ELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking capacity in these patients.

The recommended dosage regimen of ELAPRASE is 0.5 mg/kg of body weight administered every week as an intravenous infusion.

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 WARNINGS). ELAPRASE should not be infused with other products in the infusion tubing.

Preparation and Administration Instructions: Use Aseptic Techniques

ELAPRASE should be prepared and administered by a health care professional.

1. 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.
   Patient's weight (kg) × 0.5 mg per kg of ELAPRASE ÷ 2 mg per mL = Total # mL of ELAPRASE
   Total # mL of ELAPRASE ÷ 3 mL per vial = Total # of vials
   Round up to determine the number of whole vials needed from which to withdraw the calculated volume of ELAPRASE to be administered.
2. Perform a visual inspection of each vial. 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.
3. Withdraw the calculated volume of ELAPRASE from the appropriate number of vials.
4. 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 should be discarded if not administered or refrigerated within 8 hours of preparation. Diluted solution may be stored refrigerated for up to 48 hours.
5. 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.

Storage

Store ELAPRASE vials under refrigeration at 2°C to 8°C (36°F to 46°F), and protect from light. Do not freeze or shake. Do not use ELAPRASE after the expiration date on the vial.

This product contains no preservatives. The diluted solution should be used immediately. If immediate use is not possible, the diluted solution can be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 48 hours, or must be administered within 8 hours if held at room temperature.

ELAPRASE is a sterile, aqueous, clear to slightly opalescent, colorless solution supplied in a 5 mL Type I glass vial. The vials are closed with a butyl rubber stopper with fluororesin coating and an aluminum overseal with a blue flip-off plastic cap.

NDC 54092-700-01

ELAPRASE is manufactured for: Shire Human Genetic Therapies, Inc. 700 Main Street Cambridge, MA 02139 US License Number 1593 OnePathSM phone # 1-866-888-0660 ELAPRASE is a trademark of Shire Human Genetic Therapies, Inc. REV 2 Last revised (October 2007). FDA Rev date: 11/24/2007

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