ELAPRASE (TM) SOLUTION FOR INTRAVENOUS INFUSION 2MG/ ML [SIN13902P]

Product Info

ELAPRASE (TM) SOLUTION FOR INTRAVENOUS INFUSION 2MG/ ML

[SIN13902P]

Indication

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

Dosing

DOSAGE AND ADMINISTRATION
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.

Preparation Instructions
Prepare and use ELAPRASE according to the following steps using aseptic technique:

a. 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.

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.

b. Before withdrawing the ELAPRASE solution from the vial, visually inspect each vial for particulate matter and discoloration. The ELAPRASE solution should be clear to slightly opalescent and colorless. Do not use if the solution is discolored or if there is particulate matter in the solution. Do not shake the ELAPRASE solution.

c. Withdraw the calculated volume of ELAPRASE from the appropriate number of vials.

d. Add the calculated volume of ELAPRASE solution to a 100 mL bag of 0.9% Sodium Chloride Injection, USP for intravenous infusion.

e. Mix gently. Do not shake the solution.

Administration Instructions
Administer the diluted ELAPRASE solution to patients using a low-protein-binding infusion set equipped with a low-protein-binding 0.2 micrometer (μm) in-line filter.

The total volume of infusion should be administered over a period of 3 hours, which may be gradually reduced to 1 hour if no hypersensitivity reactions are observed. Patients may require longer infusion times if hypersensitivity reactions occur; however, infusion times should not exceed 8 hours. The initial infusion rate should be 8 mL per hour for the first 15 minutes. If the infusion is well tolerated, the rate of infusion may be increased by 8 mL per hour increments every 15 minutes. The infusion rate should not exceed 100 mL per hour. The infusion rate may be slowed, temporarily stopped, or discontinued for that visit in the event of hypersensitivity reactions [see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. ELAPRASE should not be infused with other products in the infusion tubing.

Storage and Stability
ELAPRASE does not contain preservatives; therefore, after dilution with saline, the infusion bags should be used immediately. If immediate use is not possible, the diluted solution should be stored refrigerated at 2°C to 8°C (36°F to 46 °F) for up to 24 hours. Other than during infusion, do not store the diluted ELAPRASE solution at room temperature. Any unused product or waste material should be discarded and disposed of in accordance with local requirements.

Contraindications

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.