Ceredase® (alglucerase injection) is indicated for use as long-term
enzyme replacement therapy for children, adolescents and adult patients with
a confirmed diagnosis of Type I Gaucher disease who exhibit signs and symptoms
that are severe enough to result in one or more of the following conditions:
- moderate-to-severe anemia;
- thrombocytopenia with bleeding tendency;
- bone disease;
- significant hepatomegaly or splenomegaly.
DOSAGE AND ADMINISTRATION
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® (alglucerase injection) 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® (alglucerase injection)
after the expiration date on the bottle.
On the day of use, the appropriate amount of Ceredase® (alglucerase injection) 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® (alglucerase injection) , 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® (alglucerase injection)
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.
Ceredase® (alglucerase injection) is supplied as a clear sterile citrate
buffered solution (53 mM citrate, 143 mM sodium) containing 1% albumin human
USP. The following package is available: -The 400 unit bottle contains 5 mL
in a 10 mL glass bottle. NDC 58468-1060-1. Store at 2 - 8°C.
Ceredase® (alglucerase injection) is manufactured by:
Genzyme Corporation, 500 Kendall Square, Cambridge, MA 02142.
REV 10/04. FDA Rev date: 2/9/2006