ALDURAZYME Rx

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ALDURAZYME

Inborn errors of metabolism
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Generic Name and Formulations:

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

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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.

Warnings/Precautions:

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.

Pharmacological Class:

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.

Note:

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

How Supplied:

Single-use vial (5mL)—1

ALDURAZYME 5ml of 2.9mg/5ml vials (Qty:1)

appx. price $888.00