Elaprase Dosage/Direction for Use

Recommended Dose: The recommended dosage regimen of ELAPRASE is 0.5 mg/kg of body weight administered every week as an intravenous infusion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Administration: Preparation and Administration Instructions: Use Aseptic Techniques: ELAPRASE should be prepared and administered by a health care professional.
Determine the total volume of ELAPRASE to be administered and the number of vials needed based on the patient's weight and the recommended dose of 0.5 mg/kg.

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Round up to the next whole vial to determine the total. number of vials needed. Remove the required number of vials from the refrigerator to allow them to reach room temperature.
Before withdrawing the ELAPRASE solution from the vial, visual inspect each vial for particulate matter and discoloration. ELAPRASE is a clear to slightly opalescent, colorless solution. Do not use if the solution in the vials is discolored or particulate matter is present. ELAPRASE should not be shaken.
Withdraw the calculated volume of ELAPRASE from the appropriate number of vials.
Dilute the total calculated volume of ELAPRASE in 100 mL of 0.9% Sodium Chloride Injection, USP. Once diluted into normal saline, the solution in the infusion bag should be mixed gently, but not shaken. Diluted solution may be stored refrigerated for up to 24 hours.
ELAPRASE is supplied in single-use vials. Remaining ELAPRASE left in a vial after withdrawing the patient's calculated dose should be disposed of in accordance with local requirements.
Administration Instructions: ELAPRASE is a concentrated solution for intravenous infusion and must be diluted in 100 mL of 0.9% Sodium Chloride Injection, USP. Each vial of ELAPRASE contains a 2.0 mg/mL solution of idursulfase protein (6.0 mg) in an extractable volume of 3.0 mL, and is for single use only. Use of an infusion set equipped with a 0.2 micrometer (μm) filter is recommended.
The total volume of infusion may be administered over a period of 1 to 3 hours. Patients may require longer infusion times due to infusion reactions; however, infusion times should not exceed 8 hours (see STORAGE). The initial infusion rate should be 8 mL/hr for the first 15 minutes. If the infusion is well tolerated, the rate may be increased by 8 mL/hr increments at 15 minute 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 infusion reactions were to occur (see Precautions). ELAPRASE should not be infused with other products in the infusion tubing.