Laronidase
Laronidase is an enzyme replacement therapy designed to treat mucopolysaccharidosis type I (MPS I), a rare genetic disorder caused by deficiency of the α-L-iduronidase enzyme. By providing exogenous α-L-iduronidase, this medication helps break down glycosaminoglycans that accumulate in cells throughout the body, reducing associated symptoms and complications.
Laronidase is an enzyme replacement therapy for MPS I that replaces deficient α-L-iduronidase to help break down accumulated glycosaminoglycans.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- A16AB05
- RxNorm
- 392509
- Generic
- Laronidase
- Class
- atc-a16
- Brands
- Aldurazyme
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks to the fetus
regular fetal monitoring and ultrasound assessments
Use with caution and monitor for adverse effects.
pregnancy
third trimesteruse with caution
continue only if already initiated prior to pregnancy, consider risks vs benefits
fetal growth monitoring, non-stress tests in late pregnancy
Use with caution and monitor for adverse effects.
lactation
breastfeedingno specific adjustment
discontinue breastfeeding or pump and discard milk during treatment periods
monitor infant for signs of enzyme activity
pediatric_age
infants toddlersweight-based dosing
approved for use in pediatric patients 5 years and older, younger patients based on individual assessment
monitor for infusion reactions, growth and development
geriatric
elderlyno specific adjustment
use with caution due to limited clinical experience in patients over 65 years
monitor cardiac and respiratory function during infusion
Use with caution and monitor for adverse effects.
renal_impairment
moderate severeno specific dose adjustment in label
use with caution, no formal studies in renal impairment
monitor renal function periodically
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate severeno specific dose adjustment in label
use with caution, no formal studies in hepatic impairment
monitor liver function tests
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
Initial FDA approval for Laronidase (Aldurazyme)
Drug class
Enzyme replacement therapy for MPS I
Indication
Approved indication for Hurler, Hurler-Scheie, and Scheie forms
Standard dosage
Recommended intravenous infusion dosage
Laronidase is indicated for long-term enzyme replacement therapy in patients with confirmed diagnosis of mucopolysaccharidosis I (MPS I), including theHurler, Hurler-Scheie, and Scheie forms. It is used to treat the non-neurological manifestations of the disease.
Laronidase is a recombinant form of the human α-L-iduronidase enzyme. It works by catalyzing the breakdown of the glycosaminoglycans dermatan sulfate and heparan sulfate within lysosomes. The enzyme is taken up by cells through mannose-6-phosphate receptors and transported to lysosomes, where it replaces the deficient endogenous enzyme.
Laronidase is administered via intravenous infusion, typically weekly. Common adverse reactions include infusion-associated reactions such as fever, chills, and rash. Premedication with antihistamines and/or antipyretics may be recommended. Regular monitoring of urine GAG levels and clinical response is used to assess treatment effectiveness.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy