Cerezyme dosing can be individualized for each patient.1
Recommended Cerezyme dosing and administration
Cerezyme is administered as an intravenous infusion over 1 to 2 hours1
- Ensure physicians knowledgeable in the management of patients with Gaucher disease direct therapy with CEREZYME
- The recommended dosage of Cerezyme ranges from 2.5 units/kg 3 times a week to 60 units/kg once every 2 weeks
- For patients weighing greater than 20 kg, infuse the diluted Cerezyme solution over 1 to 2 hours. For patients weighing 20 kg or less, infuse the diluted Cerezyme solution over 2 hours
- Titrate the dosage based on disease severity and therapeutic goals for the patient
- Initiate Cerezyme in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment
- If a severe hypersensitivity reaction or a severe infusion-associated reaction (IAR) occurs, discontinue Cerezyme treatment and initiate appropriate medical treatment
- If a mild or moderate hypersensitivity reaction or a mild or moderate IAR occurs, consider decreasing the infusion rate, temporarily stopping the infusion, and/or administering antihistamines, antipyretics, and/or corticosteroids
- 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
Reconstitute each 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. Visually inspect the solution after reconstitution for particulate matter and discoloration. Discard if opaque particles or discoloration are observed. After reconstitution, each vial will yield Cerezyme at a concentration of 40 units/mL
Withdraw the required volume of Cerezyme from the vial(s)
Dilute the Cerezyme solution for infusion promptly with 0.9% Sodium Chloride Injection, USP, to a final volume that is calculated based on prescribed dose
Total infusion volumes and infusion time for Cerezyme
| Patient weight | Total infusion volumea | Infusion time | Maximum infusion rate |
| 1.5 kg to <6 kg | 12 mL (in a syringe) | 2 hours | 6 mL/hour |
| 6 kg to <13 kg | 26 mL (in a syringe) | 2 hours | 13 mL/hour |
| 13 kg to ≤20 kg | 100 mL (infusion bag) | 2 hours | 50 mL/hour |
| >20 kg to ≤100 kg | 200 mL (infusion bag) | 1 to 2 hours | 200 mL/hour |
| >100 kg | 400 mL (infusion bag) | 1 to 2 hours | 400 mL/hour |
aFinal concentration of diluted Cerezyme solution is between 6 units/mL and 30 units/mL.
If Cerezyme is prescribed at a dose lower than 60 units/kg:
- Dilute the required total units of reconstituted Cerezyme (at a concentration of 40 units/mL) with 0.9% Sodium Chloride Injection to a final concentration between 6 units/mL and 30 units/mL
- If the determined dose of Cerezyme translates into a total volume of 26 mL or less, administer using a syringe for infusion via a syringe pump
For accuracy of dilution, if less than 2 mL of reconstituted Cerezyme (40 units/mL) is needed for the preparation of the determined dose:
- Prepare a larger final volume of Cerezyme for infusion initially maintaining the final concentration of the diluted Cerezyme solution between 6 units/mL to 30 units/mL
- Subsequently, discard the excess volume and administer only the volume of Cerezyme solution corresponding to the prescribed dose
Gently invert the syringe for infusion or the infusion bag to mix the solution. Throughout Cerezyme preparation, avoid vigorous shaking, agitation, and foaming
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
Administer Cerezyme as an intravenous infusion with a 0.2 micron in-line low protein-binding filter
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)
- Once diluted, the solution can be stored at 2 °C to 8 °C (36 °F to 46 °F) for up to 24 hours
- Once reconstituted, the solution can be refrigerated at 2 °C to 8 °C (36 °F to 46 °F) or stored at room temperature at 20 °C to 25 °C (68 °F to 77 °F) for up to 12 hours
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Indication
Reference: 1. Cerezyme (imiglucerase). Prescribing information. Genzyme Corporation, Cambridge, MA.
