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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:
- bone disease
- hepatomegaly or splenomegaly
DOSAGE AND ADMINISTRATION
Cerezyme® (imiglucerase for injection) is administered by intravenous infusion over 1-2 hours. Dosage should be individualized to each patient. Initial dosages range from 2.5 U/kg of body weight 3 times a week to 60 U/kg once every 2 weeks. 60 U/kg every 2 weeks is the dosage for which the most data are available. Disease severity may dictate that treatment be initiated at a relatively high dose or relatively frequent administration. Dosage adjustments should be made on an individual basis and may increase or decrease, based on achievement of therapeutic goals as assessed by routine comprehensive evaluations of the patient's clinical manifestations.
Cerezyme® (imiglucerase) should be stored at 2-8°C (36-46°F). After reconstitution, Cerezyme® (imiglucerase) 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. Any vials exhibiting opaque particles or discoloration should not be used. DO NOT USE Cerezyme® (imiglucerase) after the expiration date on the vial.
On the day of use, after the correct amount of Cerezyme® (imiglucerase) to be administered to the patient has been determined, the appropriate number of vials are each reconstituted with Sterile Water for Injection, USP. The final concentrations and administration volumes are provided in the following table:
|200 Unit Vial||400 Unit Vial|
|Sterile water for reconstitution||5.1 mL||10.2 mL|
|Final volume of reconstituted product||5.3 mL||10.6 mL|
|Concentration after reconstitution||40 U/mL||40 U/mL|
|Withdrawal volume||5.0 mL||10.0 mL|
|Units of enzyme within final volume||200 units||400 units|
A nominal 5.0 mL for the 200 unit vial (10.0 mL for the 400 unit vial) is withdrawn from each vial. The appropriate amount of Cerezyme® (imiglucerase) for each patient is diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of 100 – 200 mL. Cerezyme® (imiglucerase) is administered by intravenous infusion over 1-2 hours. Aseptic techniques should be used when diluting the dose. Since Cerezyme® (imiglucerase) does not contain any preservative, after reconstitution, vials should be promptly diluted and not stored for subsequent use. Cerezyme® (imiglucerase) , after reconstitution, has been shown to be stable for up to 12 hours when stored at room temperature (25°C) and at 2-8°C. Cerezyme® (imiglucerase) , when diluted, has been shown to be stable for up to 24 hours when stored at 2-8°C.
Relatively low toxicity, combined with the extended time course of response, allows small dosage adjustments to be made occasionally to avoid discarding partially used bottles. Thus, the dosage administered in individual infusions may be slightly increased or decreased to utilize fully each vial as long as the monthly administered dosage remains substantially unaltered.
Cerezyme® (imiglucerase for injection) is supplied as a sterile, non-pyrogenic, lyophilized product. It is available as follows:
200 Units per Vial NDC 58468-1983-1
400 Units per Vial NDC 58468-4663-1
Store at 2-8°C (36-46°F).
Cerezyme® (imiglucerase for injection) is manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 ,USA. Certain manufacturing operations may have been performed by other firms. (4/05). FDA revision date: 3/3/2005This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/9/2008
Additional Cerezyme Information
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