ALDURAZYME Dosage & Rx Info | Uses, Side Effects

Aldurazyme Generic Name & Formulations

Legal Class

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

Sanofi Genzyme Company

Mechanism of Action

Aldurazyme therapy is to provide exogenous enzyme for uptake into lysosomes and increase the catabolism of glycosaminoglycans. Aldurazyme uptake by cells into lysosomes is most likely mediated by the mannose-6-phosphate-terminated oligosaccharide chains of laronidase binding to specific mannose-6phosphate receptors.

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

Safety and effectiveness of treating 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: Premedicate with antihistamines, with or without antipyretics, 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 1^st 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

Hypersensitivity reactions including anaphylaxis. Acute respiratory complications associated with administration.

Aldurazyme Warnings/Precautions

Warnings/Precautions

Have medical resuscitation equipment readily available. Discontinue immediately and initiate appropriate treatment if severe hypersensitivity or infusion-associated reactions occur; may be rechallenged using slower infusion rates. Acute febrile or respiratory illness: increased risk of infusion-related reactions. Susceptible to fluid overload, acute underlying respiratory illness, or compromised cardiac and/or respiratory function: increased risk of acute cardiorespiratory failure. Pregnancy. Nursing mothers.

Aldurazyme Pharmacokinetics

Absorption

Mean maximum plasma concentrations ranged from 1.2–1.7 mcg/mL (for patients ≥6yr old) after the 1st, 12th, and 26th weekly infusions; and 0.6–1.6 mcg/mL (for patients ≤6yr old).

Distribution

Mean volume of distribution: 0.24–0.60 L/kg (for patients ≥6yr old); 0.12–0.56 L/kg (for patients ≤6yr old).

Elimination

Mean plasma clearance ranged from 1.7–2.7 mL/min/kg (for patients ≥6yr old) and 2.2–7.7 mL/min/kg (for patients ≤6yr old). Mean half-life: 1.5–3.6 hours (for patients ≥6yr old); 0.3–1.9 hours (for patients ≤6yr old).

Aldurazyme Interactions