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

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
ALDURAZYME® Infusion by Patient Weight

Patient Weight Range

Total Infusion Volume

Step 1
10 mcg/
kg/hr

Step 2
20 mcg/
kg/hr

Step 3
50 mcg/
kg/hr

Step 4
100 mcg/
kg/hr

Step 5
200 mcg/
kg/hr

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

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.