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
Recommended Cerezyme dosing and administration
Cerezyme is administered as an intravenous infusion1
- 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
- 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
- Titrate the dosage based on clinical manifestations of disease and therapeutic goals for the patient
- 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
- 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)
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-approved therapy
Learn more