Laronidase Dosage
This dosage information may not include all the information needed to use Laronidase safely and effectively. See additional information for Laronidase.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Mucopolysaccharidosis Type I
Recommended dose: 0.58 mg/kg of body weight administered once-weekly by intravenous infusion.
Pretreatment with antipyretics and/or antihistamines is recommended 60 minutes prior to the start of the infusion.
The total volume of the infusion is determined by the patient's body weight and should be delivered over approximately 3 to 4 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 10 mcg/kg/hr may be incrementally increased every 15 minutes during the first hour, as tolerated, until a maximum infusion rate of 200 mcg/kg/hr is reached. The maximum rate is then maintained for the remainder of the infusion (2 to 3 hours).
For Patients Weighing 20 kg or Less
Total Volume of laronidase Infusion = 100 mL
Start at 2 mL/hr x 15 minutes (10 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 4 mL/hr x 15 minutes (20 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 8 mL/hr x 15 minutes (50 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 16 mL/hr x 15 minutes (100 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 32 mL/hr x approximately 3 hours (200 mcg/kg/hr) for the remainder of the infusion.
For Patients Weighing Greater than 20 kg
Total Volume of laronidase Infusion = 250 mL
Start with 5 mL/hr x 15 minutes (10 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 10 mL/hr x 15 minutes (20 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 20 mL/hr x 15 minutes (50 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 40 mL/hr x 15 minutes (100 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 80 mL/hr x approximately 3 hours (200 mcg/kg/hr) for the remainder of the infusion.
Usual Pediatric Dose for Mucopolysaccharidosis Type I
Greater then or equal to 5 years old:
Recommended dose: 0.58 mg/kg of body weight administered once-weekly by intravenous infusion.
Pretreatment with antipyretics and/or antihistamines is recommended 60 minutes prior to the start of the infusion.
The total volume of the infusion is determined by the patient's body weight and should be delivered over approximately 3 to 4 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 10 mcg/kg/hr may be incrementally increased every 15 minutes during the first hour, as tolerated, until a maximum infusion rate of 200 mcg/kg/hr is reached. The maximum rate is then maintained for the remainder of the infusion (2 to 3 hours).
For Patients Weighing 20 kg or Less
Total Volume of laronidase Infusion = 100 mL
Start at 2 mL/hr x 15 minutes (10 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 4 mL/hr x 15 minutes (20 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 8 mL/hr x 15 minutes (50 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 16 mL/hr x 15 minutes (100 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 32 mL/hr x approximately 3 hours (200 mcg/kg/hr) for the remainder of the infusion.
For Patients Weighing Greater than 20 kg
Total Volume of laronidase Infusion = 250 mL
Start with 5 mL/hr x 15 minutes (10 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 10 mL/hr x 15 minutes (20 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 20 mL/hr x 15 minutes (50 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 40 mL/hr x 15 minutes (100 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 80 mL/hr x approximately 3 hours (200 mcg/kg/hr) for the remainder of the infusion.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Precautions
Patients younger than 5 years of age were not included in the clinical studies because of inability to comply with efficacy outcome assessments. It is not known if children younger than 5 years of age respond differently from older children.
Clinical studies of laronidase did not include patients aged 65 and over. It is not known whether they respond differently from younger patients.
Dialysis
Data not available
Other Comments
Each vial of laronidase provides 2.9 mg of laronidase in 5 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 0.1% Albumin (Human) in 0.9% Sodium Chloride Injection, USP using aseptic techniques. laronidase should be prepared using PVC containers and administered with a PVC infusion set equipped with an in-line, low protein binding 0.2 micrometer filter. There is no information on the compatibility of diluted laronidase with glass containers.
