Elaprase
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Elaprase
INDICATIONS
ELAPRASE (idursulfase solution) is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE (idursulfase solution) has been shown to improve walking capacity in these patients.
DOSAGE AND ADMINISTRATION
The recommended dosage regimen of ELAPRASE (idursulfase solution) is 0.5 mg/kg of body weight administered every week as an intravenous infusion.
ELAPRASE (idursulfase solution) 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 (idursulfase solution) should not be infused with other products in the infusion tubing.
Preparation and Administration Instructions: Use Aseptic Techniques
ELAPRASE (idursulfase solution) should be prepared and administered by a health care professional.
- Determine the total volume of ELAPRASE (idursulfase solution) 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 (idursulfase solution) ÷ 2 mg per mL = Total # mL of ELAPRASE (idursulfase solution)
Total # mL of ELAPRASE (idursulfase solution) ÷ 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 (idursulfase solution) to be administered. - Perform a visual inspection of each vial. ELAPRASE (idursulfase solution) 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 (idursulfase solution) should not be shaken.
- Withdraw the calculated volume of ELAPRASE (idursulfase solution) from the appropriate number of vials.
- Dilute the total calculated volume of ELAPRASE (idursulfase solution) 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.
- ELAPRASE (idursulfase solution) is supplied in single-use vials. Remaining ELAPRASE (idursulfase solution) left in a vial after withdrawing the patient's calculated dose should be disposed of in accordance with local requirements.
Storage
Store ELAPRASE (idursulfase solution) 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 (idursulfase solution) 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.
HOW SUPPLIED
ELAPRASE (idursulfase solution) 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 (idursulfase solution) 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 (idursulfase solution) is a trademark of Shire Human Genetic Therapies, Inc. REV 2 Last revised (October 2007). FDA Rev date: 11/24/2007
Last reviewed on RxList: 11/28/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Elaprase Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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