Cerezyme Indications, Dosage, Storage, Stability - Imiglucerase

Cerezyme Indications, Dosage, Storage, Stability - Imiglucerase

INDICATIONS AND USES

Cerezyme ® (imiglucerase for injection) is indicated for long-term enzyme replacement therapy for patients with a confirmed diagnosis of Type 1 Gaucher disease that results in one or more of the following conditions:

1. anemia
2. thrombocytopenia
3. bone disease
4. 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 units/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 patients's clinical manifestations.

Cerezyme ® should be stored at 2-8°C (36-46°F). Each vial, after reconstitution with Sterile Water for Injection, USP, should be inspected visually for particulate matter and discoloration before use. Any vials exhibiting particulate matter or discoloration should not be used. DO NOT USE Cerezyme ® after the expiration date on the vial.

On the day of use, after the correct amount of Cerezyme ® 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:

A nominal 5.0 mL for the 200 unit vial (10.0 mL for the 400 unit vial) is withdrawn from each vial.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 ® for each patient is diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of 100 to 200 mL. Cerezyme ® is administered by intravenous infusion over 1 to 2 hours or at a rate between 0.5-1.0 unit per kg body weight per minute. Aseptic techniques should be used when diluting the dose. Since Cerezyme ® does not contain any preservative, after reconstitution, vials should be promptly diluted and not stored for subsequent use. Cerezyme ®, 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 ®, 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.

HOW SUPPLIED

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).

Rx only

Cerezyme ® (imiglucerase for injection) is manufactured by:
Genzyme Corporation
One Kendall Square
Cambridge, MA 02139 USA

Certain manufacturing operations may have been performed by other firms.

Updated on Apr 03, 2003