DOSING AND ADMINISTRATION
For your patients on Aldurazyme®, remember to check their weight and dose regularly
The importance of updating weight for accurate dosing |
The recommended dose of Aldurazyme is 0.58 mg/kg of body weight administered once weekly as an intravenous infusion1 |
Care should be taken to properly calculate the dose based on accurate and current body weight |
Because the dose is weight-based, a change in patients' body weight will require an adjustment in the dose of Aldurazyme they receive1 |
It is recommended to weigh patients at baseline and at least every 6 months or more frequently as needed to determine the appropriate dose |
Aldurazyme is a once-weekly
intravenous infusion
Aldurazyme is a
once-weekly
intravenous infusion
- Appropriate medical support should be readily available when Aldurazyme is administered1
- Because of the potential for infusion reactions, it is recommended that patients receive pretreatment medications, including antihistamines and/or antipyretics, 60 minutes prior to the start of the infusion. However, IARs may still occur in patients after receiving pre-medication.1
Drug dosage is calculated based on the patient’s
body weight1
- Each vial of Aldurazyme provides 2.9 milligrams (mg) of laronidase in 5.0 milliliters (mL) of solution and is intended for single-dose only. Do not use the vial more than one time1
-
The concentrated solution for infusion must be diluted with 0.9% sodium chloride injection, USP, to a final volume of 50mL, 100 mL or 250 mL, using aseptic techniques1
Recommended dosage should be administered over approximately 3 to 4 hours1
- Patients weighing <=2 to <4 kg the recommended total infusion volume is 50 mL
- Patients weighing >=4 to <20 kg the recommended total infusion volume is 100 mL
- Patients weighing >=20 kg the recommended total infusion volume is 250 mL
- Initial infusion rate of 10 mcg/kg/h may be incrementally increased every 15 minutes, as tolerated until a maximum infusion rate of 200 mcg/kg/h is reached. Maximum rate is maintained for the remainder of the infusion. The total infusion time is approximately 3 to 4 hours.
- 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.
- Administer the diluted Aldurazyme solution to patients using a low-protein-binding infusion set equipped with a low-protein-binding 0.2 μm in-line filter.
Table 1: Incremental Infusion Rate Steps and Volumes for
|
||||||
Patient Weight Range |
Total Infusion Volume |
Step 1
|
Step 2
|
Step 3
|
Step 4
|
Step 5
|
Infusion Rate in mL/hour |
||||||
≥2 to <4 kg | 50 mL | 1 | 2 | 4 | 8 | 16 |
≥4 to <20 kg | 100 mL | 2 | 4 | 8 | 16 | 32 |
≥20 kg | 250 mL | 5 | 10 | 20 | 40 | 80 |

Aldurazyme vials should be refrigerated at 2°C-8°C
Aldurazyme vials should be refrigerated at 2°C-8°C
It is important that vials1:
- Should not be frozen or shaken
- Should be protected from light
- Should not be used after the expiration date
Infusion bags should be used immediately after dilution with saline water. If not, it should be refrigerated at 2°C-8°C for up to 36 hours.

For full reconstitution and administration instructions, please refer to the Instructions for Use.


Reference: 1. ALDURAZYME [prescribing information]. Cambridge, MA: Genzyme Corporation.