Reconstitution and administration of Aldurazyme^®

Please see the full prescribing information in Dutch or in French (PDF) for Aldurazyme^®.

The recommended dosage regimen of Aldurazyme^® (laronidase) is 100 U/kg of body weight administered once weekly as an intravenous infusion. Pretreatment with antipyretics and/or antihistamines is recommended 60 minutes prior to the start of the first few infusions, upon re-administration following interruption of treatment, and if otherwise clinically indicated.^[1]

The total volume of the infusion is determined by the patient’s body weight and should be delivered over approximately three to four hours.

Patients with a body weight of 20 kg or less should receive a total volume of 100 ml.

Patients with a body weight of greater than 20 kg should receive a total volume of 250 ml.

The initial infusion rate of 2 U/kg/hr may be incrementally increased every 15 minutes during the first 1-1.5 hours, as tolerated, until a maximum infusion rate of 43U/kg/hr is reached.

The maximum rate is then maintained for the remainder of the infusion (2-3 hours). ^[1]

For Patients weighing 20 kg or less than 20 kg: ^[1]

Total Volume of Aldurazyme Infusion = 100 ml
2 ml/hr x 15 minutes (equivalent to 2 U/kg/h)	Obtain vital signs; if stable, increase the rate to…
4 ml/hr x 15 minutes (equivalent to 4 U/kg/h)	Obtain vital signs; if stable, increase the rate to…
8 ml/hr x 15 minutes (equivalent to 8 U/kg/h)	Obtain vital signs; if stable, increase the rate to…
16 ml/hr x 15 minutes (equivalent to 16 U/kg/h)	Obtain vital signs; if stable, increase the rate to…
32 ml/hr x 15 minutes (equivalent to 32 U/kg/h)	Obtain vital signs; if stable, increase the rate to…
43 ml/hr (equivalent to 43 U/kg/h)	For the remainder of the infusion

For Patients weighing more than 20 kg: ^[1]

Total Volume of Aldurazyme Infused = 250 ml
5 ml/hr x 15 minutes (equivalent to 2 U/kg/h)	Obtain vital signs; if stable, increase the rate to…
10 ml/hr x 15 minutes (equivalent to 4 U/kg/h)	Obtain vital signs; if stable, increase the rate to…
20 ml/hr x 15 minutes (equivalent to 8 U/kg/h)	Obtain vital signs; if stable, increase the rate to…
40 ml/hr x 15 minutes (equivalent to 16 U/kg/h)	Obtain vital signs; if stable, increase the rate to…
80 ml/hr x 15 minutes (equivalent to 32 U/kg/h)	Obtain vital signs; if stable, increase the rate to…
107 ml/hr (equivalent to 43 U/kg/h)	For the remainder of the infusion.

References:

1. Summary of Product Characteristics Aldurazyme^®