be stored refrigerated at 2 °C to 8 °C (36 °F to 46 °F)
    References:
  1. Cerezyme [prescribing information]. Cambridge, MA: Genzyme Corporation; 2021.
  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, Camelo JS, Charrow J, et al. Gaucher disease Type 1 patients from the ICGG Gaucher Registry sustain initial clinical improvements during twenty years of imiglucerase treatment. Mol Genet Metab. 2021;132(2):100-111.
Access pediatric data
An established ERT for children ages 2 and up

Studied in the largest reported group of pediatric patients with Gaucher disease type 1

Access pediatric data
When an ERT is needed, choose the longest standing therapy
Gaucher disease type 1 is manageable once diagnosed

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

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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.