Ceredase Indications, Dosage, Storage, Stability - Alglucerase

Ceredase Indications, Dosage, Storage, Stability - Alglucerase

INDICATIONS AND USAGE

Ceredase (alglucerase injection) is indicated for use as long-term enzyme replacement therapy for 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:

1. moderate-to-severe anemia
2. thrombocytopenia with bleeding tendency
3. bone disease
4. 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 is 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 degrees 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.

HOW SUPPLIED

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 packages are available:

• The 400 unit bottle contains 5 mL in a 10 ml glass bottle. NDC 58468-1060-1.
  
• The 50 unit bottle contains 5 mL in a 6 mL glass bottle. NDC 58468-1781-1.
  

Store at 2-8'C.

Ceredase (alglucerase injection) is manufactured by:

1811 /REV 6 (1/95). Copyright 1995, Genzyme Corporation