Inborn errors of metabolism:

Indications for: ALDURAZYME

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.

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.

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 Classification:

Recombinant human alpha-L-iduronidase enzyme.

Adverse Reactions:

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


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

How Supplied:

Single-use vial (5mL)—1