Cerezyme Dosage/Direction for Use

Cerezyme is administered by IV infusion over 1-2 hrs. 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. Sixty (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.
After reconstitution, Cerezyme 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 micrometer filter during administration. Any vials exhibiting opaque particles or discoloration should not be used.
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. The final concentrations and administration volumes are provided in Table 2. (See Table 2.)

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A nominal 5 mL for the 200-unit vial (10 mL for the 400-unit vial) is withdrawn from each vial. The appropriate amount of Cerezyme for each patient is diluted with sodium chloride 0.9% injection to a final volume of 100-200 mL. Cerezyme is administered by IV infusion over 1-2 hrs. 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.
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.