Medication Guide App

Laronidase Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Mucopolysaccharidosis Type I

0.58 mg/kg via IV infusion once a week

Total infusion volume:
20 kg or less: 100 mL
Greater than 20 kg: 250 mL

Usual Pediatric Dose for Mucopolysaccharidosis Type I

6 months or older: 0.58 mg/kg via IV infusion once a week

Total infusion volume:
20 kg or less: 100 mL
Greater than 20 kg: 250 mL

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Anaphylaxis and severe allergic reactions have been observed in patients during or up to 3 hours after laronidase infusions. If anaphylactic or other severe allergic reactions occur, the infusion should be discontinued at once and appropriate treatment should be started. Caution is recommended if epinephrine is considered for use in MPS I patients. The risks and benefits of readministering laronidase following an anaphylactic or severe allergic reaction should be considered. Extreme care is recommended, with appropriate resuscitation measures available, if the decision is made to readminister the product.

Caution is recommended when administering laronidase to patients at risk for fluid overload or patients with acute underlying respiratory illness or compromised cardiac and/or respiratory function where fluid restriction is indicated. These patients may be at risk of serious exacerbation of their cardiac or respiratory status during infusions. For patients with underlying cardiac or respiratory compromise who weigh up to 30 kg, physicians may consider diluting laronidase in a volume of 100 mL and administering at a decreased infusion rate.

The clinical status of patients with an acute febrile or respiratory illness should be considered carefully prior to laronidase administration and delaying the infusion should be considered.

Clinical studies of laronidase did not include patients aged 65 and over. It is not known whether they respond differently from younger patients.

Safety and effectiveness have not been established in pediatric patients less than 6 months of age.

Dialysis

Data not available

Other Comments

Pretreatment is recommended 60 minutes prior to the start of the infusion and may include antipyretics and/or antihistamines. If an infusion reaction occurs, despite pretreatment, decreasing the infusion rate, temporarily stopping the infusion, or administering additional antipyretics and/or antihistamines may improve the symptoms.

Appropriate medical support and monitoring measures should be readily available during infusion. If used during sleep, supplemental oxygen or continuous positive airway pressure should be readily available during infusion. Some patients may require prolonged observation, based on individual patient needs.

Each vial of laronidase provides 2.9 mg of laronidase in 5 mL of solution and is intended for single use only. The vial should not be used 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. Laronidase should be prepared using low-protein-binding containers and administered with a low-protein-binding 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.

The total infusion volume should be infused over approximately 3 to 4 hours. 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 infusion volume of 100 mL):
-The infusion rate should start at 2 mL/hr for 15 minutes (10 mcg/kg/hr).
-Vital signs should be obtained; if stable, the rate should be increased to 4 mL/hr for 15 minutes (20 mcg/kg/hr).
-Vital signs should be obtained; if stable, the rate should be increased to 8 mL/hr for 15 minutes (50 mcg/kg/hr).
-Vital signs should be obtained; if stable, the rate should be increased to 16 mL/hr for 15 minutes (100 mcg/kg/hr).
-Vital signs should be obtained; if stable, the rate should be increased to 32 mL/hr for approximately 3 hours (200 mcg/kg/hr) for the remainder of the infusion.

For patients weighing greater than 20 kg (total infusion volume of 250 mL):
-The infusion rate should start at 5 mL/hr for 15 minutes (10 mcg/kg/hr).
-Vital signs should be obtained; if stable, the rate should be increased to 10 mL/hr for 15 minutes (20 mcg/kg/hr).
-Vital signs should be obtained; if stable, the rate should be increased to 20 mL/hr for 15 minutes (50 mcg/kg/hr).
-Vital signs should be obtained; if stable, the rate should be increased to 40 mL/hr for 15 minutes (100 mcg/kg/hr).
-Vital signs should be obtained; if stable, the rate should be increased to 80 mL/hr for approximately 3 hours (200 mcg/kg/hr) for the remainder of the infusion.

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