The recommended dosage regimen of Elaprase is 0.5 mg/kg of body weight administered every week as an IV infusion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Administration: Administer the diluted Elaprase solution to patients using a low-protein-binding infusion set equipped with a low-protein-binding 0.2 micrometer in-line filter.
The total volume of infusion may be administered over a period of 3 hrs, which may be gradually reduced to 1 hr if no hypersensitivity reactions are observed. Patients may require longer infusion times if hypersensitivity reactions occur; however, infusion times should not exceed 8 hrs. The initial infusion rate should be 8 mL/hr for the first 15 min. If the infusion is well tolerated, the rate may be increased by 8 mL/hr increments at 15-min intervals in order to administer the full volume within the desired period of time. However, at no time should the infusion rate exceed 100 mL/hr. The infusion rate may be slowed and/or temporarily stopped, or discontinued for that visit, based on clinical judgment, if hypersensitivity reactions were to occur (see Warnings).