• Inborn errors of metabolism

Aldurazyme Generic Name & Formulations

General Description

Laronidase 0.58mg/mL; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Recombinant human alpha-L-iduronidase enzyme.

How Supplied

Single-use vial (5mL)—1


Aldurazyme Indications


For the treatment of Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms.

Limitations of Use

Risks and benefits in mildly affected patients with the Scheie form have not been established. Not evaluated for effects on CNS manifestations.

Aldurazyme Dosage and Administration

Adults and Children

<6 months: not recommended. ≥6 months: Pretreat with antipyretics and/or antihistamines 60mins prior to starting infusion. Give by IV infusion over 3–4hrs. Initial infusion rate: 10mcg/kg/hr, may be increased every 15min during the 1st hour, as tolerated, until max rate of 200mcg/kg/hr which is maintained for the remainder of infusion (2–3hrs). 0.58mg/kg once weekly.

Aldurazyme Contraindications

Not Applicable

Aldurazyme Boxed Warnings

Boxed Warning

Risk of anaphylaxis.

Aldurazyme Warnings/Precautions


Discontinue immediately if severe anaphylactic or allergic reactions develop; have appropriate medical support measures available. Acute febrile or respiratory illness: increased risk of infusion-related reactions. Compromised cardiac and/or respiratory function. Pregnancy. Nursing mothers.

Aldurazyme Pharmacokinetics

See Literature

Aldurazyme Interactions

Aldurazyme Adverse Reactions

Adverse Reactions

Rash, upper respiratory tract infection, inj site reaction, hyperreflexia, paresthesia, flushing, poor venous access, pyrexia, chills, increased BP, tachycardia, decreased oxygen saturation.

Aldurazyme Clinical Trials

See Literature

Aldurazyme Note


Visit or call (800) 745-4447 to enroll pregnant women with MPS I.

Aldurazyme Patient Counseling

See Literature