Generic name: ALGLUCERASE 80U in 1mL
Dosage form: injection, solution, concentrate
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Ceredase® (alglucerase injection) is administered by intravenous infusion over 1-2 hours. Dosage should be individualized for each patient. Initial dosage may be as little as 2.5 units/kg of body weight 3 times a week up to as much as 60 units/kg administered as frequently as once a week or as infrequently as every 4 weeks. 60 units/kg every 2 weeks is the dose for which the most data are available. Disease severity may dictate that drug be initiated with relatively high doses or relatively frequent administration. After patient response is well-established, a reduction in dosage may be attempted for maintenance therapy. Progressive reductions can be made at intervals of 3-6 months while carefully monitoring response parameters.
Ceredase® should not be shaken. Each bottle should be inspected visually for particulate matter and discoloration before use. Any bottles exhibiting particulate matter or discoloration should not be used. DO NOT USE Ceredase® after the expiration date on the bottle.
On the day of use, the appropriate amount of Ceredase® for each patient is diluted with 0.9% sodium chloride IV solution to a final volume not to exceed 200 mL. Aseptic techniques should be used when diluting the dose. Ceredase®, when diluted to 100 to 200 mL, has been shown to be stable for up to 18 hours when stored at 2-8°C. The use of an in-line particulate filter is recommended for the infusion apparatus. Since Ceredase® does not contain any preservative, after opening, bottles should not be 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 bottle as long as the monthly administered dosage remains substantially unaltered.