Dosage and Administration of Imiglucerase (Cerezyme)
Dosage and Administration Method of Imiglucerase
Imiglucerase needs to be administered by intravenous infusion, with the infusion time being 1-2 hours. The dosage should be adjusted according to the individual situation of the patient. The initial dosage range is 2.5 U/kg, three times a week, up to 60 U/kg, once every 2 weeks. After 2 years, if the therapeutic target is achieved, the dosage can be changed to 45 U/kg. The dosage of 60 U/kg once every 2 weeks has the most available data. In severe cases, a higher dosage or more frequent administration may be required. The dosage should be adjusted according to the individual situation of each patient, and the patient's clinical manifestations should be comprehensively evaluated regularly. The dosage can be increased or decreased based on whether the therapeutic target is achieved.
Precautions for Reconstitution of Imiglucerase
Imiglucerase should be stored at 2-8°C (36-46°F). After reconstitution, it should be visually inspected before use. Since this product is a protein solution, slight flocculation (i.e., the formation of slightly opaque fibers) may occasionally occur after dilution. During administration, the diluted solution can be filtered through a 0.2 μm filter membrane connected to the infusion tube (the filter membrane does not adsorb protein or has a very low degree of adsorption). After reconstitution, if opaque particles or discoloration appear, it cannot be used. This product must not be used after expiration.
On the day of administration, after determining the dosage for the patient, take the corresponding number of vials and reconstitute with sterile water for injection according to the following table. The following table shows the final concentration and administration volume:
Take 10.0 mL from each 400-unit vial and finally dilute with 0.9% sodium chloride solution to 100-200 mL. Intravenous infusion should be carried out for 1-2 hours under sterile conditions. Since this product does not contain any preservatives, it should be diluted immediately after preparation and must not be stored for later use. The prepared product can be stable for 12 hours at room temperature (25°C) and 2-8°C. After dilution, it can be stable for 12 hours at 2-8°C.
Imiglucerase has relatively low toxicity and a long duration of action, so minor dosage adjustments can be made occasionally to utilize the amount of medicine in each vial and avoid waste of the medicine, as long as the total monthly dosage remains basically unchanged.
