Generic Name and Formulations:
Laronidase 0.58mg/mL; soln for IV infusion after dilution; preservative-free.
Sanofi Genzyme Company
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.
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.
Discontinue immediately if severe anaphylactic or allergic reactions develop; have appropriate medical support measures available. Compromised respiratory function or acute respiratory disease: increased risk of infusion-related reactions. Labor & delivery. Pregnancy (Cat.B). Nursing mothers.
Recombinant human alpha-L-iduronidase enzyme.
Rash, upper respiratory tract infection, inj site reaction, hyperreflexia, paresthesia, flushing, poor venous access, pyrexia, chills, increased BP, tachycardia, decreased oxygen saturation.
Visit www.MPSIregistry.com or call (800) 745-4447 to enroll pregnant women with MPS I.
Single-use vial (5mL)—1