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Each vial of ALDURAZYME provides 2.9 milligrams (mg) of laronidase in 5.0 milliliters (mL) of solution and is intended for single use only. Do not use the vial more than one time. The concentrated solution for infusion must be diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of 100 mL or 250 mL, using aseptic techniques. The final volume of the infusion is determined by the patient's body weight. Patients with a body weight of 20 kg or less should receive a total volume of 100 mL.
Patients with a body weight greater than 20 kg should receive a total volume of 250 mL (see Dosage & Administration). For patients with underlying cardiac or respiratory compromise and weighing up to 30 kg, physicians may consider diluting ALDURAZYME in a volume of 100 mL and administering at a decreased infusion rate (see Dosage & Administration, Precautions and Adverse Reactions).
Instructions for Use: Prepare and use ALDURAZYME according to the following steps. Use aseptic techniques. Prepare ALDURAZYME using an infusion set equipped with an in-line, low-protein-binding 0.2 micron filter. There is no information on the compatibility of diluted ALDURAZYME with glass containers.
1. Determine the number of vials to be diluted based on the patient's weight and the recommended dose of 0.58 mg/kg, using the following equation: (see equation).
Click on icon to see table/diagram/image2. Round up to the next whole vial. Remove the required number of vials from the refrigerator to allow them to reach room temperature. Do not heat or microwave vials.
3. Before withdrawing the ALDURAZYME from the vial, visually inspect each vial for particulate matter and discoloration. The ALDURAZYME solution should be clear to slightly opalescent and colorless to pale yellow. Some translucency may be present in the solution. Do not use if the solution is discolored or if there is particulate matter in the solution.
4. Withdraw and discard a volume of the 0.9% Sodium Chloride Injection, USP from the infusion bag, equal to the volume of ALDURAZYME concentrate to be added.
5. Slowly withdraw the calculated volume of ALDURAZYME from the appropriate number of vials using caution to avoid excessive agitation. Do not use a filter needle, as this may cause agitation. Agitation may denature ALDURAZYME, rendering it biologically inactive.
6. Slowly add the ALDURAZYME solution to the 0.9% Sodium Chloride Injection, USP using care to avoid agitation of the solutions. Do not use a filter needle.
7. Gently rotate the infusion bag to ensure proper distribution of ALDURAZYME. Do not shake the solution.
8. The entire infusion volume (100 mL for patients weighing 20 kg or less and 250 mL for patients weighing greater than 20 kg) should be delivered over approximately 3 to 4 hours. The initial infusion rate of 10 μg/kg/hr may be incrementally increased every 15 minutes during the first hour, as tolerated, until a maximum infusion rate of 200 μg/kg/hr is reached. The maximum rate is then maintained for the remainder of the infusion (2 - 3 hours), as outlined in Tables 2 and 3.
9. Administer the diluted ALDURAZYME solution to patients using an infusion set equipped with an in-line, low-protein-binding 0.2 μm in-line filter. (See Tables 2 and 3).
Click on icon to see table/diagram/image
Click on icon to see table/diagram/imageALDURAZYME does not contain any 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° to 46°F) for up to 36 hours. Other than during infusion, room temperature storage of diluted solution is not recommended.
Any unused product or waste material should be discarded and disposed of in accordance with local requirements.
ALDURAZYME must not be administered with other medicinal products in the same infusion. The compatibility of ALDURAZYME in solution with other products has not been evaluated.
