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Aldurazyme Generic Name & Formulations
Legal Class
Rx
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
Manufacturer
Aldurazyme Indications
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
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
Notes
Visit www.MPSIregistry.com or call (800) 745-4447 to enroll pregnant women with MPS I.
Aldurazyme Patient Counseling
See Literature
