Aldurazyme Generic Name & Formulations
Laronidase 0.58mg/mL; soln for IV infusion after dilution; preservative-free.
Recombinant human alpha-L-iduronidase enzyme.
Single-use vial (5mL)—1
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 Boxed Warnings
Risk of anaphylaxis.
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 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
Visit www.MPSIregistry.com or call (800) 745-4447 to enroll pregnant women with MPS I.
Aldurazyme Patient Counseling